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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 200 out of 8,010

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VAERS ID: 1747134 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-13
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug eruption, Erythema multiforme, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (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: JPPFIZER INC202101219097

Write-up: Erythema multiforme; rash; Erythema multiforme was drug eruption; This is a spontaneous report received from a contactable physician via medical information team. A 17-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 14Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included a drug that the patient had been taking for more than half a year received from pediatrics. About 1 month after vaccination, erythema multiforme and rash appeared. On 14Aug2021 the patient received the second vaccination, and the symptoms appeared on 13Sep2021. It started from the trunk and gradually spread to the legs and hands of the body. Erythema multiforme was drug eruption, and since there was no other prior infection, drug eruption was considered. One was Pfizer''s vaccine, and the other one was a drug that the patient had been taking for more than half a year received from pediatrics, so the reporter was thinking of checking that as well. The outcome of the events was unknown. The seriousness and outcome and the causality between the event and bnt162b2 were not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Erythema multiforme and suspect drug BNT162B2 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: 1747153 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101222334

Write-up: Palpitations; headache; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21127033. A 54-years-old (reported as 54-year and 8-month-old) male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 13Sep2021 20:30 (at the age of 54 years old) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. On 13Sep2021 around 20:30 (the day of vaccination), the patient experienced palpitations and headache. On 13Sep2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 13Sep2021, after the 2nd vaccination, headache and palpitations appeared. For the purpose of observation, the patient was hospitalized in the hospital. On 15Sep2021, the symptoms were relieved, and the patient was discharged. On 15Sep2021 (2 days after the vaccination), the outcome of the events was recovering. The reporting physician classified the events as serious (hospitalized from 13Sep2021 to 15Sep2021) and assessed that the events were related to bnt162b2. Other possible cause(s) of the events such as any other diseases was not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1747205 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-13
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004231 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brugada syndrome, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Brugada syndrome; Pyrexia; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP096435) on 18-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a pharmacist, was received via the Regulatory Authority (Ref, v21127111). A few years ago, the patient fainted after taking a bedrock bath and was rushed to an emergency transported. On 16-Aug-2021, the patient received the 1st dose of this vaccine. On 13-Sep-2021, around 14:00, the patient received the 2nd dose of this vaccine. At 23:45, pyrexia developed (body temperature unknown). On 14-Sep-2021, in the morning, the patient''s temperature remained in the 38 degrees Celsius range. Around 12:30, 39.6 degree Celsius. At 14:00, since the patient was not breathing, an emergency call was made. At 14:08, the ambulance team arrived. CPA (ventricular fibrillation [VF]), direct current (DC) to VF, and 2nd DC led to return of spontaneous circulation (ROSC). At 14:15, the patient arrived at the hospital. VF to DC + adrenaline, IA to SR. The patient underwent detailed examination (12 lead electrocardiogram) and was diagnosed with Brugada syndrome. On 16-Sep-2021, the patient currently remained hospitalized. The outcome of pyrexia, Brugada syndrome was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Since the pyrexia after the vaccination with this vaccine is considered to have triggered Brugada syndrome, the association of this vaccine cannot completely be denied. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This report concerns a 26 year old male with relevant past medical history of fainting (after a bedrock bath) who was hospitalized for unexpected events of pyrexia and Brugada syndrome. The fever occurred on the same day and brugada syndrome was diagnosed one day after vaccination with second dose of the mRNA-1273. The event of pyrexia is consistent with the current understanding of the mechanism of action of the vaccine. Also, the report mentions that the Brugada syndrome was most likely triggered by the preceding pyrexia. The re-challenge was assessed as not applicable as the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1749203 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-09-13
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), 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: DEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority(Reference number: DE-PEI-202100190388) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DIABETES MELLITUS (Diabetes mellitus reactivated) in a 77-year-old male patient who received mRNA-1273 (batch no. 3002913) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced DIABETES MELLITUS (Diabetes mellitus reactivated) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Diabetes mellitus reactivated) had not resolved. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. No relevant concomitant and treatment medications were reported. Company Comment: This case concerns a 77 year old male, with no medical history details provided, who experienced the serious unexpected event of DIABETES MELLITUS. Drug ineffective was also considered as an event. The events occurred approximately 3 months after receiving the second dose. Rechallenge is not applicable as no information about the first dose is provided and no additional dose will be given. Patient''s age remains a confounder. The benefit-risk relation of is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation Received on 27-SEP-2021 includes no new information; Sender''s Comments: This case concerns a 77 year old male, with no medical history details provided, who experienced the serious unexpected event of DIABETES MELLITUS. Drug ineffective was also considered as an event. The events occurred approximately 3 months after receiving the second dose . Rechallenge is not applicable as no information about the first dose is provided and no additional dose will be given. Patient''s age remains a confounder. The benefit-risk relation is not affected by this report.


VAERS ID: 1751049 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101226606

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171820364490-RTMYT, Safety Report Unique Identifier GB-MHRA-ADR 25960722. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. The patient experienced pericarditis on 13Sep2021. The event caused hospitalization and were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test (positive) on 15Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event pericarditis was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1751109 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphonia, Chest pain, Cough, Dizziness, Headache, Hypersensitivity, Increased viscosity of upper respiratory secretion, Insomnia, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Angioedema (went in A and E to receive a injector.)
Allergies:
Diagnostic Lab Data: Test Date: 20201202; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101226690

Write-up: Allergy; Vomited; Loss of voice; Nausea; Fever; Chest pain; Oropharyngeal mucus thickening; Coughing; Sore throat; Headache; Insomnia; Dizzy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109180613598480-FYVFA, Safety Report Unique Identifier GB-MHRA-ADR 25963622. A 37-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2153), via an unspecified route of administration on 11Sep2021 as dose 2, single for covid-19 immunization. Medical history included allergy and mild angioedema (went in A and E to receive a injector) from an unknown date and unknown if ongoing. Concomitant medication included prednisone taken for allergy from 29Aug2021 to 01Sep2021. It was reported that the patient had an allergy, went in A and E to receive a injector due to mild angioedema, then prescribed medicine. Two weeks right before the 2nd vaccination. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On 13Sep2021, the patient had sore throat, headache, insomnia, dizzy, on 15Sep2021, had coughing, on 16Sep2021 had nausea, fever, chest pain, oropharyngeal mucus thickening, on 17Sep2021 had vomited, loss of voice and on an unspecified date had allergy. Started having sore throat headaches and dizzy on the third day after the jab. Also start having insomnia. Sore throat gets worse till now, following by other symptoms like fever, nausea, coughing, loss of voice and mucus thickening. 1 week after the jab still not getting much improvement and sore throat still very significant. The patient underwent lab tests and procedures which included Covid-19 virus test: negative (No - Negative COVID-19 test) on 02Dec2020. The reporter considered the events as serious (medically significant). The outcome of events allergy, sore throat, nausea, fever, coughing, insomnia, oropharyngeal mucus thickening, loss of voice was not recovered, vomited, headache was recovering, chest pain was resolved on an unspecified date in 2021, dizzy was resolved on 15Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-13
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Lymphadenopathy, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226673

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109181508296660-5LTKP, Safety Report Unique Identifier GB-MHRA-ADR 25964862. A 24-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on 20Aug2021 as dose 2, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single dose for COVID-19 immunisation and experienced swollen lymph node in neck. After her second dose, now have a swollen lymph node in her armpit, and have started bleeding. She has been on Cerzate for a number of years which blocked her periods and she have been now bleeding for 5 days. On an unspecified date the patient experienced bleeding, swollen lymph node in her armpit, on 13Sep2021 patient experienced irregular periods. Patient has not had symptoms associated with COVID-19. Patient had not a COVID-19 test. Outcome of the events swollen lymph node in her armpit was unknown, irregular periods was not recovered and rest of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101231680 same patient, different dose, different event (dose 1)


VAERS ID: 1751199 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Chest discomfort, Chest pain, Dyspnoea, Fatigue, Paraesthesia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (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: Allergy; DVT.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101227008

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109182224439140-LYGD8; safety report unique identifier: GB-MHRA-ADR 25965243). A 47-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 47, on Sep 11, 2021, single dose, for COVID-19 immunization. Medical history included hypersensitivity, deep vein thrombosis as a result of the contraceptive pill. Patient cannot take any hormonal medication or receive codeine. Patient not enrolled in a clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, nor currently breastfeeding. The patient''s concomitant medications not reported. Past drug history included codeine. The patient experienced breast pain, tiredness, chest pain, pins and needles, all on an unspecified date with unknown outcomes. On Sep 12, 2021, patient experienced breast pain female, with outcome of recovered on Sep 17, 2021; shortness of breath on Sep 14, 2021 with outcome of not recovered; and chest tightness on Sep 14, 2021 with outcome of not recovered. All events considered serious (medically significant). The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative. The verbatim clinical course reported as follows: "Initially I had a sore arm which within a day or two became breast pain on the side of the injection. I noticed the following evening that lying on my back in bed made me struggle to breath. I felt like I was not getting enough air into my lungs and there was a tightness in my chest. It has now been a week since my first injection and I''m getting pins and needles in my chest, shortness of breath, extreme tiredness and chest pain." The patient has not tested positive for COVID-19 since the vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1751320 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
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: Body temperature, Gait disturbance, Hallucination, Headache, Muscular weakness, Pyrexia, Weight bearing difficulty
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 37.8 C; Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 38.8 C; Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 37.4 C
CDC Split Type: HRJNJFOC20210956641

