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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 230 out of 5,069

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VAERS ID: 1414925 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210635047

Write-up: VERY HIGH PULSE RATE FOR 8 HOUR; SEVERE HEADACHE FOR MORE THAN 10 HOURS; FEVER; SHIVERING AND SHAKING A LOT; MUSCLE PAIN; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-897224] concerned a 36 year old female. The patient''s weight was 64 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms in total, administered to left arm on 05-JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-JUN-2021, severe headache for more than 10 hours, shivering and shaking a lot, muscle pain, very high pulse rate for 8 hours, felt like heart was going to stop any moment, fever 39, very hot body, burning, nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very high pulse rate for 8 hour, shivering and shaking a lot, muscle pain, fever, and severe headache for more than 10 hours on 06-JUN-2021. This report was serious (Life Threatening).; Sender''s Comments: V0:20210635047-COVID-19 VACCINE AD26.COV2. S-Very high pulse rate for 8 hours, severe headache for more than 10 hours, fever, shivering and shaking a lot, muscle pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1415588 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Coma scale, Dizziness, Dyspnoea, Heart rate, Loss of consciousness, Oxygen saturation, Pupillary light reflex tests, Respiratory rate, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: PAROXETINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:105/64 mmHg; Test Name: temp; Result Unstructured Data: Test Result:36.6; Test Name: gcs; Result Unstructured Data: Test Result:15/15; Test Name: Heart rate; Result Unstructured Data: Test Result:74 bpm; Test Name: sat; Result Unstructured Data: Test Result:94; Test Name: pearl- size; Result Unstructured Data: Test Result:2; Test Name: respiratory rate; Result Unstructured Data: Test Result:22
CDC Split Type: GBPFIZER INC2021657374

Write-up: LOC; dizzy; difficult to breathe; Faint; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority report number is GB-MHRA-APPCOVID-202106051528509140-ABZIX. Safety Report Unique Identifier GB-MHRA-ADR 25426026. A 31-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW3143), via an unspecified route of administration on 05Jun2021 (at the age of 31 years old) as first dose, single for covid-19 immunisation. Medical history included anxiety depression. Concomitant medication included paroxetine hydrochloride for anxiety depression from 05Jun2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. On 05Jun2021, the patient experienced suddenly felt faint. On unspecified date, the patient experienced dizzy, difficult to breathe and LOC (loss of consciousness). The patient was transferred to observation area and laid supine. Felt dizzy and LOC for 2 seconds, recovered spontaneously. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure (bp) 105/64, heart rate 74bpm, oxygen saturation (sat) 94, respiratory rate (rr) 22, body temperature (temp) 36.6, Glasgow coma scale (gcs) 15/15 and pearl- size 2 inches. Outcome of the event faint was recovered on 05Jun2021; events dizzy and LOC was recovered on unspecified date. Outcome of the event difficult to breathe was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415589 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine, Blood pressure measurement, Body temperature, Coma scale, Dizziness, Heart rate, Investigation, Nausea, Oxygen saturation, Pallor, Skin abrasion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: crt; Result Unstructured Data: Test Result:<3; Test Name: BP; Result Unstructured Data: Test Result:110/70; Test Name: Temperature; Result Unstructured Data: Test Result:36.6; Test Name: gcs; Result Unstructured Data: Test Result:15/15; Test Name: bpm; Result Unstructured Data: Test Result:72; Test Name: rr; Result Unstructured Data: Test Result:16; Test Name: sat; Result Unstructured Data: Test Result:99
CDC Split Type: GBPFIZER INC2021657511

Write-up: Faint; felt faint/placed on bed in supine position; pale; nauseous; Graze on left elbow and knees; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-202106051819594790-YYLTT. Safety Report Unique Identifier GB-MHRA-ADR 25426288. A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (at the age of 30 years) (Batch/Lot Number: EW3143) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. On 05Jun2021, the patient felt faint and fall 4-5 min after the vaccination. The patient fainted, looks pale, nauseous and had graze on the left elbow and knees. It was mentioned that the patient was not nervous or anxious before having the vaccine. He was placed on the bed in supine position, alert and orientated. Taking sips pf fluid+ tolerating. The event fainted was assessed as serious (medically significant). Lab data includes BP 110/70, BPM 72, Sat 99, RR 16, Temperature 36.6, CRT <3 and GCS 15/15 all on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event fainted was recovered on 05Jun2021, while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear haemorrhage, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Haemorrhage terms (excl laboratory terms) (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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657808

Write-up: Ear bleeding; suspected covid-19; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050036353120-YDO3B, Safety Report Unique Identifier GB-MHRA-ADR 25424816. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jun2021 (Batch/Lot Number: ET8885) as 1st dose, single for covid-19 immunisation. Medical history was not reported. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced ear bleeding (medically significant) on 05Jun2021. It was reported patient had suspected covid-19 from 05Jun2021 and ongoing, clinical course as follows: Woke up in the middle of the night pillow was covered in blood and was checking his body and couldn''t find where it was coming from until he sat up and could feel liquid inside his ear and when he put his finger in it was blood he kept his head tilted to the left to drain out the rest of the blood and applied gauze and medical tape to apply pressure to soak up the remaining g blood seems to be stopping. Patient has not tested positive for COVID-19 since having the vaccine. details of any relevant investigations or tests conducted was None. The patient underwent lab tests and procedures which included COVID-19 virus test on unspecified date: no - negative covid-19 test. Outcome of Ear bleeding was recovering. Outcome of suspected covid-19 was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Investigation, Oxygen saturation, Respiratory rate, Syncope, Tonic convulsion, Tonic posturing, Visual acuity tests
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Test Name: BP; Result Unstructured Data: Test Result:138/78; Test Name: Temp; Result Unstructured Data: Test Result:36.6; Test Name: HR; Result Unstructured Data: Test Result:88; Test Name: AVPU; Result Unstructured Data: Test Result:A; Test Name: O2 sats; Result Unstructured Data: Test Result:99; Test Name: RR; Result Unstructured Data: Test Result:16; Test Name: Acuity score; Result Unstructured Data: Test Result:No Reply
CDC Split Type: GBPFIZER INC2021657331

Write-up: Tonic posturing; fainted; tonic seizure; This is a spontaneous report from a contactable healthcare professional received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051107542250-6XUEE. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: EW3143) as 1ST DOSE, SINGLE for COVID-19 immunisation then adrenaline [epinephrine] via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced tonic posturing, fainted, and tonic seizure on 05Jun2021. The patient underwent lab tests and procedures which included blood pressure (BP): 138/78, temp: 36.6, heart rate (HR) : 88, acuity test: no reply, AVPU: A, respiratory rate (RR) 16, O2 sats: 99. Therapeutic measures were taken as a result of the events included treatment with elevated legs. The action taken in response to the events for adrenaline [epinephrine] was unknown. Outcome of the event tonic posturing was recovered on Jun2021, while of the remaining events was recovered on 05Jun2021. The clinical course was reported as follows: Time from vaccination to onset of symptoms: 5-20 minutes. Allergic symptoms:- AIRWAY: [Not Asked]- BREATING: [Not Asked]- CIRCULATION: [Not Asked]- SKIN: [Not Asked]- GI: [Not Asked]- OTHER: [Not Asked][Not Asked]. Other symptoms: Vasovagal reaction: Severe. Cardiac rhythm disturbance: N/A. Cardiac event: N/A. Details of event: fainted and also had tonic seizure? resolved in 2 mins, no amnesia, full recollection. TREATMENT: IM adrenaline: No / Unknown (No. doses=[Not Asked]). IV fluids: No / Unknown. Oxygen: No / Unknown. Antihistamine: No / Unknown. Steroid: NO / UNKNOWN. Other: nil treatment, elevated legs and improved, advised to seek medical advice if reoccurs, declined LAS. Patient outcome: Discharged home. Past Medical History: nil. Previous allergic reactions: No details: [Not Asked]. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415876 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Lip pruritus, Skin lesion, Throat irritation, Tongue pruritus
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Gluten intolerance; Lactation decreased; Milk allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657202

Write-up: itchy lips; feel itchy lips/tongue/throat; Itchy throat; fairly uncomfortable/ Skin lesion; fairly uncomfortable/ Skin lesion; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051131395100-VJQHI, Safety Report Unique Identifier GB-MHRA-ADR 25425579. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Lot Number: Ew3143) (at the age of 30-years-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included lactation decreased, allergy, mild allergy to milk/gluten; from unknown dates and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On 05Jun2021, after about 30 minutes of having the jab, the patient started to feel itchy lips/tongue/throat, fairly uncomfortable/skin lesion (as reported), resolved within 2 hours. The events were considered serious, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was recovered on 05Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Illness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? 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 INC2021657469

Write-up: faint; dizzy; anxious; sick; Dizziness; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106051157175190-FE4EK, Safety Report Unique Identifier GB-MHRA-ADR 25425993. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (Lot Number: EW3143) as 1st dose, single on an unspecified date for covid-19 immunisation. The patient medical history was not reported. Past drug included Adrenaline. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced faint and dizzy on an unspecified date, dizziness on 05Jun2021. The outcome of faint and dizzy was unknown, dizziness was recovered on 05Jun2021. Clinical course reported as following: He felt dizzy as was very anxious and then fainted after being observed for 5 minutes. Adrenaline shot was administered. he came round and then was taken to lie on a bed. He felt sick and was going to faint again, was monitored closely. he was there for 45 minutes and the ambulance came to take him to hospital. The patient underwent lab tests and procedures included COVID-19 virus tested Negative on an unspecified date, pulse checked. Dizziness was recovered on 05Jun2021, other event outcome was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Case reported serious due to Caused hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415895 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657577

