Pfizer BNT162b2 adverse events as of February 28, 2021

Posted on by Jesse Santiano, M.D.

The data for this article is taken from the Pfizer document, 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021. The pdf link is embedded in the title.

In it are the adverse events that are listed in The Complete List of the Pfizer Adverse Events of Special Interest that Pfizer would monitor, government health agencies, and the population vaccinated. If you know someone who had an adverse event after COVID shots, their case should be reported for documentation.

General Overview:

It is estimated that approximately 126,212,580 doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorization for emergency supply on December 1, 2020, through February 28, 2021.

Cumulatively, through February 28, 2021, there were 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events.

Here is a direct quote from page 6 of the report. Emphasis added.

Due to the large numbers of spontaneous adverse event reports received for the product, the Marketing Authorisation Holder has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.

Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately 600 additional fulltime employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.

Most cases (34,762) were received from the United States (13,739), United Kingdom (13,404), Italy (2,578), Germany (1913), France (1506), Portugal (866), and Spain (756); the remaining 7,324 were distributed among 56 other countries.

Pfizer BNT162b2 5.3.6

The number of relevant cases in this table is highest among the 18 to 64 age groups. This is consistent with the age groups with the highest excess deaths reported by an insurance CEO in Indiana life insurance CEO says deaths are up 40% among people ages 18-64.

The graph below shows the Total Number of BNT162b2 Adverse Events by System Organ Classes and Event Seriousness. I rotated the original graph to the right to make the organ systems easier to read.

The most common is general disorders. To me, that means undiagnosed and does not necessarily mean that the adverse event is not serious. Example: A person may complain of fatigue and palpitations which fall under general disorders. However, if further testing was done, it could have uncovered myocarditis.

Likewise, a report of headache may turn out to be a cerebral venous sinus thrombosis   if an MRI or a CT scan of the head was done. 

In the table below, MedDRA stands for Medical Dictionary for Regulatory Activities. MedDRA standardizes the verbiage for reporting adverse events. PT means Preferred Term and SOC stands for System Organ Class. AERP is the Adverse Event Report Program

The following Adverse Events of Special Interest are from Table 7 of the Pfizer 5.3.6 Report. These cases already happened to people injected with the Pfizer shot.

There were two items that I highlighted for emphasis. The number of fatal cases and the latest end of the range of onset. The purpose is to show that people can die from adverse events and to show that the adverse events can happen several days to weeks after the shots.

Anaphylaxis Adverse Events of Special Interest

  • There were 1002 cases (54.0% of the potentially relevant cases retrieved), and 2958 potentially relevant events, from the Anaphylactic reaction.
  • Relevant event seriousness: Serious (2341), Non-Serious (617)
  • Relevant outcomes: fatal (9), resolved/resolving (1922), not resolved (229), resolved with sequelae (48), unknown (754).
  • Most frequently reported (≥2%), from the Anaphylactic reaction. The number of cases is in parenthesis. I included a brief definition of the medical term.
  1. Anaphylactic reaction (435)
  2. Dyspnoea (356) – shortness of breath
  3. Rash (190)
  4. Pruritus (175) – itchiness
  5. Erythema (159) – redness of the skin
  6. Urticaria (133) – raised rash
  7. Cough (115)
  8. Respiratory distress (97)
  9. Throat tightness (97) – impending closure of the upper airway.
  10. Swollen tongue (93)
  11. Anaphylactic shock (80) – Note: this gets admitted to the intensive care unit
  12. Hypotension (72) – life-threatening low blood pressure
  13. Chest discomfort (71) –  considered as chest pain
  14. Swelling face (70)
  15. Pharyngeal swelling (68) – throat swelling
  16. Lip swelling (64)