Write-up: I THINK I HAVE MILD HALLUCINATIONS IN THE DARK (FLASHES OF LIGHT).; DIFFICULTY LIFTING LIGHT THINGS, LIKE A BACKPACK, ETC.; FEVER; DIFFICULTY WALKING; SEVERE MUSCLE WEAKNESS; HEADACHE; HIGH TEMPERATURE; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300050854) on 29-SEP-2021 and concerned a 22 year old male of unspecified race and ethnic origin. The patient''s weight was 70.4 kilograms, and height was 177 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 was not reported, expiry: UNKNOWN) 0.5 ml, 1 total administered on 13-SEP-2021 for covid-19 immunisation. The batch number was not reported. Per procedure ,no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced i think i have mild hallucinations in the dark (flashes of light), difficulty lifting light things, like a backpack, etc, fever, difficulty walking, severe muscle weakness, headache and high temperature. Laboratory data included: Body temperature (NR: 36 - 37) 37.8 C, 37.4 C, 38.8 C, 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from i think i have mild hallucinations in the dark (flashes of light)., difficulty lifting light things, like a backpack, etc., fever, difficulty walking, severe muscle weakness, headache, and high temperature. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Degree of causal relationship as assessed by the reporter: unlikely


VAERS ID: 1751370 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017/21402 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Pruritus, Throat tightness, Venous pressure jugular, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: DIRAHIST [CHLORPHENAMINE MALEATE;TRIAMCINOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-786073) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA, WHEEZING, VENOUS PRESSURE JUGULAR, PRURITUS, INJECTION SITE OEDEMA, THROAT TIGHTNESS and INJECTION SITE ERYTHEMA in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017/214024) for COVID-19 immunisation. The patient''s past medical history included Allergic asthma. Concomitant products included CHLORPHENAMINE MALEATE, TRIAMCINOLONE for an unknown indication. On 13-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. On 13-Sep-2021, the patient experienced DYSPNOEA (seriousness criterion medically significant), WHEEZING (seriousness criterion medically significant), VENOUS PRESSURE JUGULAR (seriousness criterion medically significant), PRURITUS (seriousness criterion medically significant), INJECTION SITE OEDEMA (seriousness criterion medically significant), THROAT TIGHTNESS (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (seriousness criterion medically significant). On 13-Sep-2021, DYSPNOEA, WHEEZING, VENOUS PRESSURE JUGULAR, PRURITUS, INJECTION SITE OEDEMA, THROAT TIGHTNESS and INJECTION SITE ERYTHEMA had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not provided Patient underwent complete blood count test on 13-SEP-2021 and the results were not provided. Company Comment: This case concers a 17-year old female patient, with medical history of allergic asthma who experienced the unexpected events of dyspnoea, wheezing, throat tightness and pruritus. Additionally, venous pressure jugular was also reported. The events occurred the same day after dose of mRNA-1273. The rechallange is unknown, since it is not clear in the SD if the dose received is the first or second one (awaiting for translation). Patient?s history of allergic asthma remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant Follow-Up Appended : Events (Throat constriction, Injection site erythema, Injection site oedema) & Concomitant were added.; Sender''s Comments: This case concers a 17-year old female patient, with medical history of allergic asthma who experienced the unexpected events of dyspnoea, wheezing, throat tightness and pruritus. Additionally, venous pressure jugular was also reported. The events occurred the same day after dose of mRNA-1273. The rechallange is unknown, since it is not clear in the SD if the dose received is the first or second one (awaiting for translation). Patient?s history of allergic asthma remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1751371 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Photophobia, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: CEFALEA,FEBBRE,NAUSEA,FOTOBIA; CEFALEA,FEBBRE,NAUSEA,FOTOBIA; CEFALEA,FEBBRE,NAUSEA,FOTOBIA; CEFALEA,FEBBRE,NAUSEA,FOTOBIA; This case was received via regulatory authority (Reference number: IT-MINISAL02-786112) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PHOTOPHOBIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA), HEADACHE (CEFALEA,FEBBRE,NAUSEA,FOTOBIA), PYREXIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) and NAUSEA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 13-Sep-2021, the patient experienced PHOTOPHOBIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) (seriousness criterion hospitalization), HEADACHE (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) (seriousness criterion hospitalization), PYREXIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) (seriousness criterion hospitalization) and NAUSEA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) (seriousness criterion hospitalization). At the time of the report, PHOTOPHOBIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA), HEADACHE (CEFALEA,FEBBRE,NAUSEA,FOTOBIA), PYREXIA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) and NAUSEA (CEFALEA,FEBBRE,NAUSEA,FOTOBIA) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Lab data includes Fever and the results are unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the serious, unexpected event of Photophobia Headache, Pyrexia and Nausea. The events occurred three days after the first dose of mRNA-1273. The rechallenge was unknown as the event occurred after the first dose. 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.; Reporter''s Comments: Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the serious, unexpected event of Photophobia Headache, Pyrexia and Nausea. The events occurred three days after the first dose of mRNA-1273. The rechallenge was unknown as the event occurred after the first dose. 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: 1751428 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Bilirubin conjugated, Blood bilirubin, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood lactic acid, Blood test, CSF test, Clonic convulsion, Coma scale, Computerised tomogram, Depressed level of consciousness, Encephalopathy, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: D-Bil; Result Unstructured Data: Test Result:0.3; Test Date: 20210917; Test Name: T-Bil; Result Unstructured Data: Test Result:5.0; Test Date: 20210917; Test Name: CK; Result Unstructured Data: Test Result:866; Test Date: 20210917; Test Name: Lactate; Result Unstructured Data: Test Result:49; Test Date: 20210917; Test Name: blood test; Result Unstructured Data: Test Result:no other abnormalities; Test Date: 20210917; Test Name: JCS; Result Unstructured Data: Test Result:10; Test Date: 20210917; Test Name: CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210917; Test Name: cerebrospinal fluid test; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202101227851

Write-up: clonic convulsion; consciousness disturbed; Convulsion; JCS 10; encephalopathy; CK: 866; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is v21127173. A 12-year and 9-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection Lot number FE8162, Expiration date 30Nov2021), via an unspecified route of administration on 12Sep2021 at 10:00 as dose 2, single (at the age of 12 years old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 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) was unknown as the patient did not receive the vaccination at the hospital. On 13Sep2021 at 06:00 (1 day after the vaccination), the patient experienced convulsion, consciousness disturbed and encephalitis/encephalopathy. On 13Sep2021 (1 day after the vaccination), the patient was admitted to the hospital and on 15Sep2021 (3 days after the vaccination), the patient was discharged from hospital. The course of the event was as follows: At 06:00 on 13Sep2021, clonic convulsion appeared for two minutes, and the patient was move to the hospital by ambulance. As JCS 10 continued, the patient was admitted to the hospital for investigation and treatment. CK: 866, T-Bil: 5.0, D-Bil: 0.3 and Lactate: 49. There were no other abnormalities founded in blood test. There were also no abnormalities on CT or cerebrospinal fluid test. The patient was diagnosed with encephalopathy, and steroid pulse was performed. From the night on 13Sep2021, the patient woke up, and condition turned to normal. On 15Sep2021 (3 days after the vaccination), the outcome of the events was recovered. The reporting other HCP classified the event as serious (Hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1751472 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005293 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (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: Medical History/Concurrent Conditions: Food allergy (Buckwheat allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncope; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094181) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Agency by a physician, was received via the (Ref, v21127815). Syncope was assessed as serious. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 13-Sep-221, at 14:05, the patient received the 1st dose of this vaccine. At 14:25, the patient complained of sick feeling. The patient had syncope while moving to bed. Consciousness recovered in 2 or 3 seconds. Blood pressure 91/45 mmHg, pulse 50/min, SpO2 97%. Complexion ill was noted. There were no symptoms such as difficulty breathing or pain. The symptoms were considered to be vasovagal reflex, and the patient was followed up in a spine position with leg elevation. After 10 minutes of bed rest, physical condition and facial color improved. Blood pressure 101/71, pulse 67, SpO2 98%. After 1 hour of bed rest, the patient had slightly decreased blood pressure (blood pressure 86/54) while sitting. After 1 and a half hours of bed rest, the patient recovered from the symptoms and left the room (blood pressure 95/62). The outcome of syncope and vasovagal reflex was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of syncope. The event occurred on the same day after the first dose of mRNA 1273 vaccine. The rechallenge was unknown since only the first dose was given. The event was considered not related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1752961 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, SARS-CoV-2 test, Suspected 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: ACETYLCYSTEINE; CO-AMOXICLAV [AMOXICILLIN TRIHYDRATE;CLAVULANATE POTASSIUM]; HYDROXYUREA; TWYNSTA; CLOPIDOGREL; GALVUS MET
Current Illness: Alcohol use (Consume 3 times a week); Diabetes; Hypertension; Polycythemia vera ((diagnosed last 2018)); Smoker (not sure how many cigarettes he was consuming)
Preexisting Conditions: Comments: No known allergies or drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: positive; Test Date: 20210922; Test Name: Chest X-ray; Result Unstructured Data: No significant cardiopulmonary findings
CDC Split Type: PHJNJFOC20210957174

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 54 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: polycythemia vera, hypertension, diabetes, alcohol user, smoker and other pre-existing medical conditions included: no known allergies and drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212C21A, and expiry: unknown) dose was not reported, frequency time 1 total was administered on 06-AUG-2021 in right deltoid for prophylactic vaccination. Concomitant medications included acetylcysteine, amoxicillin trihydrate/clavulanate potassium (Co-amoxiclav) for cough, hydroxycarbamide (hydroxyurea) for polycythemia vera, amlodipine besilate/telmisartan (Twynsta), clopidogrel and Galvus met for unknown indication. On 13-SEP-2021, the patient experienced fever after he got back from work, also had cough and colds so he was tested for covid on 22-SEP-2021 and got a positive result (suspected clinical vaccination failure) on 23-SEP-2021 "the result will be given once they are cleared or have finished their quarantine" (sic). The patient had suspected covid-19 infection and chest X-ray (NR: not provided) showed no significant cardiopulmonary findings. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQC number: 90000195116; Sender''s Comments: V0 20210957174-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1753160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-13
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243069