Write-up: Faint; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051402454910-KYVGE Safety Report Unique Identifier GB-MHRA-ADR 25425864. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: et8885), via an unspecified route of administration on 05Jun2021 at the age of 37-year-old as single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced faint on 05Jun2021, the event was serious per medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 05Jun2021. The outcome of event was resolved on 05Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Hypotension, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: CHLORPHENAMINE MALEATE
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:79/49; Comments: low; Test Date: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657476

Write-up: is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051423228640-MWX2A. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 04Jun2021 (batch/lot number EW3143 and expiry date unknown) as 1st dose, single for covid-19 immunization. The patient''s medical history was not reported. The patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial. Concomitant medications included chlorphenamine maleate taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced fainted. On 05Jun2021, the patient experienced low blood pressure. The reporter informed that the patient nearly fainted soon after waking up and going to brush teeth. The patient lay down for 5 minutes. Then got into bed and took blood pressure which was 79/49. The events were reported serious as other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 01Jun2021. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event low blood pressure/blood pressure which was 79/49 was not recovered, while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415905 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Head injury, Heart rate, Loss of consciousness, Oxygen saturation, SARS-CoV-2 test, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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? 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: Allergic rhinitis; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:Unknown; Test Name: pulse; Result Unstructured Data: Test Result:Unknown; Test Name: O2 sat; Result Unstructured Data: Test Result:Unknown; Test Date: 20210114; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657482

Write-up: pfizer vaccine adminstered today; Dizziness; fell head first sustaining head injuries; Blackout; Fainting; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202106051516054240-6VP7K, Safety Report Unique Identifier GB-MHRA-ADR 25426005. A 30-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jun2021 (Lot Number: Ew3143) at 30-year-old as SINGLE DOSE for covid-19 immunisation. Medical history included rhinitis allergic, patient does not take any medication for this, suspected covid-19 from 12Jan2021 to 19Jan2021. The patient''s concomitant medications were not reported. Pfizer vaccine adminstered today, patient does not recieve needles well. Patient sat down post vaccine for 2-3 minutes and then pt felt dizzy, and fainted. Pt fell to the floor and fell head first sustaining head injuries (carpet burns across forehead). Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced pfizer vaccine adminstered today (urticaria) on an unspecified date with outcome of unknown , dizziness (dizziness) on 05Jun2021 with outcome of recovering , blackout (loss of consciousness) on 05Jun2021 with outcome of recovering , fainting (syncope) on 05Jun2021 with outcome of recovering. All the events were assessed non-serious. The lab tests included yes - positive covid-19 test on 14Jan2021, blood pressure measurement: unknown on unknown date, oxygen saturation: unknown on unknown date, heart rate: unknown on unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Eye pain, Photopsia, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (narrow), Vestibular disorders (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: CO-CODAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657537

Write-up: 30pm on the 4th/ Dizziness; Flash vision/ Constant flicker/flash within my vision; Blurred vision; There is a full ache left in both eyes; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051838588050-GLGN5 Safety Report Unique Identifier GB-MHRA-ADR 25426307. A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 04Jun2021 13:30 (Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included lactation decreased and pain from unknown dates and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medication included codeine phosphate, paracetamol (CO-CODAMOL) taken for pain from 15May2021 to 31May2021. On 05Jun2021, the patient experienced flash vision and blurred vision. The clinical course was also reported as follows: The patient''s vaccine took place at 1.30 pm on 04Jun2021, upon waking up on 05Jun2021, she had a constant flicker/flash within her vision. In between flickers and flashes, her vision was very blurred. This lasted about 5-6 hours and thankfully passed around 24 hours after the vaccine had took place. There was a full ache left in both eyes but vision was restored. The patient also experienced 30pm on the 4th/dizziness (as reported) on 05Jun2021. The events were considered serious, medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event 30pm on the 4th/ dizziness was recovered on unspecified date, outcome of flash vision and blurred vision was recovering, while outcome of full ache left in both eyes was not recovered. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1415935 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Dental treatment; passed-out.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657529

Write-up: This is a spontaneous report from a contactable physician, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202106051846325830-BWEPY; safety report unique identifier: GB-MHRA-ADR 25426308). A 31-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ET8885), at the age of 31, via an unspecified route of administration, on Jun 5, 2021, single dose, for COVID-19 immunization. It was reported the patient usually passed-out after dental procedures. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient is not enrolled in a clinical trial. The patient''s concomitant medications were not reported. On Jun 5, 2021, patient experienced syncope, passed-out and was unresponsive. The clinical course was reported as follows: Patient passed-out while waiting after having Pfizer vaccine. Unresponsive for a few minutes. Recovered well. Patient has not tested positive for COVID-19 since the vaccination. The outcome of the syncope: recovering; outcome for passed-out and unresponsive: recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Headache, Pyrexia, Suspected COVID-19
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased; Comments: Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657962

Write-up: This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. A 35-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included Lactation decreased. She had not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant, was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced fever chills , backache, and headache, suspected covid-19, all on 05Jun2021 with outcome of not recovered. All events were assessed as medically significant. Patient had not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Feeling hot, Nausea, SARS-CoV-2 test, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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: FERROUS FUMARATE
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 INC2021657967

Write-up: Vomited; Drowsiness; Feeling hot; Feeling cold; Nausea; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052116424380-7KYUF, Safety Report Unique Identifier GB-MHRA-ADR 25426478. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Lot Number: EW3143) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Concomitant medication included ferrous fumarate (FERROUS FUMARATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced vomited, drowsiness, feeling hot, feeling cold, nausea, dizziness on 05Jun2021. Outcome of events was not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Case was reported as serious due to medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416030 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, 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: Test Name: BP; Result Unstructured Data: Test Result:131/81 mmHg; Test Name: HR; Result Unstructured Data: Test Result:80; Test Name: Sats; Test Result: 99 %
CDC Split Type: GBPFIZER INC2021657795

Write-up: Syncope vasovagal/fainted; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106052137173450-KVLOI. Safety Report Unique Identifier is GB-MHRA-ADR 25426501. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jun2021 (at the age of 26 years old) (Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced syncope vasovagal (medically significant) on 05Jun2021. Clinical course: Patient fainted a minute or so after administration of Pfizer Covid Vaccine, whilst under observation. Patient has not tested positive for COVID-19 since having the vaccine. Reporter considered this report was not related to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included blood pressure (BP): 131/81 mmHg on an unspecified date, heart rate (HR): 80 on an unspecified date, oxygen saturation (Sats): 99 % on an unspecified date. Outcome of the event was recovered on 05Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416037 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021657657

Write-up: This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052212172690-SIDYS. Safety Report Unique Identifier: GB-MHRA-ADR 25426543. A 31-year-old patient of an unspecified gender received BNT162B2(COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration at the age of 31 years old, on 05Jun2021 as single dose for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced syncope vasovagal on 05Jun2021. Vasovagal syncope within minutes of administration of vaccine - promptly resolved Reaction. The patient''s report did not relate to possible blood clots or low platelet counts. The outcome of the event was recovered on 05Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysuria, Erythema, Hypersensitivity, Lip swelling, Pruritus, Swelling face, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Fever; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657275

Write-up: Fainting; Painful urination; itchy/her scalp got itchy, then under her bust it got itchy; swelling/right lip started to swell; her chin was red and swollen; her chin was red and swollen; Allergic reaction; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202106052256567810-8MQPE], Safety Report Unique Identifier [GB-MHRA-ADR 25426583]. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included pyrexia and suppressed lactation, both from an unknown date and unknown if ongoing; and allergic reactions since Aug2020. The patient''s concomitant medications included cetirizine for pericoronitis. The patient experienced fainting, painful urination, itchy/her scalp got itchy, then under her bust it got itchy, swelling/right lip started to swell on an unspecified date; and allergic reaction on 05Jun2021. Therapeutic measures were taken as a result of ''swelling/right lip started to swell'' and ''her chin was swollen''. The outcome of the event ''''allergic reaction was recovering; events ''her chin was red and swollen'' was unknown; and outcome of the other events was recovered on an unspecified date. The clinical course was reported as follows: After 3 hours of the vaccine, the patient was walking in the park where her scalp got itchy, then under her bust it got itchy, her upper right lip started to swell. When she got home, she found her chin was red and swollen. She took cetirizine and ice to reduce swelling. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. She has been getting these allergic reactions since August 2020, yet to find the cause. But she had been okay since the last two months. She''s never had the chin swell up before. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416045 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUSCOPAN; IMODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Irritable bowel syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657211

Write-up: tingling sensation; allergic reaction; Allergy; mild rash on the 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-202106052359294870-V1WZU, Safety Report Unique Identifier GB-MHRA-ADR 25426622. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: EY5456) (at the age of 34-years-old) as 1st dose, single for Covid-19 immunisation. Medical history included irritable bowel syndrome and diarrhea. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included hyoscine butylbromide (BUSCOPAN) taken for irritable bowel syndrome from Apr2021 to May2021; loperamide hydrochloride (IMODIUM) taken for diarrhea from Apr2021 to May2021. The patient experienced tingling sensation, allergic reaction, allergy on 05Jun2021. The events were reported as serious (medically significant). The clinical course was reported as follows: mild allergic reaction (some tingling sensation and some mild rash on the arm). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of allergy was recovering while unknown for the other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416062 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache
SMQs:, Anaphylactic reaction (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 INC2021663853

Write-up: Cough; Head pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106061302086040-ELIWL, Safety Report Unique Identifier GB-MHRA-ADR 25427208. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Jun2021 as 1st dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced cough and head pain on 05Jun2021. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1416063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021663639

Write-up: Rash; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106061442198120-ZQA5N, Safety Report Unique Identifier GB-MHRA-ADR 25427326. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Jun2021 as 1st dose, single for COVID-19 immunization. The patient''s 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 rash on 05Jun2021. The reporter assessed the event as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test t: no - negative COVID-19 test on an unspecified date. The outcome of the event was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1416073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Herpes zoster, Influenza like illness, Photosensitivity reaction, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Hypersensitivity (broad), Opportunistic infections (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: Medical History/Concurrent Conditions: Shingles
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671285

