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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 333 out of 7,116

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VAERS ID: 1571572 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/90 mmHg, Elevated
CDC Split Type: PHJNJFOC20210811307

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095119] concerned a 70 year old female of unspecified race and ethnic origin. The patient''s weight, height were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, frequency time 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 09:20 the patient blood pressure (BP) had elevated and the measurements were 200/90 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP) This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review, following information was amended: The case was reassessed as serious (Other Medically Important Condition).; Sender''s Comments: V1: Version created for amendments. Case upgraded to serious with seriousness- Other Medically Important Condition. 20210811307-COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. 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: 1571573 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809639

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095244] concerned a 60 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 14:05, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), event onset time updated.; Sender''s Comments: V1:20210809639-COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. 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: 1571574 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, elevated
CDC Split Type: PHJNJFOC20210809743

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095261] concerned a 53 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 10:18, the patient experienced elevated BP (blood pressure). Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP (blood pressure). This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: case was re-assessed as serious and seriousness level of event elevated BP (blood pressure) was updated to serious from non-serious.; Sender''s Comments: V0: 20210809743-COVID-19 VACCINE AD26.COV2.S. Elevated BP. This event is considered unassessable. The event 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.


VAERS ID: 1571575 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 240/110 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210809210

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095274] concerned a 57 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 10:48, the patient was diagnosed with elevated blood pressure (240/110 mmHg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), event onset time updated.; Sender''s Comments: V1:Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), event onset time updated. 20210809210- covid-19 vaccine ad26.cov2.s-ELEVATED BLOOD PRESSURE . 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: 1571576 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, elevated BP 200/120
CDC Split Type: PHJNJFOC20210809685

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095283] concerned a 48 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 12:23, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), event onset time updated.; Sender''s Comments: V1: Version created to amend the seriousness of the event-elevated blood pressure and event onset time updated. 20210809685-covid-19 vaccine ad26.cov2.s- elevated blood pressure. 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: 1571577 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, 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)

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: PHJNJFOC20210823917

Write-up: FAINTING; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096338] concerned a 23 year old female of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21A expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 09:45 A.M the patient experienced fainting and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, and dizziness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210823917-Covid-19 vaccine ad26.cov2.s - fainting. 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: 1573561 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Lip dry, Pain in jaw
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Osteonecrosis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976723

Write-up: Jaw pain; Dry mouth; dry lips; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210730115548, and Safety Report Unique Identifier is GB-MHRA-ADR 25737029. A 37-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (lot number: FF3319) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced jaw pain on 30Jul2021 with outcome of not recovered, dry mouth on 30Jul2021 with outcome of not recovered, and dry lips on 30Jul2021 with outcome of not recovered. The events were considered serious as other medically important condition. Additional information: Left side jaw pain, from below chin to behind ear. Pain when opening mouth. Very dry mouth and lips which is not subsiding with drinking fluids. 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: 1575028 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: ESMODERNATX, INC.MOD20212

Write-up: This case was received via Agency (Reference number: 963117) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING in a 42-year-old female patient who received mRNA-1273 (batch no. 214010) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Jul-2021, after starting mRNA-1273 , the patient experienced HEAVY MENSTRUAL BLEEDING (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING was resolving. mRNA-1273 (Intramuscular) was withdrawn on 28-Jul-2021. Relevant concomitant medications were not reported. Treatment information was not provided. 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.; 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.


VAERS ID: 1575241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977238

Write-up: Aching joints; Muscle ache; Headache; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107301221534370-I3OVS. Safety Report Unique Identifier GB-MHRA-ADR 25732471. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced fever on 30Jul2021, aching joints, muscle ache, headache on an unspecified date; all medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Diarrhoea, Headache, Nausea, Neck pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 INC202100976751

