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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 192 out of 8,010

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VAERS ID: 1742566 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Diarrhoea, Headache, Illness, SARS-CoV-2 test, Sinus headache
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217789

Write-up: Sickness; Diarrhea; Sinus headache; Frontal headache; Armpit pain; This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109152021411610-LBYU8 Safety Report Unique Identifier GB-MHRA-ADR 25948009. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, suspected covid-19 from 10Jan2021 and ongoing, immunodeficiency from an unknown date and unknown if ongoing Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef. The patient''s concomitant medications were not reported. On 14Sep2021, the patient experienced sickness, diarrhea, sinus headache, frontal headache, armpit pain. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jan2021 Yes - Positive COVID-19 test. The outcome of the events (sickness, diarrhea) was recovering, events (sinus headache, frontal headache, armpit pain) was not recovered. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742568 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dysmenorrhoea, Eye pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217620

Write-up: Fever; Dizziness; Period pains; Painful hips; Painful L arm; Eye pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109152046036100-OE4YB, Safety Report Unique Identifier GB-MHRA-ADR 25948067. A 30-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 14Sep2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and was not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On 14Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 14Sep2021, the patient experienced eye pain and on 15Sep2021, 1 day after the vaccination, the patient experienced fever, dizziness, period pains, painful hips and painful L arm; all the events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event eye pain, fever, dizziness, period pains, painful hips and painful L arm was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217592

Write-up: Feverish; Sore throat; Nose congestion; Lethargy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109152102135030-EY9FU with Safety Report Unique Identifier GB-MHRA-ADR 25948092. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Sep2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. On 14Sep2021, 4 days after vaccination, the patient experienced sore throat, feverish, nose congestion, and lethargy; all events were reported as serious for being medically significant. On 14Sep2021, the patient underwent a COVID-19 virus test and the result was negative. The clinical outcome of the events feverish, sore throat, nose congestion, and lethargy was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dyspepsia, Dyspnoea, Hyperhidrosis, Inappropriate schedule of product administration, Inflammation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217810

Write-up: shortness of breath; heart pain and inflammation; inflammation; 1st dose on 19Jun2021 and 2nd dose on 12Sep2021; heart pain; Heartburn; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160552201280-IFHX5, Safety Report Unique Identifier GB-MHRA-ADR 25949268. A 20-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 19Jun2021 as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021 (after 2 days of vaccination), patient experienced heartburn. On an unspecified date, patient experienced slight shortness of breath when it comes, heart pain and inflammation, with a fluttering feeling. Adverse reaction did not occur as a result of an exposure during pregnancy. All events were medically significant. The outcome for event heartburn was not resolved and for other events was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1742636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Limb injury, Muscular weakness, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224738

Write-up: pins and needles; Weakness in my left arm; Arm injury; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161252085040-XUPCR. Safety Report Unique Identifier GB-MHRA-ADR 25952481. A 35-year-old non pregnant female patient received bnt162b2 (PFIZER- BIOTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FE3380), dose 2 via an unspecified route of administration in left arm on 13sep2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER- BIOTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, patient experienced pins and needles, weakness in my left arm and arm injury on 14Sep2021. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (no - negative covid-19 test). The outcome of arm injury was not recovered, pins and needles, weakness in my left arm was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1742647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224812

Write-up: pain; Backache; This is a spontaneous report from a contactable consumer (Patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161406325370-IX7QE, safety report unique identifier is GB-MHRA-ADR 25953123. A 29-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number not reported), via an unspecified route of administration on 12Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history and patient concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 14Sep2021, the patient experienced backache, and on an unspecified date, the patient had pain. It was reported that the bottom of patient spine was painful. Almost as if he had slipped a disc (he had not ever done this, but the pain described reminded him fiance of it), patient had not been injured recently or any other reason for this to happen, so he do believe it was a side effect of the vaccine. It was so bad that he could not walk for 24 hours. It hurt to sit and move in general for 24-hours. He consulted a doctor but nothing was done at this time. The next day, it still hurt but a sudden change around lunch time made it much better. It still hurts now, but not nearly the same as it was. The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on 13Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event pain was recovering, and backache was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Amnesia, Anaphylactic reaction, Blood test, Fatigue, Headache, Insomnia
SMQs:, Anaphylactic reaction (narrow), Taste and smell disorders (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina attack; Asthma
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101258920

Write-up: Tired every day; Could not sleep properly; Head pain; Lost of memory; Lost of taste; Anaphylaxis; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109221439081110-O62BH, Safety Report Unique Identifier is GB-MHRA-ADR 25979405. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Aug2021 (Lot Number: FE3380, Expiry date not reported) as dose 1, single for COVID-19 immunization. Medical history included angina pectoris (angina attack) and asthma. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced anaphylaxis on 14Sep2021 with outcome of recovered with sequelae on an unspecified date, tired every day on an unspecified date with outcome of unknown, could not sleep properly on an unspecified date with outcome of unknown, head pain on an unspecified date with outcome of unknown, lost of memory on an unspecified date with outcome of unknown, and lost of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Therapeutic measure was taken as a result of anaphylaxis that included Epipen. The events were assessed as serious, hospitalization, medically significant, and life threatening. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743077 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Auscultation, Body temperature, Cough, Dyspnoea, Feeling hot, Pharyngeal stenosis, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Infective pneumonia (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative (Currently being treated with AZANIN and HUMIRA.)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Auscultation; Result Unstructured Data: Test Result:Pharyngeal stenosis sound; Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101207322

Write-up: Anaphylaxis; Pharyngeal stenosis sound; Hot feeling generalised; Pharynx closed sensation of; Dyspnoea exacerbated; cough/cough aggravated; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126781. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF9942, Expiration date: 30Nov2021) via an intramuscular route of administration on 14Sep2021 at 12:18 (the day of vaccination, at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade on 14Sep2021. The patient medical history included Colitis ulcerative. Patient was currently being treated with concomitant medications Azathioprine (AZANIN) and Adalimumab (HUMIRA) taken for Colitis ulcerative. The patient previously received REMICADE and experienced infusion reaction. On 14Sep2021 at 12:23 (5 minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: On 14Sep2021 around 12:18, the patient received the Comirnaty vaccination. Right after the intramuscular vaccination, the patient experienced Hot feeling generalized and Pharynx closed sensation of but she thought that was just her illusion, so she kept on observation. Then the patient slowly felt Dyspnoea exacerbated and cough appeared, so she contacted the nurse, called the doctor. During Auscultation, Pharyngeal stenosis sound was heard and BOSMIN was administrated. POLARAMINE, HYDROCORTONE, Famotidine and Rinderon treatment started. After that cough aggravated, Pharyngeal stenosis sound was heard, BOSMIN was administrated again (3 times in total). After that the symptoms relieved. The patient underwent lab tests and procedures on 14Sep2021 which included body temperature result included 36.4 Centigrade and auscultation showed Pharyngeal stenosis sound. The outcome of the events was recovered on an unspecified date in Sep2021. The reporting physician classified the event as serious (Medically significant) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Treated as Anaphylaxis, planned to consult if the patient need hospitalization. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743220 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Dysarthria, Feeling abnormal, Head discomfort, Headache, Pyrexia, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Decreased level of consciousness; Somnolence tendency; Sick feeling; Slurred speech; Low grade fever; Headache; Feeling of heaviness of head developed; This case was received via regulatory agency (Reference number: 2021TJP095737) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory agency by a physician, was received via the RA (Ref, v21126990). On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 14-Sep-2021, at 21:15, the patient received the 1st dose of this vaccine. At 21::25, feeling of heaviness of head developed. The patient was encouraged fluid intake. Headache and decreased level of consciousness were noted. At 21:30, the patient complained of slight sick feeling. The patient moved to the first aid room in a wheelchair. BP 128/91, P 84, SpO2 99 to 100%, JCS 1-1. At 21:45, OS1 was taken. The patient had headache. The patient had a severe pain in the forehead. Somnolence tendency was noted. Queasiness persisted. At 22:03, BT 37.5 degrees Celsius, BP 127/95, P 91, Sp02 100%, JCS1-1. Slurred speech persisted. At 22:05, emergency call was made. After that, blood test and computed tomography (CT) from head to pelvis were performed at the emergency outpatient department. Although there were no obvious abnormal findings, the patient was admitted the hospital because of decreased level of consciousness. The outcome of headache, decreased level of consciousness, sick feeling, somnolence tendency, slurred speech, and low grade fever 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: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19-year-old, female subject with no relevant history reported, who experienced the unexpected events of depressed level of consciousness, somnolence, feeling abnormal, dysarthria, pyrexia, headache and head discomfort. The events occurred on the same day of the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The events was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1744942 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-09-14
   Days after vaccination:224
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Sars-CoV-2 PCR test; Test Result: Negative ; Comments: nasal swab; Test Date: 20210918; Test Name: Sars-CoV-2 PCR test; Test Result: Positive ; Comments: nasal swab
CDC Split Type: BEPFIZER INC202101229903

Write-up: Lack of efficacy: PCR test positive despite being vaccinated; Lack of efficacy: PCR test positive despite being vaccinated; cough; sore throat; This is a spontaneous report from a contactable Pfizer colleague. A 51-years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM0477) via an unspecified route of administration on 02Feb2021, (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced cough and sore throat and on 18Sep2021, lack of efficacy: PCR test positive despite being vaccinated. The patient underwent lab tests and procedures which included nasal swab: negative on 13Sep2021 and nasal swab positive on 18Sep2021. Therapeutic measures were taken as a result of lack of efficacy: PCR test positive despite being vaccinated, cough, and sore throat including Colludol and Strepsil. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-09-14
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: ESPFIZER INC202101239627

Write-up: Herpes zoster; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1002612. An adult non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ET1831) via an unspecified route of administration, in left arm on 04Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Whether patient has passed COVID-19 was unknown. On 14Sep2021, the patient experienced herpes zoster. The outcome of the event was unknown. No follow up attempts possible, no further information expected.