Write-up: This is a spontaneous report from a noncontactable other healthcare professional (HCP), via the regulatory authority (report number: 624205). A 39-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, solution for injection, batch/lot# unknown), via an unspecified route of administration, Aug 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not provided. On Sep 13, 2021 (48 days after vaccination), patient developed atrial fibrillation. The event reported serious (medically significant); with outcome of recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1754670 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-13
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Reversible ischaemic neurological deficit
SMQs:, Ischaemic central nervous system vascular conditions (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? 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: Deficit neurologic reversible; This case was received via Regulatory Agency (Reference number: ES-AEMPS-1002563) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT (Deficit neurologic reversible) in a 13-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT (Deficit neurologic reversible) (seriousness criterion hospitalization). On 13-Sep-2021, REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT (Deficit neurologic reversible) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication provided. Company Comment: This case concerns a 13-year-old, male patient with no relevant medical history, who experienced the unexpected events of Reversible ischemic neurological deficit. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no event with the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 28-SEP-2021: contain Anatomical Location was updated.; Sender''s Comments: This case concerns a 13-year-old, male patient with no relevant medical history, who experienced the unexpected events of Reversible ischemic neurological deficit. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no event with the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1754675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101239631

Write-up: Myopericarditis; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number ES-AEMPS-1003639. An adolescent male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm on 10Sep2021 (Batch/Lot Number unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm on 18Aug2021 (Batch/Lot Number unknown) as single dose for covid-19 immunisation. On 13Sep2021, the patient experienced myopericarditis, which was considered as serious for hospitalization. The outcome of the event was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1754680 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-13
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214020 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Electrocardiogram, Myocarditis, Troponin T
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: Test Date: 20210913; Test Name: C-reactive protein; Result Unstructured Data: 55 ng/L; Test Date: 20210913; Test Name: ECG; Result Unstructured Data: patient ECG on admission (no pain): Sinus rhythm 75 lpm, axis 40?, decreased PR in V3-V6 peri cordials, incomplete RBBB, early repolarization; Test Date: 20210913; Test Name: Cardiac troponin T; Result Unstructured Data: units: ng/L Increased
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via regulatory authority (Reference number: ES-AEMPS-1004325) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005790 and 214020) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 13-Sep-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 13-Sep-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, C-reactive protein (0-5): 55 (High) 55 ng/L. On 13-Sep-2021, Electrocardiogram: abnormal (abnormal) patient ECG on admission (no pain): Sinus rhythm 75 lpm, axis 40?, decreased PR in V3-V6 peri cordials, incomplete RBBB, early repolarization. On 13-Sep-2021, Troponin T (0-5): 318 (High) units: ng/L Increased. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment information was not provided. Action taken with mRNA-1273 (Spikevax) was not applicable. Company Comment: This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 4 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-2021 and included patient lab data.; Sender''s Comments: This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 4 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Discomfort, Drug ineffective, Dyspnoea, Headache, Influenza, Influenza like illness, Lethargy, Pain, Panic reaction, Productive cough, Rhinorrhoea, SARS-CoV-2 test, Suspected COVID-19, Tinnitus
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225504

Write-up: Suspected COVID-19; Suspected COVID-19; Flu; Nasal mucus increased; Tightness in chest/ tight chest; Chest burning; Headache occurring/ headache; Breathlessness; feeling dreadful; lethargic; ringing in ears; very bad flu like symptoms; Coughing up green/brown mucus; pain; discomfort; This is a spontaneous report from a contactable consumer (patient) received from the authority report number is GB-MHRA-WEBCOVID-202109162248259000-LVJIM, Safety Report Unique Identifier GB-MHRA-ADR 25956548. A 43-year-old female patient received dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration on 06Sep2021 as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single; both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took iron medication. On 13Sep2021, the patient was suspected COVID-19, experienced flu, nasal mucus increased, tightness in chest/ tight chest, chest burning, headache occurring/ headache, breathlessness, feeling dreadful, ringing in ears, lethargic, very bad flu like symptoms, coughing up green/brown mucus, pain and discomfort. The clinical course was reported as follows: Feeling dreadful, very bad flu like symptoms, coughing up green/brown mucus, lots of nasal mucus, ringing in ears, lethargic, headache on and off, tight chest, breathless, some pain and discomfort. All started 7 days after the 2nd COVID19 vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant).The patient had COVID-19 Virus Test (Unknown date): No - Negative COVID-19 test. The outcome for suspected COVID-19, flu, nasal mucus increased, tightness in chest/ tight chest, chest burning, headache occurring/headache and breathlessness was not recovered; outcome for feeling dreadful, ringing in ears, lethargic and very bad flu like symptoms was recovering; outcome for coughing up green/brown mucus, pain and discomfort was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Eczema, Eczema nummular, Headache, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226935

Write-up: general feeling of being unwell; muscle aches; Headaches; appearance of discoid eczema on hand; joint pain; Dermatitis nummular; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171002295730-G8RG5, Safety Report Unique Identifier GB-MHRA-ADR 25957875. A 26-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 11Sep2021 (Batch/Lot Number: FE3380) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced appearance of discoid eczema on hand (medically significant) on an unspecified date with outcome of unknown, joint pain (medically significant) on an unspecified date with outcome of unknown, dermatitis nummular (medically significant) on 13Sep2021 with outcome of not recovered, general feeling of being unwell (medically significant) on an unspecified date with outcome of unknown, muscle aches (medically significant) on an unspecified date with outcome of unknown, headaches (medically significant) on an unspecified date with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755270 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-09-13
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
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: 20210913; Test Name: PCR; Result Unstructured Data: Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: IEPFIZER INC202101233446

Write-up: Lack of efficacy; diagnosed with COVID 19; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown), via intramuscular route, administered in Arm Left on 15Feb2021 16:15 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient did not diagnosed with COVID-19 Prior to vaccination. On 13Sep2021, the patient experienced lack of efficacy and COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction positive on 13Sep2021. The patient did not receive any treatment for the adverse events experienced. The outcome of the events was recovering.


VAERS ID: 1755321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-09-13
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Electrocardiogram, Headache, Nausea, Neurological examination, Specialist consultation, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: brain computed tomography scan; Result Unstructured Data: Test Result:Unknown; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown; Test Name: neurological examination; Result Unstructured Data: Test Result:Unknown; Test Name: otolaryngology examination; Result Unstructured Data: Test Result:Unknown
CDC Split Type: ITPFIZER INC202101228706

Write-up: Vertigo; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number IT-MINISAL02-786064. A 61-year-old male patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FG4493, Expiry date: not reported), dose 1 via intramuscular, administered in left arm on 15Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Sep2021, the patient experienced vertigo, nausea, vomiting, headache. The patient underwent lab tests and procedures which included computerised tomogram head: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, neurological examination: unknown on an unspecified date, otolaryngology examination: unknown on an unspecified date. Therapeutic measures (Levobren 25 mg/ml) were taken as a result of nausea. The outcome of events was recovering. Health Authority comment: As of today (15Sep2021) mild headaches and a slightly annoying pain in the left ear are continuing. I take Levobren 25 mg/ml to reduce the feeling of nausea. Sender comment: Examinations outcome requested to the reporter No follow-up attempts are possible. No further information expected.


VAERS ID: 1755389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-13
   Days after vaccination:221
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: Glaucoma; Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210913; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101231408

Write-up: vaccination failure; Covid-19; Carducci cluster. Positive molecular swab in vaccine; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787216. A 86-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: EK9788 and Expiration Date: 31May2021) via intramuscularly in arm left on 04Feb2021 as booster dose 2, 0.3 ml single and received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: EL1484 and Expiration Date: 30Apr2021) via intramuscularly in arm left on 14Jan2021 as booster dose 1, 0.3 ml single for COVID-19 immunization. Medical history included glaucoma from 02Jan2002 and hashimoto''s thyroiditis from 20Dec2017. The patient''s concomitant medications were not reported. On 13Sep2021, the patient experienced carducci cluster. Positive molecular swab in vaccine. On an unspecified date, the patient experienced vaccination failure and COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR test negative on 23Aug2021, on 25Aug2021 on 30Aug2021 and on 06Sep2021 and COVID-19 PCR test positive on 13Sep2021. The outcome of the events was unknown. Investigation for EK9788 PRD: 25Mar2021 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 EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (RA) 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. Investigation for EL1484 PRD: 28May2021 The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 "EL1484". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1755556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes
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: PHJNJFOC20210960071

Write-up: DIFFICULTY OF BREATHING; FEVER; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300107796] concerned a male of unspecified age, 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: unknown, and expiry: unknown) dose was not reported, 1 total administered for an unspecified indication on an unspecified date in 2021. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced cough and on and off fever. On 14-SEP-2021, the patient experienced difficulty of breathing (DOB). On 15-SEP-2021, the patient sought consultation and was hospitalized. The number of days hospitalized and discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, fever, and difficulty of breathing. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210960071 -covid-19 vaccine ad26.cov2- cough, difficulty of breathing. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210960071-covid-19 vaccine ad26.cov2. s-Fever. This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1756464 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0581 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dizziness, Hypoaesthesia, Movement disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101238356

Write-up: CVA; Inability to move body; Dizziness; Numbness of lower extremities (both feet); This is a spontaneous report from a contactable other hcp. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: EY0581, Expiration Date: 23Sep2021), at the age of 37 years old, via an unspecified route of administration on 13Sep2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced dizziness, numbness of lower extremities (both feet), inability to move body and cerebrovascular accident (CVA) on 13Sep2021. All events reported as serious. The patient was hospitalized from 13Sep2021 and was still in the hospital. The outcome of events was not recovered.; Sender''s Comments: .As per temporal association , causal association of events(dizziness, numbness of lower extremities (both feet), inability to move body and cerebrovascular accident (CVA)) 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: 1757694 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: KRJNJFOC20211001524

