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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 541 out of 10,317

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VAERS ID: 1987637 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-11-19
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Off label use, Product use issue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101805118

Write-up: body malaise; fever; mother is lactating; mother is lactating; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: PH-PHFDA-300125720 (PHFDA). A 33 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (hospitalization) with onset 19Nov2021, outcome "recovering", described as "body malaise"; PYREXIA (hospitalization) with onset 19Nov2021, outcome "recovering", described as "fever"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "mother is lactating"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PH-PFIZER INC-202101843633 Baby case


VAERS ID: 1987759 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1015A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Chest discomfort, Echocardiogram, Immunisation
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to nuts (hazelnuts); Asthma; Enlarged prostate (slightly); Food allergy (zucchini)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:unknown results; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: SEPFIZER INC202101765124

Write-up: Pressure over chest; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-095967 (MPA). Other Case identifier(s): SE-VISMA-1638632987797 (MPA). A 81 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: 1F1015A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (ongoing), notes: slightly; "Allergy to nuts" (ongoing), notes: hazelnuts; "Asthma" (ongoing); "Food allergy" (ongoing), notes: zucchini. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, single, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; CHEST DISCOMFORT (hospitalization) with onset 30Nov2021, outcome "recovered", described as "Pressure over chest". The man was transported to hospital by ambulance. The patient underwent the following laboratory tests and procedures: angiocardiogram: unknown results; echocardiogram: unknown results. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987838 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Inappropriate schedule of product administration, Palpitations, Pericardial effusion
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Myocardial infarction; Stent insertion NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101849331

Write-up: chest tightness; 1st dose: 25-Sep-2021; 2nd dose: 09-Nov-2021; HEARTBACKER''S WATER; DIFFICULTIES IN BREATHING; PALPITATIONS; This is a spontaneous report received from non-contactable healthcare professional from Regulatory Authority via License Party (BIONTECH SE). Regulatory number: TW-TFDA-TVS-1100014329. Other Case identifier(s): TW-Fosun-2021FOS006825. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014329. A 49-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number: unknown) on 09-Nov-2021 via intramuscular at an unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on 25-Sep-2021. Medical history included hypertension, myocardial infarction and had a bracket. Concomitant medications and past product were not reported. The patient experienced difficulties in breathing, palpitations on 19-Nov-2021, experienced heartbacker''s water on 23-Nov-2021. On 25-Sep-2021, the patient received the 1st dose of BNT vaccine. On 09-Nov-2021, the patient received the 2nd dose of BNT vaccine. On 19-Nov-2021, the patient experienced difficulties in breathing and palpitations. On 23-Nov-2021, the patient went to cardiac outpatient for medical treatment. After diagnosis and treatment, heartbacker''s water (unspecified) was found. The patient was given oral anti-inflammatory conicine and cataflam. On 02-Nov-2021, the patient had improved, but there was still occasional chest tightness and palpitations. Difficulties in breathing, palpitations and heartbacker''s water met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Drug = COMIRNATY, Event = Breathing difficult, Palpitations, Cardiac disorder. Per Reporter = Possible, Per Company (BioNTech SE) = Possible.


VAERS ID: 1987965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101854884

Write-up: CHEST PAIN; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014138 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007050. A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Sep2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 19Nov2021, outcome "recovering", described as "CHEST PAIN". Addition information: The patient had no fever, no cold sweating, no refer pain, no doe, no orthopnea. On an unknown date, the physician explained the report to the patient and the patient was discharged. Detail of hospitalization was not reported. Drug: Comirnaty; Causality Assessments: Chest Pain; Per Reporter: Possible; Per Company (BioNTech): Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987997 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H059A_1101204- / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Fatigue, Headache, Heart rate, Muscular weakness, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/88; Test Date: 20211119; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/62; Test Date: 20211119; Test Name: Heart rate; Result Unstructured Data: Test Result:88
CDC Split Type: TWPFIZER INC202101853620

Write-up: TIRED; HEADACHE; NAUSEA; VOMIT; AWARENESS CHANGE; LIMB WEAKNESS; BLOOD PRESSURE DECREASED; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013858. Other Case identifier(s): TW-Fosun-2021FOS007101. A 50-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was 1H059A_1101204-CDC) on 19-Nov-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. The 1st dose of vaccination was received on an unknown date. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced tired, headache, nausea, vomit, awareness change, limb weakness and blood pressure decreased on 19-Nov-2021. On 19-Nov-2021, the patient was inoculated the second agent of BNT vaccine, and the lab data showed that blood pressure(BP) was 131/88; heart rate(HR) was 88. The patient had discomfort and vomiting about 20-30 minutes after the inoculation. After check, the blood pressure (BP) was 90/62, then the patient was given Bosmin 1Amp IM, but the blood pressure was still not good, so the patient was given the second dose of Bosmin, but the blood pressure (BP) still not good, then the patient was given the third dose of Bosmin and IV Hydration. Tired, headache, nausea, vomit, awareness change, limb weakness and blood pressure decreased met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments for all events: Per Reporter and Company (BioNTech SE) = Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1988035 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dizziness, Neck pain, Swelling, Tenderness, Visual analogue scale
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Numbness in hand (especially in the morning for years)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Visual analogue scale; Result Unstructured Data: Test Result:3-5
CDC Split Type: TWPFIZER INC202101855417

Write-up: DIZZINESS; SWELLING PAIN; CARDIAC PAIN; EFT NECK SWELLING; TENDERNESS; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014032 (regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS007192 (regulatory authority). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014032. A 52-year-old female patient started to receive the 2nd dose of (COMIRNATY) (batch number was not reported) on 17-Nov-2021 via intramuscular at unknown dose with single frequency for COVID-19 immunization. Detail of first-dose vaccination was not reported. Medical history included bilateral hand numbness especially in the morning for years. Concomitant medication and past product were not reported. The patient experienced left neck swelling, tenderness on 19-Nov-2021, dizziness, swelling pain, cardiac pain on an unknown date. Since 19-Nov-2021, the patient experienced left neck swelling and tenderness. Visual analogue scale (VAS) was tested of 3-5. It was reported "normal shoulder and neck (range of motion) ROM". The patient was suggested to have a nerve conduction velocity (NCV) test but the patient refused. The patient was prescribed soma (chlorzoxazone at 150 mg/acetaminophen at 250 mg) at 1 po, twice a day (bid)/as needed (PRN) by oral to relieve the symptoms. On an unknown date, the patient''s symptom of pain on the left side of neck (pain in the left) improved. The patient still experienced symptoms of tenderness (stress will be pain), neck swelling. On 29-Nov-2021, the patient''s symptoms of dizziness and swelling pain improved. The symptom of cardiac pain continued. Left neck swelling, tenderness, dizziness, swelling pain, cardiac pain met the seriousness criterion of Other Medically Important Condition. The actions taken for (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: Drug: bnt162b2 Left neck swelling, tenderness, dizziness, swelling pain, cardiac pain Per Reporter = Possible Per Company (BioNTech SE)= Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Palpitations, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101855191

Write-up: CHEST TIGHTNESS; PALPITATION; FEVER; This is a spontaneous report received from a non-contactable reporter (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014099 (Regulatory Authority Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS007227. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014099. A 23-year-old female patient started to receive 2nd dose of TOZINAMERAN (COMIRNATY) (batch number: unknown) on 17-Nov-2021 via intramuscular at an unknown dose single for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. The patient experienced chest tightness, palpitation, fever on 19-Nov-2021. On 17-Nov-2021, the patient received 2nd dose of BNT vaccine. On 19-Nov-2021, due to chest tightness, palpitations, fever and the patient went to emergency, the patient was hospitalized for observation. Chest tightness, palpitation, fever met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE Drug: Comirnaty Causality Assessments: chest tightness, palpitation, fever Per Reporter= Possible Per Company (BioNTech SE) = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988116 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood creatine phosphokinase, Body temperature, Cardiovascular examination, Discomfort, Dizziness, Electrocardiogram, Feeling cold, Myocardial infarction, Syncope, Troponin I, Vomiting, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Subdural hematoma.
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: CPK; Result Unstructured Data: Test Result:584; Comments: Units:U/L increased; Test Date: 20211124; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20211124; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:Right Coronary Artery (RCA) infarction; Test Date: 20211124; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211124; Test Name: Troponin I; Result Unstructured Data: Test Result:2283 pg/mL; Comments: increased; Test Date: 20211124; Test Name: White blood cells; Result Unstructured Data: Test Result:12800; Comments: Units:/uL increased
CDC Split Type: TWPFIZER INC202101855362

Write-up: MYOCARDIAL INFARCTION; SYNCOPE; DIZZINESS; WANT TO VOMIT; ALL-END WEAKNESS; CHILLING; UNCOMFORTABLE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014241 (TFDA). Other Case identifier(s): TW-Fosun-2021FOS007517 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014241. A 55-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 19-Nov-2021 (at 55 years old) via intramuscular as dose 1, single for COVID-19 immunization. Medical history included right frontal subdural hematoma. Concomitant medications and past product were not reported. The patient experienced dizziness, want to vomit, all-end weakness, chilling, syncope on 19-Nov-2021, myocardial infarction on 24-Nov-2021 and uncomfortable on 01-Dec-2021. On 19-Nov-2021, the patient had dizziness, wanted to vomit, all-end weakness and chilling after the first dose of BNT vaccine. At 14:10 of 24-Nov-2021, the patient went to the emergency room. The patient''s body temperature was 36.1 Centigrade. The patient had a medical examination, and the electrocardiogram was arranged. The blood test showed Hypersensitive Troponin-i: 2283 pg/mL, increased; CPK: 584 U/L, increased; White Blood Cells: 12800/uL, increased, suspected myocardial infarction anti-coagulation drug were given and cardiococcal examination: Right Coronary Artery (RCA) infarction. After Percutaneous Transluminal Coronary Angioplasty (PTCA) and 1 bracket, the patient was admitted into ICU. On 27-Nov-2021, the patient was discharged. On 01-Dec-2021, the patient was working properly, and the body was currently uncomfortable. Dizziness, want to vomit, all-end weakness, chilling, syncope and myocardial infarction met the seriousness criterion of caused hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering, the outcome of the uncomfortable was unknown. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessment: Discomfort, Syncope, Myocardial infarction, Chilliness, Weakness generalised, Vomiting, Dizziness, Per Reporter was Possible, Per Company (BioNTech SE) was Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 1988118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Muscular weakness, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Glucose; Test Result: 467 mg/dl.
CDC Split Type: TWPFIZER INC202101855423

Write-up: CAN''T SPEAK CLEARLY; LIMB WEAKNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number TW-TFDA-TVS-1100014263, other case identifier(s) TW-Fosun-2021FOS007531. This is a spontaneous report received from a non-contactable HCP received via the Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014263. A 62-year-old female patient started to receive the 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 16-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included type 2 diabetes mellitus under irregular control. Concomitant medication and past product were not reported. The patient experienced can''t speak clearly and limb weakness on 19-Nov-2021. At 00:30 of 19-Nov-2021, the patient experienced weakness of left limbs and lisp. The patient''s blood sugar was 467 mg/dL, and he went to the emergency department of a hospital. After vital diagnosis and treatment, the patient was administered medicines of superoxide dismutase, chloride injection (INJ) 0.9% at 500 ml, humulin R need and bokey at 100 mg, famotidine at 20 mg by oral. The patient was hospitalized for treatment according to the doctor. Can''t speak clearly and limb weakness met the met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of this report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments per reporter and Company (BioNTech) Lisp and Weakness of limbs were possible related to COMIRNATY. COMIRNATY is under agreement with BioNTech. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1989144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G044A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood creatine, C-reactive protein, Confusional state, Diarrhoea, Gamma-glutamyltransferase, Glomerular filtration rate, Immunisation, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORASEMID; GLUCOPHAGE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Kr; Result Unstructured Data: Test Result:1,2; Test Date: 20211121; Test Name: CRP; Result Unstructured Data: Test Result:3,7; Test Date: 20211121; Test Name: GGT; Result Unstructured Data: Test Result:81; Test Date: 20211121; Test Name: GFR; Result Unstructured Data: Test Result:43
CDC Split Type: ATPFIZER INC202101816969

Write-up: Nausea; 3 days after vaccination, profuse watery diarrhea; Weakness; Confusion; Booster; This is a spontaneous report received from a contactable Physician from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063396. A 95 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: 1G044A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TORASEMID; GLUCOPHAGE. Vaccination history included: Comirnaty (dose 1), for Covid-19 immunisation; Comirnaty (dose 2), for Covid-19 immunisation. The following information was reported: NAUSEA (life threatening) with onset 22Nov2021, outcome "recovered", described as "Nausea"; DIARRHOEA (life threatening) with onset 22Nov2021, outcome "recovered", described as "3 days after vaccination, profuse watery diarrhea"; ASTHENIA (life threatening) with onset 22Nov2021, outcome "recovered", described as "Weakness"; CONFUSIONAL STATE (life threatening) with onset 22Nov2021, outcome "recovered", described as "Confusion"; IMMUNISATION (life threatening) with onset 19Nov2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: blood creatine: (21Nov2021) 1,2; c-reactive protein: (21Nov2021) 3,7; gamma-glutamyltransferase: (21Nov2021) 81; glomerular filtration rate: (21Nov2021) 43. Relatedness of drug to reaction(s)/event(s) for Comirnaty: Nausea, Watery diarrhea, Weakness, Confusion Source of assessment/Primary source / Result of Assessment : Certain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-11-19
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4222 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIX; NOLITERAX; SOTALOL; NEBILET; PRADAXA; ZARANTA
Current Illness: Atrial fibrillation; Cerebral infarction; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101799387

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA and product quality group. Regulatory number: EE-SAM-63182111295. A 72 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Aug2021 (Lot number: FF4222, Expiration Date: 31Oct2021) as dose 2, 0.3 ml single and intramuscular, administration date 09Jul2021 (Lot number: FE2083, Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (ongoing); "Cerebral infarction" (ongoing); "Hypertension" (ongoing). Concomitant medication(s) included: SPIRIX; NOLITERAX; SOTALOL; NEBILET; PRADAXA; ZARANTA. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Vaccination failure"; COVID-19 (medically significant) with onset 19Nov2021, outcome "recovering", described as "COVID-19" with symptoms of runny nose, fatigue. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. The course of the disease was mild, treatment at home, symptomatic. As of 29th November 2021, the patient was recovering. Therapeutic measures were taken as a result of covid-19. The product quality group reported that the investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF4222. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE2083. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101841441 same patient, different event


VAERS ID: 1990377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Disease recurrence, Fatigue, Feeling abnormal, Immunisation, Insomnia, Nightmare
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; LERCANIDIPINE; METFORMIN; OMEPRAZOL; TAMSULOSIN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Blood pH abnormal; Borderline diabetes; Gastritis; Hypertension; Insomnia; Nightmares (for the last few years); Urinary urgency
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101796666

