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From the 10/8/2021 release of VAERS data:

Found 781,870 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 426 out of 7,819

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VAERS ID: 1710295 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Hypersensitivity, Oxygen saturation, Rash, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypersensitivity (narrow), 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: Allergy to animal; Allergy to vaccine; House dust allergy; Mite allergy; Seafood allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (family history: mother); Asthma; Cockroach allergy; Insect bite allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: BP; Result Unstructured Data: Test Result:141/61; Comments: AT 14:25; Test Date: 20210817; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210817; Test Name: HR; Result Unstructured Data: Test Result:65; Comments: At 14: 25; Test Date: 20210817; Test Name: HR; Result Unstructured Data: Test Result:61; Comments: At about 16: 00; Test Date: 20210817; Test Name: SPO2; Test Result: 98 %; Comments: around 14:25; Test Date: 20210817; Test Name: SPO2; Test Result: 98 %; Comments: at 14:37; Test Date: 20210817; Test Name: SPO2; Test Result: 98 %; Comments: at 14:54; Test Date: 20210817; Test Name: SPO2; Test Result: 98 %; Comments: Around 16: illegible3; Test Date: 20210817; Test Name: SPO2; Test Result: 98 %; Comments: at 16:30
CDC Split Type: JPPFIZER INC202101071268

Write-up: Allergic reaction; a strange sensation in throat (the patient felt throat got narrow); Skin eruption; blood pressure increased; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). Regulatory authority report number is v21123806. A 14-year-old male patient received bnt162b2 (Pfizer; Lot Number: FF4204; Expiration Date: 31Oct2021), Dose 1 intramuscular on 17Aug2021 at 14:18 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing crab/shrimp allergy, ongoing house dust allergy, ongoing mite allergy, ongoing allergy to leopard/cat, asthma from an unknown date and unknown if ongoing, ongoing allergy to influenza vaccine, cockroach allergy from an unknown date and unknown if ongoing. The patient had a family history of allergy (mother). The patient''s concomitant medications were not reported. As reported: On 17Aug2021 at 14:18 (the day of vaccination), the patient received the first single dose of BNT162B2 (Pfizer, Solution for injection, Lot number FF42204, Expiration date 31Oct2021) via an unspecified route of administration for COVID-19 immunization. On 17Aug2021 at 14:25 (7 minutes after the vaccination), the patient experienced allergic reaction, a strange sensation in throat (felt throat got narrow), skin eruption and blood pressure increased. On 17Aug2021, the outcomes of the events were recovered with medication treatments. The reporting physician classified that the event, a strange sensation in throat (felt throat got narrow) was non-serious and the event was related to bnt162b2. Treatment received (POLARAMINE 1A (ampoule) + Saline 100ml Div (drip intravenous); Famotidine 1A + saline 20ml iv). The outcome of the events was recovered. The course of the event was as follows: History of allergies (+) (Shrimp, crab; Influenza vaccine; house dust, cat, mite, leopard, cockroach, mosquitoes) At 14:18, vaccination. Around 14:25, Feeling tight in the throat (+), other symptoms (-). SpO2 (Oxygen saturation) 98%, BP (blood pressure) 141/61, HR (heart rate) 65. Skin eruption (-), Airway narrowing (-). At 14:37, SpO2 98%. Drug administration. At 14:54, SpO2 98% At 14:55, symptoms did not change. At 15:10, it had not changed since then. Around 16: illegible3, the discomfort disappeared after drinking water. SpO2 98%. After that, recurrence (-) At 16:30, the patient went home. From the history and symptoms, it seemed to be an allergic reaction. All the signs and symptoms of the event were as follows: a strange sensation in throat (felt throat got narrow) Other skin symptoms (-), Dyspnoea (-) Airway narrowing (-) BP 141/61, HR 65, SpO2 98% (14:25), SpO2 98% (14:37), SpO2 98% (16:30) The time course of the event was as follows: At 14:18, vaccination. Around 14:25, appearance of the above symptoms. Other symptoms (-) After that, symptoms did not change, at least exacerbation (-) At 16:00, symptoms did not change, symptoms improved with fluid intake. The patient went home. At 16:30, the patient went home. The patient required medical intervention of antihistamines, infusions. Details were as follows: Around 14:37 SOLACET F 500ml*Div POLARAMINE 1A+ Saline 100ml Div Famotidine 1A+ Saline 20ml iv No further information was available from the medical record. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1710347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Back pain, Chest pain, Myocardial infarction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101155139

Write-up: myocardial infarction; Aortic dissection; Tingling; chest pain; back pain; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21126512. A 43-year and 11-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration on 13Aug2021 (the day of vaccination) as dose 1, single for COVID-19 immunization. It was unknown if there were any points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient medical history and concomitant medications were not reported. On 17Aug2021 at 19:00 (4 days after the vaccination), the patient experienced chest pain and back pain. On an unknown date, the patient experienced myocardial infarction, aortic dissection and tingling. The course of the event was as follows: From the back to the right chest, a stinging, tingling and intense pain appeared. On 19Aug2021 (6 days after the vaccination), the outcome of the events chest pain and back pain was not recovered and all other events was unknown. The reporting physician classified the event as serious (risk of disability) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Considered that the symptom developed may be a sign of myocardial infarction, and aortic dissection. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1710501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Myalgia, Peripheral swelling, Thrombosis, Walking disability
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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)

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: ATORVASTATIN XIROMED; ESOMEPRAZOL PENSA; ACIDUM LACTICUM [LACTIC ACID]; CARDIZEM RETARD; BLUEBERRIES
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia; Stomach ulcer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101166825

Write-up: UNILATERAL LEG SWELLING; barely being able to walk,; MUSCLE SORENESS LEGS; LIMBS STIFFNESS LEGS; THROMBOSIS; This is a spontaneous report from a contactable consumer and a contactable other health professional downloaded from the Agency WEB. This is a report received from the Regulatory Authority, Regulatory authority report number NO-NOMAADVRE-PASRAPP-2021-Urqqpe. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 12Aug2021 09:00 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included Stomach ulcer, hypercholesterolaemia. Concomitant medications included atorvastatin calcium (ATORVASTATIN XIROMED) taken for hypercholesterolaemia from 2010 and ongoing; esomeprazole sodium (ESOMEPRAZOL PENSA) taken for Stomach ulcer from 2020 and ongoing; acidum lacticum [lactic acid] (ACIDUM LACTICUM [LACTIC ACID]) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (CARDIZEM RETARD) taken for gastric ulcer from 2020 and ongoing; vaccinium myrtillus (BLUEBERRIES) taken for an unspecified indication, start and stop date were not reported, and an unspecified vitamin supplement. The patient experienced muscle soreness legs on 17Aug2021, limbs stiffness legs on 17Aug2021, thrombosis on 17Aug2021, unilateral leg swelling on 21Aug2021. Verbatim: The patient developed LIMBS STIFFNESS LEGS, THROMBOSIS, MUSCLE SORENESS LEGS, UNILATERAL LEG SWELLING. Patient reports acute LIMBS STIFFNESS LEGS without any physical activity as cause. Patient reports barely being able to walk, and still affected when sitting down. Not affecting sleep during the night. A follow-up PasRapp was received where patient reports legs becoming worse, and UNILATERAL LEG SWELLING occurring, causing the patient to go to the emergency room. A 30 cm THROMBOSIS were discovered in the leg. Patient was sent home with medication and is going for a control the next day. The patient''s outcome was: Not recovered/not resolved: LIMBS STIFFNESS LEGS, THROMBOSIS, MUSCLE SORENESS LEGS, Unknown: UNILATERAL LEG SWELLING. Therapeutic measures were taken as a result of the events. The outcome of the event unilateral leg swelling was unknown while for the rest of the events was not recovered. The reactions/case was considered to be Serious due to (Life Threatening). No more information is available regarding this case. Reporter''s comments: 31Aug2021: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-PASRAPP-2021-Urqqpe (this report). Report NO-NOMAADVRE-PASRAPP-2021-Ud2my1 has been nullified. Contact with healthcare professionals: Other health care professional. Patient reported blood pressure medicine for stomach ulcer as indication for Cardizem Retard Prolonged-release tablets 120 mg. Sender''s Comment: The patient reported onset date for ADR [Adverse Drug Reaction] THROMBOSIS to be 17Aug2021, but also reported it to 21Aug2021 (the date it was discovered at the hospital). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: 31Aug2021, Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-PASRAPP-2021-Urqqpe (this report). Report NO-NOMAADVRE-PASRAPP-2021-Ud2my1 has been nullified. Contact with healthcare professionals: Other health care professional. Patient reported blood pressure medicine for stomach ulcer as indication for Cardizem Retard Prolonged-release tablets 120 mg.


VAERS ID: 1710596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-08-17
   Days after vaccination:203
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 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? 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: 20210817; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101164842

Write-up: Vaccination failure; SARS-CoV-2 PCR test: Positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202108-2799. A 51-years-old female patient received first dose of bnt162b2 (COMIRNATY; Solution for injection, Lot Number: EJ6797; Expiry date was not reported),via intramuscular on 05Jan2021 as dose 1, 0.3 ml single, and received second dose of bnt162b2 (COMIRNATY; Solution for injection, Lot Number: EJ6797; Expiry date was not reported), via intramuscular on 26Jan2021 as dose 2, 0.3 ml single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Aug2021, (reported as after 2nd dose of vaccine), the patient experienced sars-cov-2 pcr test resulted as positive with vaccination failure. The case was assessed as serious - medically significant. The patient underwent lab tests and procedures which included sars-cov-2 pcr test resulted as positive on 17Aug2021 (Positive IU international unit(s)). The outcome of the events was resolving at the time of report. The reporter''s assessment of the causal relationship of the (vaccination failure, covid-19) with the suspect product 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1710601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (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: PTJNJFOC20210930260

Write-up: Drug ineffective; This spontaneous report received from a health care professional by a Regulatory authority (PT-INFARMED-T202108-3561) was received on 15-SEP-2021 and concerned a 27 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-05 expiry: UNKNOWN) .5 ml, 1 total, administered on 06-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-AUG-2021, the patient experienced drug ineffective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug ineffective was not reported. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information: work contact - user works; reported fever that subsided with Paracetamol during the first days; arthralgias, aggusia, myalgias, cough, nasal congestion, fatigue, headache, diarrhea for several days, anosmia;


VAERS ID: 1714830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Peripheral swelling (Blood and water was extracted from the feet and legs. Blood sample was also taken.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155208