Write-up: DIZZINESS; OTHER EVENTS; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 6 decade 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: 211A21A and expiry: 14-DEC-2021) dose was not reported, 1 total administered on 13-SEP-2021 on deltoid for an unspecified indication. No concomitant medications were reported. On 13-SEP-2021, the patient experienced dizziness, other events, nausea and was hospitalized (date unspecified) and inpatient treatment administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the nausea, dizziness and other events was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0;20211001524 -COVID-19 VACCINE AD26.COV2.S- Dizziness and other events. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211001524 -COVID-19 VACCINE AD26.COV2.S-. Nausea .This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1757839 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: SEMODERNATX, INC.MOD20213

Write-up: This case was received via European Medicines Agency (Reference number: SE-MPA-2021-084137) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CHILLS, HEADACHE, DIZZINESS and VOMITING in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced CHILLS (FROSSA) (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization), DIZZINESS (seriousness criterion hospitalization) and VOMITING (seriousness criterion hospitalization). On 14-Sep-2021, VOMITING had resolved. At the time of the report, CHILLS, HEADACHE and DIZZINESS was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was reported. No treatment information was reported. Company Comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of chills headache, dizziness and vomiting which required hospitalization. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29 SEP 2021 which contains no new information.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of chills headache, dizziness and vomiting which required hospitalization. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1758145 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood pressure measurement, Chest pain, Heart rate, Laryngeal stenosis, Oxygen saturation, Pharyngeal paraesthesia
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: BP; Result Unstructured Data: Test Result:150/85 mmHg; Comments: Subject with arterial hypertension; Test Date: 2021; Test Name: BP; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:80-85; Comments: bpm; Test Date: 2021; Test Name: SO2; Result Unstructured Data: Test Result:98-97 %
CDC Split Type: ITPFIZER INC202101229267

Write-up: He also reports a slight sensation of tightening and tingling in the throat.; Gastralgia and mild chest pain occurring 30 minutes after vaccination.; The subject is eupnoic/ Laryngeal stricture; Gastralgia and mild chest pain occurring 30 minutes after vaccination.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-785701. A 26-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FG4686; Expiration Date: Nov2021) via intramuscular route of administration in right deltoid on 13Sep2021 as dose 1, single (at the age of 26 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Sep2021 the patient experienced Gastralgia and mild chest pain occurring 30 minutes after vaccination and a slight sensation of tightening and tingling in the throat (reported as: He also reports a slight sensation of tightening and tingling in the throat). The patient was in a good general condition. Taking into account the symptoms, patient was transferred by ambulance to a hospital emergency room. The patient is eupnoic (reported as The subject is eupnoic/ Laryngeal stricture). The patient underwent lab tests and procedures which included blood pressure measurement: 150/85 mmHg -140/80 mmHg with arterial hypertension, heart rate: 80-85 bpm, oxygen saturation (SO2): 98-97 % on an unspecified date in 2021. The clinical outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1758271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Vaccination site pain, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Patient had similar symptoms as the reported event - abnormal vision when they had COVID-19); Pneumonia (Unilateral pneumonia, patient used antibiotics (NOS)and bromhexine containing medication to treat it)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101228845

Write-up: Dizziness; Abnormal vision; Headache; Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from theregulatory authority number LV-SAM-2021096600. A 61-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number, Expiry date was not reported), via intramuscular route of administration on 12Sep2021 as Dose 1, 0.3ml Single for COVID-19 immunization. Medical history included covid-19 from Mar2021-to-Mar2021 Patient had similar symptoms as the reported event - abnormal vision when they had COVID-19, Pneumonia from Aug2021-to-Aug2021 Unilateral pneumonia, patient used antibiotics (NOS) and bromhexine containing medication to treat it. The patient concomitant medications were not reported. On 13Sep2021 11:00, patient experienced abnormal vision, headache, injection site pain, dizziness. The reporter stated that had white and black spots in their field of vision, difficulty reading text). The patient was scheduled to have a consultation with an ophthalmologist. The outcome of the events was recovering. No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1759929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-13
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Auscultation, Blood cholesterol, Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Eosinophil count, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Mean platelet volume, Monocyte count, Myalgia, Myocarditis, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin index, Prothrombin level, Prothrombin time, Prothrombin time ratio, Red cell distribution width, Respiratory rate, Troponin I, Ventricular tachycardia, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tobacco user (half pack / day)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: TTPA - Ratio; Result Unstructured Data: Test Result:1.21; Test Date: 2021; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:rhythmic, no friction is heard; Test Date: 2021; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:both hemithorax ventilate; Test Name: Cholesterol; Result Unstructured Data: Test Result:226; Test Date: 2021; Test Name: Creatinine; Test Result: 0.8 mg/dl; Test Date: 2021; Test Name: Fibrinogen derivative; Test Result: 509 mg/dl; Test Date: 2021; Test Name: Glucose; Test Result: 99 mg/dl; Test Date: 2021; Test Name: Potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/70; Test Date: 2021; Test Name: Sodium Ion; Result Unstructured Data: Test Result:136 mmol/L; Test Date: 2021; Test Name: Urea; Test Result: 34 mg/dl; Test Date: 2021; Test Name: Chest Rx; Result Unstructured Data: Test Result:no signs of failure; Test Date: 2021; Test Name: C-reactive protein; Test Result: 7.0 mg/dl; Test Date: 2021; Test Name: Ultrasound at the foot of the bed; Result Unstructured Data: Test Result:undilated cardiac chambers; Comments: Inferolateral frank hypokinesia. No significant heart valve disease. Systolic displacement of the tricuspid annulus plane (TAPSE) 23. Hyperrefringent pericardium, especially inferolateral. No pericardial effusion. Inferior cava not dilated and with adequate collapse.; Test Date: 2021; Test Name: Left ventricular ejection fraction; Result Unstructured Data: Test Result:preserved; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:RS. Supra unevenness of the ST; Comments: in I-AVL-II-AVF-V5-V6 and subsequent derivations. Descent of the ST in AVR and V1.; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:similar; Comments: but with a tendency to decrease the supra unevenness of the TS.; Test Date: 2021; Test Name: Eosinophils; Test Result: 1.9 %; Test Date: 2011; Test Name: Glomerular filtration; Result Unstructured Data: Test Result:90; Test Date: 2021; Test Name: Hematocrit; Test Result: 48.1 %; Test Date: 2021; Test Name: Hemoglobin; Result Unstructured Data: Test Result:17.3 g/dl; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:83; Test Date: 2021; Test Name: Abdomen E Abduction; Result Unstructured Data: Test Result:soft and depressible; Test Date: 2021; Test Name: Red blood cells; Result Unstructured Data: Test Result:5.28 10^6/uL; Test Date: 2021; Test Name: Lymphocytes; Test Result: 38.2 %; Test Date: 2021; Test Name: mean corpuscular hemoglobin; Test Result: 32.8 pg; Test Date: 2021; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:36.0 g/dl; Test Date: 2021; Test Name: medium corpuscular volume; Result Unstructured Data: Test Result:91.1; Comments: fl; Test Date: 2021; Test Name: Medium Platelet Volume; Result Unstructured Data: Test Result:9.8; Comments: fL; Test Date: 2021; Test Name: Monocytes; Result Unstructured Data: Test Result:1.290 10^3//uL; Test Date: 2021; Test Name: Monocytes; Test Result: 17.8 %; Test Date: 2021; Test Name: Neutrophils; Test Result: 41.5 %; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 99 %; Test Date: 2021; Test Name: Platelets; Result Unstructured Data: Test Result:195 10^3/uL; Test Date: 2021; Test Name: TP - INR; Result Unstructured Data: Test Result:0.93; Test Date: 2021; Test Name: TP - Activity; Test Result: 116.0 %; Test Date: 2021; Test Name: TP - Prothrombin time; Test Result: 11.00 s; Test Date: 2021; Test Name: TP - Ratio; Result Unstructured Data: Test Result:0.92; Test Date: 2021; Test Name: Erythrocyte Distribution Width; Test Result: 11.9 %; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: Test Result:25; Test Date: 2021; Test Name: Troponin I I (ultrasensible); Result Unstructured Data: Test Result:9950 pg/mL; Test Date: 2021; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.260 10^3/uL
CDC Split Type: ESPFIZER INC202101239647