Write-up: Shingles; headache; flu like symptoms; sensitive to light; 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-202106072346018410-DMH95, Safety Report Unique Identifier GB-MHRA-ADR 25434828. A 32-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW3143), via an unspecified route of administration on 04Jun2021 as single dose for covid-19 immunisation. Medical history included shingles from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 05Jun2021, the patient experienced headache and flu like symptoms, on 07Jun2021 the patient experienced shingles. On the second day after the vaccine patient had a headache, sensitive to light and flu like symptoms. Then on the 3rd day he developed painful shingles on his back. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event was unknown and outcome of shingles was recovered on 07Jun2021. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Urgent care center confirmed I have shingles." No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416086 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, 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: GEDAREL; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain in arm; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) for Endometriosis, IBUPROFEN for Migraine. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness). On 08-Jun-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. I was reported that the patient was not pregnant and patient was not currently breastfeeding. And patient was not sure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. It was not reported if the patient was received any corrective treatment for the event.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured Events seriousness per overall case assessment by Authority


VAERS ID: 1416116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657719

Write-up: Pain menstrual; Painful arm; This is a solicited case from the UK-MHRA Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202105310745105430-UK8UY, Safety Report Unique Identifier GB-MHRA-ADR 25426392. A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: EW3143) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patients last menstrual period date was 22May2021. Patient has not had symptoms associated with COVID-19. Patient has Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced painful arm on 05Jun2021 and pain menstrual on 18Jun2021. The events were medically significant. Very painful prolonged menstrual cramps, lasting longer than usual. Menstrual cycle was on time. The clinical outcome of the event was not recovered. The reporters assessment of the causal relationship of the events Painful arm and Pain menstrual 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 are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, there is a reasonable possibility that the events of Painful arm and Pain menstrual were related to suspect drug. 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: 1416117 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage in pregnancy, Maternal exposure during pregnancy, Morning sickness, Pain in extremity, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; IRON; PARACETAMOL; VITAMIN D 3; ANTI-D IMMUNOGLOBULIN
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia of pregnancy; Asthma (mildly asthmatic and take a reliever inhaler when needed.); Folic acid supplementation; Hay fever (quite bad hayfever but given pregnancy can''t currently take meds.); Hemorrhage in pregnancy (Bleed at 10wks, scan all fine, no cause identified); Migraine; Migraine without aura (sometimes get migraines without aura.); Miscarriage (miscarried the first at 6 weeks); Rhesus negative
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:all fine; Comments: at 8wks; Test Name: scan; Result Unstructured Data: Test Result:all fine; Comments: at 10wks; Test Name: scan; Result Unstructured Data: Test Result:both fine; Comments: at 12wks; Test Name: scan; Result Unstructured Data: Test Result:both fine; Comments: at 14wks; Test Name: scan; Result Unstructured Data: Test Result:all is fine; Comments: at 16 wks+5
CDC Split Type: GBPFIZER INC2021657570

Write-up: morning sickness; very light spotting and a scan at 16 wks+5; Patient was exposed to the vaccine Second-trimester; Pain in arm; This is a solicited report from the Regulatory Agency from a contactable consumer (patient). The regulatory authority report number is GB-MHRA-YCVM-202106021701206250-RPDYV, Safety Report Unique Identifier GB-MHRA-ADR 25426259. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 33-years-old, on 05Jun2021 (Lot Number: EW3143) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy. Patient had mildly asthmatic and took a reliever inhaler when needed. The patient also got quite bad hay fever but given pregnancy can''t currently take meds, sometimes got migraines without aura, folic acid supplementation, anaemia of pregnancy, migraine, rhesus negative, bled during pregnancy (Bleed at 10wks, scan all fine, no cause identified), miscarried the first at 6 weeks in Nov2020. Concomitant medications included folic acid taken for vitamin supplementation and pregnancy from 01Sep2020 to an unspecified stop date; iron taken for anaemia of pregnancy from 20Apr2021 to an unspecified stop date; paracetamol taken for migraine from 28May2021 to 28May2021; colecalciferol (VITAMIN D 3) taken for pregnancy from 01Sep2020 to an unspecified stop date; anti-d immunoglobulin taken for rhesus negative and bled during pregnancy from 11Jun2021 to an unspecified stop date. The patient reported she became pregnant while taking bnt162b2. The patient was 15 weeks pregnant at the onset of the event. The patient was due to deliver on 23Nov2021. The patient had pain in arm on 05Jun2021, morning sickness and very light spotting and a scan at 16 wks+5 on an unspecified date. The events were reported as serious (medically significant). The patient stated this is her second pregnancy, she miscarried the first at 6 weeks (Nov2020). Currently all is well, but ''morning'' sickness is evil. Patient was exposed to the vaccine second-trimester (13-28 weeks). Details of scans or investigations: Some spotting at 8wks, scan all fine. Bleed at 10wks, scan all fine, no cause identified. Dating scan at 12wks and reassurance scan at 14wks - both fine. Have since had 1 instance of very light spotting and a scan at 16 wks+5, all is fine. The outcome of the event pain in arm was recovered on 08Jun2021. The outcome of the other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: There is reasonable possibility that the reported event pain in extremity is related to BNT162B2 based on known safety profile of suspect product. The events morning sickness is likely due to the pregnancy while cause of spotting has been unidentified prior to vaccination. Both events are unrelated to BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1416123 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, 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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657787

Write-up: Painful periods; Painful arm; Tiredness; YELLOW CARD VACCINE MONITOR This is a non-interventional study report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-YCVM-202106051841442530-6PGUK, Safety Report Unique Identifier GB-MHRA-ADR 25426303. A 32-years-old female subject received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Lot Number: EW3143) at 32-years-old as single dose for COVID-19 immunisation. The subject medical history was not reported. The subject''s concomitant medications were not reported. The subject experienced tiredness on 05Jun2021 with outcome of not recovered, painful periods, painful arm on 06Jun2021 with outcome of not recovered. Seriousness criteria reported as medical significant. The subject underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. Subject has not had symptoms associated with COVID-19. Subject is not enrolled in clinical trial. Subject is not pregnant. Subject is not currently breastfeeding. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected; Sender''s Comments: There is a reasonable possibility that the events tiredness and painful arm were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event painful period with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1416242 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:203/105; Comments: increased; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 degrees Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: SPO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021659486

Write-up: This is a spontaneous report from a contactable physician received from the Agency. The patient was a 78-year-old female. Body temperature before vaccination was 35.4 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Jun2021 at 10:40 (the day of vaccination), at the age of 78-years-old, the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY2173, Expiration date: 31Aug2021) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. The course of the event was as follows: On 05Jun2021 at 10:52 (12 minutes after the vaccination), the patient blood pressure increased, NIFEDIPINE 5mg was orally taken. Systolic blood pressure was 203, diastolic blood pressure was 105. SPO2 was 98%. On 05Jun2021 (the day of vaccination), the outcome of the event 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. The reporting physician commented as follows: It was suspected to be the side reaction after vaccination.


VAERS ID: 1416243 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oropharyngeal discomfort, Oxygen saturation, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:119/73; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210605; Test Name: pulse; Result Unstructured Data: Test Result:80; Comments: /min; Test Date: 20210605; Test Name: SaO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021659525

Write-up: Mild respiratory failure; pharynx discomfort; This is a spontaneous report from a contactable other health care professional received from the Regulatory Agency. Regulatory authority report number is v21111937. The patient was a 57-year and 11-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade. On 05Jun2021 at 10:27 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FA5765, Expiration date: 30Sep2021) via an unspecified route of administration at a single dose (at the age of 57-years-old) for COVID-19 immunization. On 05Jun2021 at about 11:20 AM (also reported as 06Jun2021 at 12:15 (the day after vaccination)), the patient experienced mild respiratory failure and pharynx discomfort. On 06Jun2021 (as reported), the outcome of the events was recovering. The course of the event was as follows: On 05Jun2021 at about 11:20 AM, after the second vaccination, clinical observation for about 30 minutes, pharynx discomfort was strongly and medical examination. SaO2 was 98%, blood pressure 119/73, pulse rate was 80/min. Due to mild respiratory failure, the patient was given the intravenous drip of gaster 1A and POLARAMINE 1A treatment. Due to the symptoms improved, Allegra was prescribed and the patient went home. The reporting other health care professional classified the event as non-serious and assessed that the events were related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting other health care professional commented as follows: Although there was the causal relationship with vaccination, the symptoms were mild.


VAERS ID: 1416246 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oropharyngeal discomfort, Oxygen saturation, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:119/73; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: Pulse; Result Unstructured Data: Test Result:86; Comments: /min; Test Date: 20210605; Test Name: arterial oxygen saturation; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021659854

Write-up: Mild Respiratory failure; a strong sense of Pharynx discomfort; This is a spontaneous report from a contactable health professional received from the regulatory authority. Regulatory authority report number is v21111947. The patient was a 57-year and 11-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade. On 05Jun2021 at 10:27 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jun2021 at 12:15 (the day of vaccination), the patient experienced pharynx discomfort and mild Respiratory failure. On 05Jun2021 (the day of vaccination), the outcome of the events was recovering. The course of the events was as follows: Around 11:20 on June 5th (about 30 minutes after the second vaccination)-as reported, a strong sense of pharynx discomfort appeared. The test results were SaO2 98%, Blood pressure 119/73, and Pulse 86/min. Because of mild respiratory failure symptoms, patient was given for GASTER 1A and POLARAMINE1A Intravenous drip. As the symptoms were recovering, the patient went home after giving the ALLEGRA prescription. The reporting physician classified the events as non-serious and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the events were related to vaccination, and the symptoms were mild.