Write-up: Nausea; Sore armpit; Neck ache; Diarrhoea; headache; aching joints; This is a spontaneous report from a contactable consumer received from theThe regulatory authority report number is GB-MHRA-WEBCOVID-202107301312164010-IOH1V. Safety Report Unique Identifier GB-MHRA-ADR 25732843. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown) via an unknown route on 28Jul2021, as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown) via an unknown route on an unknown date, as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced aching joints, headache, sore armpit, neck ache, and diarrhoea. On 30Jul2021, the patient had nausea. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no, negative COVID-19 test). The outcome of the event nausea was not recovered, and the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Headache, Hot flush, Malaise, Nervousness, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976653

Write-up: Hot flush; Headache; Nose bleed; Sickness; Shaking inside; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107301320395680-LPKPM, Safety Report Unique Identifier GB-MHRA-ADR 25732882. A 20-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via unspecified route of administration on 26Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced hot flush, headache, nose bleed, sickness and was shaking inside (all events were serious medically significant) on 30Jul2021. The patient underwent laboratory test which included Sars-cov-2 test: negative on 30Jul2021. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575411 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-30
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976900

Write-up: stomach cramps; Diarrhoea/Severe diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107301519589930-KRA27. Safety Report Unique Identifier GB-MHRA-ADR 25733730. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jul2021 (Batch/Lot Number: EW4109) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased and suspected COVID-19 from 18Dec2019 to 04Jan2020. Patient not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The event severe diarrhoea on 30Jul2021 and stomach cramps on an unspecified date (reported "for a fortnight"). The events were assessed as serious (medically significant and have caused disability). The outcome of the event stomach cramps was unknown; event diarrhoea was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysmenorrhoea, Hyperhidrosis, Presyncope, Syncope, Tremor, Tunnel vision
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976974

Write-up: temporary extreme tunneling of vision; faint feeliing; shaking; sweating; incredibly strong period pains; faint; Near fainting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301531403280-2TTGO and Safety Report Unique Identifier GB-MHRA-ADR 25733806. A 32-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 25Jul2021 as dose 2, single, COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced temporary extreme tunneling of vision, faint feeling, shaking, sweating, incredibly strong period pains and faint. On 30Jul2021, the patient experienced near fainting. The clinical course was reported as follows: Temporary extreme tunneling of vision, and faint feeling. Shaking, strong sweating and incredibly strong period pains. This has happened on both periods following the vaccines. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the events temporary extreme tunneling of vision, faint feeling, shaking, sweating, incredibly strong period pains and faint was unknown; outcome for the event near fainting was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Head injury, SARS-CoV-2 test, Syncope, Wound
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976980

Write-up: Fainting; fell hitting the front of their head; hitting the front of their head; cut just above the eye; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107301538110820-ZHVXK. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and Unsure if patient is enrolled in clinical trial. It was reported that after the first vaccine was administered on 30Jul2021, the patient then fainted and fell hitting the front of the head which resulted in a cut just above the eye. The patient was attended to by the pharmacist who had made the patient comfortable and treated the cut the patient had sustained using some steri strips. The patient took some time to recover and then felt well enough to leave. The customer had brought somebody who was there during the incident and then left with him. The event fainted was assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event fainting was recovered on 30Jul2021, while unknown for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1575440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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? 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 INC202100976860

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-202107301655338130-MRMTN, Safety Report Unique Identifier GB-MHRA-ADR 25734256. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jul2021 (Lot Number: ff3319) as first dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced faint on 30Jul2021 (five minutes after vaccination) with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Lymphadenopathy, Malaise, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100977025

Write-up: Swollen lymph nodes; Flu-like aching; Feeling sick; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107301659394090-AMY6V. Safety Report Unique Identifier GB-MHRA-ADR 25734266. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Jul2021 (Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 30Jul2021, the patient experienced swollen lymph nodes, flu-like aching, feeling sick. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 28Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Insomnia, Lymphadenopathy, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976841

Write-up: Swollen lymph nodes; Headache; Insomnia; Nausea; Ache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301814052970-B25NS. Safety Report Unique Identifier is GB-MHRA-ADR 25734813. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased and depression. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included sertraline taken for depression. The patient experienced swollen lymph nodes, headache, insomnia, nausea, and ache, all on 30Jul2021 with outcome of not recovered. She has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blindness transient, Body temperature, Body temperature decreased, Deafness unilateral, Defaecation urgency, Diplegia, Dysphagia, Dyspnoea, Feeling hot, Hyperhidrosis, Hypopnoea, Monoplegia, Nausea, Paraesthesia, Paralysis, Peripheral coldness, SARS-CoV-2 test, Skin discolouration, Thirst, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (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: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:35.3 Centigrade; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976681