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112141712031070-EKWLV (RA). Other Case identifier: GB-MHRA-ADR 26334104 (RA). A 77-year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing); "Borderline Diabetic" (unspecified if ongoing); "Urinary urgency/ urinary issue" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Atrial Fibrillation (AF)" (unspecified if ongoing); "difficult to sleep/ sleepness night" (unspecified if ongoing); "Blood pH" (unspecified if ongoing); "nightmares" (unspecified if ongoing), notes: for the last few years. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Concomitant medication(s) included: BISOPROLOL taken for blood ph abnormal, start date: 2015; LERCANIDIPINE taken for blood ph abnormal, start date: 2012, stop date: 01Sep2021; METFORMIN taken for diabetes mellitus, start date: 2015; OMEPRAZOL taken for gastritis, start date: 2010; TAMSULOSIN taken for micturition urgency, start date: 2010; WARFARIN taken for blood ph abnormal, start date: 2012. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 30Nov2021, outcome "not recovered", described as "Tiredness"; NIGHTMARE (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Brief nightmare"; INSOMNIA (medically significant), DISEASE RECURRENCE (medically significant) all with onset 2021, outcome "not recovered" and all described as "return of sleepless nights"; CONFUSIONAL STATE (medically significant) with onset Dec2021, outcome "recovered", described as "confused"; FEELING ABNORMAL (medically significant) with onset Dec2021, outcome "recovered", described as "fuzz-brain". Clinical course: I become very tired. Often need a quick power nap, then 5 minutes later need an another. Sleeping for longer difficult. At night, I find it difficult to sleep normally. I have suffered from nightmares for the last few years, and my GP was very helpful in diagnosing that they were probably caused by my medication which she adjusted (approximately Sep2021). I was just returning to a better sleeping pattern without nightmares when I had the booster on 19Nov2021. That has coincided with a return of sleepless nights, although the dream pattern is different, the current dreams are not as severe, but they are almost ever-present whenever I try to sleep all night, or just catch a nap in the day. Additionally, I also had two mornings in early Dec2021 when I became confused on waking up and could not operate my TV/Sky Box/Recorder correctly. I contacted my GP and she diagnosed ''fuzz-brain'' as a side effect of the vaccine. I only had it two mornings, each time for less than an hour, and am now back being lucid. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211209; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Comments: PRIVACY Positive molecular swab in vaccine. Asymptomatic
CDC Split Type: ITPFIZER INC202101791886

Write-up: vaccination failure; PRIVACY Positive molecular swab in vaccine. Asymptomatic; Asymptomatic COVID-19; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a Regulatory Authority and product quality group. Regulatory number: IT-MINISAL02-819864. A 86 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 19Nov2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single, intramuscular, administered in arm left, administration date 12May2021 (Lot number: EX7389, Expiration Date: 31Aug2021) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 21Apr2021 (Lot number: EX0893, Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 09Dec2021, outcome "unknown", described as "vaccination failure"; COVID-19 (medically significant) with onset 09Dec2021, outcome "recovering", described as "PRIVACY Positive molecular swab in vaccine. Asymptomatic"; ASYMPTOMATIC COVID-19 (medically significant) with onset 09Dec2021, outcome "unknown", described as "Asymptomatic COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) positive, notes: PRIVACY Positive molecular swab in vaccine. Asymptomatic. Upon follow-up report from product quality group providing investigation results: Additional information: Conclusion The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX7389. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX0893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Upon follow-up report from product quality group providing investigation results: Additional information: Conclusion The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF2382. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1991087 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1613 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Anxiety, Blood pressure measurement, Cardiac telemetry, Cough, Dizziness, Headache, Heart rate, Heart rate increased, Hyperaemia, Hypertension, Hypoventilation, Mean arterial pressure, Mean arterial pressure increased, Oxygen saturation, Respiratory rate, Respiratory rate increased, Sensation of foreign body, Sinus tachycardia, Tachypnoea
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN HYDROCHLORIDE; PROPANOLOL [PROPRANOLOL]; CARBAMAZEPINE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (In apparent control only with rescue inhaler, last asthma crisis 2 years ago); Diabetes mellitus (In treatment with metformin every 12 hours); Hypertension arterial (In treatment with Propanol); Schizophrenia (On treatment with Carbamazepine 2 every 12 hours.)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:125/61; Test Date: 20211119; Test Name: Blood pressure; Result Unstructured Data: Test Result:157/85; Test Date: 20211119; Test Name: telemetry; Result Unstructured Data: Test Result:Sinus tachycardia; Test Name: Heart rate; Result Unstructured Data: Test Result:92; Test Date: 20211119; Test Name: Heart rate; Result Unstructured Data: Test Result:103; Test Name: mean blood pressure; Result Unstructured Data: Test Result:83; Test Date: 20211119; Test Name: mean blood pressure; Result Unstructured Data: Test Result:108; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97%; Test Date: 20211119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97%; Test Date: 20211119; Test Name: respiratory rate; Result Unstructured Data: Test Result:27
CDC Split Type: MXPFIZER INC202101822139

Write-up: Anaphylactic shock/anaphylaxia; Headache; Dizziness; sinus tachycardia; cough/dry cough; foreign body sensation in throat; anxious patient; polypnoea/ evident use of respiratory muscles; hypoventilated pulmonary fields, no rattles or wheezes; hyperemia of upper limbs and anterior thorax; Blood pressure 157/ 85; Heart rate 103; Mean arterial pressure 108; Respiratory rate 27; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18228-12. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FJ1613, Expiration Date: 01Feb2022) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: In apparent control only with rescue inhaler, last asthma crisis 2 years ago; "Diabetes mellitus" (unspecified if ongoing), notes: In treatment with metformin every 12 hours; "Schizophrenia" (unspecified if ongoing), notes: On treatment with Carbamazepine 2 every 12 hours.; "Systemic arterial hypertension" (unspecified if ongoing), notes: In treatment with Propanol. Concomitant medication(s) included: METFORMIN HYDROCHLORIDE taken for diabetes mellitus; PROPANOLOL [PROPRANOLOL] taken for hypertension; CARBAMAZEPINE taken for schizophrenia; SALBUTAMOL taken for asthma. Vaccination history included: Covid-19 vaccine (Dose 1 , Manufacturer Unknown), for Covid-19 Immunization. No infectious disease in the last 15 days before vaccination. Healthy patient before vaccination. Family member did not administere any treatment or remedy prior to medical care. She went to Privacy after the second application of Pfizer, brought directly from Privacy, due to foreign body sensation in throat, dizziness and dry cough, admitted to Privacy on 19Nov2021 with heart rate 103, blood pressure 157/85, mean arterial pressure 108, oxygen saturation 97%, respiratory rate 27. Anxious patient, polypnea, evident use of respiratory muscles, heart rate with sinus tachycardia by telemetry, hypo ventilated pulmonary fields, no rattles or wheezing, hyperemia in upper limbs and anterior thorax, no pruritus or other dermatological data, proceeded to the application of adrenaline 0.5 mg intramuscular single dose, she presented headache after the same (not specified), it was decided to add difenidramine 3 mL intravenous + hydrocortisone 100 mg intravenous single dose with improvement of symptoms, but oscillation of arterial tension at the moment. Stable, she was discharged with arterial tension 125/ 61, mean arterial pressure 83, cardiac frequency 92 and oxygen saturation 97%. The onset dates of all events were on 19Nov2021. type was serious. Hospitalisation required. Current status: Hospitalised. The outcome of all events was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991088 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1618 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Headache, Pain, Pruritus, Pyrexia, Rhinorrhoea, Sensitive skin, Vaccination site abscess
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: BODY TEMPERATURE; Result Unstructured Data: Test Result:Fever greater than or equal to 38 Centigrade
CDC Split Type: MXPFIZER INC202101822140

Write-up: Fever greater than or equal to 38 Celsius degrees; Headache; Pain; Sensitivity; Pruritus; Abdominal pain; Rhinorrhea; abscess at the vaccination site; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18229-12. A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FJ1618, Expiration Date: 28Feb2022) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 19Nov2021, outcome "unknown", described as "Fever greater than or equal to 38 Celsius degrees"; HEADACHE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Headache"; PAIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "Pain"; SENSITIVE SKIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "Sensitivity"; PRURITUS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Pruritus"; ABDOMINAL PAIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "Abdominal pain"; RHINORRHOEA (medically significant) with onset 19Nov2021, outcome "unknown", described as "Rhinorrhea"; VACCINATION SITE ABSCESS (medically significant) with onset 19Nov2021, outcome "unknown", described as "abscess at the vaccination site". Therapeutic measures were taken as a result of all events included paracetamol 1 gram every 8 hours, loratadine 1 tablet every 12 hours, dexamethasone 8 milligrams single dose. type was severe. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-19
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H055A_1101118- / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101810899

Write-up: CHEST TIGHTNESS; BREATHING DIFFICULT; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014179 (regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS006771 (RA). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014179. A 33-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1H055A_1101118-CDC) on 30-Oct-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced chest tightness on unknown date, experienced breathing difficult on 19-Nov-2021. On 30-Oct-2021, the patient received the 1st dose inoculation of BNT vaccine. On an unknown date, the patient experienced chest tightness. On 19-Nov-2021, the patient went to the clinic, then the patient was transferred to the emergency room of a hospital due to a breathing difficult. The patient was in the hospital currently. Chest tightness and breathing difficult met the seriousness criterion of Life Threatening and Hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drug: Comirnaty Causality Assessments: Breathing difficult, Chest tightness Per Reporter= Possible Per Company (BioNTech) = Possible; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Chest discomfort and Dyspnoea cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1991449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease (without control.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101818729

Write-up: CHEST PAIN(HURT BEHIND); CHEST TIGHTNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014361 . Other Case identifier(s): -Fosun-2021FOS006838. This is a spontaneous report received from a non-contactable HCP received via. The regulatory authority report number is -TFDA-TVS-1100014361. A 53-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 11-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history included the coronary artery disease without control. Concomitant medication and past product were not reported. The patient experienced chest tightness and chest pain (hurt behind) on 19-Nov-2021. On 11-Nov-2021, the patient was given 1st dose of vaccination. On 19-Nov-2021, the patient experienced chest tightness, hurt behind and went to the emergency for treatment because the above symptoms were not improved. Treatments of "the N/S 500ml, Diphenhydramine 30mg 1ml, Acetamol inj. 1g, Morphine inj, 6000 Anti-Xa Iu /0.6ml Needle and Bokey 100mg, Bokey 100mg, Magnesium Oxide 250mg, Crestor 10mg, Sigmart 5mg" were prescribed. It was reported that "oral pharmacy visit, suggesting to be a cardiac surgery". On 26-Nov-2021, consciousness of the patient was awake, and after the physician was estimated, the patient shall be discharged. Chest tightness, hurt behind and chest pain met the seriousness criterion of life threatening and hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Causality Assessments: Chest pain, Chest tightness Per Reporter= Possible Per Company (Fosun) = Possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Follow-up closed, no further information is possible.


VAERS ID: 1991529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Dizziness, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101834310

Write-up: FULL BODY WEAKNESS; CHEST TIGHTNESS; CHEST PAIN; DIZZINESS; FEVER; This is a spontaneous report received from non-contactable healthcare professional from Regulatory number: TW-TFDA-TVS-1100013895 Other Case identifier(s): TW-Fosun-2021FOS007125 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100013895. A 44-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number: unknown) on 18-Nov-2021 via unknown route at unknown dose with an unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced fever, chest pain on 19-Nov-2021, experienced full body weakness, chest tightness on 22-Nov-2021, and experienced dizziness on an unknown date. On 19-Nov-2021, the patient went to an emergency room (ER). On 22-Nov-2021, the patient was in hospitalization due to chest pain, chest tightness and full body weakness and discharged on the same day. On 26-Nov-2021, the patient had slight chest pain and dizziness. Chest pain, full body weakness and chest tightness met the seriousness criterion of Hospitalization. Fever and dizziness met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the dizziness was unknown. the outcomes of the other events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: Drug: COMIRNATY Event: Chest tightness, Dizziness, Weakness generalized, Chest pain, Fever Per Reporter = Possible Per Company = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1992938 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEH4 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple sclerosis relapse
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101799657

Write-up: Multiple sclerosis flare; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the RA. Regulatory number: DE-DCGMA-21195043. Other Case identifier(s): DE-PEI-202100275045. A 23 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: SDEH4) at the age of 23 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unknown if ongoing), notes. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Substance Name: mRNA TOZINAMERAN, /Strength: 0.3mL, Indication: Prophylactic vaccination), administration date: 28May2021, for COVID-19 immunisation, reaction(s): "Hypaesthesia". The following information was reported: MULTIPLE SCLEROSIS RELAPSE (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Multiple sclerosis flare". Reporter Comment: Measures: Cortisone shock therapy, including improvement with partial remission. Clinical course: Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Measures: Cortisone shock therapy, including improvement with partial remission.


VAERS ID: 1993364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVD1 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101826536

Write-up: COVID-19; Vaccination failure; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-RS20214134 (RA). A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: SCVD1) as dose 3 (booster), single, intramuscular, administration date 18Feb2021 (Lot number: EK9788) as dose 2, single and intramuscular, administration date 29Jan2021 (Lot number: EJ6788) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; COVID-19 (medically significant) with onset 26Nov2021, outcome "recovered" (2021), described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 26Nov2021, outcome "recovered" (2021), described as "Vaccination failure". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993629 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis)
Allergies:
Diagnostic Lab Data: Test Date: 20211214; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101805792

Write-up: Shortness of breath; Persistent cough; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112151819448450-TZIZI (Regulatory Authority). Other Case identifier(s): GB-MHRA-ADR 26340927 (Regulatory Authority). A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fh4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; COUGH (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Persistent cough"; DYSPNOEA (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKU112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Immunisation, Influenza like illness, Lower respiratory tract infection, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QVAR; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201029; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101813697

Write-up: coughing; difficulty breathing; Flu like symptoms; aching all over; Chest infection; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112160747282750-KOH5R (Regulatory Authority). Other Case identifier(s): GB-MHRA-ADR 26342836 (Regulatory Authority). A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FKU112) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 29Oct2020, stop date: 06Mar2021; "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR taken for asthma; VENTOLIN [SALBUTAMOL SULFATE] taken for asthma. Past drug history included: Thyroxine. Vaccination history included: Covid-19 vaccine (Dose 1. manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 manufacturer unknown), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; COUGH (medically significant), outcome "not recovered", described as "coughing"; DYSPNOEA (medically significant), outcome "not recovered", described as "difficulty breathing"; LOWER RESPIRATORY TRACT INFECTION (medically significant) with onset 20Nov2021, outcome "recovered with sequelae" (05Dec2021), described as "Chest infection"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "Flu like symptoms"; PAIN (non-serious), outcome "not recovered", described as "aching all over". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Oct2020) positive. Therapeutic measures were taken as a result of cough, dyspnoea, lower respiratory tract infection, influenza like illness, pain. Clinical Information: It was reported that, Flue like symptoms aching all over coughing difficulty breathing. Extra doses of inhalers. Qvar 50 And Ventolin. Antibiotics for a week. Steroids for two weeks. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: No. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Spoke with Dr twice. Text for relevant medical history and concurrent conditions was taken pain killers for my Osteo Arthritis. Co-Codomol Qvar 50 and Ventolin for Asthma, Thyroxin 150 under active Thyroid. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993764 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Immunisation, Interchange of vaccine products, Ligament injury, Off label use, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee ligament injury (injured the medial ligament in left knee)
Allergies:
Diagnostic Lab Data: Test Date: 20211212; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101813474

Write-up: Difficult to walk; had injured the medial ligament in her left knee/ left knee had deteriorated; had injured the medial ligament in her left knee/ left knee had deteriorated; Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY; Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY; Dose number: 3; Joint pain/right knee started to pain/elbow joints started to pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112161119586490-VGC9B (MHRA). Other Case identifier(s): GB-MHRA-ADR 26343735 (MHRA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knee ligament injury", start date: Jun2021 (unspecified if ongoing), notes: injured the medial ligament in left knee. Patient had injured the medial ligament in her left knee in June this year and it was recovering reasonably well. None of the above listed. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: CANDESARTAN. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 05Mar2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), administration date: 2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Dose number: 3"; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Joint pain/right knee started to pain/elbow joints started to pain"; GAIT DISTURBANCE (medically significant), outcome "not recovered", described as "Difficult to walk"; LIGAMENT INJURY (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "had injured the medial ligament in her left knee/ left knee had deteriorated". After the injection, the right knee started to pain and patient thought it was just because it was doing extra work. Then her elbow joints started to pain too and her left knee had deteriorated. It was difficult to walk. Patient would present to GP if it didn''t subside. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Dec2021) no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993884 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Interchange of vaccine products, Limb injury, Mobility decreased, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101813785