VAERS ID: 1416249 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Heart rate, Heart rate increased, Oxygen saturation, Palpitations, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Pyrexia; Result Unstructured Data: Test Result:37.2-37.5 Centigrade; Test Date: 20210605; Test Name: Heart rate; Result Unstructured Data: Test Result:130s; Test Date: 20210605; Test Name: Oxygen saturation; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021660799

Write-up: Dyspnoea; palpitations; pyrexia; wheezing; heart rate 130s; This is a spontaneous report from a contactable physician. The regulatory authority report number is v21111939. A 42-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration on 05Jun2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Body temperature before vaccination was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). There was no relevant medical history. Concomitant medications not reported. On 05Jun2021 at 16:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 05Jun2021 at 16:10, the patient experienced palpitations, pyrexia, wheezing, heart rate 130s and dyspnea. The course of the events was as follows: After vaccination, the patient experienced palpitations and pyrexia. After that, the patient experienced dyspnoea. Heart rate was 130s. Body temperature of pyrexia was 37.2-37.5 centigrade. The patient experienced wheezing. Oxygen saturation was kept at 98%. Solu-Cortef 100 mg was administered via intravenous. The symptom of dyspnoea slowly disappeared. After that, the patient was transported in emergency. Events'' onset date was reported as 05Jun2021 at 16:10 (10 minutes after the vaccination). The clinical outcome of dyspnea was recovered on 05Jun2021, while the outcome of palpitations, pyrexia, heart rate 130s and wheezing was unknown. The reporting physician classified the events as non-serious and assessed that the events was related to BNT162b2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: After vaccination, immediately, the patient experienced palpitations, pyrexia, and wheezing. The aggravated side effect appeared pathologically. Steroid was effective.


VAERS ID: 1416257 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Bradycardia, Computerised tomogram head, Heart rate, Presyncope, Somnolence
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: BP; Result Unstructured Data: Test Result:90/-; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: head CT; Result Unstructured Data: Test Result:no obvious abnormality; Test Date: 20210605; Test Name: Pulse; Result Unstructured Data: Test Result:50s; Comments: Bradycardia
CDC Split Type: JPPFIZER INC2021665743

Write-up: bradycardia; Vagal reaction; Somnolence; This is a spontaneous report from a contactable physician, received from the regulatory authority.. Regulatory authority report number is v21111940. The patient was a 47-year and 1-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Jun2021 at 11:10 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular as a single dose for COVID-19 immunization. On 05Jun2021 at 11:30 (20 minutes after the vaccination), the patient experienced Vagal reaction. On 05Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 05Jun2021 at 11:10, COMIRNATY 0.3ml was vaccinated in right shoulder via Intramuscular. At 11:30 during the hearing in the end of the consultation hour, Somnolence was strong, Unable to have a conversation. BP 90/-. Pulse was 50s which was considered as Bradycardia. It was judged as Vagal reaction; patient was quiet in bed. In the same day, head CT performed, but no obvious abnormality was found. After 1 hour, patient returned home after consciousness. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: not provided.


VAERS ID: 1416316 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Syncope, Vaccination site pain, Visual impairment
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), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AIDEE; CLATRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Grass allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021663107

Write-up: temporary loss of consciousness; fainting; severe malaise; severe pain at the injection site; dizziness; spots in front of the eyes; general weakness of the body; not able to function independently; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jun2021 08:45 (Batch/Lot Number: FD0932) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included seasonal grass allergy. Concomitant medications included dienogest, ethinylestradiol (AIDEE) taken for an unspecified indication from 2017 to an unspecified stop date and bilastine (CLATRA) taken for seasonal grass allergy since unknown dates. On 05Jun2021 08:55 (10 minutes after administration), the patient had severe pain at the injection site, fainting, general weakness of the body, dizziness, spots in front of the eyes, and temporary loss of consciousness. During that time, the patient was not able to function independently (apart from the lying position). The symptoms that persisted (not recovered) were severe pain in the hand at the injection site and general weakness of the body while the other symptoms (fainting, dizziness, spots in front of the eyes, and temporary loss of consciousness) lasted until 05Jun2021 19:00 (approximately 10 hours after administration). The remaining event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Exam; Result Unstructured Data: Test Result:Deep vein thrombosis
CDC Split Type: PTPFIZER INC2021699071

Write-up: This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 18May2021 (Lot Number: EW6126) as 2nd dose, 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unknown date for COVID-19 immunisation. The patient experienced deep vein thrombosis on 05Jun2021 (18 days after administration of the suspected drug (2nd inoculation)) (as reported). The event was reported as life threatening. Duration was approximately 2 days (as reported). The outcome of the event was recovering (as reported). Reporter''s comments: Other information - On 18May2021 I was vaccinated with the 2nd dose of Pfizer vaccine. On 02Jun2021 I started to feel a small muscle pain in the thigh of my left leg. On 04Jun2021 the pain intensified. On the 05Jun2021 I underwent an exam and a deep vein thrombosis was detected. No follow-up attempts needed. No further information expected.; Reporter''s Comments: Other information - On 18May2021 I was vaccinated with the 2nd dose of vaccine. On 02Jun2021 I started to feel a small muscle pain in the thigh of my left leg. On 04Jun2021 the pain intensified. On the 05Jun2021 I underwent an exam and a deep vein thrombosis was detected.


VAERS ID: 1416625 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBMODERNATX, INC.MOD20212

Write-up: shivering; Fever; Generalized aching; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), CHILLS (shivering) and PYREXIA (Fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN (Generalized aching) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Fever, at a dose of 1 dosage form. On 06-Jun-2021, PAIN (Generalized aching) and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (shivering) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced high fever of 40.2 degrees. Patient was treated with bed rest, manual cooling of patient to lower temp, followed by sleeping for several hours though the rest of the night. The patient was cooled via cold compress, fanning and removing clothing. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1416633 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Sleep disturbance
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PYREXIA (Feverish) and LYMPHADENOPATHY (Swollen glands) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Sleep disturbance and Headache. Concomitant products included PARACETAMOL from 05-Jun-2021 to an unknown date for Migraine. On 04-Jun-2021, the patient received first dose of (CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 08-Jun-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On 06-Jun-2021, PYREXIA (Feverish) had resolved. At the time of the report, MIGRAINE (Migraine) had not resolved and LYMPHADENOPATHY (Swollen glands) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with (CoviD-19 Vaccine) (Unknown) was unknown. Patient diagnosed with CFS/ME, however he has never had a headache of this type. It has built over two days, disrupted his sleep, not responded to paracetamol, and not been relieved by sleep, whereas CFS/ME headaches are relieved by paracetamol, meditation or sleep. Patient has not had symptoms associated with COVID-19; was not enrolled in clinical trial and did not test positive for COVID-19 since having the vaccine. Company comment: Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the events does seem to be non-serous (not an IME).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the events does seem to be non-serous (not an IME).


VAERS ID: 1416665 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cognitive disorder, Dizziness, Headache, Lethargy, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sinusitis, Speech disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19; Comments: Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; Sinusitis; Sore throat; Headache; Unable to properly form a sentence/Could not speak; Brain fog; Dizziness/Dizzy; zero energy; Arm very sore can''t lift; High temperature; Lethargic; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (High temperature), LETHARGY (Lethargic), DIZZINESS (Dizziness/Dizzy), SINUSITIS (Sinusitis), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), COGNITIVE DISORDER (Brain fog), SPEECH DISORDER (Unable to properly form a sentence/Could not speak), ASTHENIA (zero energy) and PAIN IN EXTREMITY (Arm very sore can''t lift) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 19-Dec-2020 to 27-Dec-2020. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion disability) and LETHARGY (Lethargic) (seriousness criterion disability). 05-Jun-2021, the patient experienced ASTHENIA (zero energy) (seriousness criterion disability) and PAIN IN EXTREMITY (Arm very sore can''t lift) (seriousness criterion disability). On 06-Jun-2021, the patient experienced DIZZINESS (Dizziness/Dizzy) (seriousness criterion disability). 06-Jun-2021, the patient experienced COGNITIVE DISORDER (Brain fog) (seriousness criterion disability). On 07-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion disability) and HEADACHE (Headache) (seriousness criterion disability). 07-Jun-2021, the patient experienced SPEECH DISORDER (Unable to properly form a sentence/Could not speak) (seriousness criterion disability). On 10-Jun-2021, the patient experienced SINUSITIS (Sinusitis) (seriousness criterion disability). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). On 07-Jun-2021, DIZZINESS (Dizziness/Dizzy) had resolved. On 10-Jun-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, NAUSEA (Nausea) and PAIN IN EXTREMITY (Arm very sore can''t lift) had resolved, PYREXIA (High temperature), LETHARGY (Lethargic), SINUSITIS (Sinusitis) and HEADACHE (Headache) had not resolved and COGNITIVE DISORDER (Brain fog), SPEECH DISORDER (Unable to properly form a sentence/Could not speak) and ASTHENIA (zero energy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided. Patient was not enrolled in clinical trial On day one the patient was lethargic, had zero energy and was unable to get out of bed. The patient''s arm very sore can not lift. On day two, the patient was lethargic, dizzy, had brain fog, was unable to properly form a sentence and had a high temperature. On day three and four, the patient had a sore lumpy swollen throat, felt like shards of glass in throat, could not speak and was lethargic and had high temperature. On day five sore throat remains however less shards of glass more just swollen, and the voice was better and had high temperature. On day six to nine, the patient was lethargic zero energy, cannot do a small task without having to lie down for 40mins and recover and had high temperature and headache. Onn day seven the patient had blocked nose ears throat and sinuses. Patient has not tested positive for COVID-19 since having the vaccine


VAERS ID: 1417450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Ear pain, Facial paralysis, Headache, Paraesthesia, Paraesthesia oral, Vaccination site warmth, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021703852