VAERS ID: 1746507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Eye disorder
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225379

Write-up: Lips closing on one side and one eye blinking faster then the other one; Lips closing on one side and one eye blinking faster then the other one; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-EYC 00260801. Safety Report Unique Identifier GB-MHRA-ADR 25951333. A female patient of unspecified age (age also reported as 1-month) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), parenteral on 11Sep2021 (Batch/Lot Number: Ff2153) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history and concurrent conditions. The patient''s concomitant medications were not reported. The patient experienced lips closing on one side and one eye blinking faster than the other one on 14Sep2021. The patient needed to seek advice from the doctor. The event was reported as serious (medically significant). The outcome of the event was not recovered. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1746602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Lymphoma, SARS-CoV-2 test
SMQs:, Lipodystrophy (broad), Malignant lymphomas (narrow), Haematological malignant tumours (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217802

Write-up: Lymphoma; sharp pain under armpit of the injected arm; pain in left breast same side as injection; 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-202109152021389430-KEPBU, Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25948018. A 22-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Ff2153), via an unspecified route of administration, administered in arm on 13Sep2021 as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. It was stated that, on 14Sep2021, the patient was presented with lymphoma. On unspecified date in 2021, the patient experienced sharp pain under armpit of the injected arm and pain in left breast same side as injection. The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result (No - Negative COVID-19 test) on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for the event lymphoma was not recovered, at the time of report and the outcome for other events was unknown. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1746751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225178

Write-up: Perimyocarditis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109161554127380-ZKLYN, Safety Report Unique Identifier: GB-MHRA-ADR 25953794. A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 01Sep2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not on any regular medications prior to admission and 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. On 14Sep2021, the patient experienced perimyocarditis. Peri-myocarditis 2 weeks post first dose of Pfizer. The patient underwent lab tests and procedures which included Covid-19 virus test: negative (No - Negative COVID-19 test) on 15Sep2021. The reporter considered the event as serious (medically significant). The outcome of event was recovering. The report does not relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746757 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225012

Write-up: Painful arm; Headache; This is a spontaneous report from a contactable other health care professional, This report is received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161616495470-ZJOCR and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25953923. A 39-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Sep2021 (age at vaccination: 39-year-old) as single dose for COVID-19 immunisation. Patient last menstrual period date was 07Sep2021.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. On 14Sep2021, the patient experienced headache. On an unspecified date, the patient experienced painful arm. Painful arm Bad head Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on 16Sep2021. The outcome of the event headache was not resolved and event painful arm was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1746778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-14
   Days after vaccination:45
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: Abortion spontaneous, Dysmenorrhoea, Maternal exposure timing unspecified, Pain, Pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infertility; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: pregnancy; Result Unstructured Data: Test Result:14Aug2021; Comments: On the 14Aug I had a positive pregnancy test; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225130

Write-up: pain; Maternal exposure during pregnancy; Period pains; On the 14Sep I miscarried; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161855055250-MSXAA, Safety Report Unique Identifier GB-MHRA-ADR 25954887. A 32-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing Patient no longer pregnant at the time of reporting, infertility from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine Before pregnancy. Patient is not enrolled in clinical trial. Concomitant medications included folic acid 5mg taken for folic acid supplementation, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 05Jun2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced pain, maternal exposure during pregnancy, period pains. On the 14Aug I had a positive pregnancy test. Once I knew I was pregnant I told my GP about the pain I had experienced 11 days after my second dose but was told it could have been implantation bleeding. On the 14Sep I miscarried. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test and pregnancy: 14aug2021 positive pregnancy test. The outcome of the events pain and period pains was recovered and unknown for other events. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1746786 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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 INC202101225479

Write-up: asthma; Asthma aggravated; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161941456510-ICSBU, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25955000. A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Sep2021 (Lot Number: FF8222) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant nor currently breastfeeding. The patient experienced asthma on an unknown date and asthma aggravated on 14Sep2021. Events described as follows: asthma became much more difficult to control, and had to be treated with a course of steroids. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient was recovering from the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
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: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101224960

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable non-health care professional. This is report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170023524490-ATTEQ, Safety Report Unique Identifier number is GB-MHRA-ADR 25956595. A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported) via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received historical vaccine first dose of BNT162B2 as dose 1, single for COVID-19 immunization. The patient experienced swollen lymph nodes (medically significant) on 14Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test (negative covid-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event swollen lymph nodes was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746874 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-14
   Days after vaccination:62
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: Chills, Fatigue, Glossodynia, Headache, Oropharyngeal pain, Pruritus, Rash, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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 ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: rash all over; itchy; chills; sore throat; Tender tongue; Hives; Headache; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25972271) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (rash all over), PRURITUS (itchy), CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), FATIGUE (Tiredness), URTICARIA (Hives), GLOSSODYNIA (Tender tongue) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 14-Jun-2021. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On 19-Sep-2021, the patient experienced GLOSSODYNIA (Tender tongue) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (rash all over) (seriousness criterion medically significant), PRURITUS (itchy) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). On 15-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, RASH (rash all over), PRURITUS (itchy), CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), FATIGUE (Tiredness) and URTICARIA (Hives) had not resolved and GLOSSODYNIA (Tender tongue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. The patient experienced chills, headaches, tiredness - need extra sleep throughout day, sore throat, tender at vaccine insertion site.Some of these the patient thought may happen. The next part the patient have not expected. The patient have rash all over body and every night midway through sleep, the patient have woke up extremely hot. Happened every day since vaccine and rash/ hives appeared the following day after injection. Today it''s getting itchy as before it was just raised, giving the appearance of dappled skin, all over (less on face) Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This case concerns a 38-year-old male patient with medical history of Suspected COVID-19., who experienced Urticaria 2 months 2 days after, Glossodynia 2 months 6 days after, Fatigue and Headache 2 months 1 day after Oropharyngeal pain Rash, Pruritus, Chills unspecified days after first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was unknown. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 38-year-old male patient with medical history of Suspected COVID-19., who experienced Urticaria 2 months 2 days after, Glossodynia 2 months 6 days after, Fatigue and Headache 2 months 1 day after Oropharyngeal pain Rash, Pruritus, Chills unspecified days after first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was unknown. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1749148 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Feeling hot, Flushing, Hypoaesthesia, Muscle spasms, Muscle spasticity
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypersensitivity (broad), Sexual dysfunction (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Complex regional pain syndrome; Spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101226333

Write-up: Within one minute of injection, my left arm, neck, head started to feel warm, my jaw turned numb, my face started to droop, my face flushed a bright red, then all my head got numb; my left arm, neck, head started to feel warm,; my jaw turned numb; my face flushed a bright red; then all my head got numb,; started getting spasms in my arms and legs.; I started getting spasms in my arms and legs.; This is a spontaneous report received via Regulatory Authority from a contactable consumer (patient). A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: fd7204) dose 1 via an unspecified route of administration, administered in Arm Left on 14Sep2021 as dose 1, single (At the age of 52-years) for covid-19 immunisation. Medical history included spinal stenosis, complex regional pain syndrome both from an unknown date and unknown if ongoing. Concomitant medications included nabilone, hydrochlorothiazide (APO HYDRO) both taken for an unspecified indication from an unspecified start date and ongoing. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Sep2021 15:00, the patient experienced within one minute of injection, my left arm, neck, head started to feel warm, my jaw turned numb, my face started to droop, my face flushed a bright red, then all my head got numb, started getting spasms in my arms and legs. The intensity went down after 15 minutes but the numbness and spasms were present for 48hrs. Events required Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse event. The outcome of the event was recovered on an unspecified date. No follow up attempts are possible. No further information is expected.


VAERS ID: 1749150 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Dyspnoea, Headache, Heart rate, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OZEMPIC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Heart rate; Result Unstructured Data: Test Result:140-150
CDC Split Type: CAPFIZER INC202101227241

Write-up: Heart rate 140-150; Hard to breathe; dizzy; Headache; cold sweats; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 13Sep2021 (at the age of 37-years-old) at dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Prior to vaccination, she was not diagnosed with COVID-19. Concomitant medications included semaglutide (OZEMPIC) and birth control pill. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 22Aug2021 (at the age of 37-years-old) at dose 1, single for COVID-19 immunisation. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Since the vaccination, she has not been tested for COVID-19. On 14Sep2021, the patient experienced heart rate of 140-150. Her heart rate went up if she exerted any energy. She also reported that it was hard to breathe, she was dizzy, and experienced headache and cold sweats. The events required emergency room/department or urgent care visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event heart rate increased and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1749202 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-14
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002620 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: DEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: DE-PEI-202100189730) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VENTRICULAR FIBRILLATION in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced VENTRICULAR FIBRILLATION (seriousness criterion medically significant). At the time of the report, VENTRICULAR FIBRILLATION had resolved with sequelae. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of ventricular fibrillation.. The events occurred approximately 3 months and 5 days after the second dose of Spikevax. The rechallenge was unknown since no information about 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 22-Sep-2021: Translation received on 27-SEP-2021 as live follow up contained no new information.; Sender''s Comments: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of ventricular fibrillation.. The events occurred approximately 3 months and 5 days after the second dose of Spikevax. The rechallenge was unknown since no information about 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: 1750917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-14
   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 FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder, Menstruation irregular, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Gave birth on 17Ju2021)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225404

Write-up: bleeding/ Sudden onset of period; breastfeeding; Breastfeeding; Irregular periods; This is a spontaneous report from a contactable consumer (patient). This report was received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160939113690-LMOQL. Safety Report Unique Identifier GB-MHRA-ADR 25951337. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Aug2021 (Lot Number: FE3380) as dose 1, single for COVID-19 immunisation. The patient medical history included pregnancy (gave birth on 17Jul2021) and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at the time of the report and not enrolled in clinical trial. The patient experienced bleeding/ Sudden onset of period on an unspecified date with outcome of recovering and irregular periods on 14Sep2021 with outcome of not recovered. The events were reported as serious and medically significant. The patient is also breastfeeding. The patient underwent lab tests and procedures which included Covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course was reported as follows: Sudden onset of period which should not have happen and very unusual. Gave birth 17th July, bleeding stopped beginning of September and all of a sudden I experience a period despite Breastfeeding entirely. I had 2 previous children entirely BF and never experienced a period until 9 month in. Adverse reaction did not occur as result of an exposure during pregnancy. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1750926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   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 FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Heart rate, Heart rate increased, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:155 bpm; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225252