Write-up: Arm injury; Off label use; Interchange of vaccine products; Booster; muscle ache/Arm muscle ache constantly; Arm numbness; Reduction in arm mobility gradually; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112161918289410-9RI0D. Other Case identifier(s): GB-MHRA-ADR 26346435. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FC9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 2021, outcome "not recovered", described as "muscle ache/Arm muscle ache constantly"; LIMB INJURY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Arm injury"; HYPOAESTHESIA (medically significant) with onset 2021, outcome "unknown", described as "Arm numbness"; MOBILITY DECREASED (medically significant) with onset 2021, outcome "unknown", described as "Reduction in arm mobility gradually". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1993971 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Insomnia, Loss of personal independence in daily activities, Neuralgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Dementia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTROGEN; FLUOXETINE; IBUPROFEN; MIRENA; PARACETAMOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Hormonal imbalance; HRT; Pain.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101813890

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112170457368370-MF94X. Other Case identifier(s): GB-MHRA-ADR 26348265. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hormonal imbalance" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "HRT" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN, start date: 10Jan2017; FLUOXETINE taken for hormone level abnormal, start date: 11Jul2015; IBUPROFEN taken for arthritis, start date: 04Jun2016; MIRENA taken for hormone replacement therapy, start date: 08Oct2019; PARACETAMOL taken for pain. Vaccination history included: Comirnaty (Dose 1), administration date: 24Sep2021, for COVID-19 Immunisation.The following information was reported: NEURALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Nerve pain"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "dull ache sensation in right arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "Limiting activities of living"; INSOMNIA (medically significant), outcome "unknown", described as "Due to pain very in sleepy during the day as it''s interrupting my sleep"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Patient received Vaccine Dose 1 on 24Sep2021, Dose 2 on 19Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of neuralgia, pain in extremity, loss of personal independence in daily activities, insomnia.Additional information: The patient had pain and dull ache sensation in right arm which had worsened since being vaccinated. She had limiting activities of living. Due to pain very in sleepy during the day as it''s interrupting her sleep. The patient was seeing physio and chiropracter. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not considered as related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994262 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Blood gases, Blood pressure measurement, Electrocardiogram, Nausea, Oxygen saturation, Pain, Physical examination, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: arterial blood gas analysis; Result Unstructured Data: Test Result:unknown results; Test Name: Blood pressure; Result Unstructured Data: Test Result:145/90 mmHg; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: saturation; Test Result: 97 %; Test Name: general examination; Result Unstructured Data: Test Result:vesicular murmur present; Comments: vesicular murmur present diffusely without added noise; heart tones valid, rhythmic, free pauses; abdomen flat, treatable, not sore or painful.
CDC Split Type: ITPFIZER INC202101818711

Write-up: Vomiting; epigastric pain radiating to the chest; Nausea; Asthenia; epigastric pain radiating to the chest; FARO This is a non-interventional study report from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-820943 (MINISAL02). A 42 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 11:06 (Lot number: 1F1016A, Expiration Date: 31Jan2022) as dose 2, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (biontech manufacturing gmbh) (j07bx03) (1st dose, 10:00 am, lot FG7387, expiration 30Nov2021, right arm.), administration date: 14Oct2021, for COVID-19 vaccination. The following information was reported: VOMITING (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Vomiting"; ABDOMINAL PAIN UPPER (hospitalization), PAIN (hospitalization) all with onset 19Nov2021, outcome "not recovered" and all described as "epigastric pain radiating to the chest"; NAUSEA (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Nausea"; ASTHENIA (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Asthenia". The patient was hospitalized for vomiting, abdominal pain upper, nausea, asthenia, pain (start date: 2021). The events "vomiting", "epigastric pain radiating to the chest", "nausea", "asthenia" and "epigastric pain radiating to the chest" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood gases: unknown results; blood pressure measurement: 145/90 mmHg; electrocardiogram: unknown results; oxygen saturation: 97 %; physical examination: vesicular murmur present, notes: vesicular murmur present diffusely without added noise; heart tones valid, rhythmic, free pauses; abdomen flat, treatable, not sore or painful. Therapeutic measures were taken as a result of vomiting, abdominal pain upper, nausea, asthenia, pain included Perfalgan (1 vial) + Levopraid (1 vial) in saline 250 ml; Pantoprazole (1 vial) in saline 100 ml. Recommended: light diet for 2 days, paracetamol 1 g in case of pain). The reporter''s assessment of the causal relationship of the "vomiting", "epigastric pain radiating to the chest", "nausea" and "asthenia" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Reporter Comment: The suspected Adverse Drug Reaction (ADR) was observed as part of the analysis of adverse drug reactions in the emergency room. The patient received first dose of vaccine on 14Oct2021, 10:00 am, lot FG7387, expiration 30Nov2021, right arm No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The suspected Adverse Drug Reaction (ADR) was observed as part of the analysis of adverse drug reactions in the emergency room. The patient received first dose of vaccine on 14Oct2021, 10:00 am, lot FG7387, expiration 30Nov2021, right arm; Sender''s Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on the temporal relationship and since it is part of the product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1994406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage, Vision blurred
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101810145

Write-up: eye spill; Blurred vision for 7h - starting 1h after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: PT-INFARMED-M202112-442 Regulatory Authority. A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FF8288) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VISION BLURRED (medically significant) with onset 19Nov2021, outcome "recovered", "2021", described as "Blurred vision for 7h - starting 1h after vaccination"; EYE HAEMORRHAGE (medically significant) with onset 04Dec2021, outcome "recovering", described as "eye spill". The events "blurred vision for 7h - starting 1h after vaccination" and "eye spill" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vision blurred, eye haemorrhage. There was no reduction in dosage. There was no suspicion of drug interactions. Previous reactions to the same drug or to other drugs were not known. The ADRs motivated an ophthalmology consultation. Due to its severity criteria, it was referred to causality imputation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1995702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH S0EJ8 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Pericardial effusion, Troponin, Troponin increased
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiac troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: ATPFIZER INC202101817484

Write-up: Perimyocarditis; Chest pain; Cardiac troponin increased; Pericardial effusion; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063386 (RA). A 25 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 05Nov2021 (Lot number: S0EJ8) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Perimyocarditis"; CHEST PAIN (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Chest pain"; TROPONIN INCREASED (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Cardiac troponin increased"; PERICARDIAL EFFUSION (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Pericardial effusion". The patient underwent the following laboratory tests and procedures: troponin: increased. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996561 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101876539

Write-up: off label use; Interchange of vaccine products; booster; Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). A 62-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection), as dose 3 (booster), via unspecified route of administration, on 19Nov2021 (Lot number: FK9413) (at the vaccination age of 62 years old), at single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE, described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS, described as "Interchange of vaccine products"; IMMUNISATION, described as "booster"; DRUG INEFFECTIVE, described as "Drug ineffective"; SUSPECTED COVID-19, described as "Suspected COVID-19"; all events with seriousness of (medically significant), all events with onset 19Nov2021, all events with outcome "unknown". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101629227 Original Case : 202101629227


VAERS ID: 1998581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Back pain, Blood albumin, Blood folate, Blood glucose, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Borrelia test, CSF glucose, Electromyogram, Formication, Influenza A virus test, Influenza B virus test, Laboratory test, Magnetic resonance imaging, Magnetic resonance imaging head, Mononuclear cell count, Neurological examination, Oxygen saturation, Pain in extremity, Paraesthesia, Protein total, Red blood cell count, Reflex test, SARS-CoV-2 test, Spinal X-ray, Vitamin B12
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Iodine allergy (manifests with erytema); Specific allergy (drug) (ketoprofen, biseptol (manifests with erytema))
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (moderately severe course, hospitalization without oxygenation); Skull trauma (from car accident); Comments: The patient was not being treated for anything.
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Angiography; Result Unstructured Data: lower limbs - no signs of DVT; Test Date: 20211125; Test Name: Reflex test; Result Unstructured Data: upper limbs C5-8 symmetrical; Test Date: 20211125; Test Name: Oxygen saturation; Result Unstructured Data: 98 %; Test Date: 20211125; Test Name: Neurological examination; Result Unstructured Data: conclusion: acute lumbalgia; Test Date: 20211125; Test Name: Blood pressure; Result Unstructured Data: 118/81 mmHg; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: 36.6 C; Test Date: 20211127; Test Name: Mononuclear cell count; Result Unstructured Data: 1 /uL; Test Date: 20211127; Test Name: Albumin; Result Unstructured Data: 102 mg/L; Test Date: 20211127; Test Name: Influenza B virus test; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: Borrelia test; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: Borrelia test; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: IgA; Result Unstructured Data: 1.9 mg/L; Test Date: 20211127; Test Name: Albumin; Result Unstructured Data: 6.2 /10*3; Test Date: 20211127; Test Name: Borrelia test; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: IgA; Result Unstructured Data: 0.23 (unit unspecified); Test Date: 20211127; Test Name: RBC count; Result Unstructured Data: less than 1 /uL; Test Date: 20211127; Test Name: Protein total; Result Unstructured Data: 227 mg/L; Test Date: 20211127; Test Name: IgG; Result Unstructured Data: 0.57 (unit unspecified); Test Date: 20211127; Test Name: IgM; Result Unstructured Data: 1.54 g/L; Test Date: 20211127; Test Name: Glucose; Result Unstructured Data: 0.83 (unit unspecified); Test Date: 20211127; Test Name: IgG; Result Unstructured Data: 1.55 /10*3; Test Date: 20211127; Test Name: IgG; Result Unstructured Data: 20.2 mg/L; Test Date: 20211127; Test Name: IgM; Result Unstructured Data: less than 0.3 mg/L; Test Date: 20211127; Test Name: Glucose; Result Unstructured Data: 4 mmol/L; Test Date: 20211127; Test Name: IgA; Result Unstructured Data: 0 mg/L; Test Date: 20211127; Test Name: CSF glucose; Result Unstructured Data: 3.3 mmol/L; Test Date: 20211127; Test Name: IgG; Result Unstructured Data: 0 mg/L; Test Date: 20211127; Test Name: COVID-19 PCR test; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: IgA; Result Unstructured Data: 3.08 g/L; Test Date: 20211127; Test Name: IgA; Result Unstructured Data: 0.62 /10*3; Test Date: 20211127; Test Name: Mononuclear cell count; Result Unstructured Data: 2 /uL; Test Date: 20211127; Test Name: H1N1 influenza PCR; Result Unstructured Data: Negative; Test Date: 20211127; Test Name: Albumin; Result Unstructured Data: 37.7 g/L; Test Date: 20211127; Test Name: IgG; Result Unstructured Data: 13 g/L; Test Date: 20211127; Test Name: Borrelia test; Result Unstructured Data: Negative; Test Date: 20211129; Test Name: EMG; Result Unstructured Data: without signs of polyneuropathy; Test Date: 20211130; Test Name: Blood folic acid; Result Unstructured Data: 15.3 nmol/L; Test Date: 20211130; Test Name: Head MRI; Result Unstructured Data: application of 15 ml of Dotarem; Test Date: 20211130; Test Name: Spine X-ray; Result Unstructured Data: L-S spine, incip. spondylarthrosis; Test Date: 20211130; Test Name: Vitamin B12; Result Unstructured Data: 391 pmol/L; Test Date: 20211130; Test Name: EMG; Result Unstructured Data: within the normal standards; Test Date: 20211130; Test Name: TSH; Result Unstructured Data: 5.02 mU/L; Test Date: 20211201; Test Name: MRI; Result Unstructured Data: spine MR, without pathological; Test Name: Laboratory test; Result Unstructured Data: energy balance coefficient: 29.3
CDC Split Type: CZJNJFOC20211266846

Write-up: PARAESTHESIA OF LIMBS/TINGLING OF EXTREMITY/LOCALIZED TINGLING/FACIAL PARESTHESIA; FORMICATION; LUMBALGIA; PAIN LEGS; This spontaneous report received from a lawyer by a Regulatory Authority (CZ-CZSUKL-21013662) on 31-DEC-2021 concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: skull trauma, and covid-19, and concurrent conditions included: iodine allergy, and specific allergy (drug), and other pre-existing medical conditions included: The patient was not being treated for anything. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expiry: unknown) 1 dosage forms, dose number in series was 1, 1 total administered on 19-NOV-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced pain legs. On 23-NOV-2021, Laboratory data included: Angiography (NR: not provided) lower limbs - no signs of deep vein thrombosis (DVT). On 25-NOV-2021, the patient experienced paraesthesia of limbs, tingling of extremity, formication, and lumbalgia. On 26-NOV-2021, thee patient experienced localized tingling and facial paresthesia. Laboratory data included: Blood pressure (NR: not provided) 118/81 mmHg, Body temperature (NR: not provided) 36.6 Celsius, Neurological examination (NR: not provided) conclusion: acute lumbalgia with development in recent days, palpation sensitivity of spasms in the area of the lumbar-sacral spine and paresthesia in quadru distribution from 20-NOV-2021. Neurological discovery without deficit. upper limbs: muscle eutrophy, normal tone, C5-8 reflexes symmetrical, bilaterally stable in Mingazzini "sic", grip symmetrical. Lower limbs: muscle eutrophy, tone in normal L2-4 reflexes symmetrical, hyporeflexia L5-S2 bilaterally, bilaterally stable in Mingazzini "sic", slight weakening of the thumb bilaterally more to the left 4/5, otherwise muscle strength in other myotomes 5/5 symmetrically, without signs of irritation bilaterally, taxa and metrics targeted bilaterally, Lasseque "sic" negative bilaterally, Oxygen saturation (NR: not provided) 98 %, and Reflex test (NR: not provided) upper limbs C5-8 symmetrical bilaterally stable in Mingazzini "sic", lower limbs: L2-4 symmetrical, hyporeflexia L5-S2 bilaterally, bilaterally stable in Mingazzini "sic". On 27-NOV-2021, Laboratory data included: Albumin (NR: not provided) 102 mg/L (:cerebrospinal fluid), 6.2 /10*3 (quotient according to age), 37.7 g/L (serum-plasma), Borrelia test (NR: not provided) were Negative for four time, Covid-19 polymerase chain reaction (PCR) test (NR: not provided) Negative, CSF glucose (NR: not provided) 3.3 mmol/L, Glucose (NR: not provided) 0.83 (unit unspecified), 4 mmol/L, H1N1 influenza PCR (NR: not provided) Negative, Immunoglobulin A (IgA) (NR: not provided) 3.08 g/L (serum-plasma), 0.62 /10*3 (quotient), 0.23 (unit unspecified), 0 mg/L (intrathecal synthesis), 1.9 mg/L (cerebrospinal fluid), Immunoglobulin G (IgG) (NR: not provided) 13 g/L (serum-plasma), 0.57 (unit unspecified), 0 mg/L (intrathecal synthesis), 1.55 /10*3, 20.2 mg/L (cerebrospinal fluid), Immunoglobulin M (IgM) (NR: not provided) less than 0.3 mg/L (cerebrospinal fluid), 1.54 g/L, Influenza B virus test (NR: not provided) Negative, Mononuclear cell count (NR: not provided) 1 /uL, 2 /Ul (medium), Protein total (NR: not provided) 227 mg/L (cerebrospinal fluid), and RBC count (NR: not provided) less than 1 /uL. On 29-NOV-2021, Laboratory data included: EMG (NR: not provided) without signs of polyneuropathy of the limbs, without signs of demyelinating lesions of the peripheral nerves of the upper and lower limbs, the finding does not support the suspicion of Guillain-Barre syndrome (AIDP). Only borderline signs of chronic neurogenic lesions in needle Electromyography (EMG) in the examination of lower limb muscles, motor fitness studies completely normal. On 30-NOV-2021, Laboratory data included: Blood folic acid (NR: not provided) 15.3 nmol/L, EMG (NR: not provided) within the normal standards, Head MRI (NR: not provided) application of 15 ml of Dotarem cerebellum, brain stem and brain tissue without pathological changes, without signs of fresh ischemic changes, ventricular system normally formed, without overpressure, external cerebrospinal fluid spaces are straight width, Spine X-ray (NR: not provided) L-S spine, incip. "sic" Spondylarthrosis, maximum caudally, thyroid stimulating hormone (TSH) (NR: not provided) 5.02 mU/L (blood-serum), and Vitamin B12 (NR: not provided) 391 pmol/L. On 01-DEC-2021, Laboratory data included: magnetic resonance imaging (MRI) (NR: not provided) spine MR, without pathological changes. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) energy balance coefficient: 29.3 on 30-NOV-2021. Hospitalization report on14-DEC-2021. On an unspecified date, she was hospitalized. Number of days hospitalized and discharge information was not reported (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from paraesthesia of limbs/tingling of extremity/localized tingling/facial paresthesia, and had not recovered from formication, lumbalgia, and pain legs. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).