Write-up: Myopericarditis; An episode of nonsustained ventricular tachycardia (TVNS) of 4 beats; myalgia; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority, regulatory authority number ES-AEMPS-1004216. A 26-year-old male patient received the second dose of BNT1612B2 (COMIRNATY) via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: FF2752) as single dose for COVID-19 immunization. Medical history included tobacco user (half pack / day) and unknown if ongoing. It was unknown whether the patient had COVID-19. No known allergy. Active basal life. Did not take usual medication. Cholesterol 226. No Hypertension or known diabetes. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 03Aug2021 (Batch/Lot Number: FG4686) as single dose for COVID-19 immunization. On 13Sep2021, the patient experienced myalgia. On 14Sep2021, the patient experienced myopericarditis. The event of myopericarditis resulted in hospitalization. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 1.21 on 2021, auscultation: rhythmic, no friction is heard on 2021, auscultation: both hemithorax ventilate on 2021, blood cholesterol: 226 on unknown date, blood creatinine: 0.8 mg/dl on 2021, blood fibrinogen: 509 mg/dl on 2021, blood glucose: 99 mg/dl on 2021, blood potassium: 4.3 mmol/l on 2021, blood pressure measurement: 100/70 on 2021, blood sodium: 136 mmol/l on 2021, blood urea: 34 mg/dl on 2021, chest x-ray: no signs of failure on 2021, c-reactive protein: 7.0 mg/dl on 2021, echocardiogram: undilated cardiac chambers on 2021 Inferolateral frank hypokinesia. No significant heart valve disease. Systolic displacement of the tricuspid annulus plane (TAPSE) 23. Hyperrefringent pericardium, especially inferolateral. No pericardial effusion. Inferior cava not dilated and with adequate collapse , ejection fraction: preserved on 2021. Previously well, on day 13Sep2021 began with myalgia without fever or other associated symptoms. The night of 13 to 14Sep woke up with oppressive centrothoracic pain that lasted several hours until disappearing in the morning, later asymptomatic until this morning when he repeated the picture about 6 hours, going to the Emergency Room where he arrived at 7:00 hours, partially ceding the picture after 3 cc of morphic chloride + 300 mg AAS + 180 mg ticagrelor, persisting a discomfort that clearly increased with inspiration and disappeared into apnea. They perform ECG that shows diffuse elevation of the TS and after contacting Hemodynamics, it is decided decided to perform urgent catheterization, after which he is admitted to the Intensive Care Unit (ICU). Physical examination: Blood pressure (TA) 100/70 Heart rate (HR) 83 Respiratory rate (FR) 25 Oxygen saturation (SatO2) 99% Afebrile. C and C: symmetrical laten carotids. Cardiac auscultation (AC): rhythmic, no friction is heard. Pulmonary Auscultation (PA): both hemithorax ventilate. Abdomen E Abduction (ABD): soft and depressible. Unknown meaning (EXT): conserved and symmetrical pulses. Complementary tests: Electrocardiogram (ECG) Emergencies: RS. Supra unevenness of the ST in I-AVL-II-AVF-V5-V6 and subsequent derivations. Descent of the ST in AVR and V1. ECG Post-catheterization ICU: similar but with a tendency to decrease the supra unevenness of the TS. hest Rx: no signs of failure. Analytics: Substrates: Glucose 99 mg/dL (70.0 - 105.0), Urea 34 mg/dL (19.0 - 49.0), Creatinine 0.8 mg/dL (0.5 - 1.5), Glomerular filtration (CKD-EPI,2011) 90. Ions: Sodium Ion 136 mmol/L (136.0 - 147.0), Potassium Ion 4.3 mmol/L (3.5 - 5.1). Cardiac markers: Troponin I (ultrasensible) 9950 pg/mL (0.0 - 20.0). Proteins: C-reactive protein 7.0 mg/dL (0.1 - 0.5). Blood count : Leukocytes 7.260 10^3/uL (3.91 - 8.77), Neutrophils 41.5 % (42.0 - 75.0), Lymphocytes 38.2 % (20.0 - 50.0), Monocytes 17.8 % (2.0 - 12.0), Eosinophils 1.9 % (2.0 - 5.0), Monocytes 1.290 10^3//uL (0.1 - 1.0), Red blood cells 5.28 10^6/uL (4.7 - 6.1), Hemoglobin 17.3 g/dL (14.0 - 18.0), Hematocrit 48.1 % (40.0 - 54.0), mean corpuscular volume (VCM) 91.1 fL (80.0 - 93.6), mean corpuscular hemoglobin (HCM) 32.8 pg (27.0 - 32.0), mean corpuscular hemoglobin concentration (CHCM) 36.0 g/dL (32.0 - 36.0), Erythrocyte Distribution Width 11.9 % (12.0 - 15.0), Platelets 195 10^3/uL (135.0 - 304.0), Mean Platelet Volume 9.8 fL (7.0 - 11.0). Basic coagulation*: TP - Prothrombin time 11.00 sec (11.0 - 15.0), TP - Activity 116.0 % (70.0 - 120.0), TP - Ratio 0.92 (0.7 - 1.3), TP - INR 0.93 (0.9 - 1.5), Activated partial thromboplastin time (TTPA) - Ratio 1.21 (0.7 - 1.3), Fibrinogen derivative 509 mg/dL (150.0 - 450.0). Ultrasound at the foot of the bed (EcoTT at the foot of the bed): undilated cardiac chambers. Global Left ventricular ejection fraction (FEVI) preserved. Inferolateral frank hypokinesia. No significant heart valve disease. Systolic displacement of the tricuspid annulus plane (TAPSE) 23. Hyperrefringent pericardium, especially inferolateral. No pericardial effusion. Inferior cava not dilated and with adequate collapse. Cardiac catheterization: Access by right radial route without complications. Coronary arteries with right dominance without significant lesions. Proposed treatment: Medical treatment. Clinical judgment: Acute myopericarditis. Plan: Ibuprofen + colchicine. An episode of nonsustained ventricular tachycardia (TVNS) of 4 beats and a doublet is appreciated: beta-blockers at low doses. Therapeutic measures were taken for events. The events resulted in emergency room visit. The outcome of myopericarditis was recovering. The outcome of other event was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1759951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial necrosis marker, Supraventricular tachycardia
SMQs:, Supraventricular tachyarrhythmias (narrow)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:Normal
CDC Split Type: FIPFIZER INC202101239677

Write-up: Supraventricular tachycardia; This is a spontaneous report received from a contactable Physician downloaded from the WEB. The regulatory authority report number is FI-FIMEA-20214814. A 14-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration as a single dose on 07Sep2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Sep2021, the patient experienced Supraventricular tachycardia. It was reversed with medication in the university hospital. Cardiac enzymes was normal, no myo/pericarditis as assessed by a pediatric cardiologist. The patient recovered from the event on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760629 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101226976

Write-up: upset stomach; Vomiting; Nausea; Fever; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (non-HCP) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141246484530-BQXSY, Safety Report Unique Identifier GB-MHRA-ADR 25938612. A 24-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 13Sep2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 13Aug2021 to 20Aug2021 and not ongoing and contraception from an unspecified date and unspecified if ongoing. The patient was not enrolled in clinical trial. Concomitant medications included ethinylestradiol/levonorgestrel (RIGEVIDON) taken for contraception from 16Oct2020 to an unspecified stop date. On 13Sep2021, the patient experienced nausea, fever and swollen lymph nodes; on 14Sep2021, the patient experienced vomiting and an on an unspecified date the patient experienced upset stomach. The events were serious for medically significant. The course of the events was as follows: the patient experienced an upset stomach as she was going to bed. She woke up at 3am with extreme nausea and vomited approximately 5 times in the space of 2 hours. She also had swollen lymph node in the arm with jab. The patient underwent lab tests and procedures which included COVID-19 virus test which was positive on 16Aug2021. The clinical outcomes of the events nausea, fever and vomiting were recovering/resolving; swollen lymph nodes were not recovered/not resolved, and the clinical outcome of the event upset stomach was unknown. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1760796 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inappropriate schedule of product administration, Insomnia, SARS-CoV-2 test, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101242822

Write-up: insomnia; chills; Fainting; inappropriate schedule of vaccination administered; subsequent fit due to fainting; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109201818032720-40JN5,Safety Report Unique Identifier(GB-MHRA-ADR 25969867). A 23-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF8222), dose 2 via an unspecified route of administration on 13Sep2021 (at the age of 23-years-old) as a DOSE 2, SINGLE (at the age of 23-year-old) for COVID-19 immunization. No other medications or ailments at the time. Medical history included suspected covid-19 (unsure when symptoms stopped) from 14Jun2021 to an unknown date. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 14Jul2021 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Patient was not pregnant, Patient was not currently breastfeeding. Patient had not been tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced 10 hours after receiving second dose of Pfizer vaccine, fainted and experience subsequent fit due to fainting. Precluding side effect included insomnia, as the side effect occurred at 4am and chills on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Jun2021. The outcome of the events chills and subsequent fit due to fainting was unknown, outcome of the event fainting was recovered on 14Sep2021, and insomnia was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1761115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Disturbance in attention, Fatigue, Narcolepsy
SMQs:, Convulsions (broad), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (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: TOPIRAMATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243248

Write-up: Narcolepsy; Diarrhoea; Disturbance in attention; Fatigue; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 624537. A 32-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection), via an unspecified route of administration on 13Sep2021 (Batch or lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications included topiramate taken for an unspecified indication, start and stop date were not reported. On 13Sep2021, the patient experienced narcolepsy, diarrhoea, disturbance in attention and fatigue. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763253 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Impaired quality of life, Limb discomfort, Loss of consciousness, Pain in extremity, Pyrexia, Vaccination site pain
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACEROLA; SULFUR; THUYA OCCIDENTALIS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: fever; Result Unstructured Data: Test Result:37.9 Centigrade; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:6/10
CDC Split Type: ITPFIZER INC202101237589

Write-up: Blackout 10 minutes after vaccine injection.; Heaviness left arm and left leg.; Fever at 37.9 the following day (lasting less than 24 hours).; Right arm pain at the injection site.; Right arm pain at the injection site; Heaviness left arm and left leg.; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787765. A 25-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG3739) intramuscularly, administered in right arm on 13Sep2021 (at the age of 25-year-old) as dose 1, 0.3 ml single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included acerola (ACEROLA), sulfur (SULFUR) and thuja occidentalis (THUYA OCCIDENTALIS) taken for an unspecified indication, start and stop date were not reported. On 13Sep2021 the patient experienced blackout 10 minutes after vaccine injection, heaviness left arm and left leg, fever at 37.9 the following day, right arm pain at the injection site. The patient underwent lab tests and procedures which included fever result was 37.9 centigrade on 14Sep2021, impaired quality of life: 6/10 on an unspecified date. Outcome of the events blackout 10 minutes after vaccine injection, heaviness left arm and left leg, fever at 37.9 the following day (lasting less than 24 hours), right arm pain at the injection site were resolving and outcome of events right arm pain at the injection site coded with vaccination site pain and heaviness left arm and left leg coded with heaviness in arm were unknown. Sender''s comment: Other products taken by the patient: Acerola 1000, MGK forte, Sulfur 200k, Thuya 200k.