Write-up: dizzy; heart rate/heart rate was very fast; Chest pain; Palpitations; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161206224010-W4DMY. Safety Report Unique Identifier GB-MHRA-ADR 25952203. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Sep2021 (Lot Number: FF2153) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced dizzy on an unspecified date with outcome of recovering, heart rate/heart rate was very fast on 14Sep2021 with outcome of not recovered, chest pain on 14Sep2021 with outcome of not recovered, palpitations on 14Sep2021 with outcome of not recovered. The patient was hospitalized due to the events. The patient underwent lab tests and procedures which included heart rate: 155 bpm on an unspecified date, Covid-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). Therapeutic measures were taken as result of the events of heart rate/heart rate was very fast and palpitations. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as serious caused hospitalization and medically significant. The clinical course was reported as follows: I woke up and my heart rate was very fast, then I went dizzy and called ambulance. In the ER I had resting heart rate of 155bpm non stop, my heart remained elevated for 12 hours and they gave me medication to help slow it down a little. It is still fast now. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750961 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Lymphadenopathy, Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Date: 20210915; Test Name: temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: GBPFIZER INC202101226587

Write-up: Swollen glands; nauseous; unwell; High temperature/raised temperature to 37.3 c; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170901133130-CKGEC. Safety Report Unique Identifier GB-MHRA-ADR 25957738. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 14Sep2021 (at the age of 12 years old) (Lot Number: FF8222) as dose 1, single for COVID-19 immunization. Medical history included suspected COVID-19 from 24Jul2021 to 01Aug2021. The patient''s concomitant medications were not reported. On 14Sep2021, the patient experienced sore and painful arm pretty much straight away and continued the following day. On 15Sep2021, the patient felt unwell, had high temperature/raised temperature to 37.3 c, painful to move arm that had vaccine, felt nauseous after eating evening meal. On 17Sep2021, arm was less sore but gland under left arm (vaccinated arm) was swollen and sore. The outcome of the event painful arm was recovering, the outcome of unwell, and nausea was unknown. The outcome of high temperature was recovered on 16Sep2021. The outcome of swollen glands was not recovered. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included positive COVID-19 test on 24Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226538

Write-up: Swollen lymph nodes; painful lymph nodes; Off-label use; booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171659456100-TCQY0, Safety Report Unique Identifier GB-MHRA-ADR 25960228. A 42-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE3380) via an unspecified route of administration, on 14Sep2021 as DOSE 3a (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history included suspected covid-19 from 26Mar2020 to 18Apr2020. The patient''s concomitant medications were not reported. The patient''s historical vaccine included the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) both doses via an unspecified route of administration, on an unspecified date as dose 1, dose 2 single for covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient experienced swollen lymph nodes, painful lymph nodes on 16Sep2021; off-label use and booster on 14Sep2021. Clinical information included swollen, painful lymph nodes from ear to clavicle. The patient underwent lab tests and procedures which included sars-cov-2 test/ COVID-19 virus test was negative (no - negative covid-19 test) on 10Sep2021. Outcome of the events swollen lymph nodes, painful lymph nodes was not recovered. No follow up attempts are needed. No further information is expected.


VAERS ID: 1751089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Headache, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226528

Write-up: Stomach cramps; Swollen lymph nodes; Dizziness; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109172150263000-DNMTX. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25961701. A 23-year-old non pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection), via an unspecified route of administration on 13Sep2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, via an unspecified route of administration on unknown date for COVID-19 immunisation. The patient experienced stomach cramps on 15Sep2021, swollen lymph nodes, dizziness and headache on 14Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. All events are medically significant. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative 14Sep2021, No - Negative COVID-19 test. The outcome of the event swollen lymph nodes was recovered with sequel and not recovered for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Psychotic disorder, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101227124

Write-up: Psychosis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109190142330620-CIMFT. Safety Report Unique Identifier GB-MHRA-ADR 25965302. A 23-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced psychosis on 14Sep2021 with outcome of recovered with sequel. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Seriousness criteria of the event was reported as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1751468 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-14
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Immune thrombocytopenia, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alopecia areata
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Platelet count; Result Unstructured Data: 3000
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Recurrence of idiopathic thrombocytopenic purpura; This case was received via regulatory authority on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a physician via a medical representative. On 15-Sep-2021, follow-up information was reported by a physician via a medical representative. The patient was diagnosed with idiopathic thrombocytopenic purpura (in 2013) and received a treatment with corticosteroids (9 month in total until 2014), and remission of the disease had been maintained with no treatment after that. On 29-Jul-2021, the patient received the 1st dose of the vaccine. On 26-Aug-2021, the patient received the 2nd dose of the vaccine. On 14-Sep-2021, the patient had purpura, and the result of a blood test showed platelet counts with a low level of 3,000. Idiopathic thrombocytopenic purpura relapsed. On 15-Sep-2021, the patient was admitted to the reporting hospital. PSL: 1 mg/kg + intravenous injection of immunoglobulin (IVIG) was started. Subsequently, an increase in platelet counts was confirmed. The outcome of recurrence of idiopathic thrombocytopenic purpura was reported as unknown. Follow-up investigation will be made. Follow-up received on 15-SEP-2021 Updated: Patient Information, Other Relevant History, Product Information, Event Information, Narrative, Reporter Comments Company Comment: This case concerns a 30-year-old, female patient with relevant medical history of idiopathic thrombocytopenic purpura, who experienced the unexpected event of idiopathic thrombocytopenic purpura. The event idiopathic thrombocytopenic purpura occurred 19 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The medical history of idiopathic thrombocytopenic purpura remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: This vaccine is the suspect product. The patient received no other new medications or developed concurrent infection. Sender''s comments: Although the event "immune thrombocytopenia" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions may have also had an influence.; Sender''s Comments: This case concerns a 30-year-old, female patient with relevant medical history of idiopathic thrombocytopenic purpura, who experienced the unexpected event of idiopathic thrombocytopenic purpura. The event idiopathic thrombocytopenic purpura occurred 19 days after the second dose of mRNA-1273 vaccine administration.The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The medical history of idiopathic thrombocytopenic purpura remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751475 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Hypertensive emergency, Peripheral coldness
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypoglycaemia (broad)

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

Write-up: Suspected hypertensive emergency; Cold feeling of fingers; Sweating on the trunk; This case was received via regulatory authority (Reference number: 2021TJP095149) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the RA (Ref, v21127834). Suspected hypertensive emergency was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 14-Sep-2021, at 10:00, the patient received the 1st dose of this vaccine. At 10:15, the patient had cold sweat and cold feeling of the fingers. The patient was awake and alert. Blood pressure 155/93 mmHg, pulse rate 93/min, and SpO2 99% during bed rest. Hypertensive emergency was suspected. At 10:35, cold sweat improved. Although blood pressure improved to 138/93 mmHg, it was usually high. At 11:05, cold feeling of fingers resolved. At 11:45, the symptoms were resolving. Blood pressure improved to 117/75. The patient recovered and left the room walking without assistance. The outcome of suspected hypertensive emergency, cold feeling of fingers, and sweating on the trunk 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.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of hypertensive emergency. The event occurred approximately 15 minutes after the first dose of Moderna COVID-19 Vaccine. The patient had cold sweat and cold feeling of the fingers and blood pressure 155/93 mmHg with pulse rate 93/min. The event resolved after half an hour. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in source document.


VAERS ID: 1751476 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brugada syndrome
SMQs:, Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow)

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

Write-up: This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP095741) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Agency (RA) by an administrator, was received via the RA (Ref, v21126974). On 16-Aug-2021, the patient received the 1st dose of the vaccine. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 13-Sep-2021, in the afternoon, the patient received the 2nd dose of the vaccine. At night, pyrexia occurred. On 14-Sep-2021, in the early evening, the patient suddenly lost consciousness and was transported to hospital by ambulance. In ambulance, the patient suffered cardiopulmonary arrest and was hospitalized. On 15-Sep-2021, the patient had been treated in ICU. The patient was told by a physician that there was a possibility of Brugada syndrome. The outcome of Brugada syndrome was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 26 year-old male with no medical history provided, who experienced the unexpected event of Brugada syndrome, This event started the night after the second dose of COVID-19 vaccine mRNA.The event was considered related to the study drug per the reporter''s assessment.The benefit-risk relationship of COVID-19 vaccine mRNA in not affected by this report


VAERS ID: 1751491 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nasal stuffiness; Sputum
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Bronchial asthma; Anaphylaxis; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP097654 ) on 22-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0021836), and this case, initially reported to the RA by a physician, was received via the RA (Ref, v21127529). On 17-Aug-2021, at 14:00, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.6 degrees Celsius. On 14-Sep-2021, at 14:27, the patient received the 2nd dose of this vaccine. At 14:40, the patient complained of feels poorly in the waiting room after vaccination and moved to the treatment room. The patient''s symptoms developed suddenly with rapid progression. Blood pressure was 144/80 and SPO2 was 91 to 92%. Because wheezing was noted in both breasts, administration of 2 L/min of oxygen was started. SPO2 improved to 98%. The blood pressure was good at 134/90, but the patient had persistent dyspnoea and wheezing in both breasts; thus, the patient was considered to have anaphylaxis. At 15:08, adrenaline 0.3 mg was injected intramuscularly into the right thigh, and dyspnoea tended to improve. However, wheezing persisted in the chest, and the patient was admitted to the hospital for treatment after drip infusion of hydrocortisone 100 mg. Mild dyspnea and wheezing persisted after admission. On 15-Sep-2021, at 00:20, intramuscular injection of adrenaline 0.3 mg was added. The patient''s wheezing was then diagnosed as a condition of bronchial asthma. Inhaled steroid was started, and the symptoms gradually improved. On 21-Sep-2021, since the patient''s symptoms improved, the patient was discharged from the hospital. The patient was scheduled to be an outpatient at the department of respiratory medicine. The outcome of anaphylaxis and bronchial asthma was reported as resolving. 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.; Sender''s Comments: This case concerns a 20-year-old, male patient with medical history nasal stuffiness, who experienced the unexpected event of Asthma and expected event of Anaphylactic reaction. The events occurred the same day as the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter''s assessment. The event of Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1751492 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005699 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