VAERS ID: 2002428 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Blood lactate dehydrogenase, Chest pain, Computerised tomogram head, Exercise tolerance decreased, Fatigue, Headache, Hemianopia, Inappropriate schedule of product administration, Nuchal rigidity, Platelet count, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPIN [AMLODIPINE]
Current Illness: Arteriosclerosis; Hypertension arterial; McArdle''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Fibrinogen; Test Result: 234 mg/dl; Test Date: 20211123; Test Name: LDH; Result Unstructured Data: Test Result:262 IU/l; Test Date: 20211123; Test Name: CT skull; Result Unstructured Data: Test Result:normal; Test Date: 20211123; Test Name: Thrombocytes; Result Unstructured Data: Test Result:185 g/l
CDC Split Type: ATPFIZER INC202101827961

Write-up: Sensation of neck stiffness/ Neck rigid; massive Fatigue; suspected transient ischaemic attack; Cephalea with a left hemianopia for 30 min; Cephalea with a left hemianopia for 30 min; constant drop in performance/ Exercise tolerance decreased; chest pain on the left side without dyspnoea; inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency-WEB. Regulatory number: AT-BASGAGES-2021-062942. A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FD4555) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "McArdle''s disease" (ongoing); "Hypertension arterial" (ongoing); "Arteriosclerosis" (ongoing). Concomitant medication(s) included: AMLODIPIN [AMLODIPINE] taken for hypertension. Vaccination history included: Comirnaty (1st dose; LOT: unknown), administration date: 30Jun2021, for COVID-19 immunisation. The following information was reported: NUCHAL RIGIDITY (hospitalization) with onset 19Nov2021, outcome "recovering", described as "Sensation of neck stiffness/ Neck rigid"; FATIGUE (hospitalization) with onset 19Nov2021, outcome "recovered", described as "massive Fatigue"; TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 19Nov2021, outcome "recovered", described as "suspected transient ischaemic attack"; HEMIANOPIA (hospitalization) with onset 19Nov2021, outcome "recovered", HEADACHE (hospitalization) with onset 19Nov2021, outcome "not recovered" and all described as "Cephalea with a left hemianopia for 30 min"; EXERCISE TOLERANCE DECREASED (hospitalization) with onset 19Nov2021, outcome "recovered", described as "constant drop in performance/ Exercise tolerance decreased"; CHEST PAIN (hospitalization) with onset 19Nov2021, outcome "recovered", described as "chest pain on the left side without dyspnoea"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: blood fibrinogen: (23Nov2021) 234 mg/dl; blood lactate dehydrogenase: (23Nov2021) 262 IU/l; computerised tomogram head: (23Nov2021) normal; platelet count: (23Nov2021) 185 g/l. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2002606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836365

Write-up: Cerebrovascular accident; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 683659 (RA). A 71 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Cerebrovascular accident". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2002810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH P-FK8911 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Impaired work ability, Lymphadenopathy, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101817494

Write-up: Severe swelling of the lymph nodes especially in the gore, neck and top of the collarbone; Exhaustion; Shivering; Fever; On the day of vaccination and the following 2 days, especially pain in the injection arm; Inability to work for a week; Myalgia; Headache; Hip pain / discomfort (possibly related to the lymph nodes); Arthralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110393. A 38 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: P-FK8911) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (disability) with onset 22Nov2021, outcome "recovering", described as "Severe swelling of the lymph nodes especially in the gore, neck and top of the collarbone"; ARTHRALGIA (disability) with onset 19Nov2021, outcome "recovering", described as "Hip pain / discomfort (possibly related to the lymph nodes)"; ARTHRALGIA (disability) with onset 19Nov2021, outcome "recovering", described as "Arthralgia"; FATIGUE (disability) with onset 22Nov2021, outcome "recovering", described as "Exhaustion"; MYALGIA (disability) with onset 19Nov2021, outcome "recovering", described as "Myalgia"; HEADACHE (disability) with onset 19Nov2021, outcome "recovering", described as "Headache"; CHILLS (disability) with onset 22Nov2021, outcome "recovering", described as "Shivering"; PYREXIA (disability) with onset 22Nov2021, outcome "recovering", described as "Fever"; VACCINATION SITE PAIN (disability) with onset 19Nov2021, outcome "recovering", described as "On the day of vaccination and the following 2 days, especially pain in the injection arm"; IMPAIRED WORK ABILITY (disability) with onset 19Nov2021, outcome "recovered" (26Nov2021), described as "Inability to work for a week". Therapeutic measures were not taken as a result of lymphadenopathy, arthralgia, arthralgia, fatigue, myalgia, headache, chills, pyrexia, vaccination site pain, impaired work ability. Clinical course: Additional information: Reporter comments: Treatment - No. Evolution of the ADR - In the process of healing. ADR time relationship - on the day of vaccination and the following 2 days mainly pain in the injected arm, joint and muscle pain and headaches from day 3 to day 6 after vaccination significant swelling of the lymph nodes especially in the area around tonsils/throat, neck and upper collarbone day 3 to day 6 fever and chills day 3 to day 8 fatigue and exhaustion as well as episodes of joint and muscle pain and headaches - hip pain / discomfort (possibly related to the lymph nodes) inability to work for a week until now episode of fatigue and exhaustion. ADR description - severe swelling of lymph nodes exhaustion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2002999 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FS9019 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Extensive swelling of vaccinated limb, Fatigue, Headache, Hypersensitivity, Immunisation, Loss of consciousness, Malaise, Myalgia, Nausea, Scan, Sensory disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Scanner; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC202101839388

Write-up: booster; Nausea; Myalgia; Somesthesia; Loss of consciousness; Shivering; Extended swelling of the arm; Malaise; Headache; Fatigue; Arthralgia; Somesthesia of the lower and upper left limbs/unused left limbs (vaccine side); This is a spontaneous report received from a contactable reporter Consumer from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: BE-FAMHP-DHH-N2021-111106. A 50 year-old female patient received BNT162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FS9019) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: PRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]. Vaccination history included: Comirnaty (dose 1, batch number: EW4811), administration date: 08Apr2021, for COVID-19 immunisation; Comirnaty (dose 2, batch number: EW6126), administration date: 12May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (life threatening) with onset 19Nov2021, outcome "unknown", described as "booster"; NAUSEA (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Nausea"; MYALGIA (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Myalgia"; HYPERSENSITIVITY (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Somesthesia"; LOSS OF CONSCIOUSNESS (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Loss of consciousness"; CHILLS (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Shivering"; EXTENSIVE SWELLING OF VACCINATED LIMB (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Extended swelling of the arm"; MALAISE (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Malaise"; HEADACHE (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Fatigue"; ARTHRALGIA (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Arthralgia"; SENSORY DISTURBANCE (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Somesthesia of the lower and upper left limbs/unused left limbs (vaccine side)". Clinical course: Somesthesia of the lower and upper left limbs since the injection of the 3rd dose. Discomfort requiring dispatch to the emergency room (loss of consciousness, unused left limbs (vaccine side)). Today (11Dec) still no improvement !!! be patient + asaflow !!! scheduled additional exams, not before 31Jan2022(who does not care). The patient was disgusted and not very reassured. Examinations included Scanner, the others not before the end of January 2022. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003231 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ultrasound Doppler, Vascular stent occlusion
SMQs:, Myocardial infarction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASS; EZETIMIBE; ATORVASTATIN; CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Arterial hypertension; Glucose tolerance impaired; Hypercholesterolaemia; Popliteal artery aneurysm; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: duplex sonography; Result Unstructured Data: Test Result:the stent was normal
CDC Split Type: DEPFIZER INC202101816881

Write-up: Closure of the stent located in the left popliteal artery; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Other Case identifier(s): DE-PEI-202100276620 (PEI), DE-DCGMA-21195134 (RA). A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: Unknown) at the age of 63 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Adipositas" (unknown if ongoing); "Glucose tolerance impaired" (unknown if ongoing); "Hypercholesterolaemia" (unknown if ongoing); "Stent placement" (unknown if ongoing); "Popliteal artery aneurysm" (not ongoing); "Arterial hypertension" (unknown if ongoing). Concomitant medication(s) included: ASS taken for stent placement, start date: Aug2019; EZETIMIBE taken for hypercholesterolaemia, start date: 2020; ATORVASTATIN taken for hypercholesterolaemia, start date: Aug2019; CANDESARTAN taken for hypertension, start date: Aug2019. The following information was reported: VASCULAR STENT OCCLUSION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "Closure of the stent located in the left popliteal artery". The patient was hospitalized for vascular stent occlusion (start date: 2021). The patient underwent the following laboratory tests and procedures: ultrasound doppler: (Sep2021) the stent was normal. Therapeutic measures were taken as a result of vascular stent occlusion. Clinical course: Measures because of critical ischaemia, surgical therapy (left femorocrural bypass) was necessary. The vascular situation and perfusion of the lower extremity had previously been checked regularly by duplex sonography, the stent was normal in Sep2021. The relatedness of Comirnaty to the event Vascular stent occlusion was reported as unclassifiable. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2003888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101876281

Write-up: This is a spontaneous report from a contactable consumer (patient). This is the third of three reports. The first report is a report downloaded from Regulatory Authority. Regulatory number: FI-FIMEA-20217701 (RA). A 60-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection), administered in the left upper arm, administration date 19Nov2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (dose 2, single; site: left upper arm), administration date: 19May2021, for COVID-19 immunization, reaction(s): "Retinal vein thrombosis"; COMIRNATY (dose 1, single; site: left upper arm), for COVID-19 immunization, reaction(s): "Arthralgia", "Weakness", "Headache", "Pyrexia", "Snoring". The following information was reported: On 19Nov2021, the patient received the booster dose. On an unspecified date, the patient''s upper arm was sore for about a week and the lymph nodes in her armpit were swollen. The patient mentioned that despite all the nasty symptoms she''d rather have a vaccine than a corona. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s): FI-PFIZER INC-202101876280 same reporter, patient, and drug; different dose and event; FI-PFIZER INC-202101817738 same reporter, patient, and drug; different dose and event.


VAERS ID: 2004070 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Sickle cell anaemia with crisis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROXYUREA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthenia (since about 1 week before vaccination); Sickle cell disease (SS sickle cell patient); Vascular disorder (about 3 vaso oclusive attacks per year, the last one in May2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101828237

Write-up: Vaso-occlusive crisis; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-PC20215369 (RA). A 34 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: Unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Drepanocytosis/ Sickle cell disease" (unspecified if ongoing), notes: SS sickle cell patient; "vaso oclusive attacks" (unspecified if ongoing), notes: about 3 vaso oclusive attacks per year, the last one in May2021; "Asthenia" (unspecified if ongoing), notes: since about 1 week before vaccination. Concomitant medication(s) included: HYDROXYUREA taken for sickle cell disease. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, 2nd dose, no notable adverse effects), for Covid-19 immunisation, reaction(s): "no notable adverse effects"; Covid-19 vaccine (Manufacturer unknown, 1st dose, no notable adverse effects), for Covid-19 immunisation, reaction(s): "no notable adverse effects". The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; SICKLE CELL ANAEMIA WITH CRISIS (hospitalization, medically significant) with onset 20Nov2021, outcome "recovered" (29Nov2021), described as "Vaso-occlusive crisis". Therapeutic measures were taken as a result of sickle cell anaemia with crisis. Clinical course: This non-serious case, of the type Spontaneous Notification, received by Internet Site, was notified by a doctor. SS sickle cell patient, about 3 vaso oclusive attacks per year, the last one in May2021. Under long term hydroxyurea treatment, no recent change in compliance (mean corpuscular volume increased by the treatment, which is stable). The next day: occurrence of a hyperalgesic vasoocclusive crisis of the back, failure of analgesia with paracetamol - tramadol motivating a hospitalization for analgesia + monitoring of acute chest syndrome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Inflammation, Palpitations, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101829192

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (RA). Regulatory number: GB-MHRA-APPCOVID-202112200518084950-B2MSW (RA). Other Case identifier(s): GB-MHRA-ADR 26361109 (RA). A 56-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Lot number: FK0112) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The following information was reported: SWELLING (medically significant) with onset 19Nov2021, outcome "recovered" (28Nov2021), described as "Swelling"; INFLAMMATION (medically significant) with onset 19Nov2021, outcome "recovered" (24Nov2021), described as "Inflammation"; FATIGUE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Shortness of breath"; PALPITATIONS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Palpitations". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Exercise tolerance decreased, Gait disturbance, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101824191

Write-up: Painful joints; previously received doses 1 and 2 of Covid-19 vaccine (MANUFACTURER UNKNOWN) and COMIRNATY as dose 3 (booster); previously received doses 1 and 2 of Covid-19 vaccine (MANUFACTURER UNKNOWN) and COMIRNATY as dose 3 (booster); previously received doses 1 and 2 of Covid-19 vaccine (MANUFACTURER UNKNOWN) and COMIRNATY as dose 3 (booster); Affects walking and bending until joints loosen up; Unable to do my normal 60 minute morning exercise routine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112170800456360-GT2XT (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26349508 (regulatory authority). A 60-year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The patient was not on any medication. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient previously received doses 1 and 2 of Covid-19 vaccine (MANUFACTURER UNKNOWN) for COVID-19 immunisation. The patient experienced painful joints on 21Nov2021. The event was reported as serious (other medically important condition). The clinical course was reported as follows: very painful knees especially in the mornings. Affects walking and bending until joints loosen up in 2021. The patient was unable to do her normal 60 minute morning exercise routine in 2021. The patient will go to GP if not recovered by early Jan2022. Patient has not tested positive for COVID-19 since having the vaccine. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of painful joints was not recovered while unknown for the other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Rash, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Coeliac disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101821679