Write-up: Thrombosis; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021172698. A 21-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: Unknown) at dose number unknown, 0.3 ml single for COVID-19 immunization. Medical history included serious swelling as blood and water were extracted from the feet and legs (blood sample was also taken). The patient''s concomitant medications were not reported. On 17Aug2021, the patient experienced thrombosis. The event was reported as serious due to hospitalization from an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1715977 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Disease recurrence, Headache, Hypertension, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Hypertension (narrow), 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: Medical History/Concurrent Conditions: Arthritis rheumatoid; Cerebral haemangioma; Epilepsy; Hypertension arterial (no longer treated); Migraine; Myasthenia gravis
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: hypertensive episode; Result Unstructured Data: Test Result:180/100 mmHg; Comments: 15 minutes after the vaccination; Test Date: 20210817; Test Name: hypertensive episode; Result Unstructured Data: Test Result:180/130 mmHg; Comments: 30 minutes afterwards
CDC Split Type: FRPFIZER INC202101155984

Write-up: Hypertensive episode at 180/100 mmHg then 30 minutes afterwards: 180/130 mmHg; Hypertensive episode at 180/100 mmHg then 30 minutes afterwards: 180/130 mmHg; headache; visual disorder; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-PV20212496. A 57-year-old female patient received bnt162b2, dose 2 intramuscular, administered in arm right on 17Aug2021 (at the age of 57-years) (Lot Number: FE2707) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included myasthenia gravis, hypertension arterial (no longer treated); arthritis rheumatoid, epilepsy, migraine, and cerebral haemangioma. Historical vaccine included BNT162B2 (first dose, batch number: FE1573) on 20Jul2021 for COVID-19 immunisation. Concomitant medication included unspecified immunosuppressants. On 17Aug2021, 15 minutes after the vaccination, the patient experienced hypertensive episode at 180/100 mmHg then 30 minutes afterwards: 180/130 mmHg, headache, and visual disorder. The events were assessed as serious (hospitalization). Therapeutic measures were taken as the result of hypertensive episode at 180/100 mmHg then 30 minutes afterwards: 180/130 mmHg which included AMLOR 10 mg/day + RAMIPRIL 2.5 mg/day for 3 months. In summary, hypertensive episode within 15 minutes following the second injection of the BNT162B2 Covid-19 vaccine. History of hypertension arterial that was no longer treated. Outcome of the events was recovering (also reported as duration: 1 day). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716212 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: DEPFIZER INC202101155630

Write-up: Deep vein thrombosis leg; This is a spontaneous report from a non-contactable physician downloaded from the regulatory agency-WEB, company number DE-PEI-202100180610. A 41-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 16Aug2021 (batch/lot number and expiry date unknown) at 41 years of age as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced deep vein thrombosis leg. This report was serious - other. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716242 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Pulmonary embolism, Vaccination site pain
SMQs:, Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155117

Write-up: Lung embolism; Arrhythmia; Injection site pain; This is a spontaneous report from non-contactable consumer or other non-HCP downloaded from the regulatory authority, regulatory authority number DE-PEI-CADR2021172505. A 50-year-old male patient received bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: 1E028A), via an unspecified route of administration on 17Aug2021 (at the age of 50-year-old) as dose number unknown, 0.3ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced injection site pain. On 22Aug2021, the patient experienced lung embolism and arrhythmia. The patient was hospitalized on an unspecified date in Aug2021. This report is serious - hospitalization. The patient received Eliquis 2-0-2 as a treatment medication for the event lung embolism. Outcome of the events lung embolism, arrhythmia was not recovered and injection site pain was recovered on 26Aug2021. Reportercomment: Sender comment: Do you or the person concerned have any known allergies? If so, which ones? None. Details of risk factors or previous illnesses. None. I am an athlete. /Pulmonary embolism. Treatment with Eliquis 2-0-2. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Injection site inflammation, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: Medical History/Concurrent Conditions: Allergy to antibiotic (norfloxacin); Drug allergy (limonene and linalool); Penicillin allergy (norfloxacin); Perfume sensitivity (certain perfumes,)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101166483

Write-up: Influenza like illness; Inflammation at site of injection; fever; body aches; headache; inflammation at the injection site, with swelling, redness, heat; inflammation at the injection site, with swelling, redness, heat; inflammation at the injection site, with swelling, redness, heat; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a Regulatory Authority FR-AFSSAPS-BX20218026. A 48-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via intramuscularly, in left arm on 16Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history included allergy to norfloxacin, penicillin, certain perfumes, limonene and linalool. The patient''s concomitant medications were not reported. She had no history of COVID-19 (she had not been tested). On 17Aug2021, (1 day after injection of the vaccine Comirnaty), onset of flu-like syndrome with fever, body aches, headache, and inflammation at the injection site, with swelling, redness, heat. Ongoing medical care was consultation. Sick leave from work during 4 days. Accountability without prejudice to the elements of investigations that could be carried out as part of legal or amicable compensation procedures. The outcome of events influenza like illness, inflammation at site of injection while the outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1716604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholestasis, Cytomegalovirus infection reactivation, Hepatic cytolysis, Pulmonary embolism
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Embolic and thrombotic events, venous (narrow), Biliary tract disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101158270

Write-up: Cytomegalovirus infection reactivation; Embolism pulmonary; Hepatic cytolysis; Cholestasis; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20212369. A 53-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 06Aug2021 (Lot Number: FF4213) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hepatic cytolysis (hospitalization) on 17Aug2021 with outcome of recovering, cholestasis (hospitalization) on 17Aug2021 with outcome of recovering, cytomegalovirus infection reactivation (hospitalization) on 20Aug2021 with outcome of recovering, embolism pulmonary (hospitalization) on 20Aug2021 with outcome of recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-08-17
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / 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? 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: Breast cancer; Total hysterectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101156816

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from regulatory authority number FR-AFSSAPS-CN20212754. A 37-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 02Mar2021 (Batch/Lot Number: EP2166; Expiration Date: 31May2021) as dose 2, single and intramuscular, administered in left arm on 08Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer and total hysterectomy. The patient had no history of COVID-19. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and COVID-19 confirmed by positive COVID-19 test on 17Aug2021 (Day 167). Vaccination failure on Day 167 with positive PCR test on 17Aug2021 and symptoms (myalgias, asthenia, cough, dysgeusia and change of smell). The patient underwent lab tests and procedures which included SARS-COV-2 PCR: positive on 17Aug2021. The outcome of the events was recovering. On 08Sep2021, information from Product Complaint Team was provided from division Puurs. 1. Reference PR ID 5779916. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 EP2166. 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.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 were identified as the complaint was not confirmed. 2. Reference PR ID 5732035 .The complaint for LOE/adverse event of PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 EJ6789. 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. 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 were identified as the complaint was not confirmed.


VAERS ID: 1716735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation, Magnetic resonance imaging heart, Myocardial oedema, Myocarditis, SARS-CoV-2 test, Troponin, Troponin increased
SMQs:, 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), 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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: aucun.
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: electrocardiography; Result Unstructured Data: Test Result:ST elevation; Test Date: 20210818; Test Name: Cardiac Magnetic Resonance Imaging; Result Unstructured Data: Test Result:acute myo-pericarditis; Comments: conclusion of a typical acute myo-pericarditis with obvious myocardial edema of the lateral wall of the left ventricle; Test Date: 20210819; Test Name: Tested for COVID 19; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210817; Test Name: troponin; Result Unstructured Data: Test Result:600 ng/ml; Comments: Elevated troponin
CDC Split Type: FRPFIZER INC202101155360

Write-up: myocardial edema; Myopericarditis; chest pain; Elevated troponin at 600 ng/ml; ST elevation in the electrocardiography; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-RN20212692. An 18-year-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot Number: FG4493), intramuscularly administered in Arm Left on 15Aug2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient allergies were not specified. Patient had no medical history of COVID-19. On 17Aug2021, the patient experienced myopericarditis, chest pain, elevated troponin at 600 ng/ml, st elevation in the electrocardiography. On 17Aug2021, onset of chest pains motivated a consultation in the Emergency Room. On 18Aug2021, patient experienced myocardial edema. The patient was hospitalized for in response to the events from 18Aug2021 to 23Aug2021. The patient underwent lab tests and procedures which included electrocardiogram: ST elevation on 17Aug2021, magnetic resonance imaging heart: acute myo-pericarditis on 18Aug2021 conclusion of a typical acute myo-pericarditis with obvious myocardial edema of the lateral wall of the left ventricle, sars-cov-2 test: unknown result on 19Aug2021, troponin: 600 ng/ml on 17Aug2021 Elevated troponin. Patient was discharged on 23Aug2021 and put on Bisoprolol 2.5 mg treatment. A follow-up of cardiac magnetic resonance imaging was scheduled in 3 months. Therapeutic measures were taken in response to the events. The outcome of all events was not resolved. "Subject to further elements of investigation that could be carried out as part of legal or amicable compensation procedures." Official Bulletin of the Ministry of Health No. 84/50, January 24, 1985, published in: Therapie 1985; 40:111-8 No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: Medical History/Concurrent Conditions: Atrial septal defect; Cardiac operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101159669

Write-up: Idiopathic acute peripheral facial nerve palsy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-SE20212314. A 14-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), intramuscular, administered in right arm on 03Aug2021 as dose 2, single for covid-19 immunisation. Medical history included atrial septal defect from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Medical history of COVID-19 noted that this patient was a person at risk of developing a severe form of COVID-19 because history of heart surgery; person who had no COVID-19; and a person who has not been tested. On 17Aug2021 (day 14), patient had idiopathic acute peripheral facial nerve palsy, while the adolescent was on vacation abroad. No additional information (no blood tests). Conclusion noted the report as first episode of idiopathic peripheral facial paralysis in a 14-year-old adolescent 14 days from dose 2 of Comirnaty, with favorable development. Patient had good recovery on corticosteroid, recovery without sequelae within 13 days on 30Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716973 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Nervousness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168387

Write-up: Swollen lymph nodes; Pain in joint; Pain muscle; Shaky feelings; Chills; Pain in arm; dose 1 of BNT162B2 on 21Jun2021/ dose 2 of BNT162B2 on 17Aug2021; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority(UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061204465810-K0KUK, safety report unique identifier is GB-MHRA-ADR 25899868. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number: Ff3319) dose 2 via an unspecified route of administration on 17Aug2021, age at vaccination of 39-years-old, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number: Fa1027), dose 1 via an unspecified route of administration on 21Jun2021 for covid-19 immunisation. The patient experienced swollen lymph nodes (medically significant) on 17Aug2021, pain in joint (medically significant) on 17Aug2021, pain muscle (medically significant) on 17Aug2021, shaky feelings (medically significant) on 17Aug2021, chills (medically significant) on 17Aug2021, pain in arm (medically significant) on 17Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. The patient recovered with sequelae from the event swollen lymph nodes on on an unspecified date, recovered from the event pain in joint on 23Aug2021, recovered from the event pain muscle on 19Aug2021, recovered from the event shaky feelings on 19Aug2021, recovered from the event chills on 19Aug2021, recovered from the event pain in arm on 22Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717262 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Oedema peripheral, Palpitations, Tachycardia, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy; Insect sting allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101155506