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

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP097754) on 22-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21127426). Anaphylaxis was assessed as serious. On an unknown date, the patient received the 1st dose of the vaccine. On 14-Sep-2021, at 15:27, the patient received the 2nd dose of the vaccine. At 16:21, anaphylaxis developed. Rash appeared on both legs. About 80 minutes after the vaccination, abdominal pain, and discomfort and swelling of pharyngeal mucosa developed, and methylprednisolone sodium succinate 125 mg and d-chlorpheniramine maleate were administered intravenously. After the vaccination, symptoms were resolving and eventually resolved. A little over 2 hours after the vaccination, the patient returned home. The outcome of anaphylaxis was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 24-year-old, female patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day (54mins) after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1752911 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-09-14
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; Swollen arm; Throbbing headache; Fever; Fatigue; This case was received via RA (Reference number: RA-ADR 25976603) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Throbbing headache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Throbbing headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 15-Sep-2021, TREMOR (Shaking) had resolved. On 16-Sep-2021, PERIPHERAL SWELLING (Swollen arm), HEADACHE (Throbbing headache) and PYREXIA (Fever) had resolved. On 17-Sep-2021, FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient experienced uncontrollable shaking about 5 hours after the vaccine and could barely walk and had intense fever, painful sore arm. The next day patient fatigued, slept all day with fever. Company Comment : This case concerns a 29-year-old, female patient with no reported medical history. Reportedly, the second dose of the vaccine was given 2 months and 25 days after the first dose which is considered to be Inappropriate schedule of product administration. The patient experienced serious (Medically significant) events Pain in extremity, Gait disturbance, Tremor, Peripheral swelling, Headache, Pyrexia and Fatigue during the same day after the second dose of Moderna CoviD-19 Vaccine. The outcome of events was recovered, except for the events of Pain in extremity and Gait disturbance for which the outcome was not specified. Causality was not provided by reporter. Although the action taken was captured as per RA source document, the patient experienced AEs after the second dose, therefore the rechallenge is not applicable. The company causality for the Inappropriate schedule of product administration is not applicable. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, female patient with no reported medical history. Reportedly, the second dose of the vaccine was given 2 months and 25 days after the first dose which is considered to be Inappropriate schedule of product administration. The patient experienced serious (Medically significant) events Pain in extremity, Gait disturbance, Tremor, Peripheral swelling, Headache, Pyrexia and Fatigue during the same day after the second dose of Moderna CoviD-19 Vaccine. The outcome of events was recovered, except for the events of Pain in extremity and Gait disturbance for which the outcome was not specified. Causality was not provided by reporter. Although the action taken was captured as per RA source document, the patient experienced AEs after the second dose, therefore the rechallenge is not applicable. The company causality for the Inappropriate schedule of product administration is not applicable. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1752974 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash; Itching; Redness; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itching) and ERYTHEMA (Redness) in a 32-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, RASH (Rash), PRURITUS (Itching) and ERYTHEMA (Redness) had not resolved. No Concomitant medications was provided. No Treatment medications was provided. Company Comment: This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of rash, pruritus and erythema. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of rash, pruritus and erythema. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1755083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   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: Glossodynia, Internal haemorrhage, Mouth ulceration, SARS-CoV-2 test, Tongue disorder
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: C-section (I had a baby by c section 10 weeks ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210918; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233710

Write-up: internal mouth; painful bump has appeared on side of tongue; Sore under tongue and on top as well.; Mouth ulcer; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109192051410200-7OWXK. Safety Report Unique Identifier GB-MHRA-ADR 25966312. A 35-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. Medical history included caesarean section (patient had a baby by c section 10 weeks ago). Patient had no symptoms associated with COVID-19. Concomitant medications were not reported. Patient previously received bnt162b2 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced internal mouth, painful bump had appeared on side of tongue and sore under tongue and on top as well. On 14Sep2021, the patient experienced mouth ulcer. Patient reported that all of her inner lips and gums had gone red raw. Now a painful bump had appeared on side of tongue. Sore under tongue and on top as well. Her whole internal mouth was sore. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no- negative covid-19 test on 18Sep2021.The outcome of the event (internal mouth, painful bump has appeared on side of tongue and sore under tongue and on top as well) was unknown and event (mouth ulcer) was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1755392 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-09-14
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; Benign prostatic hypertrophy; Cachexia; Cholelithiasis; Cognitive deterioration; COPD; Hernia inguinal; Hypopotassaemia; Osteoarthrosis; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101239735

Write-up: positive molecular test; vaccination failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the REGULATORY AUTHORITYWEB:IT-MINISAL02-787391. A 84-year-old elderly male patient received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number: EK9788 and expiry date: 31May2021), via an intramuscular route of administration at right shoulder, on 29Jan2021, as a dose 1, 0.3ml single (booster dose 1) for COVID-19 immunization and received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number: EP9598 and expiry date: 30Jun2021), via an intramuscular route of administration at right shoulder, on 22feb2021, as a dose 2, 0.3ml single (booster dose 2) for COVID-19 immunization. The patient''s medical history includes hypopotassaemia, cholelithiasis, COPD, cachexia, benign prostatic hypertrophy, vascular encephalopathy, cognitive deterioration, hernia inguinal, acute on chronic renal failure and osteoarthrosis. The patient concomitant medications was not reported. On 14Sep2021, the patient had positive molecular test and vaccination failure. The patient hospitalized due to positive molecular test. The hospitalization details were unspecified. Reportedly on 14Sep2021, the patient had laboratory test COVID-19 PCR test and result was positive. Reportedly at emergency room visit the patient received therapy: perfalgan intravenous 12 vial 100ml10mg / ml, sodium chloride Fresenius Kabi Italia 0.9 percent 500ml, ringer acetate intravenous 10 vial 500ml. Outcome was not recovered for the event positive molecular test. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788 (Dose 1) and lot EP9598 (Dose 2). 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1756465 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Injection site cellulitis, Injection site erythema, Lymphadenopathy, Malaise, Sepsis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (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: ZAPFIZER INC202101249848

Write-up: Large lump in my armpit; Painfail and the arm was warm to the touch; I felt unwell; Cellulitis at injection site; Blood poisoning at the injection site; A bit red at injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Vaccine Helpline. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took off the cotton wool and strip that patient had placed on the needle prick on the night of 14Sep2021. The patient noticed that it was a bit red and thought it was normal. On 15Sep2021, it was more red and it had got worse. On 17Sep2021 morning. the patient had a large lump in armpit that felt like an extra breast. It was very painfail and the arm was warm to the touch and patient felt unwell. The patient saw doctor and was informed by doctor that patient got blood poisoning at the injection site and also mentioned cellulitis. The patient was also told by doctor that patient would have ended up in hospital if patient had to wait another day to see him. Patient reported that patient was extremely upset and had to get antibiotics for the problem which patient has not expected. Patient''s arm still looked sore after 3 days of antibiotics and the site was now turning brown. The patient received treatment for the events. The outcome of the event malaise was unknown and the outcome of other events was not recovered. No further information was available at the time of this report


VAERS ID: 1757810 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hyperpyrexia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Body temperature; Result Unstructured Data: over 38 degrees
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-788505) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214024) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Asthma and Psoriasis. On 14-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), DYSPNOEA and MYALGIA at the time of the report, HYPERPYREXIA, DYSPNOEA and MYALGIA had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: over 38 (High) over 38 degrees. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information was provided. It was reported that report relating to Moderna vaccine of 14 SEP 2021 with fever in the evening, over 38 degrees, myalgia in the arms, legs and joints, mild dyspnea the following day and fever, muscle pain. It was reported that the patient had asthma and psoriasis. Company comment: This case concerns a 46-year-old, female patient with relevant medical history of asthma, who experienced the serious unexpected event of Hyperpyrexia, non-serious unexpected event of dyspnoea and non-serious expected event of myalgia. The events occurred the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The medical history of asthma remains a confounder. The event Myalgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report. Asthma and Psoriasis are requested to be added in other relevant history. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-SEP-2021 included updated Reaction/event asreported by primary source, lab data added, updated Reporter''s comments and updated Narrative.; Sender''s Comments: This case concerns a 46-year-old, female patient with relevant medical history of asthma, who experienced the serious unexpected event of Hyperpyrexia, non-serious unexpected event of dyspnoea and non-serious expected event of myalgia. The events occurred the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The medical history of asthma remains a confounder. The event Myalgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report. Asthma and Psoriasis are requested to be added in other relevant history.


VAERS ID: 1757814 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Oestrone
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: ; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-788670) 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 TACHYCARDIA in a 19-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Oestrone. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced TACHYCARDIA (seriousness criterion medically significant). On 14-Sep-2021, TACHYCARDIA had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by reporter. Treatment information was not provided Patient was suspected TPSV Tachycardia the day after the administration of modern a vaccine. Patient was admitted to the emergency room, symptoms in remission . Company comment:: This case concerns a 19 year old female patient with no relevant medical history, who experienced the unexpected event of tachycardia. The event occurred approximately1 day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-2021 as live follow up and updated with event verbatim and Reporter''s comments; Sender''s Comments: This case concerns a 19 year old female patient with no relevant medical history, who experienced the unexpected event of tachycardia. The event occurred approximately1 day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1758290 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
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: 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: 20210914; Test Name: Cardiac troponin T; Result Unstructured Data: 352 nanogram per litre
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: PERIMYOCARDITIS; This case was received via Regulatory Authority (Reference number: E2B_00051163) 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 (PERIMYOCARDITIS) in a 22-year-old male patient who received mRNA-1273 for COVID-19 vaccination. Previously administered products included for Vaccination: mRNA-1273 (Substance / Specified Substance Name - 5''capped mRNA encoding full length SARS-CoV-2 spike protein). On 11-Sep-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced MYOCARDITIS (PERIMYOCARDITIS) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (PERIMYOCARDITIS) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Troponin T: abnormal (abnormal) 352 nanogram per litre. For mRNA-1273 (Intramuscular), the reporter considered MYOCARDITIS (PERIMYOCARDITIS) to be possibly related. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The event of Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received. Translation done on reporter comment, Additional information on drug and dosage form.; Sender''s Comments: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The event of Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1758332 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   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: Abdominal pain, Chills, Palpitations, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Endometriosis
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder operation; Migraine (As a previous suspected adverse reaction of the vaccine against German measles.); Removal of wisdom teeth
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: ABDOMINAL PAIN; PALPITATIONS; FEBER; CHILLS; This case was received via regulatory authority (Reference number: SE-MPA-2021-084178) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (ABDOMINAL PAIN), PALPITATIONS (PALPITATIONS), PYREXIA (FEBER) and CHILLS (CHILLS) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Migraine (As a previous suspected adverse reaction of the vaccine against German measles.), Removal of wisdom teeth and Gallbladder operation in 2020. Concurrent medical conditions included Endometriosis. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced ABDOMINAL PAIN (ABDOMINAL PAIN) (seriousness criterion hospitalization), PALPITATIONS (PALPITATIONS) (seriousness criterion hospitalization), PYREXIA (FEBER) (seriousness criterion hospitalization) and CHILLS (CHILLS) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL PAIN (ABDOMINAL PAIN), PALPITATIONS (PALPITATIONS) and CHILLS (CHILLS) was resolving and PYREXIA (FEBER) had not resolved. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Company comment: This case concerns a 40-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of ABDOMINAL PAIN, PALPITATIONS, PYREXIA and CHILLS. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. 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 document received 29-SEP-2021 has information on dose number.; Sender''s Comments: This case concerns a 40-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of ABDOMINAL PAIN, PALPITATIONS, PYREXIA and CHILLS. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1759844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pain in extremity
SMQs:, Termination of pregnancy and risk of abortion (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: AUPFIZER INC202101243037