Write-up: rash started on left arm; Skin rash; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112172009162150-I8VSA (RA). Other Case identifier(s): GB-MHRA-ADR 26354663 (RA). A 49-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef... Concomitant medications included: influenza vaccine inact SAG 3V (INFLUVAC) taken for prophylaxis, administration date 10Nov2021; ethinylestradiol;levonorgestrel (MICROGYNON) taken for contraception, start date: 1986. Past drug history included: Penicillin, reaction: "allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; RASH ERYTHEMATOUS (medically significant), outcome "recovering", described as "rash started on left arm"; RASH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Skin rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of rash erythematous, rash included taking strong anti histamine, steroid cream, eunovate cream and using calamine lotion. Clinical course: Rash started on left arm, then side of neck and face, then spread to right arm, chest. 4 wks o.n its now on back. Patient has not had symptoms associated with COVID-19. Patient last menstrual period date was 22Nov2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Dysaesthesia, Fatigue, Herpes zoster, Immunisation, Noninfective gingivitis
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Gingival disorders (narrow), Guillain-Barre syndrome (broad), Arthritis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; LOSARTAN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101822833

Write-up: gum inflammation; worsening of arthritis; loss of stamina; Funny fizzy skin feelings; Shingles; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202112172208053010-ZFBAW (RA). Other Case identifier(s): GB-RA-ADR 26355498 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pain" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication(s) included: IBUPROFEN taken for pain; LOSARTAN taken for hypertension; PARACETAMOL taken for pain. Vaccination history included: Bnt162b2 (DOSE: 01, lot number: EN1185), administration date: 16Feb2021, for COVID-19 Immunisation; Bnt162b2 (DOSE: 02, lot number: ER7934), administration date: 09May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; NONINFECTIVE GINGIVITIS (medically significant), outcome "recovering", described as "gum inflammation"; HERPES ZOSTER (medically significant) with onset 12Dec2021, outcome "not recovered", described as "Shingles"; ARTHRITIS (medically significant), outcome "unknown", described as "worsening of arthritis"; FATIGUE (medically significant), outcome "unknown", described as "loss of stamina"; DYSAESTHESIA (medically significant), outcome "unknown", described as "Funny fizzy skin feelings". The events "gum inflammation", "shingles", "worsening of arthritis", "loss of stamina" and "funny fizzy skin feelings" were evaluated at the physician office visit. After each of the three doses experienced a worsening of arthritis and loss of stamina, for a few weeks. Measurable with Garmin info as well. Funny fizzy skin feelings after each jab too for a while. Gum inflammation without infection on a still healing socket. Shingles developed unexpectedly 12/12 but possibly as a result of being debilitated from the vaccine or possibly coincidence. But felt essential to report and had not previously reported the arthritis and loss of stamina so this report includes that. The patient had GP diagnosis. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 2006972 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Fatigue, Headache, Malaise, Myalgia, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Fever; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: Moderate fever
CDC Split Type: BEPFIZER INC202101762678

Write-up: Myalgia; Extensive swelling of vaccinated limb; Fever/Moderate fever 38.7 centigrade; Fatigue; Headache; vaccination site reaction; Malaise; Exhaustion; Arthralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Agency-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109689. An adult male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH0114) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1; lot: FJ5782), administration date: 28Oct2021, for COVID-19 immunisation. The following information was reported: MYALGIA (disability) with onset 19Nov2021, outcome "recovering", described as "Myalgia"; EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 19Nov2021, outcome "recovering", described as "Extensive swelling of vaccinated limb"; PYREXIA (disability) with onset 19Nov2021, outcome "recovering", described as "Fever/Moderate fever 38.7 centigrade"; FATIGUE (disability) with onset 19Nov2021, outcome "recovering", described as "Fatigue"; HEADACHE (disability) with onset 19Nov2021, outcome "recovering", described as "Headache"; VACCINATION SITE REACTION (disability) with onset 19Nov2021, outcome "recovering", described as "vaccination site reaction"; MALAISE (disability) with onset 19Nov2021, outcome "recovering", described as "Malaise"; FATIGUE (disability) with onset 19Nov2021, outcome "recovering", described as "Exhaustion"; ARTHRALGIA (disability) with onset 19Nov2021, outcome "recovering", described as "Arthralgia". The patient underwent the following laboratory tests and procedures: pyrexia: (19Nov2021) 38.7 Centigrade, notes: Moderate fever. Therapeutic measures were not taken as a result of myalgia, extensive swelling of vaccinated limb, pyrexia, fatigue, headache, vaccination site reaction, malaise, fatigue, arthralgia. Reporter Comment: Treatment: No. Evolution of the ADR: In the process of recovering No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: No. Evolution of the ADR: In the process of recovering


VAERS ID: 2009558 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211208; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Eye swelling; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26391995) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EYE SWELLING (Eye swelling) (seriousness criterion medically significant). On 22-Nov-2021, EYE SWELLING (Eye swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided Patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials. Company comment: This regulatory case concerns a 63-year-old male patient, with no medical history reported, who experienced the serious unexpected event of EYE SWELLING. The event occurred on the same day of the third dose of mRNA-1273. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 63-year-old male patient, with no medical history reported, who experienced the serious unexpected event of EYE SWELLING. The event occurred on the same day of the third dose of mRNA-1273. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2009743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Back pain, Blood pressure increased, Dizziness, Fatigue, Hypoaesthesia, Myocarditis, Pericarditis
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101830976

Write-up: suspicion for myocarditis; suspicion for pericarditis; Fatigue extreme; Numbness of lower extremities; Blood pressure increased (circa 19); intense back pain; intense Cardiac pain; prolonged Dizziness for almost 20 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: -GREOF-202110004 . A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "Fatigue extreme"; HYPOAESTHESIA (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "Numbness of lower extremities"; BLOOD PRESSURE INCREASED (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "Blood pressure increased (circa 19)"; BACK PAIN (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "intense back pain"; ANGINA PECTORIS (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "intense Cardiac pain"; DIZZINESS (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "prolonged Dizziness for almost 20 days"; MYOCARDITIS (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "suspicion for myocarditis"; PERICARDITIS (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "suspicion for pericarditis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-19
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve repair
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20220105450

Write-up: VACCINATION FAILURE; COVID-19 RESPIRATORY INFECTION; This spontaneous report received from a physician via a Regulatory Authority (FR-AFSSAPS-ST20214858) on 05-JAN-2022 and concerned a 61 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: mitral valve repair and concurrent conditions included: hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) 0.5 ml, 4 weeks, administered on an unspecified date in JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced vaccination failure and covid-19 respiratory infection. On an unspecified date patient was hospitalized. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vaccination failure, and covid-19 respiratory infection. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.


VAERS ID: 2011319 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004674 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Myocarditis, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211205; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue/unusual tiredness; Heart palpitations; Chest pain; Racing heart (tachycardia); Myocarditis; This case was received via Regulatory Agency (Reference number: GB-MHRA-WEBCOVID-202112131354319050-WUSOW) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations), MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain) and TACHYCARDIA (Racing heart (tachycardia)) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT 3004674) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-Mar-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations), CHEST PAIN (Chest pain) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown and MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. No treatment medication was provided. Company comment: This regulatory authority case concerns a 63-year-old male patient with no relevant medical history reported, who experienced the expected serious (medically significant) event of Myocarditis and the unexpected serious (medically significant) events of Fatigue, Palpitations, Chest pain and Tachycardia after mRNA- 1273 vaccine, third dose of the vaccination schedule (reported as 3b dose). The patient had previously received dose of COVID-19 Vaccine AstraZeneca. The event Myocarditis occurred on the day after the third dose of mRNA- 1273 vaccine. For the rest of the events, temporal relationship was not disclosed. Palpitations, Chest pain and Tachycardia might be in connection with Myocarditis, however temporal association is unknown. No information was provided regarding diagnostic criteria, clinical course and treatment for Myocarditis. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 63-year-old male patient with no relevant medical history reported, who experienced the expected serious (medically significant) event of Myocarditis and the unexpected serious (medically significant) events of Fatigue, Palpitations, Chest pain and Tachycardia after mRNA- 1273 vaccine, third dose of the vaccination schedule (reported as 3b dose). The patient had previously received dose of COVID-19 Vaccine AstraZeneca. The event Myocarditis occurred on the day after the third dose of mRNA- 1273 vaccine. For the rest of the events, temporal relationship was not disclosed. Palpitations, Chest pain and Tachycardia might be in connection with Myocarditis, however temporal association is unknown. No information was provided regarding diagnostic criteria, clinical course and treatment for Myocarditis. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2011845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Odynophagia, SARS-CoV-2 test, Swelling, Swollen tongue, Tongue disorder, Tonsillar hypertrophy
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101847070

Write-up: Swelling; Bumps tongue; Swollen tonsils every week for a few days; Tongue swelling; Dry cough; painful to swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112220651117830-YP1UE, other case identifier(s) GB-MHRA-ADR 26375942. A 25 year-old female patient (not pregnant, not currently breastfeeding) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient last menstrual period date 06Nov2021. The following information was reported SWELLING (medically significant) with onset 19Nov2021, outcome not recovered; TONGUE DISORDER (medically significant) with onset 19Nov2021, outcome not recovered; TONSILLAR HYPERTROPHY (medically significant) with onset 2021, outcome unknown; SWOLLEN TONGUE (medically significant) with onset 2021, outcome unknown; COUGH (medically significant) with onset 2021, outcome unknown; ODYNOPHAGIA (medically significant) with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstruation irregular, Off label use, Pelvic haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101852187

Write-up: I have not had a period for almost 12 months; Pelvic bleeding; Heavy period; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112222207059730-ENV1N (MHRA). Other Case identifier(s): GB-MHRA-ADR 26381908 (MHRA). A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PELVIC HAEMORRHAGE (medically significant) with onset 19Dec2021, outcome "not recovered", described as "Pelvic bleeding"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset Dec2021, outcome "unknown", described as "Heavy period"; MENSTRUATION IRREGULAR (medically significant), outcome "unknown", described as "I have not had a period for almost 12 months". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Last menstrual period was on 19Dec2021. Heavy period started almost exactly 4 weeks following dose of pfizer vaccine. I have not had a period for almost 12 months. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pericarditis, SARS-CoV-2 test, Scan, Troponin, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CARVEDILOL; CETIRIZINE; DEXAMETHASONE; FRAGMIN; RANOLAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Microvascular angina; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211124; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20211125; Test Name: scan; Result Unstructured Data: Test Result:Unknown results; Test Name: Troponin; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211124; Test Name: Xray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101856857

Write-up: Fatigue/unusual tiredness; Chest pain/pain in chest.; Shortness of breath; Pericarditis; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112231423526180-M1IBV (RA). Other Case identifier: GB-MHRA-ADR 26386011 (RA). A 51-year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: FL1939) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy); "Microvascular angina" (unspecified if ongoing); "Chemotherapy" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19. Concomitant medications included: CARVEDILOL taken for microvascular coronary artery disease; CETIRIZINE taken for chemotherapy; DEXAMETHASONE taken for chemotherapy; FRAGMIN taken for chemotherapy; RANOLAZINE taken for microvascular coronary artery disease. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PERICARDITIS (medically significant) with onset 21Dec2021, outcome "recovering", described as "Pericarditis"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain/pain in chest."; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath". The events "pericarditis", "fatigue/unusual tiredness", "chest pain/pain in chest." and "shortness of breath" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (24Nov2021) unknown results; electrocardiogram: (24Nov2021) unknown results; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test; scan: (25Nov2021) unknown results; troponin: (unspecified date) unknown results; x-ray: (24Nov2021) unknown results. Going for a short walk (less than a mile); Walking up / downstairs; Walking on the flat and then increase incline (hill), all resulting shortness of breath and pain in chest. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2013011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Irritable bowel syndrome, Prostatitis
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Grass allergy; Irritable bowel syndrome; Multiple allergies (allergies to parietariae and grasses,); Prostatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101817487

Write-up: Severe lower abdominal pain; intensification of urogenital (prostatitis) symptoms; intensification of gastrointestinal (ibs) symptoms/still present, as are the exacerbated symptoms.; This is a spontaneous report received from a contactable reporter(s) (Lawyer) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-820501. A 42 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unknown if ongoing); "Irritable bowel syndrome" (unknown if ongoing); "Multiple allergies" (unknown if ongoing), notes: allergies to parietariae and grasses,; "grass allergy" (unspecified if ongoing); "Prostatitis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN LOWER (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Severe lower abdominal pain"; PROSTATITIS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "intensification of urogenital (prostatitis) symptoms"; IRRITABLE BOWEL SYNDROME (medically significant) with onset 19Nov2021, outcome "not recovered", described as "intensification of gastrointestinal (ibs) symptoms/still present, as are the exacerbated symptoms.". Therapeutic measures were taken as a result of abdominal pain lower, prostatitis, irritable bowel syndrome. Severe pain in the lower abdomen, never felt before with intensification of gastrointestinal and urogenital symptoms already suffered. The pain decreased only somewhat after a few weeks, but is still present, as are the exacerbated symptoms. Influence on quality of life: 9/10. Actions taken: intake of corticosteroids. He takes cernilen flogo. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2013085 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-11-19
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Alpha-1 anti-trypsin, Antibody test, Antinuclear antibody, Asthenia, Beta 2 microglobulin, Biopsy liver, Blood alkaline phosphatase, Ceruloplasmin, Chromaturia, Decreased appetite, Differential white blood cell count, Epstein-Barr virus antibody, Gamma-glutamyltransferase, Hepatitis A antibody, Hepatitis B surface antigen, Hepatitis C antibody, Hepatitis acute, Hyperbilirubinaemia, Immunoglobulins, Specialist consultation, Toxoplasmosis, Transaminases, Ultrasound abdomen
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Alpha-1 anti-trypsin; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Antibody test; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Antinuclear antibody; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Beta 2 microglobulin; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211125; Test Name: Biopsy liver; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: ALK phosph; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Ceruloplasmin; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Differential white blood cell count; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Epstein-Barr virus antibody; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Gamma GT; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Hepatitis A IgM; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: HBsAg; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Hepatitis C antibody; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Bilirubinaemia; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Immunoglobulins; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211210; Test Name: Gastroenterologist consultation; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Toxoplasmosis; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Transaminases; Test Result: Inconclusive ; Result Unstructured Data: Report not provided; Test Date: 20211119; Test Name: Ultrasound abdomen; Test Result: Inconclusive ; Result Unstructured Data: Report not provided
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.; Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.; Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.; Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.; Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.; This case was received via regulatory agency (Reference number: IT-MINISAL02-821813) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This case was received via regulatory agency (Reference number: IT-MINISAL02-821813) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATITIS ACUTE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), DECREASED APPETITE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), ABDOMINAL PAIN (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), ASTHENIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) and CHROMATURIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005687 and 3005687) for COVID-19 vaccination. The patient''s past medical history included Hashimoto''s thyroiditis on 01-Jan-2007 and COVID-19 on 01-Nov-2020. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced HEPATITIS ACUTE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) (seriousness criterion hospitalization), ABDOMINAL PAIN (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) (seriousness criterion hospitalization), ASTHENIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) (seriousness criterion hospitalization) and CHROMATURIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) (seriousness criterion hospitalization). At the time of the report, HEPATITIS ACUTE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), DECREASED APPETITE (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), ABDOMINAL PAIN (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.), ASTHENIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) and CHROMATURIA (Progressive onset following dose II of the Moderna covid19 vaccine of asthenia, lack of appetite, abdominal pain and hyperchromic urine, with the aforementioned diagnosis of hepatitis frank.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Alpha-1 anti-trypsin: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Antibody test: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Antinuclear antibody: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Beta 2 microglobulin: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Blood alkaline phosphatase: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Ceruloplasmin: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Differential white blood cell count: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Epstein-Barr virus antibody: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Gamma-glutamyltransferase: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Hepatitis A antibody: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Hepatitis B surface antigen: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Hepatitis C antibody: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Hyperbilirubinaemia: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Immunoglobulins: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Toxoplasmosis: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Transaminases: report not provided (Inconclusive) Report not provided. On 19-Nov-2021, Ultrasound abdomen: report not provided (Inconclusive) Report not provided. On 25-Nov-2021, Biopsy liver: report not provided (Inconclusive) Report not provided. On 10-Dec-2021, Specialist consultation: report not provided (Inconclusive) Report not provided. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. On an unknown date, biopsy was taken which identified aggressive chronic hepatitis. Liver biopsy showed evidence of aggressive hepatitis compatible with autoimmune damage. Patient parameters were improving. Blood chemical investigations ruled out Viral hepatitis or accumulation diseases. Highlighted positive for ANA 1/640 autoantibodies. Relevant concomitant product usage were not reported by the reporter. No treatment details were added.; Reporter''s Comments: Hepatitis of an autoimmune nature in a predisposed patient, in need of hospitalization and monitoring, presented frankly about a month after the second dose of the anticovid 19 Moderna vaccine. The parameters are currently improving. The biopsy identified aggressive chronic hepatitis but monitoring over time is required to establish its chronic character.Blood chemical investigations ruled out viral hepatitis or accumulation diseases, highlighting positiveness for ANA 1/640 autoantibodies. Subsequently, liver biopsy with the evidence of aggressive hepatitis compatible with autoimmune damage.; Sender''s Comments: This is a regulatory case concerning a 30-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Hepatitis acute, Decreased appetite, Abdominal pain, and Asthenia(seriousness criterion hospitalization). These events occurred approximately 1 month after the patient received second dose of mRNA-1273 (Spikevax). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2013153 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Cardiac failure congestive, Echocardiogram, Immunisation, Magnetic resonance imaging heart, Myocarditis, Overdose, Serology test, Troponin
SMQs:, Cardiac failure (narrow), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Coronarography; Result Unstructured Data: Test Result:negative for plaques or circulatory disorders; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal limits; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:left edema; Test Name: Serology test; Result Unstructured Data: Test Result:negative for viruses; Test Name: Troponin; Result Unstructured Data: Test Result:elevated
CDC Split Type: ITPFIZER INC202101838838