VAERS ID: 1764161 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-06
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: SEMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: SE-MPA-2021-083909) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 17-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. Company comment: This case concerns a 17-year-old male patient with no relevant medical history, who experienced serious AESI, listed, events of myocarditis. The event occurred at unspecified duration after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was unknow as the date and the dose of Moderna COVID-19 Vaccine was not provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 30-Sep-2021, contains no new information.; Sender''s Comments: This case concerns a 17-year-old male patient with no relevant medical history, who experienced serious AESI, listed, events of myocarditis. The event occurred at unspecified duration after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was unknow as the date and the dose of Moderna COVID-19 Vaccine was not provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1766545 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
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: Acute respiratory failure, Hypoxia, Motor neurone disease, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20211008169

Write-up: MOTOR NEURON DISEASE; ACUTE RESPIRATORY INSUFFICIENCY; HYPOXIC; HYPERCAPNIC RESPIRATORY FAILURE; This spontaneous report received from a physician via a Regulatory authority (regulatory authority, IT-MINISAL02-793650) on 05-OCT-2021 and concerned a 62 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), 0.5 ml, 1 total, administered on 03-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced motor neuron disease, acute respiratory insufficiency, hypoxic and hypercapnic respiratory failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from motor neuron disease, acute respiratory insufficiency, hypoxic, and hypercapnic respiratory failure. This report was serious (Life Threatening).


VAERS ID: 1770157 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211010065

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (PT-INFARMED-T202109-1756) on 06-OCT-2021 and concerned a 31 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: 21C19-02 expiry: UNKNOWN) 0.5 ml, frequency 1 total administered administered on 27-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 13-SEP-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1770990 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005695 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: ES-AEMPS-1009440) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005695) for SARS-CoV-2 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ANGIOEDEMA (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had Lip and hand angioedema. It was reported that rechallenge was done and reaction reoccurred. Treatment medication was not provided by the reporter. Company Comment: This case concerns a 14-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Angioedema. The event occurred 1 day after the unspecified dose of Spikevax. The re-challenge was reported as positive; however no additional information regarding the doses. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to ES-AEMPS-1009414 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation Received on 02-Oct-2021: Event details added to the narrative.; Sender''s Comments: This case concerns a 14-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Angioedema. The event occurred 1 day after the unspecified dose of Spikevax. The re-challenge was reported as positive; however no additional information regarding the doses. The benefit-risk relationship of Spikevax is not affected by this report. ES-AEMPS-1009414:


VAERS ID: 1772442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-08
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: DEJNJFOC20211010983

Write-up: VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100200863) on 06-OCT-2021 concerned a 38 year old female patient 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, route of administration not reported, batch number: 21C11/01 expiry: unknown) 1 dosage forms, 01 total, administered on 01-JUN-2021 for drug use for unknown indication. No concomitant medications were reported. On 13-SEP-2021, the patient experienced coronavirus disease (covid-19) and vaccination failure. . The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination failure, and covid-19. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1783396 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-13
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diplopia, Fatigue, Guillain-Barre syndrome, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Ocular motility disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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: This case was received via regulatory authority (Reference number: ES-AEMPS-1013587) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DIPLOPIA, FATIGUE, PARAESTHESIA and HEADACHE in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005790 and 214013) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced GUILLAIN-BARRE SYNDROME (seriousness criteria hospitalization, disability, medically significant and life threatening), FATIGUE (seriousness criteria hospitalization and life threatening) and HEADACHE (seriousness criteria hospitalization and life threatening). On 21-Sep-2021, the patient experienced DIPLOPIA (seriousness criteria hospitalization and life threatening). On 22-Sep-2021, the patient experienced PARAESTHESIA (seriousness criteria hospitalization and life threatening). At the time of the report, DIPLOPIA, FATIGUE and HEADACHE outcome was unknown and GUILLAIN-BARRE SYNDROME and PARAESTHESIA had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No treatment medications were provided. Company Comment: This case concerns a 16-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Diplopia, gullain barre syndrome, fatigue, parasthesia , and headache . The events occurred 35 days after except diplopia and paresthesia which occurred 43 and 44 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation received on 07-OCT-2021 contains translated event verbatim and dosage text.; Sender''s Comments: This case concerns a 16-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Diplopia, gullain barre syndrome, fatigue, parasthesia , and headache . The events occurred 35 days after except diplopia and paresthesia which occurred 43 and 44 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1784098 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
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: Test Name: Troponin; Result Unstructured Data: MILLIGRAM(S) 655,3
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: IT-MINISAL02-792273) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 16-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Troponin: abnormal (abnormal) MILLIGRAM(S) 655,3. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment information was not provided. The dose of the vaccine was 0.5 milliliter. Company Comment: This case concerns a 16-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 1 days after the first dose of Spikevax. The lab indicated that the level of troponin was elevated. The rechallenge was unknown since no information about the second dose was provided. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 16-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 1 days after the first dose of Spikevax. The lab indicated that the level of troponin was elevated. The rechallenge was unknown since no information about the second dose was provided. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1693356 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW968 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Fatigue, Pharyngeal swelling, Pleural effusion, Secretion discharge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Lasix atenolol amlodipine losartan vit C zinc KCl Fiber probiotic
Current Illness: Hypertension parathyroid excess hep c( Metyvir tx viral load not detected lymphedema morbid obesity mild cardiomegaly osteo: penia, arthritis , porosis bipolar disorder 1 CVA 2003
Preexisting Conditions: HypeTension parathyroid excess bipolar osteo
Allergies: Corticosteroids bipolar meds antidepressants morphine codeine toradol
Diagnostic Lab Data: None Doctors and nurses were there by my side when symptoms progressively went to coughing and sob
CDC Split Type:

Write-up: Started dry cough, to excess mucus throat, throat swelling, fluid filling in upper chest, chest pain, sob, lasted approximately 5 min then symptoms went away one by one. Left after another 1 hour watch. Chest pressure and fatigue lasting 24 hours then 0 symptoms


VAERS ID: 1693358 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Headache, Neck pain, Pain in extremity
SMQs:, Arthritis (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: None
Current Illness: None
Preexisting Conditions: Hashimotos
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm soreness, chills, neck pain, headache


VAERS ID: 1693359 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash on hands and foot; burning rash


VAERS ID: 1693363 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Menstruation irregular
SMQs:, Fertility 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: Ibuprofen
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Period 8 days early Always regular


VAERS ID: 1693376 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816022 / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Myalgia, Neck pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: N/A
CDC Split Type:

Write-up: Immediate: arm soreness, which worsened for the next 3 hours Morning of 9/12: awoke with fever, headache, myalgias, neck pain, severe fatigue, continued arm soreness


VAERS ID: 1693382 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pfizer covid 19
Other Medications: Zyrtec
Current Illness:
Preexisting Conditions: Tinnitus, hyperacusis, hemochromatosis
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizzy, short of breath, disoriented


VAERS ID: 1693396 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Headache, Heart rate increased, Mobility decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The day after the 2nd dose I was knocked out with standard side effects, such as chills, headache, fatigue, and could not do much. The headache passed by 9/11 at night, but chest pain started to take over. Right now, in the morning, I still feel tightness in my chest, and my resting heart rate is faster than normal.


VAERS ID: 1693400 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Chest pain
SMQs:, 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:

Write-up: Chest pain and weakness.


VAERS ID: 1693422 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Bronchospasm, Cough, Heart rate increased, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (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: Benadryl 50ml (oral)
Current Illness: POTS, Mast Cell Elevation
Preexisting Conditions:
Allergies: Unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Within seconds of Pfizer vac administration patient starts coughing and having bronchospasm with O2 sat initially between 89-95%. We immediately administered one dose=0.03 ml of epipen 1 mg/ml (lot # 33912, Exp 12/22) SC at 8:10 am. and patient condition improved significantly in a few minutes. After the epipen her heart rate when up to 145 and BP when up to 134/84 but after a few minutes both came down gradually until normal. We advised the patient to go on ambulance to hospital for observation. At 8:45 am she started shaking and coughing again and EMS administered Benadryl 25 mg IM and We gave a 2nd dose= 0.03 ml SC at 8:57 am of epipen 1 mg/ml. After the 2nd dose of Epipen Pt condition improved again. (cont) At this time an ambulance was called by both the patient and EMT. The abulance called by EMT and therefore unable to have the patient handed off to them. The patient called an ambulance which was ACLS and therefore able to receive the patient. Patient''s condition reported to Hospital and patient was sent in stable condition


VAERS ID: 1693426 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan. Atorvasratin Zetia isosorbide carvedilol metformin Lantus aspirin wellbutrin jardiance
Current Illness:
Preexisting Conditions: Heart disease diabetes highblood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intense body aches, fever, headaches


VAERS ID: 1693429 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Feeling hot, Oropharyngeal pain, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Sore throat a few weeks prior
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: O2 sats 98% 9/12/2021 temp 98.4 9/12/2021
CDC Split Type:

Write-up: Woke up in the AM with sore throat, shakiness, shortness of breath, feeling hot Ibuprofen given


VAERS ID: 1693432 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Oropharyngeal pain, Rhinorrhoea
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Vyvanse, effexor, Trileptal, abilify
Current Illness: None
Preexisting Conditions: ODD, depression, anxiety, ADD
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore throat, runny nose


VAERS ID: 1693449 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30130BA / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate decreased, Hyperhidrosis, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (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: PATIENT EXPERIENCED SYNCOPE FOLLOWING VACCINATION WITHIN A FEW MINUTES. PATIENT WAS ABLE TO REMAIN SEATED, ALTHOUGH HE DID APPEAR TO LOSE CONSCIOUSNESS FOR A BRIEF MOMENT. PATIENT WAS SWEATING, HAD BLURRED VISION, AND HAD A LOW PULSE. PATIENTS MOTHER SAID HE WAS ANXIOUS OVER VACCINE. PATIENT DRANK SOME WATER AND STARTED TO GET COLOR BACK AND SWEATING STOPPED. HE SAT FOR 30 MINUTES AFTER AND SAID HE FELT BETTER.


VAERS ID: 1693453 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Condition aggravated, Dysphagia, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Allergy medication and steroid nasal spray
Current Illness: Had throat closing sensation 5 days ago.
Preexisting Conditions:
Allergies: Currently in assessment by ENT (prior to today)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Immediately felt like her throat was swelling, hard to swallow. States this has been frequently happening to her since March, unrelated to illness or medications. Is under treatment by ENT to discover etiology.