Write-up: Abortion spontaneous; Pain in extremity; This is a spontaneous report from a contactable healthcare professional via the regulatory authority. Regulatory authority report number is 624153. A 41-year-old female patient received BNT162b2 (Comirnaty reported as Comirnaty COVID-19 vaccine (BNT162b2 (mRNA)), via an unspecified route of administration on 07Sep2021 (batch/lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced abortion spontaneous and pain in extremity. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animals; Atopic dermatitis; Celiac disease; Food allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101256288

Write-up: Ophthalmic herpes zoster; This is a spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number is FI-FIMEA-20214873. A 38-year-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 09Sep2021 as dose 2, single for covid-19 immunisation. Medical history included food allergy, pollen allergy, allergy to animal, coeliac disease, atopic dermatitis. The patient''s concomitant medications were not reported. On 14Sep2021 the patient experienced ophthalmic herpes zoster. Patient reported that she had an itchy red rash with small blisters appeared in the right corner of the eye. The rash spread all over the right eye and cheek. The blistering rash was really sore. Dg shingles that had time to go very close to sair. With medication, the ailment was improving but caused several on, patient was on sick leave and serious inconvenience to all activities. Vision was compromised. Therapeutic measures were taken. The outcome of event was not recovered. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1760726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Headache, Nausea, Paraesthesia, Rectal haemorrhage, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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: IBUPROFEN; KLONOPIN; LAMICTAL; MIRTAZAPINE; NORETHINDRONE ACETATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Endometriosis; Ovarian cyst; Pineal gland cyst; Seizures
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101242842

Write-up: weakness; tingling sensation; abdominal pain; Headache; Nausea; Tingling feet/hands; Rectal bleeding; Vaginal bleeding; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109200856117790-R4BBQ, Safety Report Unique Identifier GB-MHRA-ADR 25969437. A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 14Sep2021 as dose 1, single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Medical history included pineal gland cyst from an unknown date and unknown if ongoing, seizure from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, endometriosis from an unknown date and unknown if ongoing, ovarian cyst from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for dysmenorrhoea from 04Apr2020 to an unspecified stop date; clonazepam (KLONOPIN) taken for anxiety disorder from 05Jan2016 to an unspecified stop date; lamotrigine (LAMICTAL) taken for depressed mood from 03Feb2018 to an unspecified stop date; mirtazapine (MIRTAZAPINE) taken for major depression from 04Dec2020 to an unspecified stop date; norethindrone acetate (NORETHINDRONE ACETATE) taken for endometritis from 01Mar2021 to an unspecified stop date. It was reported that on an unspecified date the patient experienced weakness, tingling sensation, abdominal pain. On 14Sep2021 the patient experienced rectal bleeding, vaginal bleeding. On 17Sep2021 the patient experienced nausea, tingling feet/hands. On 18Sep2021 the patient experienced headache. The seriousness criteria of the event were medically significant. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On an unspecified date the patient underwent lab tests and procedures which included covid-19 virus test which was resulted as no - negative covid-19 test (NEGATIVE). The outcome of the events nausea and rectal bleeding was not recovered, outcome of the events weakness, tingling sensation and abdominal pain was unknown and that of the rest of the events headache, vaginal bleeding, tingling feet/hands was recovering. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1761090 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Peripheral swelling, Vasculitis
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Arthritis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211005261

Write-up: MASSIVE ARTHRALGIA OF THE LARGE JOINTS, SWELLING OVER METACARPALS; MASSIVE ARTHRALGIA OF THE LARGE JOINTS, SWELLING OVER METACARPALS; SEVERE VASCULITIS (DD) IN BOTH LOWER EXTREMITIES; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-048916) on 04-OCT-2021 and concerned a 58 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 10-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-SEP-2021, the patient experienced massive arthralgia of the large joints, swelling over metacarpals and severe vasculitis (dd) in both lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive arthralgia of the large joints, swelling over metacarpals, massive arthralgia of the large joints, swelling over metacarpals, and severe vasculitis (dd) in both lower extremities. This report was serious (Other Medically Important Condition).


VAERS ID: 1761155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
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: Palpitations, Pneumonia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244430

Write-up: Pneumonia; Palpitations; Tachycardia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627343. A 35-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on 12Sep2021 as dose number unknown, single for COVID- 19 Immunization. Medical history and concomitant medications were not reported. It was reported that on 14Sep2021 (2 days after the vaccination) patient experienced Pneumonia, Palpitations, Tachycardia. 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: 1761164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
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: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244505

Write-up: Facial paralysis; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 627360. A 42-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced facial paralysis. The outcome of the event facial paralysis was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762758 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Antibody test, Antinuclear antibody, Cardiolipin antibody, Computerised tomogram, Fall, Headache, Investigation, Ischaemic stroke, Magnetic resonance imaging head, NIH stroke scale, SARS-CoV-2 test, Ultrasound Doppler, Urine analysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEELOO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Scarring; Smoker (5 cigarettes/day); Tooth fracture; Tooth pain (due to a tooth fracture on 08Sep2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Computerized tomography angiogram; Result Unstructured Data: Test Result:No constituted ischemic or hemorrhagic lesion..; Comments: ..but presence of a right proximal M1 thrombus, with repercussions on the perfusion mapping in the right superficial sylvian territory suspicion of thrombus of the left auricle (kinetic artefacts +++); Test Date: 20210915; Test Name: Anti-B2 glycoprotein 1 antibodies; Result Unstructured Data: Test Result:in progress; Test Date: 20210915; Test Name: Antinuclear antibodies; Result Unstructured Data: Test Result:in porgress; Test Date: 20210915; Test Name: Anticardiolipin antibodies; Result Unstructured Data: Test Result:in porgress; Test Date: 20210915; Test Name: Computerized tomography; Result Unstructured Data: Test Result:No bleeding, no constitution; Test Date: 20210915; Test Name: Family investigation; Result Unstructured Data: Test Result:in porgress; Test Date: 20210914; Test Name: Magnetic resonance imaging brain; Result Unstructured Data: Test Result:Right M1 thrombus responsible..; Comments: ..for slowing downstream flow and oligemia (61 ml of parenchyma); Test Date: 20210914; Test Name: Stroke Scale; Result Unstructured Data: Test Result:0; Test Date: 20210915; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210915; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:supra-aortic trunks satisfactory; Test Date: 20210915; Test Name: tTanscranial doppler; Result Unstructured Data: Test Result:Satisfactory flow at the level of the middle..; Comments: ..cerebral arteries M1 and M2; Test Date: 20210915; Test Name: Urinalysis; Result Unstructured Data: Test Result:testing for urinary toxic substances: negative for; Comments: testing for urinary toxic substances: negative for cocaine, amphetamine, opiates and cannabis
CDC Split Type: FRPFIZER INC202101256307

Write-up: Ischemic stroke; Slight fall on the isolated bar; Temporal headaches; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-PO20214915. A 16-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), intramuscularly administered in the arm (unspecified which side) on 09Sep2021 (at the age of 16-years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included smoker (5 cigarettes/day), traces of scarring, dental pain due to a tooth fracture on 08Sep2021. Concomitant medication included ethinylestradiol, levonorgestrel (LEELOO). The patient previously took amoxicillin and experienced cutaneous intolerance. On 14Sep2021 07:00, upon wakening, the patient experienced sudden left-side body deficit without facial involvement. The patient hospitalized in the emergency department. The patient had no recent infection, no trauma, no cervical manipulation, just dental pain due to a tooth fracture on 08Sep2021. On an unspecified date, the patient reported having had right temporal headaches, pulsatile within minutes after the first symptoms. Numerical scale: 4/10, no other symptoms, Stroke scale: 0, during the transfer to imaging, recovery of the deficit of the left hand. Computerized tomography angiogram at 10:58, no constituted ischemic or hemorrhagic lesion but presence of a right proximal M1 thrombus, with repercussions on the perfusion mapping in the right superficial sylvian territory suspicion of thrombus of the left auricle (kinetic artefacts +++). Magnetic resonance imaging of the brain at 11:26: right M1 thrombus responsible for slowing downstream flow and oligemia (61 ml of parenchyma). Intravenous thrombolysis performed at 11:55. At 12:10, on the examination, the patient had slight fall on the isolated bar. Additional examinations on 15Sep2021 included testing for urinary toxic substances: negative for cocaine, amphetamine, opiates, and cannabis. Anticardiolipin antibodies (in progress), antinuclear antibodies (in progress), anti-B2 glycoprotein 1 antibodies (in progress), family investigation (in progress). COVID polymerase chain reaction test negative. Doppler ultrasound of the supra-aortic trunks satisfactory. Transcranial Doppler ultrasound: satisfactory flow at the level of the middle cerebral arteries M1 and M2. Computerized tomography follow-up: no bleeding, no constitution. The patient was diagnosed with ischemic stroke. The patient was doing well as of 15Sep2021. The outcome of event ischemic stroke was recovering while the outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1769912 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Pain in extremity
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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: This case was received via regulatory authority (Reference number: IT-MINISAL02-790322) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS, CHEST PAIN and PAIN IN EXTREMITY in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 14-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant), CHEST PAIN (seriousness criterion hospitalization) and PAIN IN EXTREMITY (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS, CHEST PAIN and PAIN IN EXTREMITY had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Patient had taken second dose on 08-Sep-2021 after 6 days patient developed chest pain, left arm pain and vaccine induced myocarditis. Company comment: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of myocarditis, chest pain and pain in extremity which required hospitalization. Myocarditis is expected event for adult patients. The events occurred approximately 6 days 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 reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain is likely the consequence of myocarditis. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation document received on 01-Oct-2021, added dose information in I-narrative.; Reporter''s Comments: Hospitalized due to finding of myocarditis induced by the covid-19 vaccine; Sender''s Comments: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of myocarditis, chest pain and pain in extremity which required hospitalization. Myocarditis is expected event for adult patients. The events occurred approximately 6 days 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 reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain is likely the consequence of myocarditis.