Write-up: Myocarditis; Booster; magnetic resonance imaging heart: left edema; patient received bnt162b2 as dose 3 (booster), 0.45 ml single; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-822698 Regulatory Authority. A 53-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 19Nov2021 10:47 (Lot number: 1F1005A, Expiration Date: 31Mar2022) as dose 3 (booster), 0.45 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 19Nov2021, described as "Booster"; MYOCARDITIS (hospitalization) with onset 10Dec2021, outcome "recovering", described as "Myocarditis"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "magnetic resonance imaging heart: left edema"; OVERDOSE (non-serious) with onset 19Nov2021, described as "patient received bnt162b2 as dose 3 (booster), 0.45 ml single". The patient underwent the following laboratory tests and procedures: angiocardiogram: negative for plaques or circulatory disorders; echocardiogram: normal limits; magnetic resonance imaging heart: left edema; serology test: negative for viruses; troponin: elevated. Reporter Comment: ELEVATED TROPONINS; SEROLOGIES NEGATIVE FOR VIRUSES; LEFT OEDEMA FOR MAGNETIC RESONANCE IMAGING ECHOCARDIO WITHIN NORMAL LIMITS; CORONARY ANGIOGRAPHY NEGATIVE FOR PLAQUES OR CIRCULATORY DISORDERS DIAGNOSIS: ASEPTIC MYOCARDITIS. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: ELEVATED TROPONINS; SEROLOGIES NEGATIVE FOR VIRUSES; LEFT OEDEMA FOR MAGNETIC RESONANCE IMAGING ECHOCARDIO WITHIN NORMAL LIMITS; CORONARY ANGIOGRAPHY NEGATIVE FOR PLAQUES OR CIRCULATORY DISORDERS DIAGNOSIS: ASEPTIC MYOCARDITIS.


VAERS ID: 2013495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-11-19
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: covid-19; Test Result: Positive
CDC Split Type: NLPFIZER INC202101842443

Write-up: On 19Nov2021 I tested positive for covid.; vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): 00520423. A female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Nov2021, outcome "unknown", described as "On 19Nov2021 I tested positive for covid."; DRUG INEFFECTIVE (medically significant) with onset 19Nov2021, outcome "unknown", described as "vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2013706 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: ELEVATED BP; Result Unstructured Data: Test Result:150/90; Comments: at 13:37
CDC Split Type: PHPFIZER INC202101663564

Write-up: Elevated BP (150/90); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120647. A 14 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: PCB0002) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 19Nov2021 13:37, outcome "recovered" (19Nov2021), described as "Elevated BP (150/90)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 150/90, notes: at 13:37. The reporter classified the event as non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2013820 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache, Hypoaesthesia, Immunisation, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101859243

Write-up: lack of sensation in the left leg/ I haven''t felt my left leg; Weakness/ I''m just weak; still on sick leave; Vomiting; Chills; Tiredness; Headache; Arthralgia; Pyrexia; booster; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory Authority-WEB; the Regulatory report number is AT-BASGAGES-2021-063859 (RA). A 50-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 19Nov2021 (batch/lot number: FH0161) at the age of 50 years old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (first dose, manufacturer unknown (batch/lot number: unknown) as DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (second dose, manufacturer unknown (batch/lot number: unknown) as DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown" described as "booster"; HYPOAESTHESIA (medically significant), outcome "recovered" described as "lack of sensation in the left leg/ I haven''t felt my left leg"; ASTHENIA (medically significant), outcome "not recovered" described as "Weakness/ I''m just weak"; MALAISE (non-serious), outcome "not recovered" described as "still on sick leave"; VOMITING (non-serious), outcome "recovered" described as "Vomiting"; CHILLS (non-serious), outcome "recovered" described as "Chills"; ARTHRALGIA (non-serious) with onset 01Dec2021, outcome "recovered" described as "Arthralgia"; FATIGUE (non-serious), outcome "recovered" described as "Tiredness"; HEADACHE (non-serious), outcome "recovered" described as "Headache"; and PYREXIA (non-serious) with onset 19Nov2021, outcome "recovered" described as "Pyrexia." The adverse event was reported as follows: I haven''t been to the hospital or to the doctor, I haven''t felt my left leg either, now I''m still on sick leave - I''m just weak. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015126 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Myalgia, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVERAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101859397

Write-up: Booster; Arthralgia; Headache; Shivering; Injection site reaction; Fever; Fatigue; Myalgia; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-111299. A 54-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administration date 19Nov2021 (Lot number: FJ5782) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "HTA" (unspecified if ongoing). Concomitant medication(s) included: COVERAM. Vaccination history included: Comirnaty (Dose 2, batch number: EK9788), administration date: 04Mar2021, for COVID-19 immunisation; Comirnaty (Dose 1, batch number: EJ6134), administration date: 04Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Arthralgia"; HEADACHE (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Headache"; CHILLS (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Shivering"; VACCINATION SITE REACTION (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Injection site reaction"; PYREXIA (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Fever"; FATIGUE (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Fatigue"; MYALGIA (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Myalgia". Therapeutic measures were taken as a result of immunisation, arthralgia, headache, chills, vaccination site reaction, pyrexia, myalgia including paracetamol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-11-19
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pneumonia; Wisdom teeth removal
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101859911

Write-up: Pericarditis sicca; Left pleural effusion of low abundance; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-MP20218895. A 23-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administration date 06Oct2021 (Lot number: FA4597) as dose 2, single for COVID-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing); "Wisdom teeth removal" (unspecified if ongoing); "Pneumonia", start date: 2017, stop date: 2017. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization) with onset 19Nov2021, outcome "recovering", described as "Pericarditis sicca"; PLEURAL EFFUSION (hospitalization) with onset 19Nov2021, outcome "recovering", described as "Left pleural effusion of low abundance".


VAERS ID: 2016191 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shivering; Heart pounding; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26399477) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering) and PALPITATIONS (Heart pounding) in a 76-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30004675) for an unknown indication. No medical history was reported. Concomitant products included MIRTAZAPINE from 01-Sep-2015 to an unknown date for Depression. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). On 26-Nov-2021, PALPITATIONS (Heart pounding) had resolved. At the time of the report, CHILLS (shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient had Shivering and cold. No treatment medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had visited to Hospital. Company Comment This case concerns a 76-year-old female patient with no reported medical history, who experienced the serious, unexpected events of Chills and Palpitations. The event of Palpitation occurred the same day after the third dose of mRNA-1273 vaccine while the event of Chills occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 76-year-old female patient with no reported medical history, who experienced the serious, unexpected events of Chills and Palpitations. The event of Palpitation occurred the same day after the third dose of mRNA-1273 vaccine while the event of Chills occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 2016349 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 10359267100013 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Magnetic resonance imaging head, Platelet count
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEBIVOLOL; MISSEE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign breast lump removal; COVID-19 (with mild symptoms); Endometriosis; No reaction on previous exposure to vaccine
Allergies:
Diagnostic Lab Data: Test Date: 20211206; Test Name: MRI brain; Result Unstructured Data: Test Result:sinus sigmoideus,; Comments: transverse sinus and internal jugular vein thrombosis on the left side; Test Date: 20211208; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:298 g/l
CDC Split Type: HUPFIZER INC202101859267

Write-up: Cerebral venous sinus thrombosis/with symptoms headaches,high tension was usually measured by the patient; This is a spontaneous report received from a contactable Physician from the regulatory authority-WEB. Regulatory number: HU-OGYI-0850521 (OGYI). A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: 10359267100013) at the age of 36 years as dose 1, 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 19Mar2021 (not ongoing), notes: with mild symptoms; "Endometriosis" (unknown if ongoing); "No reaction on previous exposure to vaccine (unknown if ongoing)"; "Benign breast lump removal" (not ongoing). Concomitant medication(s) included: NEBIVOLOL; MISSEE taken for endometriosis, start date: 01Jun2020, stop date: 07Dec2021. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS ( spitalization) with onset 19Nov2021, outcome "recovering", described as "Cerebral venous sinus thrombosis/symptoms headaches, high tension was usually measured by the patient". The patient was hospitalized for cerebral venous sinus thrombosis (start date: Dec2021, discharge date: 11Dec2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (06Dec2021) sinus sigmoideus,, notes: transverse sinus and internal jugular vein thrombosis on the left side; platelet count: (08Dec2021) 298 g/l. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis includes anticoagulant therapy was applied beside analgesics. Clinical course: On 06Dec2021, the patient was examined at a Neurology Department due to recurring left-sided headaches started approximately 2 months before. In addition to headaches, high tension was usually measured by the patient, which resolved after taking unknown nebivolol. The patient was observed for 4 days.The use of oral contraception may have played a role in the development of complaints and its use was not recommended by the neurologist. The causal relationship between the event and Comirnaty is considered unlikely. Sender comment: Cerebral venous sinus thrombosis is not expected after Comirnaty vaccination. Diagnosis was estabilished 17 days after vaccination, although the complaints started more than 4 weeks before. The event is more likely to be related to the concomitant drug Missee. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016393 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present; after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present; This case was received via Regulatory Authority(Reference number: IT-MINISAL02-820814) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) and ARTHRALGIA (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) in a 38-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) (seriousness criterion disability) and ARTHRALGIA (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) and ARTHRALGIA (after the second dose anticovid-19 I started to have muscle pain in the legs and joints of the lower limbs, still present) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was given. No treatment medication was given. Company Comment: This case concerns a 38-year-old male patient, with no reported medical history in this case, who experienced the unexpected serious adverse events of Pain in extremity and Arthralgia. The events occurred, as per Reported by the Primary Source after the administration of the second dose of mRNA-1273 vaccine and the outcome at the time of the report was Unknown. The rechallenge is not applicable since not another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old male patient, with no reported medical history in this case, who experienced the unexpected serious adverse events of Pain in extremity and Arthralgia. The events occurred, as per Reported by the Primary Source after the administration of the second dose of mRNA-1273 vaccine and the outcome at the time of the report was Unknown. The rechallenge is not applicable since not another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage, Immunisation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101862885

Write-up: Subconjunctival hemorrhage; Booster; This is a spontaneous report received from a contactable physician from the WEB. Regulatory number: IT-MINISAL02-823238 A 40-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection), intramuscular, administered in the left deltoid, administration date 19Nov2021 11:49 (Lot number: 1F1005A) as dose 3 (booster), 30 ug single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (dose 1, single; lot number: unknown), administration date: 07Jan2021, for COVID-19 immunization; COMIRNATY (dose 2, single; lot number: unknown), administration date: 28Jan2021, for COVID-19 immunization. The following information was reported: On 19Nov2021 11:49, the patient received the booster dose. On 20Nov2021, the patient experienced subconjunctival hemorrhage. Therapeutic measures were taken as result of the event which included heparin drops. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-11-19
   Days after vaccination:304
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101867533

Write-up: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable physician from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-167. A 45-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection), intramuscular, administration date 19Jan2021 (Lot number: EJ6797) as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 19Nov2021, outcome "unknown", described as "COVID-19". The reporter''s assessment of the casual relationship of the events with the suspect product was possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-11-19
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Goiter; Pulmonary embolism; Uncontrolled hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101874395

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from The Regulatory Authority WEB and product quality group. Regulatory number: PT-INFARMED-T202112-898 (INFARMED). A 78 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 11May2021 (Lot number: EX6537) as dose 2, 0.3 ml single and intramuscular, administration date 13Apr2021 (Lot number: EW2243) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Dyslipidaemia", start date: 2018 (unknown if ongoing); "Pulmonary embolism" (unknown if ongoing); "Goiter", start date: 2018 (unknown if ongoing); "Uncontrolled hypertension", start date: 2019 (unknown if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE with onset 19Nov2021, outcome "recovered" (29Nov2021), described as "Vaccination failure"; COVID-19 with onset 19Nov2021, outcome "recovered" (29Nov2021), described as "COVID-19". Clinical courses: The relatedness of drug to reaction(s)/event(s) was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-11-19
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positivo Iu international unit(s)
CDC Split Type: PTPFIZER INC202101846670

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-910. A 41 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 04Aug2021 (Lot number: FE8235, Expiration Date: 30Nov2021) as dose 2, 0.3 ml single and intramuscular, administration date 07Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "recovered" (03Dec2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 19Nov2021, outcome "recovered" (03Dec2021), described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive, notes: Positivo Iu international unit(s). Investigation result received on 28Dec2021 showed that the complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE8235 and FE6029. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The reporters assessment of the casual relationship of the (Vaccination failure) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Probable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2017078 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8372 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse reaction to antibiotics (Previous drug reaction: penicillin rash when I was a child. When I had an ear infection.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101833243

Write-up: Tiredness; Nausea; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. -WEB. The reporter is the patient. Regulatory number: SE-MPA-2021-097466. Other Case identifier(s): SE-VISMA-1639299413136. A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FJ8372) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adverse reaction to antibiotics" (not ongoing), notes: Previous drug reaction: penicillin rash when I was a child. When I had an ear infection. The patient''s concomitant medications were not reported. The following information was reported: NAUSEA (disability, medically significant) with onset 19Nov2021, outcome "recovered", described as "Nausea"; DIZZINESS (disability, medically significant) with onset 19Nov2021, outcome "recovered", described as "Dizziness"; FATIGUE (disability, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Tiredness". Clinical course: Reported suspected side effect was fatigue starting 3 days after vaccination, which was described as constant and that it affected both work and personal life. The report described the man as feeling ''motion sickness'' on the evening he was vaccinated, which was described as dizziness and nausea from which he recovered 3 to 4 days after onset. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2017192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0003 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Epistaxis, Immunisation, Off label use, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:high
CDC Split Type: SEPFIZER INC202101876107

Write-up: Nose bleed; On the same day as dose 3 of Comirnaty was given, the woman also received VaxigripTetra; On the same day as dose 3 of Comirnaty was given, the woman also received VaxigripTetra; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from the regulatory authority-WEB. A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: PCB0003) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: some episode of anaphylaxis and urticaria. Concomitant medication(s) included: influenza vaccine inact split 4v (VAXIGRIPTETRA) taken for immunisation, administration date 19Nov2021, same day as Comirnaty dose 3. Vaccination history included: Comirnaty (Dose 1, Batch: EJ6136), administration date: 08Feb2021, for COVID-19 immunisation, but no significant side effects from dose 1; Comirnaty (Dose 2, Batch: EP2163), administration date: 01Mar2021, for COVID-19 immunisation, reaction(s): nose bleed, myalgia, high fever, swelling of hands, vaccination site pain, arthralgia, headache and vaccination site lymphadenopathy. The following information was reported: Reported suspect adverse event was nose bleed on 23Nov2021, 4 days after dose 3, the heavy nosebleed took time to stop. However, did not need to seek care. The patient does not usually have nosebleeds in normal cases. Outcome was not recovered/not resolved. Report assessed as serious, other medically important event.