Write-up: Tachycardia; Urticaria generalised; Palpitation; Edema arms; Edema face; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-778408. A 50-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF7481), intramuscular, administered in Arm Left on 17Aug2021 (at the age of 50-year-old) as single dose for covid-19 immunization. Medical history included Insect sting allergy, food allergy. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Lot number: unknown), on 29May2021 for covid-19 immunization and after vaccination she experienced diarrhea and face, chest and lower limbs itchy wheal lesions, asthenia and dyspnoea from light exertion, episodes of right eye pain. On 17Aug2021, the patient experienced tachycardia, urticaria generalised, palpitation, edema arms and edema face. On 18Aug2021 second access to the ER, the day after the second dose of the vaccine. On 18Aug2021, the discharge report claimed: heart palpitations, palpitations, tachycardia, recurrence of urticaria Face, upper limbs and chest urticaria. During observation in regular activity always sinus rhythm with heart rate at medium-high values of the norm, not arrhythmic events. No signs to require a further examination. Outcome of the events was recovering.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101211748 same patient, diferent events


VAERS ID: 1717280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-08-17
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pain, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Colitis; Menopause; Myectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101156889

Write-up: APPEARANCE OF HEMORRAGIC LEAKS DESPITE THE MENOPAUSE; PRECEDED BY 10 DAYS OF SEVERE PAIN; This is a spontaneous report from a contactable consumer, downloaded from the regulatory authority IT-MINISAL02-778528. A 54-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular, administered in the left arm on 19Jun2021 (Batch/Lot Number: FC5089) single, for COVID-19 immunization. Medical history included menopause, spastic colitis, and myectomy intervention. The patient''s concomitant medications were not reported. On 17Aug2021, there was appearance of hemorrhagic leaks despite menopause preceded by 10 days of severe pain (onset date also reported as 17Aug2021). It was reported that the patient had "Loses lasting 3 days". Actions taken included first aid examination visits all hours in progress. Anti-inflammatory assumption for pain (6 days). Impact on the quality of life was reported as 10/10. Outcome of the events was recovered on an unspecified date. Reporter Comment: Spastic colitis, myectomy intervention; Reporter''s Comments: Spastic colitis, myectomy intervention


VAERS ID: 1717397 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Oxygen saturation, Pharyngeal disorder, Retrograde amnesia, Seizure, Somnolence, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:no abnormalities; Test Name: spo2; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202101160680

Write-up: Slight Consciousness disturbed; Convulsion around the mouth and eyes; Retrograde amnesia; abnormal throat; tremor of both hands; Prone to Somnolence; This is a spontaneous report received from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A non-pregnant 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 17Aug2021 09:30 (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021) as dose1, single at the age of 28-year-old for covid-19 immunisation. Medical history included asthma bronchial. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient''s concomitant medications were none. On 17Aug2021 at 09:30 (the day of vaccination), the patient received the first single dose of bnt162b2 (Solution for injection, Lot number FF2782, Expiration date 30Nov2021) intramuscular in the left arm for COVID-19 immunization. On 17Aug2021 at 09:45 (15 minutes after the vaccination), the patient experienced slight consciousness disturbed, convulsion around the mouth and eyes, retrograde amnesia, abnormal throat, tremor of both hands, prone to somnolence. Detailed information is as follows: The patient experienced abnormal throat and tremor of both hands 10 minutes after the inoculation (as reported). Immediately orally received with fexofenadine OD tablet 60 mg. During the course, there were no abnormalities in vital signs such as blood pressure and SPO2, and no other gastrointestinal or skin symptoms were observed. Due to convulsions around the mouth and eyes, the intravenous route was maintained with hydrocortone 2ml IV. After that, abnormal throat tended to ease, but the patient prone to somnolence (had response to the call). Although the patient answered the question, the response was poor than usual, with slight consciousness disturbed. One and a half hours after the vaccination, the patient suddenly became conscious, due to retrograde amnesia, memory was gone from the vaccination to that moment. The event resulted in emergency room/department or urgent care. The outcome of the events were recovered with treatment including oral fexofenadine OD tablet 60 mg, intravenous administration hydrocortone 2ml. Since the vaccination, the patient has not been tested for COVID-19. The reporter classified the event as non-serious.; Sender''s Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of consciousness disturbed, convulsion cannot be excluded. 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: 1717588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extensive swelling of vaccinated limb, Inappropriate schedule of product administration, Lymphadenopathy, Oedema peripheral, Ultrasound scan, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Ultrasound neck and arms; Result Unstructured Data: Test Result:enlarged axillary lymph nodes
CDC Split Type: NLPFIZER INC202101155718

Write-up: Edema arms; Lymphadenopathy axillary; Extensive swelling of vaccinated limb; Injection site swelling; Dose 1: 06Jul2021/Dose 2: 17Aug2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00673838. A 30-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: FG4509), via an unspecified route of administration on 17Aug2021 (at the age of 30-year-old) as single dose for covid-19 immunization. The patient''s medical history was not reported. The patient did not have a previous covid-19 infection. Concomitant medications included paracetamol (MANUFACTURER UNKNOWN: Strength: 500 mg). The patient previously took first dose of bnt162b2 (COMIRNATY, lot number not reported) on 06Jul2021 for covid-19 immunisation and experienced no adverse event. The patient experienced edema arms, lymphadenopathy axillary, extensive swelling of vaccinated limb and injection site swelling on 24Aug2021 (also reported as after seven days). Clinical course of the events were as follows: The patient was hospitalised and an ultrasound examination of the arms and neck was performed which showed enlarged axillary lymph nodes with somewhat atypical aspect. No pathological lymphoma. Structures in arm matching oedema. The patient was recovering two days after onset. The adverse reactions occurred one week after the second vaccination, with no further skin abnormalities. Ultrasound neck and arms 26Aug2021: On both sides, there was good access to the subclavian and axillary arteries, as well as to the other upper arm vessels; on both sides, there are enlarged lymph nodes in the axilla with a somewhat atypical appearance - there was an ultrasound-rich center, but also a somewhat thickened, somewhat ultrasound-rich cortex - so that it was not so much a case of pathological lymphomas (these are usually ultrasound-poor and round); there are also striking, on both sides, in the subcutis of the upper arms, ultrasound-poor structures that are consistent with edema. The patient was recovering from all the events at the time of the report. No follow-up attempts are possible. No further information expected.


VAERS ID: 1717604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101155650

Write-up: PULMONARY EMBOLISM; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number NO-NOMAADVRE-FHI-2021-U8qpwq. A 62-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 05Aug2021 (Lot Number: FE7053) as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 (COMIRNATY) in 2021 for Covid-19 immunisation. The patient experienced pulmonary embolism on 17Aug2021 with outcome of recovering. The patient was hospitalized for pulmonary embolism from 2021 to an unknown date. The event was reported as twelve days after vaccination, pulmonary embolism was detected. Treatment with enoxaparin was started, gradually transitioning to DOAC (Direct Oral Anticoagulant). There is no information on whether the patient may have had known risk factors for DVT (deep vein thrombosis), PE. Reporter comment will request discharge summary from hospital. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1717684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Malaise, Pain
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? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARISSA; EUTIROX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101176766

Write-up: indisposition; Body aches; Mental Confusion; This is a Spontaneous report from a contactable consumer(patient). This is the second of two reports. The first was downloaded from the WEB. This is a report received INFARMED Regulatory authority report number PT-INFARMED-T202108-2593 with Safety Report Unique Identifier PT-INFARMED-T202108-2593. A 26-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscularly on 16Aug2021 (Lot Number: FE4728) as 0.3 mL single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included chlormadinone acetate, ethinylestradiol (CLARISSA); levothyroxine sodium (EUTIROX). The patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 19Jul2021 (Lot Number: FF0688) as 0.3 mL single dose for covid-19 immunization and had hot flushes. The patient experienced indisposition on 17Aug2021, body aches on 17Aug2021, mental confusion for 15 minutes on 17Aug2021. Adverse Reactions were not reported to a health care professional however were considered disabling. The outcome of the event was recovered on 17Aug2021; of the other events were unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : PT-PFIZER INC-202101155886 Same product and patient, different dose and AE.


VAERS ID: 1718601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101173201

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional received via the Regulatory Agency. Regulatory authority report number is 617828. A 41-year-old male patient received a dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 04Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis on 17Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718628 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (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: PANTOPRAZOLE; NORVASC; SYNTHROID; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Sulfonamide allergy; Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: blood pressure; Result Unstructured Data: Test Result:increase; Test Date: 20210903; Test Name: Covid Test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202101168737

Write-up: localized headache at the back of the head; muscular pain; intense fatigue; Blood pressure increase; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the left arm, on 17Aug2021 at 15:00 (at the age of 61-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to sulfates, controlled hypertension, thyroid. The patient had not COVID prior vaccination. Concomitant medications included pantoprazole, amlodipine besilate (NORVASC), levothyroxine sodium (SYNTHROID), vitamin D (vitamin D NOS), reported as other medications in two weeks. No other vaccine received in four weeks. On 17Aug2021 at 15:30, the patient experienced localized headache at the back of the head, appeared 30 minutes after the vaccine and it did not go away that day. On 17Aug2021 at 15:00, the patient experienced blood pressure increase, muscular pain and intense fatigue. Blood pressure increase which did not improve with the regular dose. The physician prescribed a dose even higher, but the blood pressure did not decrease. The headache was very intense. Adverse event resulted in physician or other health care professional office visit. Treatment was administered in response to the event blood pressure increase and included amlodipine besilate. The patient underwent lab tests and procedures, which included COVID test via nasal swab on 03Sep2021: negative. The patient had not recovered from the events.