VAERS ID: 1769961 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Pallor
SMQs:, Dementia (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101266825

Write-up: Feels poorly; Pallor facial; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21127615. A 17-year and 2-month-old female patient received BNT162B2 (COMIRNATY; lot number: FE8206 and expiration date: 31Oct2021), via an unspecified route of administration in the upper left arm on 14Sep2021 at 14:59 (the day of vaccination), at the age of 17-year and 2-month-old, dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.3 Centigrade. The patient had no medical history, and the concomitant medications were not reported. On 14Sep2021 at about 15:10 (11 minutes after the vaccination), the patient experienced feels poorly. The clinical course of the event was as follows: About 10 minutes after the patient received the vaccine in the upper arm left, the patient complained of feels poorly. The patient had pallor facial. A drip infusion of Solita-T No.1 and an intravenous injection of Primperan was performed. On The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1770288 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / UNK - / OT

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? 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: Syncope; This case was received via regulatory authority (Reference number: ES-AEMPS-1009930) 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 SYNCOPE (Syncope) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214016) for SARS-CoV-2 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced SYNCOPE (Syncope) (seriousness criteria hospitalization and medically significant). On 17-Sep-2021, SYNCOPE (Syncope) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company comment: This case concerns an 18 year old male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred approximately 29 days after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation Received on 02-Oct-2021 which contains no new information.; Sender''s Comments: This case concerns an 18 year old male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred approximately 29 days after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1778359 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 2 - / 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: ITMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: IT-MINISAL02-791396) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for Vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Lab data included Magnetic resonance imaging heart on 22-SEP-2021,Troponin I on 15-SEP-2021. It stated that myocarditis was confirmed by cardiac MRI and symptoms occurred about 6 days after administration of second dose of the Covid vaccine. Treatment information was not provided. Company Comment: This case concerns a 17-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 6 days after the second dose of mRNA-1273 administration. The rechallenge was unknown as there''s no information available about the first dose. The patient''s age and gender remains confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Followup received on 04-oct-2021,contain no new information On 04-Oct-2021: Translation received on 07 Oct 2021 included: Event as reported by primary source has changed, added reporter''s comments in inarrative supplement and updated narrative. On 05-Oct-2021: Follow up received contain no new information.; Sender''s Comments: This case concerns a 17-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 6 days after the second dose of mRNA-1273 administration. The rechallenge was unknown as there''s no information available about the first dose. The patient''s age and gender remains confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1778385 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ITJNJFOC20211015907

Write-up: VACCINATION SITE PAIN; NAUSEA; VOMITING; This spontaneous report received from a consumer via Regulatory authority (IT-MINISAL02-794823) on 08-OCT-2021 concerned a 28 year old female of an unspecified race and ethnic origin. The patient''s weight was 63 kilograms, and height was 169 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: 21C19-02 and expiry: unknown) dose was not reported, 1 total was administered on 14-SEP-2021 for Covid-19 immunisation. No concomitant medications were reported. On 14-SEP-2021, the patient experienced vaccination site pain, nausea, vomiting, and was hospitalized (date unspecified) for an unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination site pain, nausea, and vomiting. This report was serious (Hospitalization Caused / Prolonged).; Reporter''s Comments: Previous cerebral edema. Kidney stones.


VAERS ID: 1779963 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 LA / -

Administered by: Other       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: ESPFIZER INC202101285252

Write-up: Syncope; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-1004800. A 13-years-old male patient received bnt162b2 (COMIRNATY) administered in arm left on 14Sep2021 (Lot Number: FG7898) as DOSE 2, SINGLE for covid-19 immunisation at the age of 13-years. Medical history and concomitant medications were not reported. The patient experienced syncope on 14Sep2021 with outcome of recovered on 14Sep2021. Course of the event was reported as follows: Syncope within 5 minutes of administration of the vaccine while sitting, spontaneous recovery after 4 minutes (according to the mother). No follow up attempts are possible. No further information is expected.


VAERS ID: 1783376 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-14
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004954 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, Chest discomfort, Chest pain, Echocardiogram, Ejection fraction, Electrocardiogram, Malaise, Myocarditis, Troponin T, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: C-reactive protein; Result Unstructured Data: 68 (increased) mg/mL; Test Date: 202109; Test Name: Echocardiography; Result Unstructured Data: OBS slightly decreased left ventricle function; Test Date: 202109; Test Name: Ejection fraction; Result Unstructured Data: 45 (%percent); Test Date: 202109; Test Name: EKG; Result Unstructured Data: Monstrous ST-elevations; Test Date: 202109; Test Name: Troponin T; Result Unstructured Data: 2289.3 (increased) ng/L
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Chest pressure; Chest pain; General malaise; Vomiting; Weakness; Perimyocarditis; This case was received via a regulatory authority (Reference number: DK-DKMA-ADR 25984621) 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 CHEST DISCOMFORT (Chest pressure), CHEST PAIN (Chest pain), MALAISE (General malaise), VOMITING (Vomiting), ASTHENIA (Weakness) and MYOCARDITIS (Perimyocarditis) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004954 and 3004954) for COVID-19 immunisation. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), MALAISE (General malaise) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization) and MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, CHEST DISCOMFORT (Chest pressure), CHEST PAIN (Chest pain), MALAISE (General malaise), VOMITING (Vomiting), ASTHENIA (Weakness) and MYOCARDITIS (Perimyocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, C-reactive protein: high (High) 68 (increased) mg/mL. In September 2021, Echocardiogram: abnormal (abnormal) OBS slightly decreased left ventricle function. In September 2021, Ejection fraction: 45 (abnormal) 45 (%percent). In September 2021, Electrocardiogram: abnormal (abnormal) Monstrous ST-elevations. In September 2021, Troponin T: 2289.3 (High) 2289.3 (increased) ng/L. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment history was not reported. Company Comment: This case concerns a 15 year old male with no reported medical history , who experienced expected event of myocarditis and other unexpected events of chest pain, chest pressure, weakness , asthenia and malaise . These events occurred 2 days after vaccination with the 2nd dose of mRNA-1273 (Spikevax) and 1 month and 2 days post vaccination with the 1st dose. The rechallenge for this case is not applicable. The benefit risk relationship of mRNA-1273 ( Spikevax) is not affected by this report.; Sender''s Comments: This case concerns a 15 year old male with no reported medical history , who experienced expected event of myocarditis and other unexpected events of chest pain, chest pressure, weakness , asthenia and malaise . These events occurred 2 days after vaccination with the 2nd dose of mRNA-1273 (Spikevax) and 1 month and 2 days post vaccination with the 1st dose. The rechallenge for this case is not applicable. The benefit risk relationship of mRNA-1273 ( Spikevax) is not affected by this report.


VAERS ID: 1783971 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: ITPFIZER INC202101273109

Write-up: chest pain; Hyperpyrexia 38.5; Regulatory Authority This is a non-interventional study report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-790235. An 18-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Sep2021 08:26 (Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) at the age of 18-year-old as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced chest pain and hyperpyrexia 38.5 on 14Sep2021 with outcome of not recovered. The patient went to the emergency room, through 118, on 16Sep2021, as the symptoms were worsening. At the moment, he is still hospitalized in the Cardiology Intensive Care Unit, awaiting assessment. The patient was hospitalized for chest pain and hyperpyrexia 38.5 from 16Sep2021 to an unknown date. The patient underwent lab tests and procedures which included body temperature: 38.5 centigrade on 14Sep2021. Measures Taken (tachipirina 1000 mg at home without any benefit, after 2 days contacted 118 and hospitalized in cardiology intensive care unit after triage and emergency room visit. The action taken in response to the events for bnt162b2 was not applicable. The reporter''s assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of chest pain,pyrexia. 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: 1693836 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Alopecia, Arthralgia, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (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:
CDC Split Type:

Write-up: joint pain. hair loss, diarrrhea since shot till present.