VAERS ID: 2020195 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tension headache
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; MIRENA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Tension headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26401432) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included LEVONORGESTREL (MIRENA) from 01-Aug-2021 to an unknown date for Prolonged heavy periods, LEVOTHYROXINE from 01-Dec-1999 to an unknown date for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced TENSION HEADACHE (Tension headache) (seriousness criterion medically significant). On 28-Nov-2021, TENSION HEADACHE (Tension headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date was 11-DEC-2021 Patient has not tested positive for COVID-19 since having the vaccine Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding No medical history was provided by the reporter No treatment information mentioned.; Sender''s Comments: This case concerns a patient, with medical history (Prolonged heavy periods), who experienced the serious unexpected events(s) of tension headache. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2020232 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes ophthalmic, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ocular infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myopia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins; Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins; Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins; This case was initially received via regulatory authority (Reference number: IT-MINISAL02-814048) on 07-Dec-2021. The most recent information was received on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins), HERPES OPHTHALMIC (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) and PYREXIA (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. The patient''s past medical history included Myopia. Previously administered products included for COVID-19 vaccination: COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) (COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03)) on 07-Jan-2021 and COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) (COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03)) on 28-Jan-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) and COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03). On 12-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 250 microliter. On 19-Nov-2021, the patient experienced MALAISE (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) (seriousness criterion medically significant), HERPES OPHTHALMIC (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) (seriousness criterion medically significant) and PYREXIA (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) (seriousness criterion medically significant). At the time of the report, MALAISE (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins), HERPES OPHTHALMIC (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) and PYREXIA (Pyrexia; malaise; Right eye herpes with impaired refraction of vision to the right eye and a feeling of splitting image margins) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided by the reporter. On 25 Nov 2021 it was reported that the patient was seen in PS for which the outcome of the ADR was not known. On 07 Dec 2021 the severity of ADR was modified. Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Follow up document was received and upgraded the event seriousness to medically significant. Event verbatim and narrative was updated.; Sender''s Comments: This regulatory authority case concerns a 52-year-old male patient with no relevant medical history and history of vaccination with COVID-19 Vaccine Pfizer BioNTech for the first two doses of COVID-19 immunization, who experienced the unexpected events of herpes ophthalmic, malaise and pyrexia.The events occurred approximately 7 days after the 3rd dose of the mRNA-1273 . Rechallenge was not applicable since the events occurred after the 3rd dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2022204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101866370

Write-up: Visual disturbance; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority WEB. Regulatory number: DE-PEI-202100275306 (PEI). A 58 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (hospitalization) with onset 19Nov2021, outcome "unknown", described as "Visual disturbance"; HEADACHE (hospitalization) with onset 19Nov2021, outcome "unknown", described as "Headache". Relatedness was assessed as D: unclassifiable by PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023546 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-11-19
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective, Interchange of vaccine products
SMQs:, Lack of efficacy/effect (narrow), Medication errors (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200026015

Write-up: asymptomatic covid-19; asymptomatic covid-19; Dose 1/2: Comirnaty, dose 3: Moderna; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 16Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 19Nov2021 (Batch/Lot number: unknown) as single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Dose 1/2: Comirnaty, dose 3: Moderna"; ASYMPTOMATIC COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "asymptomatic covid-19". It was reported the patient was a confirmed case of coronavirus disease 2019 (COVID-19) in Dec2021 and he was asymptomatic. The case involved the mutant strain of N501Y. BNT162B2 is under agreement with LLP-BioNTech SE. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.


VAERS ID: 2023848 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ACA5775 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy to furazolidon, mydocalm, milgamma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101867873

Write-up: non-specific acute pericarditis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number RO-NMA-2021-SPCOV15369. A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Batch/Lot number: ACA5775) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Allergy multiple (unspecified if ongoing), furazolidon, mydocalm, and milgamma. The patient took concomitant medications. Vaccination history included Bnt162b2 (Dose: 1, Date and Time of Start of Drug: 26Apr2021, Indication: Covid-19 Immunization), administration date: 26Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Date and Time of Start of Drug: 26Apr2021, Indication: Covid-19 Immunization), administration date: 17May2021, for Covid-19 Immunization. The following information was reported IMMUNISATION (medically significant, life threatening) with onset 19Nov2021, outcome unknown; PERICARDITIS (medically significant, life threatening) with onset 25Nov2021, outcome recovering. No follow-up attempts are possible. No further information is expected. Linked Report(s) RO-NMA-2021-SPCOV10649.


VAERS ID: 2023934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Hyperventilation, Hypoaesthesia, Oral mucosal erythema, Pain in extremity, Pyrexia, Respiration abnormal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101867304

Write-up: FEVER; BREATHING DISCOMFORT; CHEST PAIN; HYPERVENTILATION; LIMBS NUMBNESS; MOUTH VERMILION; RIGHT THIGH PAIN; RIGHT ANKLE PAIN; This is a spontaneous report received from a non-contactable other health professional from License Party(BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014303. Other Case identifier: TW-Fosun-2021FOS007136 (RA). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014303. A 21-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 18-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced fever, breathing discomfort, chest pain, hyperventilation, limbs numbness, mouth vermilion, right thigh pain and right ankle pain on 19-Nov-2021. On 19-Nov-2021, the patient went to the hospital for emergency treatment, complained that he had fever, breathing discomfort, mouth vermilion, chest pain, right thigh pain, right ankle pain, it was reported "hand fall" after vaccination of BNT vaccine. The doctor prescribed Diphenhydramine, Acetamol, the needle was used immediately and fucole paran, buclizine, Gowell oral medicine were brought back. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of mouth vermilion, right thigh pain and right ankle pain were unknown, the outcomes of other events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 2025844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Influenza like illness, Lymphadenopathy, Skin laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101873964

Write-up: associated laceration; Syncope; Booster; Swollen lymph nodes; Influenza like illness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021203103 (RA). Other Case identifier(s): DE-CADRPEI-2021203103 (RA Webportal), DE-PEI-202100228177 (RA). A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Syncope"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; SKIN LACERATION (hospitalization), outcome "unknown", described as "associated laceration"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Influenza like illness". Health authority comment: No previous illnesses/The reaction after the second vaccination was already very bad. After the third vaccination, the patient suffered from syncope and an associated laceration with subsequent hospitalisation. This reaction was therefore even worse. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2025978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E024A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Lymphadenopathy
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:132/80; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:200/100
CDC Split Type: DEPFIZER INC202101873604

Write-up: Swollen lymph nodes; Hypertension crisis from 132/80 to over 200/100 within an hour and a half, followed by a 2-day hospital stay. Therefore in treatment with antihypertensive drugs.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: DE-PEI-CADR2021210127 (PEI). Other Case identifier(s): DE-CADRPEI-2021210127 (PEI Webportal), DE-PEI-202100261665 (PEI). A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1E024A) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (hospitalization) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Swollen lymph nodes"; BLOOD PRESSURE INCREASED (hospitalization) with onset 21Nov2021, outcome "recovering", described as "Hypertension crisis from 132/80 to over 200/100 within an hour and a half, followed by a 2-day hospital stay. Therefore in treatment with antihypertensive drugs.". The patient was hospitalized for blood pressure increased (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) 132/80; (2021) 200/100. Therapeutic measures were taken as a result of blood pressure increased. SENDER COMMENT: Information on risk factors or previous illnesses None known. / High blood pressure crisis with hospitalization and treatment with antihypertensive drugs (amlodipine). Dosage text: 2 No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Facial paralysis, Hypoaesthesia, Immunisation, Interchange of vaccine products, Nose deformity, Off label use, SARS-CoV-2 test, Sinonasal obstruction, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; TRIMETHOPRIM; VAGIFEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heartbeats irregular (takes beta blocker for it); Lichen planus; UTI; Vaginal dryness; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000428

Write-up: Swelling face; Nose deformity; Dyspnoea/ Difficulty breathing; Hypoaesthesia/ Numbness facial; Nasal sinus blockage; Off label use; Interchange of vaccine products; Booster; Facial palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112260523174590-Z3XYC (RA). Other Case identifier(s): GB-MHRA-ADR 26395348 (RA). A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lichen planus" (unknown if ongoing); "Heartbeats irregular" (unspecified if ongoing), notes: takes beta blocker for it; "UTI" (unspecified if ongoing); "Vaginal dryness" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL FUMARATE taken for heart rate irregular, start date: Jan2021; TRIMETHOPRIM taken for urinary tract infection, start date: Sep2021; VAGIFEM taken for vulvovaginal dryness, start date: 2013. Past drug history included: Betnovate for Lichen planus. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; FACIAL PARALYSIS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Facial palsy"; SWELLING FACE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swelling face"; NOSE DEFORMITY (medically significant) with onset 20Nov2021, outcome "unknown", described as "Nose deformity"; DYSPNOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Dyspnoea/ Difficulty breathing"; HYPOAESTHESIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "Hypoaesthesia/ Numbness facial"; SINONASAL OBSTRUCTION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nasal sinus blockage". The events "facial palsy", "swelling face", "nose deformity", "dyspnoea/ difficulty breathing", "hypoaesthesia/ numbness facial" and "nasal sinus blockage" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of facial paralysis, swelling face, nose deformity, dyspnoea, hypoaesthesia, sinonasal obstruction.Clinical course: She first noticed something shortly after she got home from having the vaccine but it was very noticeable the next morning (right side of nose nostril flat and couldnot breathe through it properly), right side was inflamed across nose, sinus area, eye area and felt it all the way across to my ear. She called 111 as it was a Saturday morning and they suggested she go to the local pharmacy rather than hospital, where it was suggested she took antihistamines until Monday and if it was not any better to go to Dr on Monday. Went to Dr on Monday and he told her to carry on taking the antihistamines and gave her Beconase to take which she was still taking. 5 weeks on and no improvement she was going back to her Dr. after holiday. She has an auto immune condition called liken planus which she was managing under the supervision of her doctors - oral surgeon and dermatologist. She does not take any medication for the oral liken planus and sparingly use betnovate for spots that arise occasionally on her body and detmovate for the occasional spot in the vulva region. At no time has anyone ever asked me about my autoimmune condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not relate to possible inflammation of the heart (myocarditis or pericarditis). When she got home wasnot feeling very but the next day face was numb, nostril was blocked/sinuses felt blocked, she called 111 told to go to pharmacy who said this was a reaction to the vaccine and advised antihistamine, if doesnot improve got to GP- which she did they gave her a nasal spay and continue with antihistamines taking this for over a month and still not gone away. Going back to her GP tomorrow (30Dec2021) face still swollen each morning and the meds help but was not improving it. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Dizziness, Fatigue, Immunisation, Influenza, Interchange of vaccine products, Musculoskeletal stiffness, Nausea, Off label use, Pyrexia, SARS-CoV-2 test, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877714

Write-up: muscle stiffness; cough; chronic fatigue; hives; Fatigue/unusual tiredness; Chest pain; Fever; nauseous; Swelling of face; Chest pain; Acute cough; Stiff neck; Dizziness; off label use; Interchange of vaccine products; Booster; Flu/flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112280802516250-6LSNZ. Other Case identifier(s): GB-MHRA-ADR 26402054. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: FEXOFENADINE; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "muscle stiffness"; COUGH (medically significant), outcome "unknown", described as "cough"; FATIGUE (medically significant), outcome "not recovered", described as "chronic fatigue"; URTICARIA (medically significant), outcome "unknown", described as "hives"; SWELLING FACE (medically significant) with onset 21Nov2021, outcome "recovered" (25Nov2021), described as "Swelling of face"; CHEST PAIN (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), INFLUENZA (medically significant) with onset 19Nov2021, outcome "recovered" (23Dec2021) and all described as "Flu/flu symptoms"; COUGH (medically significant) with onset 21Nov2021, outcome "recovered" (30Nov2021), described as "Acute cough"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Stiff neck"; DIZZINESS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Dizziness"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; NAUSEA (medically significant), outcome "unknown", described as "nauseous". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of urticaria, swelling face, musculoskeletal stiffness. One hour after vaccine was very nauseous. For two days flu symptoms. 23rd chest pain and face swelling. Chest pain laster 4 hours. Face swelling and hives all over body lasted 5 days needed steroids to manage it. Then had chesty cough, flu symptoms, dizziness and chronic fatigue for 4 weeks. Still got fatigue. Lots of muscle stiffness in neck. Still have this, needing weekly sports massage on it 6 weeks later. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did relate to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. A diagnosis made by a medical professional. There was not any imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). It was unknown if there was any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026449 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Catarrh, Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, SARS-CoV-2 test, Suspected COVID-19, Tinnitus
SMQs:, Hearing impairment (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877588

Write-up: feeling side/Feeling unwell; Tinnitus; Nasal catarrh; Headache; Suspected COVID-19; Dose 1 and 2: COVID-19 VACCINE ASTRAZENECA; dose 3 (booster): Comirnaty; Dose 1 and 2: COVID-19 VACCINE ASTRAZENECA; dose 3 (booster): Comirnaty; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112282207129670-VHPC9. Other Case identifier: GB-MHRA-ADR 26405798. A 40 year-old female patient received BNT162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Levothyroxine, notes: 150mg. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1), administration date: 15Mar2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2), administration date: 26May2021, for COVID-19 immunisation. The following information was reported: MALAISE (disability, medically significant), outcome "not recovered", described as "feeling side/Feeling unwell"; TINNITUS (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Tinnitus"; CATARRH (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Nasal catarrh"; HEADACHE (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache". The patient also experienced OFF LABEL USE (disability, medically significant), INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Dose 1 and 2: COVID-19 VACCINE ASTRAZENECA; dose 3 (booster): Comirnaty"; IMMUNISATION (disability, medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Suspected COVID-19". Clinical course: the patient started feeling side affects after 48 hours from having the vaccine. After a week a sort advice from the GP who gave nasal and ear drops, to no avail. After another week, the patient was given antibiotics and an alternative nasal/ear drops. To 28Dec2021, the patient was still having these side affects. The events "feeling side/feeling unwell", "tinnitus", "nasal catarrh", "headache" and "suspected covid-19" were evaluated at the physician office visit. Therapeutic measures were taken as a result of malaise, tinnitus, catarrh, headache, suspected covid-19. The patient underwent COVID-19 virus test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vascular pain
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882461

Write-up: Vein pain; Off label Use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112290922262440-DR3NI (RA). Other Case identifier(s): GB-MHRA-ADR 26407467 (RA). A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3, (booster) single for COVID-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing). The patient''s concomitant medications were not reported. Patient not had symptoms associated with COVID-19. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, ), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; VASCULAR PAIN (medically significant) with onset 03Dec2021, outcome "not recovered", described as "Vein pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-11-19
   Days after vaccination:282
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Catarrh, Cough, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: SARS-CoV-2 molecular test; Test Result: Positive ; Test Date: 20211213; Test Name: SARS-CoV-2 molecular test; Test Result: Negative
CDC Split Type: ITPFIZER INC202101883756

Write-up: Vaccination Failure; molecular swab SarsCov2 result positive on 22Nov2021; catarrh; Cough; little fever; This is a non-interventional study report from the Regulatory Authority-WEB and product quality group. Regulatory number: IT-MINISAL02-825110. A 54 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 10Feb2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 2, single and administered in deltoid left, administration date 20Jan2021 (Lot number: EJ6797) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "recovered" (13Dec2021), described as "Vaccination Failure"; COVID-19 (medically significant) with onset 19Nov2021, outcome "recovered" (13Dec2021), described as "molecular swab SarsCov2 result positive on 22Nov2021"; CATARRH (non-serious) with onset 19Nov2021, outcome "recovered" (13Dec2021), described as "catarrh"; COUGH (non-serious) with onset 19Nov2021, outcome "recovered" (13Dec2021), described as "Cough"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovered" (13Dec2021), described as "little fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive; (13Dec2021) negative. The reporter''s assessment of the causal relationship of the "vaccination failure", "molecular swab sarscov2 result positive on 22nov2021", "catarrh", "cough" and "little fever" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Product Quality Group provided investigational results on 03Jan2022 for bnt162b2 lot EK9788: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events vaccination failure", Covid-19, "catarrh", "cough" and "little fever" and the administration of the vaccine cannot be excluded.