Cardiovascular Adverse Events of Special Interest

  • 1,403 cases of which 241 are medically confirmed.
  • Female (1076), male (291), and unknown (36).
  • Relevant event outcome: fatal (136), resolved/resolving (767), resolved with sequelae (21), not resolved (140), and unknown (380).
  • Onset latency: (n = 1209): Range from <24 hours to 21 days, median <24 hours
  1. Tachycardia (1098) – rapid heartbeat
  2. Arrhythmia (102) – irregular heartbeat
  3. Myocardial infarction (89)
  4. Cardiac failure (80)
  5. Acute myocardial infarction (41)
  6. Cardiac failure acute (11)
  7. Cardiogenic shock (7)
  8. Postural orthostatic tachycardia syndrome (7)
  9. Coronary artery disease (6)

COVID-19 Adverse Events of Special Interest

  • Number of cases: 3067 (7.3% of the total PM dataset), of which 1013 are medically confirmed.
  • Subjects’ age group (n= 1880): Adult (1315), Elderly (560), Infant and Adolescent (2 each), Child (1)
  • Number of relevant events: 3359, of which 2585 were serious, 774 non-serious
  • Relevant event onset latency (n = 2070): Range from <24 hours to 374 days, median 5 days
  • Relevant event outcome: fatal (136), not resolved (547), resolved/resolving (558), resolved with sequelae (9). Most frequently reported (>1 occurrence):
  1. COVID-19 (1927)
  2. SARS-CoV-2 test positive (415)
  3. Suspected COVID-19 (270)
  4. Ageusia (228) – loss of taste
  5. Anosmia (194) – loss of smell
  6. SARS-CoV-2 antibody test negative (83)
  7. Exposure to SARS-CoV-2 (62)
  8. SARS-CoV-2 antibody test positive (53)
  9. COVID-19 pneumonia (51)
  10. Asymptomatic COVID-19 (31)
  11. Coronavirus infection (13)
  12. Occupational exposure to SARS-CoV-2 (11)
  13. SARS-CoV-2 test false positive (7)
  14. Coronavirus test positive (6)
  15. SARS-CoV-2 test negative (3)
  16. SARS-CoV-2 antibody test (2)

Dermatologic Adverse Events of Special Interest

  • Number of cases: 20 cases of which 15 are medically confirmed.
  • Subjects’ age group (n=19): Adult (18), Elderly (1)
  • Relevant event onset latency (n = 18): Range from <24 hours to 17 days, median 3 days;
  • Subjects’ gender: female (17) male and unknown (1 each). Reported relevant:
  1. Erythema multiforme (13)
  2. Chilblains (7)

Hematologic Adverse Events of Special Interest

These are all blood-related adverse events. The number of cases: 932 (2.2 % of the total dataset), of which 524 were medically confirmed.

  • Subjects’ gender (n=898): female (676) and male (222);
  • Subjects’ age group (n=837): Adult (543), Elderly (293), Infant (1)
  • Relevant event onset latency (n = 787): Range from <24 hours to 33 days, median =  1 day
  • Relevant event outcome: fatal (34), resolved/resolving (393), resolved with sequelae (17), not resolved (267), and unknown (371).

Most frequently reported relevant >15 occurrences) include:

  1. Epistaxis (127)
  2. Contusion (112)
  3. Vaccination site bruising (96)
  4. Vaccination site hemorrhage (51)
  5. Petechiae (50)
  6. Hemorrhage (42) –  bleeding from a damaged blood vessel
  7. Haematochezia (34) – passage of blood in the anus
  8. Thrombocytopenia (33) – low platelet count
  9. Vaccination site hematoma (32)
  10. Conjunctival hemorrhage (29)
  11. Vaginal hemorrhage (29)
  12. Hematoma (27)
  13. Haemoptysis (coughing blood) (27)
  14. Menorrhagia, heavy menstrual blood (27)
  15. Haematemesis (throwing up blood) (25)
  16. Eye hemorrhage (23)
  17. Rectal hemorrhage (22)
  18. Immune thrombocytopenia (20)
  19. Blood urine present (19)
  20. Haematuria (blood in the urine) (16)
  21. Neutropenia (low neutrophils), a type of white blood cell) (16)
  22. Purpura (16)
  23. Hemorrhagic diarrhea (15)