VAERS ID: 1718667 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alopecia, Arthralgia, Body temperature, Haematuria, Lymph node pain, Lymphadenopathy, Malaise, Nausea, Office visit, Pain, Pyrexia, Urological examination, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

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: EUTHYROX
Current Illness: Unspecified disorder of thyroid
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210818; Test Name: Office visit; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210818; Test Name: Urological examination; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: CZPFIZER INC202101216551

Write-up: Blood in urine; joint pain; hair loss; Fever 38?C; Puncture site pain; Malaise; Whole body pain; Nauseous; Swollen axillary lymph nodes; Pain in the glands in the armpits; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21010094. This is a report for second dose. A 32-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), dose 2 via an intramuscular route of administration on 17Aug2021 (age at vaccination 32 years old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), dose 1 via an intramuscular route of administration on 26Jul2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced swollen and painful injection site, arthralgia, hair loss, swollen and painful axillary glands. Medical history included ongoing unspecified disorder of thyroid from on unknown date. Concomitant medication included levothyroxine sodium (EUTHYROX) taken for an unspecified indication, start and stop date were not reported. On 17Aug2021, after the second dose, patient experienced fever 38?C, whole body pain, puncture site pain, nauseous and malaise. On 18Aug2021, patient experienced blood in urine, joint pain and hair loss. On an unspecified date in 2021, patient experienced swollen axillary lymph nodes and pain in the glands in the armpits. The patient described urine as very dark, day after second dose vaccination. The patient contacted the covid hotline, visited her general practitioner and urology clinic. She was currently awaiting the results of the examination. On 18Aug2021, the patient underwent lab tests and procedures which included body temperature: 38 centigrade, urological examination: unknown result and office visit: unknown results. Therapeutic measures were taken as a result of the events included icing the injection site, acetate ointment, vitamins C and D; ibalgin, used to lower patient''s temperature, urological tea and urological syrup, uroval and increased fluid intake. The outcome of swollen axillary lymph nodes, malaise, whole body pain, nauseous and pain in the glands in the armpits was not recovered, events fever 38?C and puncture site pain were recovered on an unspecified date in 2021, outcome of blood in urine, joint pain and hair loss was unknown. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101166708 same patient/ vaccine, different dose/ events


VAERS ID: 1718704 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-17
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: CSF test, Guillain-Barre syndrome, Magnetic resonance imaging head, Neurological examination, Spinal myelogram
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Name: cerebrospinal fluid; Result Unstructured Data: Test Result:unknown result; Test Name: cranial MRI; Result Unstructured Data: Test Result:unknown result; Test Name: Neurophysiology; Result Unstructured Data: Test Result:unknown result; Test Name: Myelographie; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC202101180351

Write-up: Polyneuroradiculitis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority company number DE-PEI-202100180577. A 67-years-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FC1440), dose 2 via an unspecified route of administration on 08Jul2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced polyneuroradiculitis. The patient was hospitalized for the event polyneuroradiculitis. The patient underwent lab tests and procedures which included cranial MRI: unknown result, cerebrospinal fluid: unknown result, neurophysiology: unknown result and MRI myelography: unknown result on an unknown date. The outcome of the event was not recovered. Health Authority Comment: Examinations: cranial MRI, Cerebrospinal Fluid, neurophysiology, MRI Myelography; exclusion of infection in the history. Causal relationship between the event/s and the administration of CORMINATY was assessed as Unclassifiable (D) by the PEI. No follow-up attempts possible. No further information expected.


VAERS ID: 1720569 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Perimyocarditis; This case was received via Regulatory Authority (Reference number: 992700) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Perimyocarditis) in a 23-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 17-Aug-2021, the patient experienced MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Perimyocarditis) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 13-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of MYOCARDITIS. The event occurred approximately 5 days after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose and the vaccine was withdrawn. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected upon translation.; Sender''s Comments: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of MYOCARDITIS. The event occurred approximately 5 days after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose and the vaccine was withdrawn. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected upon translation.


VAERS ID: 1720646 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDN1 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Coagulation factor IX level, Coagulation factor VII level, Coagulation factor X level, Discomfort, Dysmenorrhoea, Dyspnoea, Haemoglobin, Heart rate, Iron deficiency anaemia, Palpitations, Physical examination, Prothrombin level, Pulmonary physical examination, Serum ferritin, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tendency to bruise easily (in her mother; no umbilical cord hemorrhage, no caput succedaneum.); Vaginal bleeding (Light bleeding usually over a period of 2-3 days.); Comments: RAS
Allergies:
Diagnostic Lab Data: Test Name: thyroid stimulating hormone; Result Unstructured Data: Test Result:normal; Test Name: Factor IX; Result Unstructured Data: Test Result:no abnormalities; Test Name: Factor VII; Result Unstructured Data: Test Result:no abnormalities; Test Name: Factor X; Result Unstructured Data: Test Result:borderline; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.8; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: beats per minute without murmur; Test Name: Physical examination; Result Unstructured Data: Test Result:cutaneous pallor; Comments: Clinical cutaneous-mucosal pallor digestive assessment normal, ear, nose and throat OK, lymph node chain OK.; Test Name: Factor II; Result Unstructured Data: Test Result:borderline; Test Name: pulmonary assessment; Result Unstructured Data: Test Result:normal; Test Name: Ferritin-2; Result Unstructured Data: Test Result:Normalized
CDC Split Type: FRPFIZER INC202101212120

Write-up: Iron deficiency anaemia; Dysmenorrhea; Palpitations; Dyspnea; Tachycardia; feeling of discomfort when getting up; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional. This is the second of two reports. The first report is a report downloaded from the regulatory authority number FR-AFSSAPS-CF20212537. A 13-years-old female patient received dose 2 of BNT162b2 (COMIRNATY), intramuscularly, administered in left arm on 13Aug2021 (Batch/Lot Number: SCDN1) as a single dose for COVID-19 immunization. Medical history included Light bleeding usually over a period of 2-3 days, starting in Feb2021 (Light bleeding usually over a period of 2-3 days). The patient had not had COVID-19. Family history of hemorrhage: tendency to bruise easily in her mother. The patient''s concomitant medications were not reported. On 23Jul2021, the patient underwent vaccination with BioNTech-COMIRNATY, 1st intramuscular injection (single dose) - arm not specified - batch FE7010, for COVID-19 immunization. Patient "resolved" for 6 months (Feb2021). Light bleeding usually over a period of 2-3 days. On 03Aug2021, 2 weeks after 1st injection: Unusual menometrorrhagia for 15 days, 11 days after the 1st vaccination. Haemorrhaging haemoglobin was 6.8. There was need for red blood cell transfusion. There was no evidence of gynaecological pathology. The patient was hospitalized for 3 days. Hospitalization report: Hospitalization was from 17Aug2021 to 19August2021 in the paediatric emergency room. Iron deficiency anaemia in the context of menometrorrhagia. During consultation with the general practitioner for dysmenorrhoea and anaemia, the patient complained of palpitations and dyspnoea at the slightest effort, with a feeling of discomfort when getting up. She has been menstruating for 15 days with at least 5 tampon changes per day. Family history of hemorrhage: tendency to bruise easily in her mother, no umbilical cord haemorrhage, no caput succedaneum. Clinical cutaneous-mucosal pallor, tachycardia at 130 beats per minute without murmur. Hemodynamics clear, pulmonary assessment normal, digestive assessment normal, ear, nose and throat "OK," lymph node chain "OK." During the night of "17Feb2021-18Feb2021:" Infusion of 1 dose of FERINJECT (Ferritin-2, Normalized after infusion to 30Ug/L). Transfusion of 2 Radial Glia Cells due to the absence of haematological reconstitution and the presence of a poorly tolerated major anaemic syndrome. After gynaecological advice: Thyroid stimulating hormone measurement associated with an extended coagulation assessment (Factor II, Factor X: borderline; Factor IX, Factor VII: no abnormalities, not very suggestive of Vitamin K deficiency, thyroid stimulating hormone normal). Perform a platelet closure time and platelet aggregation test. Screening for thrombopathy in progress. There was clinical improvement after 2 Radial Glia Cells, decision to be discharged on 19Aug2021, without introduction of oestroprogestogenic pill due to absence of thrombocytopaenia assessment. Day hospital on 27Aug2021: Haematology tests and in 3-4 months will be reviewed by gynaecology intern. Treatment and care, discharge: EXACYL oral solution, if heavy bleeding does not subside. To date (date of report: 06Sep2021), no resumption of bleeding. ONGOING MEDICAL CARE: Hospitalisation. EVOLUTION: Recovery without after-effects. The patient recovered from the event iron deficiency anemia on 19Aug2021, and the events of dysmenorrhea, palpitations, and dyspnea on an unspecified date. The outcome of tachycardia and discomfort was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : PFIZER INC-202101155910 Same patient different dose


VAERS ID: 1721073 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myasthenia gravis
SMQs:, Immune-mediated/autoimmune disorders (narrow)

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: ITPFIZER INC202101174651

Write-up: Worsening autoimmune disease myasthenia gravis after administration of the Pfizer covid 19 vaccine; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority report number is IT-MINISAL02-780004. A 66-years-old female patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2752; Expiration Date: unknown) intramuscular, administered in arm left (left shoulder) on 26Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced worsening autoimmune disease myasthenia gravis after administration of the Pfizer COVID-19 vaccine on 17Aug2021. Adverse drug reaction was approximately 15 days after inoculation. Doctors have increased cortisone treatment (5 times the normal dose). The reporter informed that the patient was carrying out further investigations. The outcome of event was not recovered. Health authority comments: Local Center of Pharmacovigilance 06Sep2021 Follow-up lot code - case description - vaccine inoculation date 2 dose.


VAERS ID: 1721334 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-17
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-22
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? 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: 20210817; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: PTPFIZER INC202101163277

Write-up: This is a spontaneous report from a contactable Other Health Professional, regulatory authority number PT-INFARMED-T202108-2656. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jun2021 (Batch/Lot Number: FC5435; Expiration Date: 30Sep2021) as DOSE 2, 0.3 mL, SINGLE and dose 1 intramuscular on 24May2021 (Batch/Lot Number: FA7083; Expiration Date: 30Sep2021) as DOSE 1, 0.3 mL, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccine impaired response on 17Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021. The reporter''s assessment of the causal relationship of the Vaccination failure, COVID-19 with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: definitive. On 10Sep2021 investigational result was received from product quality complaint team regarding complaint about bnt162b2 (COMIRNATY, Batch/Lot Number: FA7083, expiration date: 30Sep2021) and bnt162b2 (COMIRNATY, Batch/Lot Number: FC5435, expiration date: 30Sep2021). Conclusion from (site name) division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 FA7083 and lot FC5435. 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. Pfizer 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. Reporter''s comment: Other information-result PCR at 17Aug2021, (private). No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Other information-result PCR at 17Aug2021, (private).