Write-up: sweating; hot; nausea; losing sight; seeing sparkles; Lost all hearing in right ear; faecal urgency; weakness/ body weakness; pins and needle sensation in head, then spread to arms and legs; Breathing was shallow and difficult; Breathing was shallow and difficult; paralysis; temperature was 35.3 C; Hands and feet were ice cold; face was grey; thirsty; hard to swallow any fluid; joint aches; Paralysis legs; Paralysis arm; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202107301814194310-H9EEO, Safety Report Unique Identifier GB-MHRA-ADR 25734851. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FE3380) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 30Jul2021 (reported as almost exactly 24 hours after the vaccine), the patient experienced hot, sweating, nausea, seeing sparkles, losing sight, lost all hearing in right ear, fecal urgency, weakness/ body weakness, pins and needle sensation in head, then spread to arms and legs, breathing was shallow and difficult, paralysis, temperature was 35.3 C, hands and feet were ice cold, face grey, thirsty, hard to swallow any liquid, joint aches, paralysis of leg and paralysis of arms. The clinical course was reported as follows: Almost exactly 24-hours after vaccine. Suddenly was really hot and sweating. Extreme nausea. Began seeing sparkles and losing sight. Lost all hearing in right ear. Had fecal urgency, plus body weakness. Pins and needle sensation in head this then spread to arms and legs. Felt like patient was going to lose consciousness, so got herself onto floor. Breathing was shallow and difficult. Pins and needles in arms and legs quickly became paralysis, hands were fixed with straight fingers. Temperature was 35.3C. Hands and feet were ice cold. Face was grey. According to the patient, she was lucky that her parents live nearby, and she was able to speakerphone her mum to come and help her. Patient was not sure what would have happened otherwise because she literally could not move on the floor. The patient was thirsty but found it hard to swallow any fluid. This lasted for about thirty minutes and then movement slowly came back. She was able to get off the floor with assistance and have since just been nauseas on-and-off and have joint aches, especially in elbows and hands. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the event hot, sweating, nausea, seeing sparkles, losing sight, lost all hearing in right ear, fecal urgency, weakness/ body weakness, pins and needle sensation in head, then spread to arms and legs, breathing was shallow and difficult, paralysis, temperature was 35.3 C, hands and feet were ice cold, face grey, thirsty, hard to swallow any liquid, joint aches, paralysis of leg and paralysis of arms was recovered 30Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Influenza, Myalgia, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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:
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 INC202100976854

Write-up: Muscle ache; Leg pain; Tingling; Flu symptoms; Tiredness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301845519620-CPBLG, and Safety Report Unique Identifier is GB-MHRA-ADR 25735002. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (lot number: fd8813) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced muscle ache on 30Jul2021 with outcome of not recovered, leg pain on 30Jul2021 with outcome of not recovered, tingling on 30Jul2021 with outcome of not recovered, flu symptoms on 30Jul2021 with outcome of not recovered, and tiredness on 30Jul2021 with outcome of not recovered. The events were considered serious, other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Fatigue
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977039

Write-up: tiredness; disorientation; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301900577850-QIFZV. Safety Report Unique Identifier GB-MHRA-ADR 25735046. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Jul2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, anxiety depression. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included citalopram taken for anxiety depression from 01May2017 to an unspecified stop date and unspecified medications at 40mg taken daily at night. The patient experienced severe tiredness on an unspecified date, disorientation on an unspecified date, dizziness on 30Jul2021. Severe dizziness on moving of the neck/head. Also, if eyes move too quickly. Outcome of the events tiredness and disorientation was recovered, of the event dizziness was not recovered. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575513 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Carditis, Chest pain, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: CAPFIZER INC202101012553