Hepatic (liver) Adverse Events of Special Interest

  • The number of cases: 70 cases of which 54 were medically confirmed.
  • Number of relevant events: 94, of which 53 were serious, 41 were non-serious.
  • Relevant event onset latency (n = 57): Range from <24 hours to 20 days, median 3 days
  • Relevant event Outcome: fatal (5), resolved/resolving (27), resolved with sequelae (1), not resolved (14), and unknown (47).
  1. Alanine aminotransferase increased (16)
  2. Transaminases increased and Hepatic pain (9 each)
  3. Liver function test increased (8)
  4. Aspartate aminotransferase increased and Liver function test
    abnormal (7 each)
  5. Gamma-glutamyl transferase increased and Hepatic enzyme increased (6 each)
  6. Blood alkaline phosphatase increased and Liver injury (5 each)
  7. Ascites, Blood bilirubin increased, and Hypertransaminasaemia (3 each)

Facial Paralysis Adverse Events of Special Interest

  • Number of cases: 449, 314 medically confirmed.
  • Relevant event onset latency (n = 404): Range from <24 hours to 46 days, median 2 days
  • Relevant event outcome: resolved/resolving (184), resolved with sequelae (3), not resolved (183), and unknown (97)
  1. Facial paralysis (401)
  2. Facial paresis (64)

Immune-Mediated/Autoimmune AESIs

  • Number of cases: 1050, of which 760 were medically confirmed
  • Subjects’ gender (n=682): female (526), male (156)
  • Relevant event onset latency (n = 807): Range from <24 hours to 30 days, median <24 hour
  • Relevant event outcomes: resolved/resolving (517), not resolved (215), fatal (12), resolved with sequelae (22), and unknown (312).

Most frequently reported (10 occurrences):

  1. Hypersensitivity (596)
  2. Neuropathy peripheral (49)
  3. Pericarditis (32)
  4. Myocarditis (25)
  5. Dermatitis (24)
  6. Diabetes mellitus (16)
  7. Encephalitis (16)
  8. Psoriasis (14)
  9. Dermatitis Bullous (13)
  10. Autoimmune disorder (11)
  11. Raynaud’s phenomenon (11)

Musculoskeletal Adverse Events of Special Interest

  • Number of cases: 3600 (8.5% of the total PM dataset), of which 2045 were medically confirmed
  • Subjects’ gender (n=3471): female (2760), male (711)
  • Subjects’ age group (n=3372): Adult (2850), Elderly (515), Child
    (4), Adolescent (2), Infant (1)
  • Relevant event onset latency (n = 2968): Range from <24 hours to 32 days, median 1 day
  • Number of relevant events: 3640, of which 1614 were serious, 2026 non-serious
  • Relevant event outcome: resolved/resolving (1801), not resolved (959), resolved with sequelae (49), and unknown (853).

Reported relevant PTs:

  1. Arthralgia (3525)
  2. Arthritis (70)
  3. Rheumatoid arthritis (26)
  4. Polyarthritis (5)
  5. Polyneuropathy (4)
  6. Post viral fatigue syndrome (4)
  7. Chronic fatigue syndrome (4)
  8. Arthritis bacterial (1)

Neurologic Adverse Events of Special Interest

  • Number of cases: 501 of which 365 were medically confirmed
  • Subjects’ gender (n=478): female (328), male (150).
  • Subjects’ age group (n=478): Adult (329), Elderly (149)
  • Relevant event onset latency (n = 423): Range from <24 hours to 48 days, median 1 day
  • Relevant events outcome: fatal (16), resolved/resolving (265), resolved with sequelae (13), not resolved (89), and unknown (161)

Most frequently reported (˃2 occurrences) included:

  1. Seizure (204)
  2. Epilepsy (83)
  3. Generalized tonic-clonic seizure (33)
  4. Guillain-Barre syndrome (24)
  5. Fibromyalgia (17)
  6. Trigeminal neuralgia (17)
  7.  Febrile convulsion (15)
  8. Status epilepticus (12)
  9. Aura (11)
  10. Myelitis transverse (11 each)
  11. Multiple sclerosis relapse (10)
  12. Optic neuritis (10 each)
  13. Petit mal epilepsy (9)
  14. Tonic convulsion (9 each)
  15. Ataxia (8)
  16. Encephalopathy
  17. Tonic-clonic movements (7 each)
  18. Foaming at the mouth (5)
  19. Multiple sclerosis (4)
  20. Narcolepsy (4)
  21. Partial seizures (4)
  22. Bad sensation (3)
  23. Demyelination (3)
  24. Meningitis (3)
  25. Postictal state (3)
  26. Seizure like phenomena (3)
  27. Tongue biting (3)