VAERS ID: 1693460 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Flushing, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: UNKOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: NONE
Diagnostic Lab Data: none
CDC Split Type:

Write-up: A few minutes after vaccination, the patient began what appeared to be vasovagal syncope. Symptoms lasted for 1-2 minutes, and the patient awake from syncope and was alert and coherent. Patient felt flush and was sweating. She reported feeling completely normal approximately 5-10 minutes after awakening. Patient did not fall on the ground. She was sitting in a chair and dropped a few items from her hand and slumped into chair for entirety of symptoms. Patient reported no prior issues with vaccinations. Patient came with a friend/family member who was with her during the entirety of symptoms. Patient reported feeling anxious prior to vaccination. Patient also reported that she had nothing to eat prior to vaccination due to nervousness.


VAERS ID: 1693493 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-01
Onset:2021-09-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Diarrhoea, Injection site erythema, Injection site vesicles, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (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: Usually golf ball sized knot with flu shots and get flu symptoms.
Other Medications: Sertraline
Current Illness: N/A
Preexisting Conditions: Depression, had Covid in 2020, has had 10 day episodes of diarrhea as well as fatigue since having Covid.
Allergies: Penicillin as a child (bad rash)
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: The pt. said she felt fine at first after getting the vaccine. On days 8 and 9 she started having stomach issues with severe diarrhea. As of day 10, her diarrhea is better, but she awoke with a quarter-sized whelp with blisters at the injection site. She says it is hot to the touch and there is a lot of redness. I advised her to follow up with her doctor.


VAERS ID: 1693497 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pruritus, Taste disorder
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Hypersensitivity (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: PUS: 64 , BP: 118/76, RR: 18
CDC Split Type:

Write-up: Lack of unexplained taste, pain and itching. These reactions seemed to disappear after 5mins. Patient reported to returned to normal after 10mins. Patient was monitored for an additional 15mins.


VAERS ID: 1693514 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE3592 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Loss of consciousness
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Unknown all previous vaccines, but has had with flu shots in prior years, although never as quick as episode today. Patient gets
Other Medications: unknown
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient was alert and oriented leading up to injection. Upon completion of immunization, patient lost consciousness and went in and out several more times over next 5 minutes. Patient was able to regain consciousness, drink water, and was checked out by emergency personnel where blood pressure was normal. Patient was able to walk out of pharmacy with no additional interventions needed. Patient has had fainting spells with immunizations before per mother, which were disclosed AFTER immunization was given.


VAERS ID: 1693522 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Fear, Premenstrual syndrome, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden PMS related stomach pains that almost made me faint. My period is about to arrive, but hasn''t yet. I''ve never experienced such severe pain ever before, and especially not before my period even arrived. They lasted for about 15 minutes, which is when I took some strong pain relievers. I briefly thought of calling an emergency. It was quite scary.


VAERS ID: 1693528 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Rash erythematous, Rash macular
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? 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: Bright red blotchy rash and spots appearing on back and face


VAERS ID: 1693530 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Chills, arm pain, nauseas


VAERS ID: 1693537 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few minutes after giving a Janssen COVID 19 vaccine, the patient was warm to the touch, visibly sweaty, and very nauseous. She sat down with her head resting on her boyfriend, eyes closed, and complained she didn''t feel herself at all. I observed/verified with the patient that there was no rash, swelling, or breathing issues. She was able to speak the whole time. She does not have any allergies and did not faint. She does have a fear of needles. I called EMS to evaluate her and they took her to the hospital. When EMS arrived she stated she felt slightly better than she did ten minutes ago.


VAERS ID: 1693551 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821281 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Erythema, Paraesthesia, Paraesthesia oral, Pharyngeal swelling, Taste disorder
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Soapy taste, tingling in the left arm, tingling in the mouth. Red face, throat swollen. 1 Epi dose given, NRB applied with O2.


VAERS ID: 1693555 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-02
Onset:2021-09-12
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Vaccine breakthrough infection
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? 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: Breakthrough COVID case. Received vaccine on 1/28/21&3/2/21. Admitted for COVID on 9/12/2021.


VAERS ID: 1693557 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Hypoacusis
SMQs:, Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (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: Felt dizzy/light headed/hot/muffled noise


VAERS ID: 1693573 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypertension
Preexisting Conditions: Hypertension
Allergies: None
Diagnostic Lab Data: None taking 800mg motrin
CDC Split Type:

Write-up: Neck is very stiff and painful to perform range of motion. Very sore arm and shoulder at injection site.


VAERS ID: 1693578 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Dyspnoea, Dysstasia, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Benicar 40mg/ Metoprolol 50mg/ Flonase/ Allegra 60mg/ Goli apple cidar gummies/ Goli ashwagandha gummies/Tylenol 500mg
Current Illness: infection in my tooth (1 month ago)
Preexisting Conditions: sleep Apnea, Lymphedema, high blood pressure, seasonal allergies, arthritis
Allergies: percocet/ dilaudid/ bactrim/ penicillin/ cashews
Diagnostic Lab Data:
CDC Split Type:

Write-up: severe cramping in my back muscles causing me pain and to be bent over unable to stand straight and restricting my breath


VAERS ID: 1693582 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Left fingers and toes started to tingle about 10 minutes after vaccine. This included left pointer, middle, and ring fingers and all toes except big toe left foot. Also started to have discomfort and tingling, numbness in left knee. "Like these areas went to sleep" per patient. Had him lay down in office for an additional 15 minutes (30 minutes total monitoring), gave him water, and lollipop for sugar. He continued to have the sensations but nothing worsened 30 minutes after vaccine, so allowed him to go home.


VAERS ID: 1693584 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: patient fainted


VAERS ID: 1693585 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Electric shock sensation, Lethargy, Pyrexia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Patient received 9/11 in afternoon. patient said she woke up at 330am on 9/12 with fever of 101.6, lethargic, "felt like she was being electrocuted all over her body", tremors, and sharp chest pains. Lasted a few hours. At the time of calling the pharmacy on 9/12 at 4pm she was still feeling sharp chest pains and had a fever of 100.6. She called moderna and the reference number for them was #MOD21-142718


VAERS ID: 1693594 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: PATIENT FAINTED IMMEDIATELY AFTER VACCINE


VAERS ID: 1693596 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Injection site warmth, Rash papular, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, parental, low dose 81mg aspirin, OTC iron
Current Illness: None
Preexisting Conditions: Hashimotos Thyroiditis
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Red, raised, painful hives- they are warm to the touch and on the arm beneath the injection site. They do not itch. These showed up 2 days post injection.


VAERS ID: 1693598 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Flushing, Hypoaesthesia oral
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (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 started to feel flushed and dizzy 15-20 minutes after receiving the vaccine at 11:30am. She then started to feel like her tongue was getting numb and her throat was feeling fuzzy. Benadryl 50mg liquid was administered but 5-10 minutes later she was still feeling like her throat felt better but that the dizziness and flushing were the same or getting worse and her lips still felt numb. 911 was called but pt checked out ok medically and no extra treatment was received. Pt left with her sister by 12:35pm and was coherent and was feeling better just tired from the benadryl dose.


VAERS ID: 1693601 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
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: NONE MENTIONED
Current Illness: NONE MENTIONED
Preexisting Conditions: NONE
Allergies: NONE MENTIONED
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: ON 9/12/21 PATIENT CAME IN TO GET THE FLU SHOT VACCINE AND RECEIVED THE MODERNA VACCINE INSTEAD. PT WAS CALLED TO BE TOLD THAT HE RECEIVED THE COVID VACCINE INSTEAD OF THE FLU AND REPORTED NO SIDE EFFECTS AT THE TIME OF THE CALL ON 9/12/21. PT WIFE WAS CONCERNED BECAUSE THEY RECEIVED THE JOHNSON AND JOHNSON VACCINE IN APRIL OF 2021. PHARMACIST ON DUTY REPORTED THAT THEY SHOULD BE FINE BUT WOULD PUT A CALL IN TO THE CDC FOR MORE INFORMATION. PT WANTED TO RETURN FOR THE CORRECT VACCINE BEFORE 9/13/21 FOR A FOSTER PARENT APPLICATION.


VAERS ID: 1693607 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

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

Write-up: swollen lynphnodes


VAERS ID: 1693611 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Nasal congestion, Nausea, Pain in extremity, Pulmonary pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: NuvaRing
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: Almonds, antibiotics (sulfa, penicillin)
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: Large red patch around injection site. Painful red patch on arm - not itchy but very sensitive to touch. Arm pain, headache, nasal congestion, lung pain when taking deep breath, nausea, exhaustion.


VAERS ID: 1693615 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness, Hypotonia, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (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), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown, no medications on record
Current Illness: none
Preexisting Conditions: asthma
Allergies: Peanuts and pecans
Diagnostic Lab Data: checked pulse, strong and normal, supple skin at 1:18pm
CDC Split Type:

Write-up: 17 year old female received 2nd dose of COVID vaccine at 1:15pm, at 1:18pm mother alerted pharmacy that patient was not ok. Patient was sitting in the chair and her limbs went limp and she dropped her water bottle, she was not responding to sound or touch although her eyes were open, laid patient down on the floor with feet up and she immediately regained consciousness and was able to talk. She stated that she lost vision and was ok. Mother panicked and called 911, ambulance arrived at 1:20 and escorted the patient to the ambulance to gather more information.