Write-up: cardiac inflammation; Chest pain; heart palpitations; This is a spontaneous report from a contactable consumer (patient''s father) received via a sales representative. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Jul2021 (at the age pf 13-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. On 20Jul2021 the patient experienced chest pain and heart palpitations. She went to the hospital on 31Jul2021 where they diagnosed cardiac inflammation. The events resulted in Physician Office Visit. The outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up


VAERS ID: 1575800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Headache, Menstruation irregular, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976938

Write-up: bleeding; throbbing pain; headache; Menstrual irregularity; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107302339240570-OK9SE. Safety Report Unique Identifier GB-MHRA-ADR 25736280. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Jul2021 (Lot number: not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took levonorgestrel (MIRENA). On unspecified date, the patient experienced bleeding, throbbing pain and headache. On 30Jul2021, the patient experienced menstrual irregularity. The patient further reported severe headache following vaccination, within several hours. Persisted with throbbing pain intermittently, somewhat resolved with paracetamol or ibuprofen over the 3 days following vaccination. Bleeding started unusually. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Therapeutic measures were taken as a result of throbbing pain and headache. Outcome of the events bleeding, throbbing pain and headache was recovered on unspecified date. Outcome of the event menstrual irregularity was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575805 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Myalgia, Pain, Testicular pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: General body pain; Joint pain; Muscle pain; Testicular pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977020

Write-up: Testicular pain; General body pain; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107310118144510-HJ8LP, Safety Report Unique Identifier GB-MHRA-ADR 25736310. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE1510), via an unspecified route of administration on 30Jul2021 at the age of 22 years old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included testicular pain, general body pain, joint pain, muscle pain. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Initially he had some body pains once he got back to car. They''ve got worse all day specifically joints and muscles and now testicles are painful as if they do when he got a viral reaction to something. The patient experienced testicular pain on 30Jul2021, general body pain on 30Jul2021, joint pain on 30Jul2021, muscle pain on 30Jul2021. Events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575809 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Illness, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977000

Write-up: Sickness; Chest pain; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107310306360160-Q3SHE. A 33-years-old non-pregnant female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 30Jul2021 (at the age of 33-years-old) as dose 2, single for COVID-19 immunization. Normally healthy no health issues. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient experienced headache on 30Jul2021, sickness, chest pain/tight chest on 31Jul2021. Case narrative was as follows: Pain in chest/tight chest. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Jul2021 No- Negative COVID-19 test. The events were assessed as serious. The outcome of event for headache was recovering while for other events was not recovered. No follow-up attempts are possible, information about batch/lot number cannot be obtained.


VAERS ID: 1575814 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976732

Write-up: Fever; Nausea; Shaking; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107310509414680-XT6ZT. Safety Report Unique Identifier GB-MHRA-ADR 25736469. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced fever, nausea and shaking on 30Jul2021. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the events was not recovered. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1575816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977340

Write-up: Ache; Chills; Tiredness; Heavy feeling in arms + leg; Nausea; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107310716599650-CIRXR, Safety Report Unique Identifier is GB-MHRA-ADR 25736584. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 29Jul2021 at single dose for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced ache (medically significant) on 30Jul2021 with outcome of not recovered, chills (medically significant) on 30Jul2021 with outcome of recovering, tiredness (medically significant) on 30Jul2021 with outcome of not recovered, heavy feeling in arms + leg (limb discomfort) (medically significant) on 30Jul2021 with outcome of not recovered, nausea (medically significant) on 30Jul2021 with outcome of not recovered, headache (medically significant) on 30Jul2021 with outcome of not recovered. Symptoms occurs about 12hoirs after having vaccine. The patient underwent lab test which included sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Migraine, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976687

Write-up: Vomiting; Migraine; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107310757238660-MOO0U. Safety Report Unique Identifier GB-MHRA-ADR 25736610. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jul2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. On 30Jul2021, the patient experienced migraine, diarrhea and nausea. On 31Jul2021, the patient experienced vomiting. The patient underwent lab tests and procedures which included covid-19 virus test: No-Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events migraine, nausea and vomiting was not recovered. Outcome of the event diarrhea was recovered on 30Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575823 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped); Vertigo
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976773