Write-up: facial paralysis; dizziness; ear pain; headache; injection site warmth; Paraesthesia; Paraesthesia oral; Vision blurred; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 564484. A 51-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown, single for COVID-19 immunization. On 05Jun2021, patient experienced dizziness, ear pain, facial paralysis, headache, injection site warmth, paraesthesia, paraesthesia oral, vision blurred. The outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1418839 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza, Influenza like illness, Irritability, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ferritin low; Headache; Lactation decreased; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20201011; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021664069

Write-up: flu like symptoms; Headache; Irritable; Flu symptoms; Slight temperature; Painful arm; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106061613060710-GCSKE. An 18-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: not known) via an unspecified route of administration on 05Jun2021 (18-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history included lactation decreased and headache. The patient also experienced regular headaches and tiredness due to having low ferritin levels. Suspected to be Coeliac or have IBS or IBD or Chronhs. Tests still ongoing to decide. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included ferrous fumarate taken for ferritin low from 01May2020. The patient experienced flu like symptoms on an unspecified date, painful arm and tiredness both on 05Jun2021, headache, irritable, flu symptoms and slight temperature all on 06Jun2021. Sore and painful arm a started a few hours after having the vaccine. Woke up the next day feeling very tired, with a headache, very irritable and still with a sore arm. Developed a slight temperature mid afternoon and experiencing flu like symptoms. Sore arm was still persisting as well as all other symptoms so took paracetamol and had been resting but still feels ''under the whether.'' The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 11Oct2020. Patient had not tested positive for COVID-19 since having the vaccine. The report was reported as serious with seriousness criteria of medically significant. The outcome of all events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1419430 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021673063

Write-up: severe itching; This is a spontaneous report from a contactable physician via Pfizer. A 55-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular on 04Jun2021 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma. The patient had unspecified concomitant medications. The patient previously received the first dose of bnt162b2 (COMIRNATY), on 14May2021 for COVID-19 immunization, with rash and itching. The patient was a 55-year-old female. The patient had a medical history of asthma. On 14May2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: WE4811, Expiration date: 31Jul2021) intramuscular for COVID-19 immunization. On 04Jun2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular for COVID-19 immunization. On 15May2021 (one day after the first dose of vaccination), asthma and itching were found, and the symptoms continued to 25May2021. On 05Jun2021 (one day after the second dose of vaccination), severe itching was found. Not recovered. Even with treatment using Steroid, both of the symptoms did not get recovered. Then the patient was introduced to the hospital. The outcome of the event was not resolved.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of pruritus. There is limited information provided in this report. This case will be reassessed once additional 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: 1437913 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood calcium normal, Blood creatine phosphokinase normal, Blood potassium normal, C-reactive protein normal, Discomfort, Electromyogram normal, Hypoaesthesia, Joint range of motion decreased, Laboratory test normal, Limb discomfort, Nerve conduction studies normal, Neuropathy peripheral, Paraesthesia, Rheumatoid factor, Vitamin B12 normal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Studies conducted June 9, 2021: Serum potassium, serum calcium, Cpk, C-reactive protein, Vitamin B12, rheumatoid factor, hematic biometrics. All within normal ranges. Medical diagnosis: June 16, 2021 Incipient Neuropathy. Treatment: CMP Forte core, every 8 hours for one month. Studies conducted June 17, 2021: Electromyography and Driving Velocity of Pelvic Limbs. Results normal.
CDC Split Type:

Write-up: 24 hours after the vaccine application I experienced a numbing sensation in my left foot. As the day passed the numbness and tingling extended to both feet. 400mg of Ibuprofen was administered every 8 hours. 48 hours after vaccination the symptoms presented not only in both feet but also in the calves. Heaviness and tingling. The discomfort continued for a week. For which indicated studies for blood and visiting medical internist. Some days it presented difficult to move both legs and tickling fingers of hands. For now medical treatment has continued for a month.


VAERS ID: 1438838 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20211005)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: scans or investigations; Result Unstructured Data: Test Result:22 weeks, had all scans and all perfect; Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021710098

Write-up: Painful arm; Maternal Exposure During Pregnancy; This is a solicited report from the contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202106051914407950-3DZYE, Safety Report Unique Identifier GB-MHRA-ADR 25469516. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 at age of 32-year-old (Lot Number: EW3143) at single dose for COVID-19 immunization. Medical history included ongoing pregnancy and estimated due date is 05Oct2021, folic acid supplementation from an unknown date and unknown if ongoing. There was no pregnancy symptoms for previous pregnancies at the time of the report. Patient did not have symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy/22 weeks and painful arm on 05Jun2021. The report was serious for being medical significant. Patient did not think vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on 02Jun2021, scans or investigations: 22 weeks, had all scans and all perfect in Jun2021. The patient had not been tested positive for COVID-19 since having the vaccine. The painful arm was resolved on 08Jun2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The causal association was assessed as possibly related to BNT162B2 based on known drug safety profile and temporal association.


VAERS ID: 1445206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Investigation, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID; ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: scans or investigations; Result Unstructured Data: Test Result:No issues; Test Date: 20201001; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021737816

Write-up: Maternal exposure during pregnancy; Fatigue; This is a solicited report from a regulatory authority from a contactable other HCP. This is a report received from a regulatory authority (RA). Regulatory authority report number is GB-MHRA-YCVM-202106191926268990-VSYDA, Safety Report Unique Identifier GB-MHRA-ADR 25504874. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 at single dose for COVID-19 immunisation. Medical history included suspected covid-19 (Unsure when symptoms started; Unsure when symptoms stopped). Patient is not enrolled in clinical trial Patient is not currently breastfeeding. Concomitant medications included pertussis vaccine (Whooping cough vaccine) in May2021 (10 days before covid vaccine) for immunisation, folic acid taken for Folic acid supplementation; aspirin [acetylsalicylic acid]. The patient experienced maternal exposure during pregnancy on an unspecified date, fatigue on 05Jun2021. Report was reported as medical significant. The patient became pregnant while taking BNT162B2. Pregnant with twins (29 weeks at time of vaccine). The patient was due to deliver on 19Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 01Oct2020, investigation: no issues on unknown date. The outcome of event fatigue was recovered on 06Jun2021. The reporter''s assessment of the causal relationship of the event the suspect product was not product at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A contributory role of the suspect drug cannot be excluded for event fatigue based on temporal association and known drug profile. The patient''s concurrent pregnancy may provide an alternate explanation. This case will be reassessed upon receipt of additional information. 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: 1445300 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021730223

Write-up: Vaccination performed in the morning of 05Jun2021. In the afternoon of the same day the mother reported a probable epileptic seizure. Asthenia; Vaccination performed in the morning of 05Jun2021. In the afternoon of the same day the mother reported a probable epileptic seizure. Asthenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number IT-MINISAL02-742413.A 15-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Jun2021 11:40 (Batch/Lot Number: FC2336) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Autism. The patient''s concomitant medications were not reported. At 18:00 hours of the same day, the mother reported the onset of a probable epileptic seizure characterized by deviation of the labial rhyme and eyelid hyperactivity lasting about 30 seconds, followed by a state of drowsiness. The seizure, resolved spontaneously, reappeared the next day at 10:00 am with the same modalities. At the present moment, asthenia persists. He does not report hyperpyrexia or other symptoms. The reporter reports that no other episodes of epilepsy have occurred besides those reported. The patient underwent a neuropsychiatric examination that did not reveal any issues. The patient was not taking medications at the time of vaccination and was not placed on any medication. He remains under observation by the specialist with scheduled follow-up visits. Outcome of events was recovering. Reporter''s comments: At 18:00 hours of the same day, the mother reported the onset of a probable epileptic seizure characterized by deviation of the labial rhyme and eyelid hyperactivity lasting about 30 seconds, followed by a state of drowsiness. The seizure, resolved spontaneously, reappeared the next day at 10:00 am with the same modalities. At the present moment, asthenia persists. He does not report hyperpyrexia or other symptoms. No follow-up attempts possible. No further information expected.; Reporter''s Comments: At 18:00 hours of the same day, the mother reported the onset of a probable epileptic seizure characterized by deviation of the labial rhyme and eyelid hyperactivity lasting about 30 seconds, followed by a state of drowsiness. The seizure, resolved spontaneously, reappeared the next day at 10:00 am with the same modalities. At the present moment, asthenia persists. He does not report hyperpyrexia or other symptoms.