VAERS ID: 1721337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-17
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 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? 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: 20210817; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive
CDC Split Type: PTPFIZER INC202101163667

Write-up: Vaccine failure; SARS-CoV-2; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202108-2676 with Safety Report Unique Identifier PT-INFARMED-T202108-2676. A 71-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 18Feb2021 (Lot Number: EP9598; Expiration Date: 30Jun2021) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccine failure and sars-cov-2 on 17Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 Positive. The outcome of the events was recovering. Investigational results received on 10Sep2021 from Regulatory Authority regarding complaint about PFIZER-BIONTECH COVID-19 VACCINE ( lot number: EP9598, expiration date: 30Jun2021). For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced RA ID resulted in the following conclusion: The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 EP9598. 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. The reporters assessment of the causal relationship of the [COVID-19 and drug ineffective] with the suspect product 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1721339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-08-17
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive (IU) in international units
CDC Split Type: PTPFIZER INC202101164149

Write-up: Vaccination failure/SARS-CoV-2 test positive; Vaccination failure/SARS-CoV-2 test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number PT-INFARMED-T202108-2800, with Safety Report Unique Identifier PT-INFARMED-T202108-2800. A 30-year-old female patient received BNT162B2 (solution for injection), intramuscularly on 16May2021 (lot number: EX8680; expiry date: 31Aug2021) as dose 2, 0.3 mL single and intramuscularly on 17Apr2021 (lot number: EW9127; expiry date: 31Jul2021) as dose 1, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure/SARS-CoV-2 test positive on 17Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive [positive (IU) in international units] on 17Aug2021. The outcome of the events was recovering. On 10Sep2021, the Product Quality Complaints (PQC) group reported the following investigational results. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 lots EW9127 and EX8680. 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. Regulatory Authority 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 reporter''s assessment of the causal relationship of the [COVID-19 and vaccination failure] with the suspect product 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724258 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pruritus, Urticaria
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? 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: ESPFIZER INC202101174582

Write-up: Urticaria; pruritus; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority WEB ES-AEMPS-992820. A 24-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 03Aug2021 (Lot Number: FF2752) as 0.3 mL single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced urticaria on 17Aug2021 with outcome of recovered on 18Aug2021, pruritus on 17Aug2021 with outcome of recovered on an unknown date. The events were serious as medically significant. The clinical course was reported as follows: "24-year-old patient vaccinated with Comirnaty 03Aug2021 presented 15 days later generalized urticaria and pruritus (17Aug2021) that recovered." Follow-up attempts are completed. No further information is expected.


VAERS ID: 1724259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Physical examination
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: Test Name: Physical exploration; Result Unstructured Data: Test Result:Abnormal; Comments: Difficulty occlusion in the right eye, right facial paralysis. Nondescript Neuro Rest motor 5 / (5 normal gear) No diplopia, no dysmetria
CDC Split Type: ESPFIZER INC202101171711

Write-up: Facial droop; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB ES-AEMPS-992832. A 17-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 10Aug2021 (Lot Number: FF2752) as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial droop (medically significant) on 17Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included physical examination: abnormal on unknown date (Difficulty occlusion in the right eye, right facial paralysis). Clinical course as reported: He went to the urgencas for presenting right facial paresis one week after vaccination. Physical exploration: Difficulty occlusion in the right eye, right facial paralysis. Nondescript Neuro Rest, motor 5 / (5 normal gear), No diplopia, no dysmetria, In treatment with deflazacort 30 mg + hydroxyl. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-08-17
   Days after vaccination:179
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Myalgia, Odynophagia, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: 20210830; Test Name: SARS-CoV-2 IgG (anti-nucleocapsid); Result Unstructured Data: Test Result:0.470; Test Date: 20210830; Test Name: SARS-CoV-2 IgG (anti-spicule); Result Unstructured Data: Test Result:12412.20 IU/ml; Comments: 1762.53 BAU / mL; Test Date: 20210817; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210827; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: (Ct30-35)
CDC Split Type: ESPFIZER INC202101171114

Write-up: Vaccination failure; COVID-19; Myalgia; Odynophagia; Febricula; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number ES-AEMPS-992844. A 40-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly, second dose on 19Feb2021 (Lot Number: EL0725; Expiration Date: 31Mar2021), first dose on 29Jan2021 (Lot Number: EJ6134; Expiration Date: 30Apr2021), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure on 17Aug2021, covid-19 on 17Aug2021, myalgia on 17Aug2021, odynophagia on 17Aug2021, febricula on 17Aug2021. 17Aug2021: PCR test for COVID-19: POSITIVE. 27Aug2021: PCR test for COVID-19: POSITIVE (Ct30-35). 30Aug2021: SARS-CoV-2 IgG (anti-spicule) 12412.20 AU/mL Positive 1762.53 BAU/mL, SARS-CoV-2 IgG (anti-nucleocapsid) 0.470 Negative Index. The outcome of the events was recovered on 30Aug2021. Received from a Product Quality Complaint Group. Complaint record received from the site. Information obtained: Conclusion for lot number EL0725: 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 EL0725. 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. 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 were identified as the complaint was not confirmed. Expiry date for lot number EL0725: 31Mar2021. Conclusion for lot number EJ6134: 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 EJ6134. 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.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 were identified as the complaint was not confirmed. Expiry date for lot number EJ6134: 30Apr2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-17
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Nasal congestion, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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: 20210817; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210828; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Ct 30-35
CDC Split Type: ESPFIZER INC202101171144

Write-up: Distress respiratory; Congestion nasal; dyspnea; Drug ineffective; COVID-19; This is a spontaneous report from a contactable physician downloaded from the RA ES-AEMPS-992942. A 35-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly, second dose on 15Mar2021 (Lot Number: ER2659; Expiration Date: 30Jun2021), first dose on 22Feb2021 (Lot Number: EL0725; Expiration Date: 31Mar2021), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced drug ineffective on 17Aug2021, covid-19 on 17Aug2021, distress respiratory on 18Aug2021, congestion nasal on 18Aug2021, dyspnea on 17Aug2021. 17Aug2021 Onset of symptoms: dyspnea. Positive COVID-19 PCR test. 18Aug2021 Congestion nasal. 28Aug2021 Positive COVID-19 PCR test (Ct 30-35). The outcome of the event dyspnea was unknown, of the other events was recovered on 28Aug2021. Investigation results received on 10Sep2021 included: Lot: ER2659, Batch expiry date: 30Jun2021. 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 ER2659. 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. 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 were identified as the complaint was not confirmed. Lot: EL0725, Batch expiry date: 31Mar2021. 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 EL0725. 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. 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 were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Haematology test, Imaging procedure, Immunoglobulins, Inflammatory marker test, Joint stiffness, Joint swelling, Juvenile idiopathic arthritis, Laboratory test, Liver function test, Oedema peripheral, Pain in extremity, Renal function test, Rheumatoid factor, Thyroid function test, Urine analysis
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), 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:
Allergies:
Diagnostic Lab Data: Test Name: Haematology; Result Unstructured Data: Test Result:Normal; Test Name: imaging study response; Result Unstructured Data: Test Result:Pending; Test Name: immunoglobulin levels; Result Unstructured Data: Test Result:Normal; Test Name: inflammatory values; Result Unstructured Data: Test Result:Normal; Test Name: Laboratory test; Result Unstructured Data: Test Result:Pending; Test Name: liver test; Result Unstructured Data: Test Result:Normal; Test Name: Kidney function test; Result Unstructured Data: Test Result:Normal; Test Name: rheumatoid factor; Result Unstructured Data: Test Result:Normal; Test Name: thyroid values; Result Unstructured Data: Test Result:Normal; Test Name: urinary specimen; Result Unstructured Data: Test Result:Normal
CDC Split Type: FIPFIZER INC202101180398

Write-up: Joint swelling; heels and the joints of II and III toes sore and stiff; swelling of the fingers and hands; suspected incipient rheumatoid arthritis; Mild swelling was observed in the II and III toes, knuckle joints and middle joints of II-III fingers; pain and swelling of the fingers and hands; This is a spontaneous report from a contactable physician downloaded from the RA; FI-FIMEA-20214419. A 13-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry dates was not reported), intramuscularly, on 12Aug2021, as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient was healthy prior to the vaccination and symptoms started after the first dose of the vaccine. On 17Aug2021 the patient experienced pain and swelling of the fingers and hands and on 23Aug2021 the heels and the joints of II and III toes sore and stiff and mild swelling was observed in the II and III toes, knuckle joints and middle joints of II-III fingers. Pains so severe that cannot not sleep, painkillers do not help and was admitted to the ward for treatment and Diagnosis open, suspected incipient rheumatoid arthritis or other immunological disease and studies in progress. The patient received treatment for the events. The patient underwent lab test and procedure included haematology test, immunoglobulin levels, Inflammatory marker test, liver function test, renal function test, Rheumatoid factor, Thyroid function test, Urine analysis with normal results and laboratory test and imaging study responses are still missing. Outcome of the events were not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hyperthyroidism, Thyroiditis
SMQs:, Hypothyroidism (broad), Hyperthyroidism (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101186857

Write-up: Hyperthyroidism; thyroiditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NT20213683. A 41-year-old female patient received a dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FE8235, Expiration date: unknown), via intramuscular, administered in left arm on 15Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, after the vaccination, the patient experienced Thyroiditis with major hyperthyroidism. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1724428 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Fatigue, Hypokinesia, Loss of personal independence in daily activities, Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (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? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEST [ETHINYLESTRADIOL; LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176074

Write-up: Nausea; Muscle ache; Fever; Fatigue; Pain in arm; ability to continue with everyday activities affected; ached in body; uncomfortable; moving took extreme effort; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-EYC 00259929 with Safety Report Unique Identifier GB-MHRA-ADR 25900357. This is one of the two reports. A 18-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF3319) via an unspecified route of administration on 17Aug2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol/levonorgestrel (LEVEST) for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received paracetamol (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced hives, swelling in face and also previously received first dose of BNT162b2 (Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and experienced ache in arm. On 17Aug2021, the patient experienced fatigue, fever and muscle ache. On an unknown date in 2021, the patient was just so uncomfortable, everything ached in her body, moving took extreme effort, pain in arm and the patient had a side effects which affected her ability to continue with her everyday activities. On 18Aug2021, the patient experienced nausea. The events fatigue, fever, nausea, muscle ache and pain in arm reported as a serious for being medically significant. It was reported that the patient sat in a dark room for most of the day after the vaccination. Therapeutic measures were taken as a result of fatigue, muscle ache, ached in body and pain in arm which included treatment with ibuprofen from an unknown date. The patient found ibuprofen was helpful but did not make her feel completely normal either, just reduced the severity of the effects. The clinical outcome of the event fever was resolved on 18Aug2021 after duration of 1 day, while clinical outcome of the event fatigue and muscle ache was resolved on 19Aug2021 after duration of 2 days and nausea resolved on 19Aug2021 after duration of 1 day. The clinical outcome of the event ability to continue with everyday activities affected, ached in body, uncomfortable, moving took extreme effort, pain in arm were unknown at the time of this report. No follow-up attempts are needed. No further information is expected. Sender''s Comments: Linked Report(s): GB-PFIZER INC-202101196155 Same patient, different events/doses