VAERS ID: 1693837 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-07-01
Onset:2021-09-13
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anticoagulant therapy, Anxiety, Blood test, Catheterisation cardiac, Chest pain, Computerised tomogram, Dizziness, Echocardiogram, Electrocardiogram, Fatigue, Feeling abnormal, Heart rate decreased, Inflammatory marker increased, Musculoskeletal chest pain, Myalgia, Oesophageal spasm, Pain in extremity, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitiman c, d.and zinc
Current Illness: Sore muscles, rib pain, chest pain, went to 1st er 3 xs and was told it was anxiety.. and espogeal spasms. Did ekg and sent him home. Never did ct or tests his dr sent him.for on his 3rd er visit...and is paying for this! 2 wks ago went to hospital and the admitted hom with severe chest pains going down arm, his Troponin level was In he 350 range. , his inflammatory markers high. Placed on heperin and antiiinflammatory iv meds. Ran Ct, cardiac catheterization, echo..ect. Found no reason for such high levels. Was released on Cardizem , with f/u this wk to cardiologist. They said it could be covid related as they have seen a few patients his age with same issue. We are extremely worried as he still feel bad and tired, muscle aches ect. Also upset he was dismissed 4 times from hospital knowing this cardiac issue are a sign yet they did not listen to him or take care of chest pain. When they did the troponin levels he was taken to Hospital. They knew these younger adults where having these symptoms and took him seriously.
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data: 29 ur old 3 wks of going in with chest pains and not being taken seriously..at hospital, tired dizzy Low pulse. Refused to do ct tests dr ordered for him 3rd time. 3rd visit, 2 wks ago, excruciating pain in chest down Arm Troponin level approx 340s. High Inflammatory makers Placed on heperin and antiiinflammatory meds CT, CARDIAC CATHETERIZATION, ECHO AND BLOOD TESTS ALL DONE. was discharged with levels high, last one was at 263. Placed on Cardizem, referred to cardiologist. Advised it could be Covid related, genetics, ect. Would like to know if they have any idea of if the heat was damaged..or chances of heart attack.. Hospital is o top of taking care of the younger adults with these sypmtoms. We are now waiting on cardio appt. To see what''s nexted.
CDC Split Type:

Write-up: I did this 3 times and it wont save....please email.


VAERS ID: 1693852 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Muscle spasms, Sleep disorder
SMQs:, Dystonia (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: Horrible men steal like cramps that woke me up at night. I don?t even get cramps anymore with my period for years. & I''m not even on my period.


VAERS ID: 1694057 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: apples
Diagnostic Lab Data:
CDC Split Type:

Write-up: broke out in a rash around his ankles, aches and pains throughout his whole body, feeling very run down


VAERS ID: 1694072 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Numbness of face, numbness of arm, swelling throat


VAERS ID: 1694075 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 RA / IM

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

Write-up: Moderna vaccine was accidently administered instead of annual flu shot. No adverse events to report at this time.


VAERS ID: 1694077 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045C21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient came in for her booster shot as she is immunocompromised. Patient completed her two dose series of the Pfizer Vaccine on dates 02/22/2021 and 03/15/2021. Patient was incorrectly administered the Moderna COVID-19 Vaccine as her 3rd shot. Patient did not report of any adverse side effects and was monitored for 16 minutes after injection.


VAERS ID: 1694079 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given immunization 1 hour beyond 6 hour puncture beyond use time frame


VAERS ID: 1694091 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Pt complained of unusual swelling around the site of the injection. Swelling was described to be the size of a baseball with redness and was warm to the touch


VAERS ID: 1694093 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: acid reflux
Preexisting Conditions: acid reflux
Allergies: no known drug allergies
Diagnostic Lab Data: Blood pressure, oxygen, pulse were monitored by ems.
CDC Split Type:

Write-up: Pt. was given vaccine and felt lightheaded and dizzy shortly after while walking to waiting area. She had a seat in the waiting area and was provided water. Shortly after having a seat she passed out. Respirations and Pulse were monitored and were normal. Approximately 30 seconds after passing out, pt. returned to consciousness. 9-1-1 was called and patient was evaluated by fire dept. and ems. Pt. was anxious about receiving the vaccine and ems confirmed that heightened anxiety may have contributed to her response.


VAERS ID: 1694107 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age, 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:
CDC Split Type:

Write-up: Patient received his first and second doses of Pfizer''s COVID vaccine in May and early June of 2021. Today, we visited Pharmacy to get his flu shot. The pharmacist administered the vaccine, then notified us she had made a mistake, and that patient received a dose of Moderna''s COVID vaccine instead of his flue shot. He is not yet experiencing an adverse reaction, however I am very concerned considering he is 12, the Moderna vaccine hasn''t been cleared for children his age, and he has already had two doses of the pfizer vaccine.


VAERS ID: 1694145 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: vaccine given at 7:45am, 7:50am developed rash/redness upper torso and head, itching. No issues with breathing. BP 165/107. P 86. R 20 Benadryl 50mg IM given at 7:52am , brought to Emergency room.


VAERS ID: 1694177 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Loss of consciousness, Vision blurred
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), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Patient experienced some blurred vision, and started to loss a bit of consciousness. Despite the fact of losing a bit of consciousness but alert and oriented times 3. Blood pressure was 101/69, Oxygen sat was sitting at 100 and the pulse rate was 78.


VAERS ID: 1694185 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038A21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Condition aggravated, Fatigue, Hypoaesthesia, Lymphadenopathy, Malaise, Paraesthesia, Small fibre neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamotrigine, Nortriptyline, Metroprolol, Digestive Enzymes, Probiotics, Ubiquinol, Multi-vitamin, B-12, Vitamin D
Current Illness: None
Preexisting Conditions: Small fiber neuropathy, abnormal EEG, venous varix with scattered white matter lesions, brisk reflexes, Hypermobile Ehlers Danlos Syndrome
Allergies: Pennicillin and NSAIDs
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Just as the first dose had done, I began developing numbness and tingling (just on the left side of injection) that began in my ear and spread toward the midline of my face and down my left arm. It was an immediate exacerbation of my small fiber neuropathy that flared for 1-2 weeks and then returned to baseline. (But when I had my first shot, it was on the right side, and it did the exact same thing, but the exacerbation never went away on that side). In the next few days after the shot, I did also have an enlarged lymph node under my left armpit and felt sick for two days and then fatigue for several more days.


VAERS ID: 1694221 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 RA / IM

Administered by: Public       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: NKA
Diagnostic Lab Data: NONE.
CDC Split Type:

Write-up: PATIENT CAME TO CLINIC TO GET VACCINE. SKILLED NURSE WENT TO VEHICLE AFTER CONSENT WAS SIGNED TO GIVE VACCINE. SN SAID" HERE TODAY FOR YOUR SECOND MODERNA VACCINE". PATIENT STATES YES. ASK FOR CARD PATIENT COULD NOT FIND. GAVE VACCINE AND THEN AFTER PATIENT FOUND CARD. PATIENT FIRST COVID DOSE WAS PFIZER NOT MODERNA. HAD BEEN 21 DAYS FROM FIRST PFIZER.


VAERS ID: 1694311 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: vasovagal syncope as well, with MMR vaccine and moderna dose one. patient still age 26 when receiving those vaccines
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none known
Diagnostic Lab Data: none applicable
CDC Split Type:

Write-up: vasovagal syncope. Occurred shortly after vaccine administration. Patient was faint, nauseous, and in a cold sweat for about 15 minutes after receiving the shot. Supplied water to the patient as requested. Patient recovered after 15 minutes and was fine with no remaining symptoms.


VAERS ID: 1694317 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Lip swelling, Odynophagia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Upper lip swelling with reported pain when swallowing. Able to swallow own secretions, no tongue swelling noted, no respiratory distress. Is positive for hives. Was treated with diphenhydramine, famotidine, dexamethasone, and intramuscular epinephrine.


VAERS ID: 1694361 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Headache, Oedema peripheral, Pyrexia, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYMLOS 80 MG S/C DAILY, DILANTIN 10 MG DAILY, VIT D 1.00MG VIT. C 1000MG
Current Illness: THYROID, BRONCHIAL ASTHMA, SYNOCITIS, OSTEOPOROSIS
Preexisting Conditions: BRONCHIAL ASTHMA, CHRONIC OSTEOPOROSIS, THYROID
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: PATIENT PRESENTED WITH A GENERALIZED "RASH", SWELLING IN THE LEFT AXILLA, FEVER, HEADACHE


VAERS ID: 1694411 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-13
Onset:2021-09-13
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066D21A / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray abnormal, Cough, Dry throat, Fatigue, Pain in extremity, Pneumonia viral, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (narrow), Dehydration (broad), COVID-19 (broad)

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

Write-up: arm soreness, very fatigued, dry throat, coughing wheezing, viral pneumonia


VAERS ID: 1694431 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: Xarelto
Current Illness: None
Preexisting Conditions: MTHFR gene
Allergies: Amoxicillin. Ceclor. Nuts. Avocado. Bananas. Latex. Azithromycin. Clindamycin. Doxycycline. Levofloxacin.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Multiple bruises on legs


VAERS ID: 1694454 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline, atenolol/hydrochlorothiazide, birth control, vitamin D.
Current Illness: Positive covid test 08/11/2021.
Preexisting Conditions: Asthma, high blood pressure
Allergies: Amoxicillin and sulfa
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain at injection site that made it painful to move left arm. Headache. Low grade fever of 99.2.


VAERS ID: 1694474 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Fever, chills, fainted x 1, dizziness, headache, vomited several times, fatigue Pt was told to stay out of class for one day and was given an appt with school nurse practitioner. Rest and fluids.


VAERS ID: 1694475 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Myalgia, Neck pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Sore arm, sore neck, chills, fever, muscle aches


VAERS ID: 1694500 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Eye movement disorder, Hyperhidrosis, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (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: Patient stated that he takes no medications
Current Illness: None
Preexisting Conditions: Patient stated that he has anxiety and is not on medications for anxiety. That he has had similar reactions when he has gone to the dentist or when he has had ingrown toe nail work done
Allergies: None
Diagnostic Lab Data: Unknown patient was transported to hospital
CDC Split Type:

Write-up: Patient was given the vaccine and afterwards parked in the post vax lot. Within two minutes of the vaccine being administered the patient''s girlfriend honked the horn for assistance. When I approached the vehicle I could see that the patient was shaking with body tremors, very pale, eyes rolled back, sweating. Episode lasted for around 10 seconds. At this time emergency services was called by scriber. Patient came to I was able to communicate and I was able to talk to him. Pulse was normal. Around 60. Cold bottle of water was placed behind the patients head while we waited for ambulance.