VAERS ID: 1447835 (history)  
Form: Version 2.0  
Age: 1.67  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Exposure via breast milk, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal exposures via breast milk (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: Test Date: 20210615; Test Name: temperature; Result Unstructured Data: Test Result:high temperature ($g38.5)
CDC Split Type: GBPFIZER INC2021753384

Write-up: Fever/a high temperature ($g38.5); I''m breastfeeding my 20 month old daughter; This is a spontaneous report from a contactable consumer (mother reporting for her breastfeed daughter). This was the first report out of 2 reports. This report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106161211070840-LQXSY. Safety Report Unique Identifier: GB-MHRA-ADR 25484035. This is a baby case (a 20-month-old female patient). A patient''s mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), on 05Jun2021 as first dose, single for COVID-19 immunisation. The mother was breastfeeding her 20 month old daughter (patient). The patient''s medical history and concomitant medications were not reported. Patient did not test positive for COVID-19 since having the vaccine. Not sure this was related at all but wanted to report that 10 days after her vaccination (15Jun2021), she raised a high temperature ($g38.5). The patient experienced fever on 15Jun2021. The outcome of event fever was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021736349 Mother case


VAERS ID: 1455707 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Maternal exposure timing unspecified, Night sweats, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Pregnancy
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021765769

Write-up: night sweats; chills; fever; tiredness; continuous headache; Palpitations/heart pounding; Exposure during pregnancy; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106221339222030-QMCCG, Safety Report Unique Identifier is GB-MHRA-ADR 25520534. A 20-year-old pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EY5456), via an unspecified route of administration on 05Jun2021 (at the age of 20-years) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced night sweats, chills, fever, tiredness, and continuous headache; all on unspecified dates. The patient also experienced palpitations/heart pounding on 12Jun2021. These events were considered serious, medically significant. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient had negative COVID-19 virus test on unspecified date. The outcome of palpitations/heart pounding was not recovered, while for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1461569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Amniotic cavity infection, Antibody test, Blood pressure measurement, Body temperature, C-reactive protein increased, Coagulation test, Foetal death, HIV test, HTLV-1 test, HTLV-2 test, Haemoglobin, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Histology, Investigation, Maternal exposure during pregnancy, Microbiology test, Platelet count increased, Ultrasound scan, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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: In vitro fertilization
Allergies:
Diagnostic Lab Data: Test Name: anti-beta 2 GPI antibodies; Result Unstructured Data: Test Result:negative; Test Name: Anti-erythrocytic antibodies; Result Unstructured Data: Test Result:negative; Test Date: 20210606; Test Name: Blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Test Name: coagulation assessment; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:27 mg/l; Test Name: hemoglobin; Result Unstructured Data: Test Result:9.7 g/dl; Test Date: 20210606; Test Name: heart rate; Result Unstructured Data: Test Result:Normal; Test Name: Hepatitis B; Result Unstructured Data: Test Result:serology negative; Test Name: Hepatitis C; Result Unstructured Data: Test Result:serology negative; Test Name: anatomopathological examination; Result Unstructured Data: Test Result:no abnormality on fetopathological examination; Comments: of the deceased twin; Test Name: Pathological examinations of the 2 placentas; Result Unstructured Data: Test Result:presence of stage 2 chorioamnionitis; Comments: with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin; Test Name: HIV; Result Unstructured Data: Test Result:serology negative; Test Name: HTLV 1; Result Unstructured Data: Test Result:serology negative; Test Name: HTLV 2; Result Unstructured Data: Test Result:serology negative; Test Name: Anti-cardiolipid; Result Unstructured Data: Test Result:negative; Test Name: Foetopathological examination; Result Unstructured Data: Test Result:normal; Comments: male fetus, macerated, without apparent or visceral malformation detected, no dysmorphia of the face or extremities; Test Name: Bacteriology on the placenta; Result Unstructured Data: Test Result:rare leukocytes, direct negative examination; Comments: sterile culture; Test Name: Platelets; Result Unstructured Data: Test Result:254 g/l; Test Name: USG; Result Unstructured Data: Test Result:normal; Test Date: 20210521; Test Name: USG; Result Unstructured Data: Test Result:normal; Comments: 10% weight discrepancy between the 2 fetuses, which is not an anomaly in the context of twin pregnancy; Test Date: 20210606; Test Name: USG; Result Unstructured Data: Test Result:fetal death in utero of one of the 2 twins; Test Name: leukocytes; Result Unstructured Data: Test Result:10 g/l
CDC Split Type: FRPFIZER INC2021770452

Write-up: Foetal death in utero; Maternal Exposure During Pregnancy, third trimester ; Miscarriage; Chorioamnionitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [FR-AFSSAPS-TS20212485], Safety Report Unique Identifier [FR-AFSSAPS-2021078733]. A 38-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 21May2021 (Lot number: unknown) as dose 1, single for COVID-19 immunization. Medical history included in vitro fertilization. The patient''s concomitant medications were not reported. The patient previously took magnesium. The patient experienced foetal death in utero (hospitalization on unspecified date) on 06Jun2021, and miscarriage on 05Jun2021; both events resulted in emergency room visit. This mother reported her last menstrual period was on 08Nov2020 (as reported). The mother reported she became pregnant while taking bnt162b2 (Maternal Exposure During Pregnancy, third trimester). The mother was 28 weeks pregnant at the onset of the event. Course of events as follows: The patient who started a pregnancy on 22Nov2020 by in vitro fertilization (as reported). Twin chorionic, bi-amniotic twin pregnancy. Normal clinical and ultrasound course on unspecified date. Last ultrasound on 21May2021: normal. 10% weight discrepancy between the 2 fetuses, which is not an anomaly in the context of twin pregnancy. Last obstetric consultation (27May2021) normal. Emergency consultation on Saturday 05Jun2021 in the evening (D15 post-vaccine) for premature rupture of the membranes, spontaneous, without associated sign: frank rupture, clear liquid, no fever, no contraction, no other symptom. On ultrasound on 06Jun2021, fetal death in utero of one of the 2 twins (dating back several days, because signs of maceration and anamnios), good vitality of the other twin. The mother had not noticed any particular symptoms and felt her babies moving (difficulty assessing due to twin pregnancy?) On 06Jun2021, Normal blood pressure and heart rate, no fever (normal body temperature), no proteinuria. Start of amoxicillin (will not be not continued after birth). A few hours after admission, onset of contractions. Birth by cesarean on 06Jun2021 at 9:11 a.m., under cover of 2 g of cefazoline, of the first baby, alive, male, weighing 1.34 kg with normal pH then 1 minute later of the second baby, deceased, weighing 1.16 kg, with clear signs of maceration. Obstetricians noted that each child''s umbilical cords were very large and very swollen. For the living baby, however, the fluid was clear and no other peculiarities were observed. Baby hospitalized for prematurity, no infectious problem. Bacteriology on the placenta: rare leukocytes, direct negative examination, sterile culture. Biological assessment in the mother on unspecified date: CRP at 27 mg/L, normal coagulation assessment, hemoglobin 9.7 g/dL, platelets 254 G/L, leukocytes 10 G/L (but pregnancy). Sterile ECBU and vaginal sample. Hepatitis B, C, HIV, HTLV 1 and 2 serology negative, parvovirus and toxoplasmosis in favor of an old infection. Anti-cardiolipid and anti-beta 2 GPI antibodies negative. Anti-erythrocytic antibodies negative. Foetopathological examination: normal (male fetus, macerated, without apparent or visceral malformation detected, no dysmorphia of the face or extremities). No malformative cause identified likely to explain this MFIU. Pathological examinations of the 2 placentas: histological appearance in accordance with the term, presence of stage 2 chorioamnionitis with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin. In total, fetal death in utero of one of 2 twins in a twin chorionic, bi-amniotic twin pregnancy, discovered at 30 weeks on D15 of a first dose of Comirnaty, after premature rupture of the frank membranes of clear liquid, without fever or contraction. Aspect of maceration of the deceased twin suggesting a death dating back several days. Premature delivery in the following hours by Caesarean section of a live male child hospitalized for prematurity and of the deceased child. Chorioamnionitis for the 2 twins (stage 2 with stage 3 funniculitis for the deceased twin, less intense for the other) on anatomopathological examination of the placentas, no abnormality on fetopathological examination of the deceased twin. The outcome of the event foetal death in utero was resolved with sequel and the outcome of the remaining events was unknown. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1466496 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Discouragement, Headache, Influenza, Pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness:
Preexisting Conditions: Diabetes Mellitus
Allergies: penicillin
Diagnostic Lab Data: Covid 19 - negative ( 10 2021)
CDC Split Type:

Write-up: flu (the worst I have ever had) headache discouragement body ache


VAERS ID: 1491803 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: LAMOTRIGINE; SODIUM VALPROATE; TOPAMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021853162

Write-up: seizures; epileptic/Fit (in known epileptic); Fever; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107040650484230-DV5P8, Safety Report Unique Identifier GB-MHRA-ADR 25591567. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 05Jun2021 (at the age of 16 years old) as dose 2, single for COVID-19 immunization. Medical history included epileptic from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included lamotrigine, sodium valproate and topiramate (TOPAMAX), all taken for epilepsy, start and stop dates were not reported. The patient experienced fever on 05Jun2021, seizures and epileptic/fit (in known epileptic) on an unspecified date. It was reported that the patient was epileptic and it was well controlled. Less than 2 weeks after the 2nd jab, the seizures resumed. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the event fever was recovered on 08Jun2021 while the outcome of all other events was unknown. Therapeutic measures were taken as a result of epileptic/fit (in known epileptic). No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1175666 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-05-04
Onset:2021-06-04
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER 8.737 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil, calcium, over 50 multivitamin, trulicity, escitalopram, wellbutrin, levothyroxine, metformin, lisinipril, atorvastatin, glipizide, loratidine
Current Illness: None
Preexisting Conditions: Diabetes 2, Morbidly obese, Depressive Disorder
Allergies: Penecillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No treatment other than waiting it out. Faver 101.7, muscle aches, joint aches, site pain, headache, fatigue


VAERS ID: 1373126 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-28
Onset:2021-06-04
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site pruritus, 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: Medical marijuana Meloxicam Magnezium Multi vitamin Vitamin b
Current Illness: None
Preexisting Conditions: Chronic cough Asthma Neuropathy Spinal senois
Allergies: Gabapentin Cats Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Around midnight u noticed I was scratching my arm in the same area that my shot was...its raised like a but bite and warm to the touch. I actually took a pic and outlined it in case it was something else. Very itchy.


VAERS ID: 1373377 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-22
Onset:2021-06-04
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH LA EW 1073 / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bursitis, Fatigue, Injection site pain, Loss of personal independence in daily activities, Movement disorder, Muscular weakness, Pain, Pain in extremity, Panic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it''s as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.


VAERS ID: 1373941 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-13
Onset:2021-06-04
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: flu shot for influenza age approx 45 years old
Other Medications:
Current Illness:
Preexisting Conditions: fibroid uterine tumor
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: my right hand, index finger is in pain. when I bend my finger my knuckle area is in pain. now my right hand is swollen in index finger area. and pain in my right arm


VAERS ID: 1373943 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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

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

Write-up: Somewhat sore arm and protruding swollen lymph node on left collarbone.