VAERS ID: 1724597 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Lymphadenopathy, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190681

Write-up: Allergic reaction; Throat swelling; Swollen glands; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109090954213150-UULTB. Safety Report Unique Identifier GB-MHRA-ADR 25916861. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 as DOSE 2, SINGLE (Age at vaccination: 41-year-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Penicillin allergy very similar symptoms experienced. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine received as bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 17Aug2021, The patient experienced allergic reaction, throat swelling and swollen glands. Taking piriton numerous times through day. Therapeutic measures were taken as a result of allergic reaction, throat swelling and swollen glands. Patient has not tested positive for COVID-19 since having the vaccine. Patient was s not enrolled in clinical trial. The outcome of the events (allergic reaction, throat swelling) was recovering and event (swollen glands) was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724836 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Rash pruritic, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: SULFASALAZINE; DICLOFENAC; SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE; DIOSMIN; PREGABALIN; LOBIDIUR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 202011; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101174872

Write-up: jugular constriction feeling; irritating cough; Itchy rash limbs all limb; FARO This is a non-interventional study report from a contactable pharmacist downloaded from the regulatory authority-WEB IT-MINISAL02-779547. A 52-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 17Aug2021 09:36 (Lot Number: FG4686; Expiration Date: 30Nov2021, at age of 52 years old) as 0.3ml single dose for COVID-19 immunisation. Medical history included hypertension, venous insufficiency, asthma. Concomitant medications included sulfasalazine taken for inflammation localised; diclofenac taken for ache; fluticasone propionate, salmeterol xinafoate (SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE) taken for asthma; diosmin taken for chronic venous insufficiency; pregabalin taken for epilepsy; hydrochlorothiazide, nebivolol hydrochloride (LOBIDIUR) taken for hypertension. The patient experienced jugular constriction feeling, irritating cough, itchy rash limbs all limb on 17Aug2021. Events were reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 test: positive in Nov2020. Actions taken: trimeton 2 vials. The outcome of events was recovering. The reporter''s assessment of the causal relationship of the events with the suspect product 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''s Comments: 1st dose, at 9:36, left arm, expiration date 30Nov2021.; Sender''s Comments: Based on a positive temporal relationship, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1725877 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood potassium, Blood sodium, Chest discomfort, Computerised tomogram, Dizziness, Foaming at mouth, Limb discomfort, Loss of consciousness, Malaise, Muscle twitching, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Test Name: K; Result Unstructured Data: 3.7mEq/L; Test Name: K; Result Unstructured Data: 3.1mEq/L; Test Name: Na; Result Unstructured Data: 115mEq/L; Test Name: Na; Result Unstructured Data: 120mEq/L; Test Name: Cerebrel CT scan; Result Unstructured Data: No ICH
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Spasm (seizure/convulsion); Limb weakness; hanging of his eyes with loss of consciousness for about 5 minutes; Dizziness; General weakness; Chest tightness; Foaming at the mouth; Twitching of his hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Spasm (seizure/convulsion)), LIMB DISCOMFORT (Limb weakness), LOSS OF CONSCIOUSNESS (hanging of his eyes with loss of consciousness for about 5 minutes), DIZZINESS (Dizziness), MALAISE (General weakness), CHEST DISCOMFORT (Chest tightness), FOAMING AT MOUTH (Foaming at the mouth) and MUSCLE TWITCHING (Twitching of his hands) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced SEIZURE (Spasm (seizure/convulsion)) (seriousness criterion medically significant), LIMB DISCOMFORT (Limb weakness) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (hanging of his eyes with loss of consciousness for about 5 minutes) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), MALAISE (General weakness) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest tightness) (seriousness criterion medically significant), FOAMING AT MOUTH (Foaming at the mouth) (seriousness criterion medically significant) and MUSCLE TWITCHING (Twitching of his hands) (seriousness criterion medically significant). At the time of the report, SEIZURE (Spasm (seizure/convulsion)), LIMB DISCOMFORT (Limb weakness), LOSS OF CONSCIOUSNESS (hanging of his eyes with loss of consciousness for about 5 minutes), DIZZINESS (Dizziness), MALAISE (General weakness), CHEST DISCOMFORT (Chest tightness), FOAMING AT MOUTH (Foaming at the mouth) and MUSCLE TWITCHING (Twitching of his hands) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: 3.7 (normal) 3.7mEq/L and 3.1 (Low) 3.1mEq/L. On an unknown date, Blood sodium: 115 (Low) 115mEq/L and 120 (Low) 120mEq/L. On an unknown date, Computerised tomogram: normal (normal) No ICH. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment history was not reported. Reporter stated that 7.0mm endotracheal tube was placed. Company comment: This case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected events of seizure, limb discomfort, loss of consciousness, dizziness, malaise, chest discomfort, foaming at mouth, and muscle twitching. The events occurred approximately 2 days after the first dose of mRNA 1273. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of vaccine is not affected by this report.; Sender''s Comments: This case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected events of seizure, limb discomfort, loss of consciousness, dizziness, malaise, chest discomfort, foaming at mouth, and muscle twitching. The events occurred approximately 2 days after the first dose of mRNA 1273. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of vaccine is not affected by this report.


VAERS ID: 1729407 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Dysarthria, Erythema, Feeling hot, Hyperhidrosis, Lip swelling, Loss of consciousness, Swollen tongue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210942514

Write-up: SEVERE FAINT REACTION; BLUE SWOLLEN LIPS; HOT RED FACE; SLURRED SPEECH; LOSS OF CONSCIOUSNESS FOR 4 MINUTES; HOT RED FACE; BLUE SWOLLEN LIPS; PROFUSE SWEATING; SWOLLEN TONGUE; This spontaneous report received from a pharmacist via Regulatory Authority (IE-HPRA-2021-082766) on 22-SEP-2021 and concerned a 21 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 21C17-03 and expiry UNKNOWN) dose was not reported,1 total, drug start period 15 seconds, administered on 17-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-AUG-2021, the patient experienced severe faint reaction, blue swollen lips, hot red face, slurred speech, loss of consciousness for 4 minutes, hot red face, blue swollen lips, profuse sweating, swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe faint reaction, blue swollen lips, hot red face, slurred speech, loss of consciousness for 4 minutes, hot red face, blue swollen lips, profuse sweating, and swollen tongue. This report was serious (Other Medically Important Condition).


VAERS ID: 1729905 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210943274

Write-up: HEADACHE; FEVER; GENERAL BODY PAIN; HYPERHIDROSIS; This spontaneous report received from a consumer via Regulatory Authority (PT-INFARMED-F202109-483) on 22-SEP-2021 concerned a 27 year old male of unspecified race and ethnic origin. The patient''s weight was 87 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, parenteral, batch number: 21c 17-03 and expiry: unknown) .5 ml, 1 total administered on 17-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-AUG-2021, the patient experienced headache, fever, general body pain and had hyperhidrosis. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fever, and general body pain on 18-AUG-2021, and hyperhidrosis on 01-SEP-2021. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Did a Medication Error Occur? No


VAERS ID: 1731000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210945078

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-044586) on 23-SEP-2021 and concerned a 30 year old male. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1732925 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anembryonic gestation, Haemorrhage in pregnancy, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gravida II (one was only 6 months ago)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:had a sac but no embryo
CDC Split Type: GBPFIZER INC202101191726

Write-up: Blighted ovum; bleeding the day after jab and haven''t stopped since/found out was pregnant on the 31st of August; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109102150177790-RHCOK, Safety Report Unique Identifier GB-MHRA-ADR 25926476. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 17Aug2021 (at the age of 34 years old) as dose 2, single for COVID-19 immunisation. Medical history included 2 previous pregnancies (one was only 6 months ago). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took folic acid. The patient experienced blighted ovum on 02Sep2021 and bleeding the day after jab (18Aug2021) and haven''t stopped since/found out was pregnant on the 31st of August. The events were medically significant. The mother reported she became pregnant while taking bnt162b2. The mother was 2 weeks pregnant at the onset of the event. The mother was due to deliver on 07May2022. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on an unspecified date and scan showed had a sac but no embryo on an unspecified date. Outcome of the blighted ovum and bleeding the day after jab and haven''t stopped since/found out was pregnant on the 31st of August was not recovered. The clinical course was reported as follows: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Yes. Pregnancy adverse effects details: I had my last period on the 31st of July, I had my 2nd jab on the 17th of August. I started bleeding the day after my jab and haven''t stopped since. I found out I was pregnant on the 31st of August but have bleed heavily since and had a scan to reveal had a sac but no embryo. The reporter asked if this is a result of the jab at conception. Patient did not take folic acid supplement during pregnancy. Details of previous pregnancies: 2 previous pregnancies one only 6 months ago. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733149 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Abdominal pain, Computerised tomogram, Inappropriate schedule of product administration, Investigation, SARS-CoV-2 test, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Abdominal X-rays; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: Surgical examination; Result Unstructured Data: Test Result:mesenteric lymphadenopathy.; Comments: showed no obvious abnormalities to any organs but showed mesenteric lymphadenopathy.; Test Date: 20210701; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: laparoscopic appendectomy; Result Unstructured Data: Test Result:symptoms persisted; Comments: symptoms persisted
CDC Split Type: GBPFIZER INC202101212188

Write-up: abdominal pain; uncontrolled vomiting; Inappropriate schedule of Vaccine administered; This is a spontaneous report from a contactable consumer. This is second of two report. The first re-port is report downloaded from the Regulatory authority. This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131037486490-54EPX [Safety Report Unique Identifier: GB-MHRA-ADR 25931073]. An 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 17Aug2021 (age at the time of vaccination was 18-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no illnesses in 18 years of life prior to 2 x covid vaccinations. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on 22Jun2021 (Batch/Lot Number: not reported) as for covid-19 immunization and experienced abdominal pain, mesenteric lymphadenopathy, Adenitis, uncontrolled vomiting. On an unspecified date the patient underwent lab tests and procedures which included abdominal x-ray: unknown results, computerised tomogram: unknown results, investigation: mesenteric lymphadenopathy (showed no obvious abnormalities to any organs but showed mesenteric lymphadenopathy), sars-cov-2 test: no - negative covid-19 test on 01Jul2021, surgery: symptoms persisted. On 01Sep2021, the patient experienced abdominal pain (hospitalization, medically significant) and uncontrolled vomiting (hospitalization, medically significant). On both occasions, 9 days post 1st vaccine and then 15 days post 2nd vaccine, severe abdominal pain and uncontrolled vomiting. Patient had to be admitted to hospital for 5 days on each occasion. On fluids, morphine, sodium diclofenac suppository and finally sedation to stabilize and manage pain. Tender ROQ and lower abdomen and prostrate. Patient underwent laparoscopic appendectomy but symptoms persisted. Surgical examination showed no obvious abnormalities to any organs but showed mesenteric lymphadenopathy. No cause found. Therapeutic measures were taken as a result of abdominal pain and uncontrolled vomiting. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101205536 Same patient/reporter but different dose/event


VAERS ID: 1733675 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Fatigue, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210943313

Write-up: FEVER; CONFUSIONAL STATE; MUSCULAR PAINS; FATIGUE; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-422) on 22-SEP-2021 and concerned a 20 year old male. The patient''s weight was 67 kilograms, and height was 171 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21c11-05 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-AUG-2021, the patient experienced fever, confusional state, muscular pains and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, confusional state, muscular pains, and fatigue on 19-AUG-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1736516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210947452

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-044632) on 24-SEP-2021 concerned a 34 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) dose was not reported, 1 total administered on 09-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced sars-cov-2 infection, and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product Quality Complaint.