Other Adverse Events of Special Interest

  • Number of cases: 8152 (19.4% of the total PM dataset), of which 4977 were medically confirmed
  • Subjects’ gender (n=7829): female (5969), male (1860)
  • Subjects’ age group (n=7479): Adult (6330), Elderly (1125), Adolescent, Child (9 each), Infant (6)
  • Relevant event onset latency (n =6836): Range from <24 hours to 61 days, median 1 day
  • Number of relevant events: 8241, of which 3674 were serious, 4568 non‑serious
  • Relevant events outcome: fatal (96), resolved/resolving (5008), resolved with sequelae (84), not resolved (1429), and unknown (1685)

Most frequently reported included:

  1. Pyrexia (7666) – fever could be a sign of infection or autoimmune syndrome
  2. Herpes zoster (259) –  Shingles after COVID-19 Vaccination
  3. Inflammation (132)
  4. Oral herpes (80)
  5. Multiple organ dysfunction syndromes (18) –  likely the most common cause of the fatalities
  6. Herpes virus infection (17)
  7. Herpes simplex (13)
  8. Ophthalmic herpes zoster (10)
  9. Herpes ophthalmic (6) – shingles around the eye (needs to be seen by an eye specialist
  10. Herpes zoster reactivation (6)

Pregnancy-Related

  • Number of cases: 413,  84 serious, and 329 non-serious

Pregnancy outcomes for the 270 pregnancies were reported as:

  1. Spontaneous abortion (23)
  2. Outcome pending (5)
  3. Premature birth with neonatal death (2)
  4. Spontaneous abortion with intrauterine death (2)
  5. Spontaneous abortion with neonatal death (1)
  6. Normal outcome (1)
  7. No outcome was provided for 238 pregnancies

Breastfeeding baby cases: 133, of which 116 cases reported exposure to the vaccine during breastfeeding without the occurrence of any clinical adverse events 17 cases, 3 serious and 14 non-serious, reported the following clinical events that occurred in the infant/child exposed to vaccine via breastfeeding:

  1. Pyrexia (5) – fever
  2. Rash (4)
  3. Infant irritability (3)
  4. Infantile vomiting (2)
  5. Diarrhea (2)
  6. Insomnia (2)
  7. Illness (2)
  8. Poor feeding infant Lethargy, Abdominal discomfort, Vomiting, Allergy to the vaccine, Increased appetite, Anxiety, Crying, Poor quality sleep, Eructation, Agitation, Pain, and Urticaria (1 each).

Renal Adverse Events of Special Interest

  • Number of cases: 69 cases of which 57 were medically confirmed
  • Subjects’ gender: female (46), male (23)
  • Subjects’ age group (n=68): Adult (7), Elderly (60), Infant (1)
  • Number of relevant events: 70, all serious;
  • Reported relevant PTs: Acute kidney injury (40) and Renal failure (30)
  • Relevant event onset latency (n = 42): Range from <24 hours to 15 days, median 4 days
  • Relevant event outcome: fatal (23), resolved/resolving (10), not resolved (15), and unknown (22)

Respiratory Adverse Events of Special Interest

  • Number of cases: 130 cases, of which 107 were medically confirmed
  • Subjects’ gender (n=130): female (72), male (58).
  • Subjects’s age group (n=126): Elderly (78), Adult (47), Adolescent (1)
  • Number of relevant events: 137, of which 126 were serious, 11 non-serious
  • Relevant event onset latency (n=102): range from < 24 hours to 18 days, median 1 day
  • Relevant events outcome: fatal (41), Resolved/resolving (47), not recovered (18), and unknown (31).
  1. Respiratory failure (44)
  2. Hypoxia (42)
  3. Respiratory disorder (36)
  4. Acute respiratory distress syndrome (10)
  5. Chronic respiratory syndrome (3)
  6. Severe acute respiratory syndrome (2)