VAERS ID: 1373945 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rituxan Amlodipine Prednisone Metformin Zyrtec Vitamin D CoQ10 B12
Current Illness: N/A
Preexisting Conditions: Rheumatoid Arthritis Type 2 Diabetes High Blood Pressure Fibromyalgia
Allergies: Bactrim Levaquin Lisinopril
Diagnostic Lab Data:
CDC Split Type:

Write-up: Covid Arm; Hard, red, itchy area around the vaccine shot site.


VAERS ID: 1374010 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Dizziness, Fatigue, Injection site pain, Injection site swelling, Insomnia, Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu, associated flu symptoms
Other Medications: Anti-depressant, adderall, flexerol, seroquil, Xanax, multi-vitamin, beauty supplement(hair skin nails), collagen multi supplement, turmeric supplement, iron supplement, folic acid supplement
Current Illness: None
Preexisting Conditions: Rheumatoid Arthritis, raynauds, anemia (thought to be connective tissue disease) folliculitis (chronic staph)
Allergies: Slightly lactose intolerant
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site: sharp pain, swelling, stiffness Left arm: (injection site symptoms), shooting muscle pain from fingertips to occipital, very limited mobility in arm, wrist, shoulder, neck, sleeplessness, fatigue, dizziness, Overall joint, muscle, tissue related pain due to previously identified chronic diagnose are exacerbated/intensified to the point of interference with expected daily activity


VAERS ID: 1374077 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Pain, Pyrexia, Skin warm
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: Tylenol was taken 3 hours later.
Current Illness: None. Had COVID-19 in December.
Preexisting Conditions: None.
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Got the shot at 12:30PM on Thursday. Started feeling fever, chills, fatigue, muscle and joint pain, and slight headache at 3:10AM. Recorded temperature of 100.7 degrees with an ear thermometer. Took Tylenol, drank 32oz of cold water, put a cold wash cloth on forehead. After an hour my temperature dropped to 98.8. Felt less achy but still warm.


VAERS ID: 1374097 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JJ 206A21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site rash, 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: Advil
Current Illness: No
Preexisting Conditions: No
Allergies: Not aware of any
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Non raised rash at injection area, torso and groin. Noticed this morning 6/4/2021


VAERS ID: 1374118 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

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

Write-up: I have an extremely heavy period now, I woke up and there was a huge blood clot in my underwear and I literally gushed blood I?ve never seen that in all my 27 years of living and I?m afraid of what the next few days of my period will be like.


VAERS ID: 1374137 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Nausea, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Arthritis (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: INFLUENZA INJECTION IN 1995. HAD FLU FOR 4 DAYS AFTER INJECTION
Other Medications: Accu-Chek Guide test strips Strp Generic drug: blood sugar diagnostic Use 1 each (1 strip total) daily. fluticasone propionate 50 mcg/actuation nasal spray Commonly known as: FLONASE 50 mcg by Each Nare route daily. furosemide 20 MG tablet
Current Illness: NONE
Preexisting Conditions: HYPERTENSION TYPE 2 DIABETES TACHYCARDIA
Allergies: PENICILLIN, HYDROCHLORATHIAZIDE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: SUDDEN ELEVATION OF TEMPERATURE= 102, NAUSEA, BLOOD SHOT EYES, GENERALIZED JOINT PAIN. TOOK TYLENOL/ASPIRIN. LESSENED THE EFFECTS.


VAERS ID: 1374146 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Eye swelling, Headache, Lip swelling, Pharyngeal swelling
SMQs:, Anaphylactic reaction (narrow), 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? No
Previous Vaccinations:
Other Medications: sertraline, xanax, flexeril, aleve, topiramate, peepcid, valcyclovair, advair, epi pen albiterol
Current Illness: none
Preexisting Conditions: asthma, chronic pain, GERD
Allergies: neurontin, latex, grass, pollen, cymbatlta, bee ting
Diagnostic Lab Data: none
CDC Split Type:

Write-up: swollen eyes, swollen lips, headache, swollen throat


VAERS ID: 1374151 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Chest discomfort, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: GERD
Allergies: none that i am aware of
Diagnostic Lab Data: none at this time.
CDC Split Type:

Write-up: Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot. Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.


VAERS ID: 1374156 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (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: Temp: 97.4 C Pulse: 58 bpm respiration: 12 breaths per minutes SPO2: 100% B/P: 102/78 Exam: normal
CDC Split Type:

Write-up: AE: patient experienced blurred vision and ringing in the ears Treatment: No medical treatment were given. Patient was observed for 15 minutes. Outcome: Patient was discharged home with the help of mother.


VAERS ID: 1374176 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever, chills, sore throat. Started around 1 am according to son. Parent notified at 0730 and Tylenol given and throat spray used


VAERS ID: 1374186 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-04-01
Onset:2021-06-04
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blister, Hyperhidrosis, Scab, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: reaction on upper torso to sweat. Break out in hives from sweating blister up and scabbing over lasting several days


VAERS ID: 1374203 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 AR / IM

Administered by: Work       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: The patient stated that he became lightheaded and dizzy after taking his second vaccination.


VAERS ID: 1374213 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-01-08
Onset:2021-06-04
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

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

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

Write-up: asymptomatic testing


VAERS ID: 1374228 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: Prime dose administered 5/19/21. Patient walked into clinic on 6/4/21 too early for booster and was administered booster in error.


VAERS ID: 1374239 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-04-20
Onset:2021-06-04
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9265 / 2 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 3 - / -

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Data base says the patient received a vaccine on 4/20/21. We documented it in the patient chart. When the group home bought the patient in they said that he never received a vaccine. Pt chart has that pt received 1st vaccine from pharmacy on 4/20/21. Pt received dose of Pfizer on 5/14/21 at Covid vaccine clinic. Pt received 2nd dose at Covid vaccine clinic today, 6/4/2021. Pt and caregiver state this is patients second dose and received first dose here on 5/14/2021.


VAERS ID: 1374240 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-28
Onset:2021-06-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site reaction, Pruritus, Rash erythematous
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: mono-linyah
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the vaccine on 5/28/21 and called 6/4/21 because she developed a red rash around injection site today. She also stated that she feels itchy all over.


VAERS ID: 1374245 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

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

Write-up: Patient received prime dose 5/18/2021 Walked into clinic too early for booster dose on 6/4/21 and received booster dose in error.


VAERS ID: 1374254 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure decreased, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: patient had vasovagal reaction, blood pressure dropped 2-3 minutes post vaccine. he was fine with first dose. he had similar reaction with a meningococcal vaccine when he was 11.


VAERS ID: 1374261 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / SYR

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

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

Write-up: Vomiting


VAERS ID: 1374314 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arrhythmia, Chills, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (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: Monthly B-12 injections 125 mg erythromycin with evening meal for stomach motility due to Gastroparesis.
Current Illness: None.
Preexisting Conditions: Gastroparesis MVP
Allergies: Ampocillin
Diagnostic Lab Data: None Debated about going to hospital over the heart rhythm problem.
CDC Split Type:

Write-up: Chills, headache, muscle aches and heart rhythm variations.


VAERS ID: 1374320 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / UNK LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Chills, Confusional state, Fatigue, Hypoaesthesia oral, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: lips went numb, tiredness, muscle pain, cold chills, Mild confusion


VAERS ID: 1374329 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Nervousness
SMQs:, Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

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

Write-up: 39 y/o with past medical history of Hypertension that presents with feeling weak, nervous and concerned for BP post vaccination. Patient states that this is the first vaccination in the two-dose series. Patient denies previous vaccination reaction. Patient states that the vaccination was received in the left arm. Patient placed in wheelchair and taken to the partitioned area with the NP and Paramedics. Patient initial vitals all within normal limits, 125/92 BP, 97 HR, 98 %RA, 12 Resp. Patient provided a bottle of water and monitored for 15 mins. Patient states that is feeling better and that feels that it was just nervousness. Patient vitals reassessed and normal, 127/85 BP, 98 HR, 99% RA, 12 Resp. Patient discharged in stable condition, ambulated without difficulty. NP encouraged patient to hydrate well since patient will be going back to work in an outdoor environment.


VAERS ID: 1374340 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: diarrhea


VAERS ID: 1374341 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hyperhidrosis, Myalgia, Nausea, Pain, Sleep disorder, Tinnitus, Tremor, Visual impairment, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: ?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I had chills all night long & my entire body was so sore it hurt to lay in any position. In the morning, I still had extreme muscle pain all over. I was extremely light headed & dizzy, I had a throbbing headache so I took 2 aleve pills. I was getting super nauseous and almost passed out while trying to get to my bathroom just in time to throw up only water. Just before throwing up my vision went fuzzy, my ears were ringing, I was dripping sweat, it was getting hard to breathe, & my hands were shaking. After taking a cold shower, laying down, & drinking some water I feel a bit better but not 100% normal.


VAERS ID: 1374355 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Flushing, Presyncope
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: Vasovagal response, anxiety in Pod 7. Pt reported dizziness and was lowered to ground, supine w/ BLLE elevated on chair. Slight flushing in face. No facial edema noted. Auscultated lungs/airway, CTA, no stridor or other adventitious lung sounds noted. Transported to Med Obs 1 via litter for further assessment. VSS. Encouraged water, pt drank 1 small bottle and ate 2 pretzels. Pt reported dizziness resolved at 1025 VS prior to escorting out stable and listed below Sitting @1030 BP120/77, HR 66, RR 12, 99%RA Standing @ 1032 BP 114/73, HR 78, RR 14, 100%RA


VAERS ID: 1374356 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023C21A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Grapefruit size lump on injection site


VAERS ID: 1374361 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Head injury, Headache, Loss of consciousness, Nausea, Pain in extremity, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Patient awoke the morning after her 1st COVID vaccination. Reported she slept well. Her arm was sore from COVID shot. She was up for approximately 20 min and had brushed her teeth and did her hair. She was going to get dressed for the day and states she got a sudden pounding headache and felt nauseous. She was on her way out to the kitchen to tell us she didn''t feel good when she blacked out. She face planted, hitting her forehead on the hardwood floor witnessed by both parents. She was out for approximately 30 seconds. Her blood pressure was 90/60, HR 120, O2 on rm air was 98%. She has no previous history of syncope. After spell heart rate ran in the 100-110s for about 30 min and then normalized around 88-95. Was tired and sleepy for 2 hours after. (No post ictal sx to suggest seizure) Patient also received Tdap and meningococcal vaccine in other arm at the time of 1st Covid vaccination. The night of her COVID shot patient had normal appetite and activity level.