VAERS ID: 1737938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210946354

Write-up: ATRIAL FIBRILLATION; This spontaneous report received from a consumer via a Regulatory Authority (DE-PEI-CADR2021171758) on 23-SEP-2021 and concerned a 40 year old male. The patient''s weight was 78 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) 1 total, dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced atrial fibrillation. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1738147 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram PR interval, Electrocardiogram QRS complex, Electrocardiogram ST segment, Heart rate, Investigation, Magnetic resonance imaging, Myocarditis, Oxygen saturation, Pain in extremity, Pyrexia, SARS-CoV-2 test, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:118/78 mmHg; Test Name: EchocardioTT; Result Unstructured Data: Test Result:acute myocarditis; Test Name: EchocardioTT; Result Unstructured Data: Test Result:Preserved Left ventricular ejection fraction; Comments: Preserved Left ventricular ejection fraction (LVEF) 50%, acute myocarditis; Test Name: LVEF; Test Result: 50 %; Test Date: 20210825; Test Name: LVEF; Test Result: 61 %; Comments: Preserved; Test Name: ECG; Result Unstructured Data: Test Result:with sinus rhythm (SR); heart rate 80 bpm, PR 140; Comments: with sinus rhythm (SR); heart rate 80 bpm, PR 140 ms, narrow QRS, 80 degress axis, good precordial R progression, ST elevation 1 mm concave in V5-6, negative T wave DIII and V1; Test Date: 20210826; Test Name: ECG; Result Unstructured Data: Test Result:practically retrogradation of T-wave; Comments: practically retrogradation of T-wave negativization, troponins of 240; Test Name: PR; Result Unstructured Data: Test Result:140; Comments: ms; Test Name: QRS; Result Unstructured Data: Test Result:narrow; Test Name: ST; Result Unstructured Data: Test Result:elevation 1 mm concave in V5-6; Test Name: Heart rate; Result Unstructured Data: Test Result:72; Comments: bpm; Test Name: Heart rate; Result Unstructured Data: Test Result:80; Comments: bpm; Test Name: Analytical; Result Unstructured Data: Test Result:elevation of markers of myocardial injury; Test Date: 20210820; Test Name: Q; Test Result: 85 %; Test Date: 20210825; Test Name: NMR; Result Unstructured Data: Test Result:left ventricular ejection fraction (LVEF) (61%); Comments: left ventricular ejection fraction (LVEF) (61%). Extensive myocardial edema and pattern of late subepicardic enhancement in probable relationship with edema, globally compatible with diagnostic orientation of myocarditis; The diagnosis was perimiocarditis; Test Name: SatO2; Test Result: 100 %; Comments: aa; Test Date: 20210820; Test Name: PCR Sars Cov2; Result Unstructured Data: Test Result:Negative; Test Name: PCR Sars Cov2; Test Result: Negative ; Test Date: 20210822; Test Name: Troponin; Result Unstructured Data: Test Result:22694 ng/ml; Test Date: 20210820; Test Name: troponins; Result Unstructured Data: Test Result:20102 ng/L; Test Date: 20210820; Test Name: Troponins; Result Unstructured Data: Test Result:20102; Test Date: 20210826; Test Name: Troponins; Result Unstructured Data: Test Result:240
CDC Split Type: ESPFIZER INC202101194699

Write-up: perimyocarditis; constant oppressive centrothoracic pain radiating to both arms; constant oppressive centrothoracic pain radiating to both arms; fever; This is a spontaneous report from a contactable physician downloaded from the wregulatory authority-WEB, regulatory authority number ES-AEMPS-997995. An 18-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on 17Aug2021 (batch/lot number FE4721 and expiry date unknown) at 18 years of age as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took dose 1 of Comirnaty, intramuscular, on 27Jul2021 (batch/lot number FE8405) as 0.3 ml for COVID-19 immunisation. On 17Aug2021, the patient experienced fever. On 20Aug2021, the patient experienced perimyocarditis, constant oppressive centrothoracic pain radiating to both arms. The reporter informed that on 17Aug2021, the same day as the second vaccine dose, the patient presented fever and then asymptomatic until 20Aug2021. The patient when he presented constant oppressive centrothoracic pain radiating to both arms and worsening with decubitus, the patient went to the emergency room. The reporter informed that the patient had scan: blood pressure (BP) 118/78 mmHg, heart rate (HR) 72 bpm, afebrile and SatO2 100% aa. The electrocardiogram (ECG) (with pain) with sinus rhythm (SR); heart rate 80 bpm, PR 140 ms, narrow QRS, 80 degrees axis, good precordial R progression, ST elevation 1 mm concave in V5-6, negative T wave DIII and V1. The analytical: elevation of markers of myocardial injury. 20Aug2021: troponins 20102 ng/L (peak 22Aug2021: troponins:22694 ng/ml), Q 85%, PCR Sars Cov2 negative. The echocardioTT: preserved left ventricular ejection fraction (LVEF) 50%, acute myocarditis. The nuclear magnetic resonance (NMR) (25Aug2021): left ventricular ejection fraction (LVEF) (61%). Extensive myocardial edema and pattern of late subepicardic enhancement in probable relationship with edema, globally compatible with diagnostic orientation of myocarditis. The diagnosis was perimiocarditis. The reporter informed that the patient''s treatment (TTO) for perimyocarditis, constant oppressive centrothoracic pain radiating to both arms and evolution (evol) were AAS (aspirine) 500 mg/8h and descending pattern at discharge. There was no pain during admission, nor signs of CHF. High 26Aug21, ECG: practically retrogradation of T-wave negativization, troponins of 240. The patient was hospitalized for perimyocarditis, constant oppressive centrothoracic pain radiating to both arms from 20Aug2021 to 26Aug2021 and was prolonged as a result of this events. The outcome of the event fever was unknown, while recovering for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739192 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Hyperpyrexia, Injection site rash, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received via regulatory authority (Reference number: IT-MINISAL02-780640) on 17-Sep-2021. The most recent information was received on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 14-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA and VOMITING had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Company comment This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Hyperpyrexia, Confusional state, Injection site rash and vomiting. The events occurred on the same day after administration of mRNA-1273 (Dose sequence was not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received: Updated seriousness.; Reporter''s Comments: Sender''s Comments: This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Hyperpyrexia, Confusional state, Injection site rash and vomiting. The events occurred on the same day after administration of mRNA-1273 (Dose sequence was not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1744813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210953692

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-045579) on 28-SEP-2021 and concerned a 33 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported,1 total, administered on 17-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced SARS-cov-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition) This report was associated with a product quality complaint.


VAERS ID: 1746357 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101229360

Write-up: Acute posterior ganglionitis; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PC20213612 (patient). A 14-years-old male patient received BNT162B2 (COMIRNATY Formulation: solution for injection Batch/Lot number: J07BX03) via intramuscular, administered in Arm Right on 06Aug2021 (at age of 14 years) as dose 2, single for COVID-19 immunisation. Medical history included mite allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. He had no history of COVID-19 On the day 12 of the second dose of vaccine On 17Aug2021 the patient experienced acute posterior ganglionitis appearance of shingles in the lower back, extending on the side, to the navel. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on 08Jul2021. Therapeutic measures were taken as a result of acute posterior ganglionitis. The outcome of event was recovering.


VAERS ID: 1749061 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210957311

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045614) on 29-SEP-2021 and concerned a 27 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient had sars-cov-2 infection and experienced vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint.


VAERS ID: 1749066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210956722

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045677) on 29-SEP-2021 concerned a 19 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-05 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1750629 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210959162

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045701) on 30-SEP-2021 concerned a 22 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: UNKNOWN) dose was not reported,1 total, administered on 17-MAY-2021 for product used for unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1753096 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210959700

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory authority (AT-BASGAGES-2021-045682) on 30-SEP-2021 and concerned a 24 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint


VAERS ID: 1753097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210959166

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-045685) on 30-SEP-2021 concerned a 24 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 and expiry: unknown) dose was not reported, 1 total administered on 10-JUN-2021 for drug used for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced SARS-CoV-2 infection (severe acute respiratory syndrome coronavirus 2) and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1753101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210959878

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-045694) was received on 30-SEP-2021 concerned a 39 year old female with unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: unknown) dose was not reported, 1 total administered on 01-JUN-2021 for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient had sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1757688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Contusion, Injection site pain, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), 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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20211001901

Write-up: BRUISING OF THIGH; PAIN IN ARM; LOW BACK ACHE; INJECTION SITE PAIN; This spontaneous report received from a consumer via a Regulatory Authority (IE-HPRA-2021-084555) on 01-OCT-2021 and concerned a 64 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: none. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C19-01 expiry: unknown) dose was not reported, 1 total, administered on 16-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-AUG-2021, the patient experienced low back ache (severe back ache or constant ache in lower back), injection site pain (pain at the location of the injection), pain in arm (regular ache on left arm at location or there quite often, like a dull aching feeling and has not left yet). On 12-SEP-2021, the patient experienced bruising of thigh (bruising spots on upper inner thighs, left and right). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising of thigh, and had not recovered from low back ache, injection site pain, and pain in arm. This report was serious (Other Medically Important Condition).