VAERS ID: 1693623 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was first administered Moderna Vaccine on 8/16/21 and an incorrect MRNA COVID -19 vaccine (Pfizer) FF8839 administered for second dose in 2 -dose series on 9/12/2021


VAERS ID: 1693624 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Hypoaesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: birth control, multi-vitamin, caffeine earlier in the day
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: No
Diagnostic Lab Data: none
CDC Split Type:

Write-up: About halfway through the patient''s 15-minute waiting period after receiving the Janssen vaccine, she let me know that she felt a numbing feeling in her upper shoulder on the side she received the shot. She said it feels like when you get novocaine at the dentist''s and it starts wearing off. She said it traveled up to the same side of her face/jaw and the side of her mouth. She could move her arm fine and raise it above her head. No signs of drooping in the face when asked to smile. No other symptoms such as trouble breathing or swallowing, dizziness, or pain. When she touched herself in the numbing areas, she could still feel the touch. I called 911 to be safe. While talking to the dispatcher, she said she thinks it''s not as bad in her face but now thinks she feels it in her legs. While still on the phone, PD arrived. Shortly paramedics came and said her vitals were fine and evaluated her for signs of anaphylaxis. Since she had no immediate symptoms, the patient decided to go home instead of in the ambulance to the hospital. Her friend was with her who drove them. She was instructed to call 911 or go to the ER if symptoms worsened or new symptoms began


VAERS ID: 1693642 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Eye movement disorder, Feeling hot, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pallor, Tremor
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), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: After 10 minutes, patient got up took 2 steps and had to sit down. He then passed out, stiffened up and appeared to be seizure like (eyes in back of head, shaking, stiff). After reaching out to him, he responded to me within 30 seconds. He was pale, sweating, clammy, and hot. We gave him water, damp paper towel, and then seemed to do better. Paramedics were called and they treated him further. After he was responsive, he told me he has a phobia of needles, but did not mark anything on VAR form to let us know.


VAERS ID: 1693653 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301358A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Chest discomfort, Dizziness, Fatigue, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular 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? Yes
Hospitalized? No
Previous Vaccinations: Flu Shot, patient has experienced throat discomfort and similar symptoms with annual flu shot. Patient is not allowed to get fl
Other Medications: Atorvastatin, Atenolol
Current Illness: N/A
Preexisting Conditions: Baron Dupuytren''s Disease
Allergies: Naprosyn, possible egg allergy (issue with flu vaccine is past)
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient stated was feeling dizziness, lightheadedness, tiredness, tingling in fingers and toes. Patient was able to respond to verbal queues. Patient experienced these symptoms for approximately 10 minutes and then symptoms improved. Patient still complained of burning feeling in feet, however patient stated he thought it was due to his Baron Dupuytren''s Disease. Patient felt he could get up to walk out however I encouraged patient to stay for observation. Approximately 25 minutes after shot patient begin to experience same symptoms however was complaining of chest tightness. Called 911. EMTs arrived and took over care of patient.


VAERS ID: 1693663 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Tdap and Rabies
Other Medications: Adderall XR
Current Illness: None
Preexisting Conditions: Lingering Multiple Chemical sensitivities and multiple allergies since having a tick-borne illness that has since been treated.
Allergies: gluten, dairy, multiple chemical sensitivities
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Internal tremors lasting about 10 minutes that come and go without fever, weakness, nausea. The internal tremors are the most severe symptom.


VAERS ID: 1693670 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong product administered
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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PT CAME IN ON 9/12/21 FOR A FLU SHOT BUT RECEIVED THE MODERNA COVID SHOT INSTEAD. THE PT SAID THAT THEY NEEDED THE SHOT FOR AN APPLICATION SUBMISSION FOR A FOSTER CHILD AND WOULD RETURN TO THE STORE WITHIN THE NEXT DAY OR SO FOR THE CORRECT VACCINE. SHE WAS CONCERNED THAT THEY RECEIVED THE JOHNSON AND JOHNSON VACCINE IN APRIL 2021 AT PHARMACY. THE PHARMACIST ON DUTY CALLED CDC AND SPOKE WITH A NURSE WHO CONFIRMED THAT WE NEEDED TO CALL AND REPORT THE VACCINATION ERROR AND TO NOT ADMINISTER A SECOND DOSE OF MODERNA.


VAERS ID: 1693675 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Feeling abnormal, Feeling cold, Feeling hot, Pallor, Paraesthesia oral, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (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: None reported
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: None reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted a few minutes after administration of Pfizer COVID Vaccine (1st dose), regain consciousness within 30 seconds, looks pale, strange feelings, "in a dream", a few minutes later, she fainted again, but regain consciousness within 10 seconds, talking, feeling tongue tingling, warms on the head and back, applied Cold pack to the forehead, then she felt cold. Ambulance was called. She looks pale but talking, as we wait for the EMS to arrive, she seemed to getting better, able to drink small cup of water, pulse normal, breathing normal. When EMS arrived, suggested to be taken to hospital for observation, agreed by the father, needed assistance to stand up from seating on chair.


VAERS ID: 1693680 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphasia, Dizziness, Ear discomfort, Electrocardiogram normal, Fear of injection, Feeling abnormal, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Sexual dysfunction (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: NO KNOWN ALLERGIES
Diagnostic Lab Data: VITAL SIGNS: BP 100/72, P 62, RESPIRATIONS 16 NON-LABORED
CDC Split Type:

Write-up: 26 year old female receiving her first Moderna Covid vaccination. Immediately after receiving the shot, she felt her hands go numb, said she didn''t "feel right", and stopped talking. Her husband and I lowered her to the floor and put her feet on a chair. 9-1-1 was called. Immediately, the patient started talking again, saying she had "cotton" in her ears and felt "woozy". Vital signs assessed: BP 100/72, P 62, respirations 16 non-labored. Upon discussion, patient admitted to having a phobia of needles where she sometimes faints when giving blood. Patient had previously denied reactions following vaccination, NKDA. Paramedics arrived 15 minutes later, assessed the patient, took vitals/EKG, cleared with a refusal to transport, instructed to consume water and gatorade. Patient reported feeling much better, was escorted out with her husband.


VAERS ID: 1693684 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Heart rate increased, Injection site pain, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Dehydration (broad)

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

Write-up: Body aches, headache, tender at injection site, rapid heart rate.


VAERS ID: 1693685 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-07-25
Onset:2021-09-12
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient under 18 years of age received Moderna vaccine. Dose #1 on 7/25/21; dose #2 on 8/22/21 (lot #021c21a). Patient had no adverse event or significant side effects.


VAERS ID: 1693694 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: Patient passed out . No fall injury occurred and patient recovered from the episode immediately. Removed from vehicle to EMS to get vitals. Patient has had syncope episodes or nausea in the past after receiving a shot. Patient then returned to vehicle and was monitored by EMS for an additional 30mins.


VAERS ID: 1693695 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Eye movement disorder, Feeling cold, Presyncope, Thirst, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pt reported history of passing out after particular exposures
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient nearly lost consciousness about 10 minutes after receiving vaccine. His eyes rolled back and he was initially not very responsive. However, after calling his name and grabbing his arm, he came to. He was able to answer questions weakly. He reported feeling thirsty, dizzy, and cold. He was given water. He vomited. Emergency services were called. He eventually reported starting to feel better and refused to go to the hospital.


VAERS ID: 1693703 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: TETANUS ALSO FAINTED WHEN SHE WAS 12
Other Medications: not available
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT WAS VERY NERVOUS ABOUT GETTING A SHOT AND HAS FAINTED IN THE PAST FROM A TETANUS SHOT WHEN SHE WAS 12. SHE FAINTED ABOUT 10 MINUTES AFTER VACCINATION AND THEN PROCEEDED TO VOMIT. EMT WAS CALLED TO THE STORE AND THEY CHECKED PATIENT OUT AND RELEASED HER WHICH WAS ABOUT 30 MINUTES AFTER VACCINATION WITHOUT FURTHER INCIDENT


VAERS ID: 1693705 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was suppose to receive a 2nd dose of Pfizer and received Moderna


VAERS ID: 1693713 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMMUNIZATION (PFIZER COVID VACC)
Current Illness: NO
Preexisting Conditions: NO
Allergies: NKA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT CALLED PHARMACY A DAY AFTER SHE RECEIVED HER 2ND DOSE OF PFIZER COVID VACCINE. PATIENT STATED THAT SHE HAS A LUMP NEAR HER NECK/CLAVICLE BONE ABOUT A QUARTER SIZE AND IT HURTS WHEN SHE MOVED HER ARM.


VAERS ID: 1693728 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Muscle spasms, Muscle twitching
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Dehydration (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: Allergy shots
Current Illness: None
Preexisting Conditions: None
Allergies: Soy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Increased heart rate from 12:00am-5am, full body twitching from 2:00am- 9:00 pm. Slight muscle spasms still occurring.


VAERS ID: 1693745 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

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: N/A
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: A FEW HOURS AFTER THE VACCINE, THE PATIENT EXPERIENCES SHARP PAIN NEAR CHEST/HEART AREA.


VAERS ID: 1693769 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
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: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The patient was supposed to receive their second dose of Moderna vaccine but they were instead given a first dose of Pfizer vaccine by mistake.


VAERS ID: 1693773 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185-H / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Fall, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: PT 14 yo female, received Pfizer 1st dose LD. Once vaccinated PT attempted to get up from sitting at vaccinator table and slid from chair onto the floor unassisted. PT unresponsive RN immediately repositioned Pt on back and rolled to back with legs elevated, 1738 PT pale and A/O, BP 90/60 HR 39 O2sat 97. Parent reports child had not eaten prior to vaccine administration and had limited fluid intake. Pt alert, color returning to baseline, while talking given 11 oz of apple juice. Pt reports no nausea, HA, dizziness. Continue monitoring PT and reported improved status. Sitting BP 87/60 with heart rate 63, SPO2 99% at 1740. Pt assisted to standing position by RN and Mom without vertigo or lightheadedness, escorted and walked to post observation. Pt sitting in post observation eating a snack that parent provided and sipping juice. 1826 Pt denies vertigo and is asymptomatic when standing and discharged to home accompanied by mother. Recommended that with second dose to be well hydrated and ingest a recent meal. Encouraged her to have second dose in a supine position to avert a vasovagal response.


VAERS ID: 1693795 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-09-05
Onset:2021-09-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, 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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: None
CDC Split Type:

Write-up: One week after injection, injection site became red again & feels hard to the touch. Slight tenderness.


VAERS ID: 1693813 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-09-04
Onset:2021-09-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swollen red rash at injection site 8 days after injection


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