VAERS ID: 2026982 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-11-19
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive international unit(s)
CDC Split Type: PTPFIZER INC202200002015

Write-up: Vaccination failure; Vaccination failure/Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1480. A 56 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Jun2021 (Lot number: FC5435) as dose 2, 0.3 ml single and intramuscular, administration date 23May2021 (Lot number: FA7083) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "recovered" (26Nov2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 19Nov2021, outcome "recovered" (26Nov2021), described as "Vaccination failure/Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive, notes: Positive international unit(s). The reporter''s assessment of the casual relationship of the (All events) with the suspect product was: Method of assessment: Unknown, Result of Assessment: Possible.


VAERS ID: 2026987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-11-19
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Asthma; Stomach function disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202200001858

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1508. A 39 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 03Aug2021 (Lot number: FE8235) as dose 2, 0.3 ml single and intramuscular, administration date 05Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Asthma" (unknown if ongoing); "Stomach function disorder" (unknown if ongoing); "Allergic rhinitis" (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Nov2021, outcome "recovered" (30Nov2021) and all described as "Vaccination failure". Reporter comment- Other information-R97 ALLERGIC Allergic rhinitis 15May2019 D87 FUNCTIONAL CHANGE OF THE STOMACH 11Dec2017 R96 ASTHMA Clinical information: The reporters assessment of the casual relationship of the (All events) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible. The reporter provided that, the case was not serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Immunisation, Interchange of vaccine products, Joint range of motion decreased, Off label use, SARS-CoV-2 test, Vaccination site pruritus
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202101882632

Write-up: Can barely lift my arm up; Left arm (where I had vaccine) is very itchy; Tiredness; Joint pain; Shoulder soreness; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112291201500110-B1SVS (RA). Other Case identifier(s): GB-MHRA-ADR 26408326 (RA). A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Nov2021 (Lot number: FH4751) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (first dose), administration date: 19Feb2021, for covid-19 immunisation; Covid-19 vaccine astrazeneca (Second dose), administration date: 30Apr2021, for covid-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; FATIGUE (disability) with onset 24Nov2021, outcome "not recovered", described as "Tiredness"; ARTHRALGIA (disability) with onset 24Nov2021, outcome "not recovered", described as "Joint pain"; ARTHRALGIA (disability) with onset 24Nov2021, outcome "not recovered", described as "Shoulder soreness"; JOINT RANGE OF MOTION DECREASED (disability), outcome "unknown", described as "Can barely lift my arm up"; VACCINATION SITE PRURITUS (disability), outcome "unknown", described as "Left arm (where I had vaccine) is very itchy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2021) no - negative. Clinical details reported as follows: Can barely lift my arm up. Always tired. Can not be bothered with anything or anyone. Left arm (where I had vaccine) is very itchy. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Fatigue, Headache, Immunisation, Influenza like illness, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL [CALCIUM CARBONATE;COLECALCIFEROL]; CELECOXIB; ESOMEPRAZOLE; GAVISCON ADVANCE [POTASSIUM BICARBONATE;SODIUM ALGINATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome (for 24 years, so already had altered immune response); Hiatus hernia; Immunodeficiency (Has an illness or condition, which reduces the immune response); Myalgic encephalomyelitis (for 24 years, so already had altered immune response); Osteoporosis with fracture; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882892

Write-up: Flu like symptoms; Taste altered/strange taste in mouth; Exhaustion; Headache; Nausea; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112291651148240-4THQY. Other Case identifier: GB-MHRA-ADR 26410559. A female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "ME/Chronic Fatigue Syndrome", notes: for 24 years, so already had altered immune response; "Immunodeficiency", notes: Has an illness or condition, which reduces the immune response; "Hiatus hernia"; "Pain"; "Osteoporosis with fracture"; all unspecified if ongoing. Patient has not had symptoms associated with COVID-19. Concomitant medications included: ADCAL [CALCIUM CARBONATE;COLECALCIFEROL] taken for osteoporosis with fracture, start date: 2015; CELECOXIB taken for pain, start date: May2020; ESOMEPRAZOLE taken for hiatus hernia, start date: 2016; GAVISCON ADVANCE [POTASSIUM BICARBONATE;SODIUM ALGINATE] taken for hiatus hernia, start date: 2013. Vaccination history included: Covid-19 vaccine AstraZeneca (Dose 2), administration date: 14May2021, for COVID-19 immunization, reaction(s): "Exhaustion"; Covid-19 vaccine AstraZeneca (Dose 1), administration date: 25Feb2021, for COVID-19 vaccination, reaction(s): "Exhaustion". The following information was reported: Off label use, interchange of vaccine products and booster, all with onset 19Nov2021 and outcome of unknown; Flu like symptoms with onset 20Nov2021 and outcome "recovered" (23Nov2021); Nausea with onset 19Nov2021 and outcome "recovered" (09Dec2021); Taste altered/strange taste in mouth with onset 20Nov2021, outcome "recovered" (09Dec2021); Exhaustion with onset 20Nov2021 and outcome "recovering"; Headache with onset 20Nov2021 and outcome "recovered" (21Nov2021). All the events were reported as serious per other medically important condition. The clinical course: Immediately after booster vaccine (as reported): bad flu-like symptoms for 3 days after vaccine + headache for 24 hours. Starting after about 24 hours (as reported): Nausea all the time. Lasted for 3 weeks. Strange taste in her mouth - lasted for about 2.5 weeks. Severe exhaustion for nearly 4 weeks which was gradually improving since but still more exhausted. Also, reaction of exhaustion after previous 2 Covid vaccinations (Astra Zeneca) but this was considerably worse. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (08Oct2021) no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885799

Write-up: Clot blood; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301641408210-WHSV7 (RA). Other Case identifier(s): GB-MHRA-ADR 26417293 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (life threatening) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (life threatening) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (life threatening) with onset 19Nov2021, outcome "unknown", described as "Booster"; THROMBOSIS (life threatening) with onset 10Dec2021, outcome "recovered with sequelae" (28Dec2021), described as "Clot blood". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no-negative covid-19 test. Additional information: The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1877698 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: Bactrum
Diagnostic Lab Data:
CDC Split Type:

Write-up: swelling in anterior left axxilairy


VAERS ID: 1879928 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Desvenlafaxine Vitamin D Progesterone only birth control (Deblitane) Melatonin 2 mg
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vomiting


VAERS ID: 1880065 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Circumoral oedema, Immunisation reaction
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol 625 mg BID, Naproxen 200 mg BID, Klybella lip injections (performed in June 2021)
Current Illness: None
Preexisting Conditions: None
Allergies: KNDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received his 3rd booster fo the Moderna Covid-19 vaccine on 11/16/2021. On 11/18/2021, the patient woke up with perioral edema, presumably secondary to an immunological reaction to Klybella lip injections received in June of 2021.


VAERS ID: 1880091 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 59267-1055-01 / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, elderberry gummies
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Throwing up


VAERS ID: 1880092 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen lymph node in left armpit.


VAERS ID: 1880296 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1611 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin Escitalopram Trazadone Unisom
Current Illness: N/A
Preexisting Conditions: Anxiety PCOS
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Enlarged axillary lymph node, tender left collar bone, intractable pain of the axila.


VAERS ID: 1880361 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-15
Onset:2021-11-18
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816027 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood chloride increased, Blood culture, Blood gases, Blood sodium increased, COVID-19, Chest X-ray abnormal, Depressed level of consciousness, Endotracheal intubation, Intensive care, Lung infiltration, Mechanical ventilation, Oxygen saturation decreased, Positive airway pressure therapy, Pulmonary congestion, Pyrexia, Respiratory distress, SARS-CoV-2 test positive, Tachycardia, Tachypnoea, Tracheostomy, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Current Home Medications 1. albuterol 2.5 mg/3 mL (0.083%) inhalation solution : 3 milliliter(s) inhaled every 2 hours, As Needed - PRN for Shortness of Breath 2. ALPRAZolam 0.5 mg oral tablet, disintegrating : 1 tab(s) orally 4 times a day
Current Illness: unknown
Preexisting Conditions: CAD DM HTN History of cerebral infarction assoc w/ systemic hypoxia or ischemia (alert but non-verbal) PEG Tube, strict NPO Agitation
Allergies: none known
Diagnostic Lab Data: The patient arrived in a state of respiratory distress. She was obtunded. She was tachypneic. Her oxygen saturation dropped to the low 80s. She was tachycardic. The patient was unstable. It was decided to intubate her. This patient was intubated with a 7.5 mm endotracheal cuffed tube using rapid sequence intubation technique. The patient received etomidate for induction and cricoid pressure was applied. The patient was given Succinylcholine to facilitate the intubation. The vocal cords were visualized using a Glidescope. The patient was intubated . The cricoid pressure was released after inflating the cuff. The chest x-ray was ordered to verify the ET tube position. The ET tube was withdrawn by 2 cm. The patient was sedated using propofol. The auscultation revealed coarse crepitations over both lung fields. The patient was given Lasix 40 mg intravenously. I reviewed the lab results. The WBC count was elevated at 16,100. The sodium level was elevated at 159 and chloride at 116. The 5% dextrose in water infusion was started at 100 mL/h. The chest x-ray revealed bilateral infiltrates. The patient was febrile. She tested positive for the COVID-19 infection. The patient was given dexamethasone 6 mg intravenously. She also received cefepime 1 g after the blood samples were drawn for culture and sensitivity. The ABG results were reviewed and vent settings modified (FiO2 50% and AC 14). 7 AM: There was no bed available in any of the area hospitals. The central command transfer center was informed. 11/17/21 0927 Dr. accepts the patient for admission to ICU
CDC Split Type:

Write-up: Chief Complaint: Respiratory distress. Additional Medical History: This 68-year-old female was brought to the ED by an ambulance from a nursing home in a state of respiratory distress. The paramedics state that the patient''s oxygen saturation was in the low 70s when they arrived at the nursing home. They applied the CPAP and transported the patient to the ED. The paramedics were told that the patient has been having a chest congestion for the last 2 days. It appears that her tracheostomy was reversed in August 2021.


VAERS ID: 1880369 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dehydration, Dyspnoea, Hiccups, Hot flush, Sleep terror, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Throwing up until theres nothing to throw up any more, then continuing to throw up any bit of liquid I try to take in, now experiencing dehydration. Hiccups. Hot flashes & chills. Extremely labored breathing. First period of vomiting lasted from midnight to one am, and second period lasted from 5 to 6 in the morning. Night terrors all night. Really feeling like I can barely breathe.


VAERS ID: 1880392 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: mild arm soreness, the reason for filling out VAERS is because pt produced a record of MODERNA shot from 04/08/2002 whose second part was never completed. Moderna shot #2 is also not available at present time.


VAERS ID: 1880401 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-30
Onset:2021-11-18
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066D21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bell's palsy, Computerised tomogram, Laboratory test, Magnetic resonance imaging, X-ray
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Janumet Lisinopril Jardiance Synthroid Tamoxifen Lipitor Plaquenil Celebrex
Current Illness: None
Preexisting Conditions: Diabetes (well controlled...A1C 6.3) Rheumatoid arthritis
Allergies: Morphine
Diagnostic Lab Data: Cat scan Sept 2021, MRI Nov 2021 Labs 9/11/21 Xray 9/11/21
CDC Split Type:

Write-up: I developed symptoms of Bells Palsy within a week of receiving the first Moderna vaccine with full-blown Bells Palsy on 9/11/21


VAERS ID: 1880430 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Pt was referred to the urgent care/ER
CDC Split Type:

Write-up: Pt woke up at 2am violently "shaking" for 15-20mins


VAERS ID: 1880464 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Immunisation, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: PT and mother agreed to receive vaccine in left arm. Immediately after the needle was in his arm, and during administration of vaccine, pt jerked his arm back and pulled away. Majority of vaccine did not make it into pt''s muscle, but on his skin. Pt also bent the needle after he pulled away. A employee was immediately notified of incident, who contacted her supervisor. The supervisor gave the go ahead to have the vaccine administered in the opposite arm. Pt''s mother agreed to have her son receive the vaccine in the other arm. Mother held the pt more closely to her. Vaccine was successfully administered in the right arm with no incident.


VAERS ID: 1880469 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose normal, Cold sweat, Fall, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: Same day blood sugar done, Heart rate, blood pressure, all normal
CDC Split Type:

Write-up: Patient was given J&J vaccination, proceeded to sit down in observation area , few minutes later fell face forward, got back up immediately, ambulance came, he is feeling ok now. He was clammy, sweaty


VAERS ID: 1880492 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32030BD / 3 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm weakness, onset 11/18/21 within 72 hours of administration


VAERS ID: 1880515 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Upper respiratory virus in September- October 20th, negative covid test.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient woke up this morning 11/18/2021 with a headache and a fever of 101.1.


VAERS ID: 1880545 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939909 / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mirtazapine Tablet 15 MG daily Metoprolol Tartrate Tablet 25 MG daily Aspirin 81 Tablet Chewable 81 MG daily Multiple Minerals-Vitamins Tablet daily
Current Illness: No acute illnesses.
Preexisting Conditions: History of CVA, COPD, Encephalopathy, dementia, convulsions
Allergies: NKA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Red raised firm area at left upper arm 7.5 cm x 11.5 cm warm and tender to touch. Benadryl 25 mg 1 dose Zyrtec 10 mg daily x 5 days Famotidine 20 mg daily x 5 days Seen by nurse practitioner on 11/18/21 Physician to re-assess left upper arm on 11/20/21


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