VAERS ID: 1764433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211007014

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045716) on 05-OCT-2021 and concerned a 27 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-JUL-2021 for product use for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient had sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2 infection) and experienced vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1764434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211008046

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045717) on 05-OCT-2021 concerned a 27 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1764435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211008036

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045721) was received on 05-OCT-2021 and concerned a 26 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1764437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211007162

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045735) on 05-OCT-2021 concerned a 59 year old female patient. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) dose was not reported, 01 total (first dose), administered on 01-JUL-2021 for drug use for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1767631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010782

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045799) on 06-OCT-2021 and concerned a 19 year old female of unknown race and ethnicity. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) dose was not reported, 1 total, administered on 04-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient had vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.


VAERS ID: 1767805 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010095

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045157) on 06-OCT-2021 concerned a 47 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number XD975 expiry UNKNOWN) dose was not reported, 1 total administered on 07-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint (PQC) and PQC number requested.


VAERS ID: 1767831 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010028

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045468) on 06-OCT-2021 and concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality number.


VAERS ID: 1767843 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010342

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045747) on 06-OCT-2021 and concerned a 28 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure, and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1767844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010758

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-045748) on 06-OCT-2021 concerned a 24 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-01, expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for an unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and had vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1767845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010803

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045750) was received on 06-OCT-2021 and concerned a 51 year old female of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product Quality Complaint.


VAERS ID: 1767846 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010022

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045751) on 06-OCT-2021 and concerned a 55-year-old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: unknown) dose was not reported, 1 total administered on 17-JUL-2021 for an unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This reported is associated with product quality complaint. This report was serious (Other Medically Important Condition).


VAERS ID: 1767847 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010787

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045758) on 06-OCT-2021 and concerned a 29 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) dose was not reported, 1 total administered on 01-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number.


VAERS ID: 1767850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211009639

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045792) on 06-OCT-2021 concerned a 69 year old female. The patient''s height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 and expiry: unknown) dose was not reported, 1 total administered on 02-JUN-2021 for an unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1767851 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010192

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045794) on 06-OCT-2021 concerned a 24 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: unknown) dose was not reported, frequency time 1 total administered on 04-JUL-2021 as an drug used for unknown indication. No concomitant medications were reported. On 17-AUG-2021, the patient developed sars-cov-2 (Severe acute respiratory syndrome coronavirus 2) infection and had vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1767853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211010752

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045804) on 06-OCT-2021 and concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported, 1 total administered on 18-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccination failure, and sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1571217 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever- 101.9 Chills Injection site pain and soreness Headache


VAERS ID: 1573587 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Fatigue, Feeling cold, Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: The common cold a few weeks ago
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe chills, fatigue, body ache, chest ache, fever, pain in the injection site


VAERS ID: 1573637 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Latanoprost
Current Illness: no
Preexisting Conditions: asthma
Allergies: no
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: swelling underneath my right underarm Pfizer-BioNTech COVID-19 Vaccine EUA


VAERS ID: 1573803 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-07
Onset:2021-08-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028D21A / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Conjunctival haemorrhage, Migraine
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Conjunctival disorders (narrow)

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: NP Thyroid, Vitamin D, Dim-Plus
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Call virtual teledoc -. Doctor was not able to provide any care and referred me to my primary care provider.
CDC Split Type:

Write-up: Woke up with sever lower back pain. Migraine headaches. conjunctival hemorrhage in left eye.


VAERS ID: 1573866 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Muscle tightness, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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: Clomid 10mg/day, Vit B6 100mg/day, Vit D2 50,000 IU 2x/week, Cetirizine 10mg/day
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinging in left hand/arm, small tingling in left calf. Muscles on left side of body feel tight, along with general soreness at the injection site. Noticed when I woke up this morning around 8am on 8/16/2021 the tingling. It has been persistent through the morning so far.


VAERS ID: 1573893 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 59267-1000-01 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymph node pain, 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: Omeprazole, Calcium, D3, K2, Vitamin C, Joint Support, Magnesium, Omega 3
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling of the underarm lymph node and tenderness on left side


VAERS ID: 1573916 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-17
Onset:2021-08-16
   Days after vaccination:211
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), 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: vitamins
Current Illness: None
Preexisting Conditions: Allergies to meds.
Allergies: All meds except penicillin
Diagnostic Lab Data: All tests prescribed by dermatologist and internist reported at recorded by internist.
CDC Split Type:

Write-up: Full body breakout for 3 and 1/2 months.


VAERS ID: 1573933 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-08-16
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Exposure to SARS-CoV-2, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports to the ED with complaints of sudden onset abdominal pain with nausea and vomiting. Patient''s daughter reports that she had Covid the 2nd of this month (August) and lives with the patient. She reports she quarantined within the home after being diagnosed. She stated that her and the patient are fully vaccinated. Patient''s daughter reports her quarantining is over.. Patient received first dose 03/11/2021 and second dose 04/08/2021.


VAERS ID: 1574013 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Electrocardiogram, Hypoaesthesia, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Coreg; Elavil, Lisinopril-hctz, omeprazole
Current Illness: none
Preexisting Conditions: HTN, Pt is currently on a cardiac monitor for a possible TIA a few weeks ago that was ruled out negative
Allergies: none
Diagnostic Lab Data: ekg-08-16-2021
CDC Split Type:

Write-up: Pt became tachycardia and htn 15 minutes after vaccine. Pt complained of numbness all over. Pt was placed on oxygen, Benadryl 25mg po, and Pepcid 10mg po. Heart rate came down to 90-110 at 15 min after reaction and 30 min after back up to 130s. Pt was sent to Emergency room for further eval.


VAERS ID: 1574021 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Presyncope, Tilt table test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol 25mg, Levothyroxine 75mcg, Atorvastatin 20mg, Bupropion 150mg, Phentermine 37.5mg
Current Illness: New Rx for phentermine 8/9/21. Dose was not taken the time of the incident.
Preexisting Conditions: Hypertenion, elevated cholesterol, hypothyroid
Allergies: NKDA
Diagnostic Lab Data: n/a, orthostatic tilt test
CDC Split Type:

Write-up: Onset of acute dizziness and near syncope 8/16/21 requiring in clinic evaluation.


VAERS ID: 1574068 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: prostate cancer, CHF, gerd
Allergies: pcn, codeine, ibu, sulfa, blue dys
Diagnostic Lab Data:
CDC Split Type:

Write-up: tested positive for covid


VAERS ID: 1574088 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Dizziness/Lightheaded - vaccines/blood draws
Other Medications: blood pressure medication
Current Illness:
Preexisting Conditions: HTN
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient came for first Monderna vaccine. Pharmacist reviewed VAR with patient and discussed. Patient had felt lightheaded in past following vaccinations. Patient attributed it to anxiety with needles. Vaccine was administered in Left deltoid. Pharmacist stayed with patient to monitor. Patient was responsive in small talk, said he felt lightheaded. Pharmacist was about to ask pt to lie down, but patient was sitting upright and suddenly unresponsive for approximately 10 seconds, which is when technician was instructed to call 911. Patient regained consciousness, while asking patient how he felt (alert and responsive for approx. 30 seconds), he returned to unresponsive state for 10-15 seconds. Patient lost bladder control during this time. Medics were in route to pharmacy. Patient unaware of lost responsiveness. Medics checked BP/HR and blood glucose; all within normal limits per EMTs. Patient refused additional medical support.


VAERS ID: 1574154 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, 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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: UNKNOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: NO ADVERSE REACTIONS. The patient made an appointment via myTurn.com on 8/16/21. He wanted to get moderna vaccine on 8/16/21. He did not say anything that he already got other COVID 19 vaccines. After Moderna 1 dose administration, this office documented CAIR2 and found that he already got Pfizer on 3/3/21 and 3/24/21 and J&J on 5/19/21. He stated that he did not feel safe, and he got Moderna today. We observed him for 15 mins. No adverse events were noted.


VAERS ID: 1574166 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (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:

Write-up: Error: Wrong Dose of Vaccine - Too Low-


VAERS ID: 1574169 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), 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), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe


VAERS ID: 1574171 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939893 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was very anxious about shot. After tech administered pt reported chest tightness and " a kinda scratchy throat." Said didn''t really feel like throat was closing, nor any difficulty breathing. Mom got her something to drink. After 30 min nothing worsened and pt said felt little better. Mom said hadn''t eaten anything all day. I was said would get food and f/u with dr. Advised pt to take Benadryl when she got home where she would be monitored by another adult.


VAERS ID: 1574185 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-02
Onset:2021-08-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Menstruation irregular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Fertility disorders (broad), Hypersensitivity (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: HPV (estimated 10yrs ago) soreness of the arm
Other Medications: Vitamin C, Amoxizoll
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Penicillin, Paxil, Zoloft, Aspirin
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt. states that after receiving the 1st dose Moderna 08/02/2021, started experiencing symptoms of 08/16/2021 of a red rash at the injection site, warm to the touch, and experienced an early menstrual cycle. Planned Primary visit 08/19/2021.


VAERS ID: 1574190 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: none - never had allergic reaction previously
Diagnostic Lab Data: unknown as of right now
CDC Split Type:

Write-up: 3 days following vaccine patient called stating she was itchy all over her body and felt like bugs had bit her. She also stated she did not have a red warm rash on injection site but about 8" lower had a linear rash. Advised patient should go to urgent care or hospital to have it looked at.


VAERS ID: 1574220 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness, fatigue, and generalized body aches


VAERS ID: 1574232 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vision blurred, 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? Yes
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:
CDC Split Type:

Write-up: Blurry vision, change in eye sight 10 minutes


VAERS ID: 1574236 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-22
Onset:2021-08-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found to have completed J+J COIVD vaccine on 3/13/2021 with different vendor. Patient received Pfizer COVID vaccine as listed here on 7/22/2021.


VAERS ID: 1574247 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-22
Onset:2021-08-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received J+J COVID vaccine by different vendor on 4/3/2021. Patient then received Pfizer dose as documented on this report by us, No adverse events reported on site.


VAERS ID: 1574254 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Furuncle, Hypertension, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (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: bad pain all over, "pins & needles", high bp, boiling sensation all over


VAERS ID: 1574259 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt fainted about 5-10 minutes after shot


VAERS ID: 1574265 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA748U / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: 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: Flu vaccine
Other Medications: aderal PRN - last dose 8/13, ambien PRN- last dose 8/15
Current Illness: COVID 7/23/21
Preexisting Conditions: n/a
Allergies: PCN
Diagnostic Lab Data: none
CDC Split Type:

Write-up: fever on 8/16


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