VAERS ID: 1374392 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039C21A / 2 LA / IM

Administered by: Private       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: sertraline 100mg daily
Current Illness: none
Preexisting Conditions: anxiety
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: No adverse reactions noted. Patient came in for her second dose of the Moderna vaccine. Vial was punctured 1:55PM on 06/03/2021. Vaccine was administered from the same vial at 08:55AM 06/04/2021


VAERS ID: 1374393 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dysgeusia, Fatigue, Fear of injection, Heart rate increased, Immediate post-injection reaction, Swelling, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Pt described feeling her heart rate high and feeling dizzy immediately after the vaccine, but she stated because she has a phobia with needles, she attributed the feeling to that. She felt tired when she went home and went to bed. When she woke up this morning, her tongue was swollen, as was the left side of her neck. She stated she was drinking lots of water, but it tasted like chemicals. I recommended to the patient to take 2 benadryl, and if the symptoms did not subside, to go to the emergency room.


VAERS ID: 1374398 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Nodule, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none
Preexisting Conditions: from filled out VAR via patient- "seizures", "I have issues w/ my heart"
Allergies: latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/soreness. Also reported severe reactions to first dose Pfizer COVID 19 Vaccine (severe headache, muscle pain, injection site redness)


VAERS ID: 1374415 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: No side effect as of yet- patient given vaccine although he is not in the approved age range to receive it


VAERS ID: 1374416 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Headache, Tunnel vision
SMQs:, Anticholinergic syndrome (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gabapentin, loestrin, baclofen, lexapro
Current Illness:
Preexisting Conditions:
Allergies: All antibiotics, egg whites
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness and lightheaded constantly since getting the shot, also have had tunnel vision and a head ache


VAERS ID: 1374419 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: patient sat for 10 minutes was good , stood up too fast then walked a few aisles and then fainted


VAERS ID: 1374438 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Seizure
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lexapro, trileptal 450mg in am and 600mg in pm, nasonex
Current Illness: none
Preexisting Conditions: autism, verbal apraxia, seizure disorder
Allergies: zoloft causes muscles to stiffen
Diagnostic Lab Data: none
CDC Split Type:

Write-up: generalized seizure


VAERS ID: 1374444 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: AFTER RECEIVING JANSSEN COVID VACCINE, PT WAS TOLD TO SIT DOWN FOR 15 MINUTES. HER FIANCE NOTICED SHE WAS DIZZY AND SHOUTED FOR HELP. AFTER FEW MINUTES PT WAS AWARE OF WHAT WAS GOING ON, BUT WANTED TO CALL 911 (AND EMS) ARRIVED AND CHECK HER VITALS. SHE WAS RELEASED TO GO HOME AND REST AFTERWARDS.


VAERS ID: 1374452 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 7/21 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Headache, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: headache/fatigue/sore arm 14 years old first Pfizer covid vaccine
Other Medications: topiramate spironolactone stopped 6/2/2021 began accutane night of 6/3/2021
Current Illness: none
Preexisting Conditions: migraines
Allergies: none that we are aware of at this time
Diagnostic Lab Data:
CDC Split Type:

Write-up: vomiting several times since 8:00, it''s now 11:16 headache sore arm fatigue NO DR VISIT YET


VAERS ID: 1374454 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Mydriasis, Pallor, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient experiences blurred vision, hot, dizziness at the observation area after the vaccination. Her pupils were dilated and her lip was pale. She felt better after zip of water and felt normal after few minutes.


VAERS ID: 1374483 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: HISTORY OF PASSING OUT AFTER VACCINATIONS A FEW YEARS AGO
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE. SHE STATED SHE HAS HISTORY OF PASSING OUT AFTER VACCINATIONS A FEW YEARS AGO
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT WAS FEELING NAUSEATED, CHILL, SWEATING, LIGHTHEADEDNESS, AND EAR RINGING AFTER VACCINATION. WE GAVE HER A BOTTLE OF WATER AND A SWEATER FOR THE CHILL WHILE WAITING FOR EMS. SHE FELT BETTER ABOUT 25 MINUTES LATER. EMS CHECKED HER BLOOD PRESSURE AND BLOOD SUGAR WHICH WERE NORMAL. SHE STATED SHE HAS HISTORY OF PASSING OUT AFTER VACCINATIONS AFEW YEAR AGO. SHE STAYED FOR ANOTHER HALF AN HOURS AT PHARMACY. ADVISED HER TO DISCUSS WITH HER FAMILY DOCTOR ABOUT THE 2ND DOSE COVID-19


VAERS ID: 1374493 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: The patient received second dose of Pfizer and a card was given to her, 15 minutes later she returned and stated that she was given the vaccine by CNA and 10 minutes prior but no card . CNA declined the statement.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: There were no adverse reactions, no symptoms, but will continue to call the patient.


VAERS ID: 1374494 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient fainted after receiving vaccination. After a period of 15 minutes, patient was able to leave under her own power.


VAERS ID: 1374498 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Fatigue, Hyperhidrosis, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), 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? Yes
Office Visit? Yes
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: Upon getting up, patient experienced brief spike in fever (felt very hot to touch), unsteadiness and fainted. Temperature after fainting was 100 and patient was sweaty, fatigued and had ''wobbly'' legs. About 5 minutes later, fever subsided and patient has generally recovered.


VAERS ID: 1374514 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 LA / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Eye swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: On June 4th at 12:00am I woke up with my right eye almost swollen shut. I took Benadryl and used ice to reduce swelling. Right now it is 12:51pm on June 4th and it is still swollen but it?s better than before I treated it.


VAERS ID: 1374515 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 - / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Eye pruritus, Eye swelling, Headache, Ocular hyperaemia, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), 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: N/a
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: I had minimal pain in my arm the day of the actual vaccination but the next day my arm was completely sore and I had headaches which is understandable and I was warned about but then on the third day I around 4:00 am I woke up with my left eye severely swollen, red, and itchy. I took Benadryl and applied ice but now it?s 12:30 pm and it is still swollen and itchy


VAERS ID: 1374522 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Clonic convulsion, Dysarthria, Hyperhidrosis, Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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 (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10:17 BP 56/35 pulse 118 O2sat 98 10:20 pulse 70 O2sat 99 10:25 BP 79/53 pulse 56 O2sat 99 Then EMS arrived and took over BP monitoring
CDC Split Type:

Write-up: Following injection patient passed out, was diaphoretic and had low BP of 56/35. Became responsive then speech became garbled and went into seizure (posturing and clonic movement) for approximately 3 seconds. Called 911. Became responsive before EMS arrived and refused ambulance to the hospital.


VAERS ID: 1374524 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site erythema, Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (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: Headache, Fever of 100.5, stiffness, tired, red spot where the was administrated.


VAERS ID: 1374545 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: Immediately following injection patient passed out and was diaphoretic with a low BP of 56/35. Became responsive but speech garbled and then experienced seizure (posturing and clonic movement) that lasted 3 seconds. Called 911, became responsive before EMS arrived on scene and refused ambulance.


VAERS ID: 1374640 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Headache, Injection site induration, Limb discomfort
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (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: Levothyroxine
Current Illness: multiple sclerosis, Rheumatoid Arthritis
Preexisting Conditions: same
Allergies: mold, pain medications can only take tylenol
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving Pfizer 0.3ml IM in left deltoid, patient states could feel it traveling down her arm to her hand. Patient has raised spongy spot about the size of a quarter that appeared within minutes. B/P was 130/76 at 10:56. After waiting 15 minutes patient complains of headache and sore left wrist when bending. Patient B/P is 128/70. Patient waited an additional 15 minutes with no change in status. Plans to confer with HCP this afternoon regarding the above.


VAERS ID: 1374660 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Head injury, Loss of consciousness, Malaise, Pallor, Skin warm, Syncope
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), Accidents and injuries (narrow), Cardiomyopathy (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: Patient reports low blood pressure and 12+ hours of fasting immediately prior to receiving vaccination
Preexisting Conditions:
Allergies: Penicillin - rash
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, patient began feeling ill. As he was walking up to the drop-off window to tell staff how he was feeling, he fainted and hit the back of his head on the ground. Patient was unresponsive so 911 was called. Patient was extremely pale, hot, and clammy, but slowly started to regain responsiveness. Patient reported blacking out. While waiting for paramedics, two cold ice packs were applied to the patient''s head and neck. Paramedics arrived and assessed the patient. They released him from their care as free to go. Patient sat down outside the pharmacy for approximately ten more minutes. Once he decided he was feeling better, he walked around outside the pharmacy until he felt okay to leave. Prior to leaving, patient reported he was feeling better and appeared to be in good spirits. He also reported having fasting labs drawn 45 minutes prior to receiving the vaccine, as well as low blood pressure at his doctor''s office. He confirmed ability to drive. Patient left the pharmacy approximately 45 minutes after receiving the vaccine.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=230&PERPAGE=100&ESORT=ONSET-DATE&REVERSESORT=ON&VAX=COVID19&DIED=No


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