Thromboembolic events

  • Number of cases: 151 (0.3% of the total PM dataset), of which 111 were medically confirmed
  • Subjects’ gender (n= 144): female (89), male (55)
  • Subjects’ age group (n=136): Adult (66), Elderly (70)
  • Relevant event onset latency (n = 124): Range from <24 hours to 28 days, median 4 days;
  • Relevant event outcome: fatal (18), resolved/resolving (54), resolved with sequelae (6), not resolved (49) and unknown (42).

Most frequently reported events (>1 occurrence) included:

  1. Pulmonary embolism (60)
  2. Thrombosis (39)
  3. Deep vein thrombosis (35)
  4. Thrombophlebitis superficial (6)
  5. Venous thrombosis limb (4)
  6. Embolism (3)
  7. Microembolism (3)
  8. Thrombophlebitis (3)
  9. Venous thrombosis (3)
  10. Blue toe syndrome (2)

Clot Related:

Stroke Adverse Events of Special Interest

  • Number of cases: 275 of which 180 were medically confirmed
  • Subjects’ gender (n= 273): female (182), male (91)
  • Subjects’ age group (n=265): Adult (59), Elderly (205), Child (1)
  • Number of relevant events: 300, all serious
  • Relevant event onset latency (n = 241): Range from <24 hours to 41 days, median 2 days
  • Relevant event outcome: fatal (61), resolved/resolving (61), resolved with sequelae (10), not resolved (85), and unknown (83

Stroke related articles:

Ischemic stroke
  1. Cerebrovascular accident (160)
  2. Ischaemic stroke (41)
  3. Cerebral infarction (15)
  4. Cerebral ischemia (3)
  5. Cerebral thrombosis (3)
  6. Cerebral venous sinus thrombosis (3)
  7. Ischaemic cerebral infarction (3)
  8. Lacunal infarction (3)
  9. Basal ganglia stroke (2)
  10. Cerebellar infarction (2)
  11. Thrombotic stroke (2)
Hemorrhagic stroke
  1. Cerebral hemorrhage (26)
  2. Hemorrhagic stroke (11)
  3. Hemorrhage intracranial (5)
  4. Subarachnoid hemorrhage (5)
  5. Cerebral hematoma (4)
  6. Basal ganglia hemorrhage (2)
  7. Cerebellar hemorrhage (2)

Vasculitic Events

  • Number of cases: 32 cases, of which 26 were medically confirmed
  • Subjects’ gender: female (26), male (6)
  • Subjects’ age group (n=31): Adult (15), Elderly (16)
  • Number of relevant events: 34, of which 25 were serious, 9 non-serious
  • Relevant event onset latency (n = 25): Range from <24 hours to 19  days, median 3 days
  • Relevant event outcome: fatal (1), resolved/resolving (13), not resolved (12), and unknown (8).
  1. Vasculitis (14)
  2. Cutaneous vasculitis (4)
  3. Vasculitic rash (3)
  4. Giant cell arteritis (3)
  5. Peripheral ischemia (3)
  6. Behcet’s syndrome and Hypersensitivity vasculitis (2 each)
  7. Palpable purpura, and Takayasu’s arteritis (1 each)

Parting thoughts

Keep in mind that the adverse events that you have just read are from fourteen months ago. As of March 25, 2022, there are 1,205,753 adverse events and 26,396 deaths in VAERS.

Any significant medical event that happens to someone who has COVID shots should be reported to VAERS. That is one way of exposing the risk of the shots. The complications can happen days or weeks after the injections.

In the discussion part of the report, it says,

The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.

SUMMARY AND CONCLUSION
Review of the available data for this cumulative Post Marketing experience, confirms a favorable benefit: risk balance for BNT162b2.

Do you agree? I don’t.

 

Truth heals. Lies kill. Don’t Get Sick!

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Reference:

5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021

 

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