VAERS ID: 1694509 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Crying, Gait disturbance, Insomnia, Spinal pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin, birth control (Tri-sprintec), Vitamin D, loratadine, biotin
Current Illness: None
Preexisting Conditions: History of a spinal fusion (titanium rods) T2-L2 in 2003 for scoliosis
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I received the vaccine at 3pm and initially felt well up until 10pm where I started to get a back ache. Around 3am I was in 10/10 unbearable pain just along my entire spine. It felt as though someone had beat my spine with a baseball bat. It was very hard to walk, I took 1,000 mg of Tylenol, 800 mg of Ibuprofen, CBD oil, and 50 mg of Benadryl to try and get to sleep and relieve some of the pain. I then woke up at 7am in excruitiating pain still only along my spine. I tried to get up to use the restroom and couldn''t walk because of the pain. I was crying in the fetal position my husband actually had to lift me back up into bed. I again took all the stated medications and tried to fall back asleep. I have never had pain like this before (have a history of a spinal fusion from 2003).


VAERS ID: 1694553 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-19
Onset:2021-09-13
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CVS16241 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness: none
Preexisting Conditions: none
Allergies: None
Diagnostic Lab Data: none. I called my PCP and Pharmacy and reported symptoms and was told to go to nearest Emergency room if symptoms get worse.
CDC Split Type:

Write-up: I woke up this morning (9/13/21) and could not feel my both feet, became lightheaded and weak, had no strengths. it lasted about 30 minutes and feeling came back but I still have some tingling and numbness although better, still very weak overall. I contacted my PCP and pharmacy and was told not to get second vaccine and to go to ER if symptoms come back or get worse


VAERS ID: 1694557 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Facial spasm, Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (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: Mesalamine
Current Illness: No
Preexisting Conditions: Crohn''s disease
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: I''m having facial spasms under my Right eye. The muscle on the right side of my face is twitching involuntarily. It started around 7am this morning and has continued all morning. It''s now after 12:30 PM cst.


VAERS ID: 1694558 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 3 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Blood pressure fluctuation, Immunodeficiency, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (broad), Cardiomyopathy (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: 3/2/2021, Moderna Covid-19- High BP, 3/31/2021, Moderna Covid-19- Low BP
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt stated she had a rash on her whole body 48 hours after the injection. She took Benadryl and it went away. This was her 3rd dose of the Moderna Covid Vaccine. She states that she is immunocompromised. She did have BP issues after the first 2 doses.


VAERS ID: 1694576 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphagia, Feeling hot, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), 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), 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: AMLODIPINE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: PENCILLIN YEAST
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT RECEIVED VACCINE, AFTER 3-5 MINUTES PATIENT FELT HOT, WAS GIVEN WATER TO DRINK. PATIENT FELT SWEATY. ASKED IF PATIENT HAD OTHER SYMPTOMS. MONITORED PATIENT FOR A FEW MORE MINUTES. WHEN I WAS MONITORING HER SHE NOTIFIED US THAT SHE WAS HAVING TROUBLE SWALLOWING AND STILL FELT HOT. I THEN ADMINISTERED AN EPINEPHERINE INJECTION0.3MG DOSE INTO THE LEFT QUAD AND HAD MY TECH CALL 911. PARAMEDICS CAME AFTER 10-15 MIN. PATIENT WAS OK BUT STILL FELT AS THOUGH SHE WAS HAVING TROUBLE SWALLOWING. THE PARAMEDICS TOOK THE PATIENT TO THE HOSPITAL FOR OBSERVATION.


VAERS ID: 1694587 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted a few minutes after receiving his 2nd shot. He was seated and slumped to the floor


VAERS ID: 1694626 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Unknown       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? 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 passed out within 5 minutes of getting the vaccine. Administered ammonia inhalants to stimulate consciousness. Gave juice, water and snacks. Patient was able to stand up and leave 45 minutes after vaccine administration.


VAERS ID: 1694633 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Pyrexia, Seizure like phenomena
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (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: Fever of 103 extremely bad chills, seizure like activity


VAERS ID: 1694687 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: he got pfizer vaccine instead of moderna vaccine as his 2nd shot. Nurse called and verified the name with the patient and he informed the nurse that was his name but that was not his name. He did not have reaction to the shot, he was walking and talking fine. he did not seemed to concerned about getting the wrong dose. When I informed him of the error he responded with are they not all the same thing. I informed him that we will make a report of the error and he said ok and walked away.


VAERS ID: 1694698 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Hyperhidrosis, Vertigo
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Vestibular disorders (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: MDI asthma inhaler and loratadine.
Current Illness: None reported.
Preexisting Conditions: Asthma and seasonal allergies.
Allergies: Aspirin, pneumonia and flu vaccine.
Diagnostic Lab Data: Unknown.
CDC Split Type:

Write-up: This patient presented stating that she had an anaphylactic reaction after receiving a pneumonia vaccine. She spoke with her PCP about receiving a Janssen COVID 19 vaccine. The patient''s PCP advised her to receive the Janssen COVID vaccine. This patient went to a pharmacy and her PCP to receive a Janssen COVID vaccine. Both facilities refused to vaccinate her secondary to HX of anaphylactic reaction to the pneumonia. This facility pre-medicated this patient with 50 mg. of Benadryl PO at 11:30 AM. She developed left sided throat "tightness", diaphoresis, and vertigo at 12:20 PM. Epinephrine 0.3 mg. IM administered left thigh x one injection. 911 called. VS HR 92. RR 24. 152/88. 99% on RA. Pink color. No rash. No SOB. Patient transported to hospital at 12:40 PM.


VAERS ID: 1694706 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient received his 2nd Moderna vaccine 6 days sooner than it was due. I spoke to him and he said that he was feeling fine and that he would let me know if he had any adverse reaction.


VAERS ID: 1694732 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-03-12
Onset:2021-09-13
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Tested positive for COVID 9/13/21 after being fully vaccinated.


VAERS ID: 1694737 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ex-tobacco user, 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 RESIDES IN LONG TERM CARE FACILITY AND THEY REQUESTED A PFIZER COVID VACCINE FOR PATIENT, IT WAS ADMINISTERED AND UPON REPORTING TO IMMTRAC IT WAS DISCOVERED THAT PATIENT RECEIVED A JANSSEN VACCINE IN MARCH, PRIOR TO COMING TO THE FACILITY. NO ADVERSE EFFECTS WERE EXPERIENCED BUT NEEDED TO REPORT THIS EVENT


VAERS ID: 1694740 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

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

Write-up: Patient stated she had not received any COVID vaccinations. After she received Pfizer vaccine as documented on this report she admitted to receiving Sinopharm (2 doses) on 5/17/2021 and 6/11/2021.


VAERS ID: 1694753 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-12
Onset:2021-09-13
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Tested positive for COVID 9/13/21 after being fully vaccinated.


VAERS ID: 1694766 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-01-26
Onset:2021-09-13
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / UNK RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: No adverse event
SMQs:

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: Amlodipine Besylate 2.5 mg Oral Once Daily Metoprolol 12.5 mg tab Fosinopril Sodium 20 mg Furosemide 40 mg tab Escitalopram Oxalate 5 mg tab Vitamin D3 1000 IU Tab Ensure original (gluten-free) suspension 120ml Atorvastatin Calcium 20mg S
Current Illness: Unspecified dementia with behavioral disturbance Altered mental status, unspecified Disorientation, unspecified Dysphagia, oropharyngeal phase Muscle weakness (generalized) Need for assistance with personal care Resident?s on hospice care
Preexisting Conditions: Unspecified atrial fibrillation Secondary hypertension Acute kidney failure Anxiety disorder, unspecified Hyperlipidemia Cardiomyopathy Anemia, unspecified Nonrheumatic aortic (valve) stenosis Leakage of heart valve prosthesis, subsequent encounter Unspecified fall, subsequent encounter Urinary tract infection, site not specified Heart failure
Allergies: No known allergies/adverse reactions
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: No Adverse event noted Resident''s on hospice care


VAERS ID: 1694768 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Dizziness, Feeling hot, Hypoaesthesia, Nausea, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: TYLENOL
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: NKDA
Diagnostic Lab Data: BP TAKEN AND HR BY EMT 09/13
CDC Split Type:

Write-up: PATIENT WAS NERVOUS UPON ARRIVING. TOOK SOME CALMING DOWN AND DEEP BREATHS. GAVE THE VACCINE. PT IMMEDIATELY BECAME HOT, LIGHT HEADED, DIZZY. I TURNED ON A FAN AND GAVE WATER AS REQUESTED. BLOOD PRESSURE SEEMED TO DROP SHE WAS NAUSEATED AND HER ARM/HANDS STARTED TO GO KNUMB. GAVE IT 5-10 MINUTES THEN CALLED EMTS TO COME CHECK HER OUT BECAUSE SHE DID NOT IMPROVE. PT BEGAN TO IMPROVE JUST BEFORE EMTS ARRIVED. AT 1:25 SHE WAS RETURNED TO NORMAL AND DECLINED FURTHER CARE. PROBABLE VASOVAGAL RESPONSE ACCORDING TO EMT.


VAERS ID: 1694785 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-31
Onset:2021-09-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Seizure, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: CT scan, blood and urine tests.
CDC Split Type:

Write-up: Began having seizures on 9/13.


VAERS ID: 1694797 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Dysphagia, Hypoaesthesia oral, Inappropriate schedule of product administration
SMQs:, Neuroleptic malignant syndrome (broad), 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), Hypertension (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations: At 39 years old, on 7/11/2021 patient got her first Moderna vaccine. She states that she had tingly lips after the first dose, t
Other Medications: Lantus, Humalog, Vitamin D2, possibly promethazine and oxycodone
Current Illness: Pt stated she got Covid shortly after her first dose (first dose 7/11/21) and had surgery inbetween the time she got 1st and second dose.
Preexisting Conditions: Diabetes Type I, Asthma
Allergies: Sulfa, Cephalosporins, Vancomycin
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient stated after 1st dose she had tingly lips, but took benadryl and was fine. Gave patient her second moderna dose, she purchased and took benadryl immediately after and sat in the waiting room. We told her to wait 30 minutes . I checked on her after 15 minutes and she said she felt fine. At about 20 minutes into her waiting she started grabbing at her throat and saying she was having trouble swallowing, and that her tongue felt numb. I called 911 and the other pharmacist sat with her and checked her blood pressure (which was very elevated). EMS arrived and transported her to the hospital. She was talking, breathing, sitting up alert and awake when EMS arrived.


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