Write-up: vertigo; nauseous; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107310801111200-QCMSU, and Safety Report Unique Identifier is GB-MHRA-ADR 25736621. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included vertigo, lactation decreased, suspected COVID-19 from 01Nov2020 to an unknown date, unsure when symptoms stopped, and hypothyroidism. Patient was not pregnant and not currently breastfeeding. Concomitant medication included levothyroxine taken for hypothyroidism. The patient experienced vertigo and nauseous on an unspecified date with outcome of recovering, and nausea on 30Jul2021 with outcome of not recovered. Patient felt like she has vertigo. It started in the night and she felt like the world was spinning. It seems to be getting a little better but she still felt nauseous. The events were assessed as serious, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab test which included COVID-19 virus test: no - negative COVID-19 test on unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976712

Write-up: Discomfort; Swelling, significant swelling under left armpit; This is a spontaneous report from a contactable consumer (patient) received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107310900496430-GCZQD. Safety Report Unique Identifier GB-MHRA-ADR 25736699. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 29Jul2021 (lot number: FD8813) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced swelling on 30Jul2021. Case narrative: He got significant swelling under left armpit. He received the jab in his left arm. Swelling caused discomfort on an unspecified date. No relevant investigations or tests conducted. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The patient has not recovered from swelling/significant swelling under left armpit, while outcome of discomfort was unknown. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575834 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977095

Write-up: Headache; Feverish; Painful arm; This 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-202107311009249850-JNL22. Safety Report Unique Identifier GB-MHRA-ADR 25736779. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 30Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at age of 27-year-old for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included suppressed lactation. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date for COVID-19 immunization. The patient experienced painful arm on 30Jul2021, headache on 31Jul2021, feverish on 31Jul2021. The outcome was not recovered. The lab tests included No - Negative COVID-19 test on 28Jul2021. All the events were assessed serious as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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: PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression
Allergies:
Diagnostic Lab Data: Test Date: 20201114; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100977197

Write-up: arm pain; discomfort at injection site; abdominal discomfort; Diarrhoea; Injection site pain; This is a spontaneous report from a contactable consumer . This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107311122042000-KONZY. Safety Report Unique Identifier GB-MHRA-ADR 25736873. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: Ff3319) as DOSE 2 ,SINGLE for COVID-19 immunisation. Medical history included Anxiety depression from an unknown date and unknown if ongoing. Concomitant medication(s) included propranolol (PROPRANOLOL) taken for depression from 29Jul2021 to an unspecified stop date. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced abdominal discomfort (abdominal discomfort) (medically significant) on 30Jul2021 with outcome of recovering , arm pain (pain in extremity) (medically significant) on an unspecified date with outcome of recovering , diarrhoea (diarrhoea) (medically significant) on 30Jul2021 with outcome of recovering , injection site pain (injection site pain) (medically significant) on 30Jul2021 with outcome of not recovered , discomfort at injection site (injection site discomfort) (medically significant) on an unspecified date with outcome of unknown. The patient was well prior to vaccine. He had vaccine in the morning then in the evening abdominal discomfort and then diarrhoea all night continuing the next day. Arm pain and discomfort at injection site occurred at the same time as the severity of diarrhoea increased. The patient underwent COVID-19 virus test with positive result on 14Nov2020. 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: 1575843 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cold sweat, Fatigue, Headache, Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: DESOGESTREL; VITAMIN B12 [CYANOCOBALAMIN]
Current Illness: Fatigue
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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: Cold sweats; Fever; Shivers; Headache; Nausea; Ache; Painful arm; Fatigue; This case was received via regulatory authority (Reference number: ADR 25736893) on 01-Aug-2021 and was forwarded to Moderna on 01-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), FATIGUE, HEADACHE, COLD SWEAT (Cold sweats), PAIN (Ache), PYREXIA (Fever), CHILLS (Shivers) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Fatigue. Concomitant products included DESOGESTREL for Contraception, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Fatigue. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On an unknown date, the patient experienced COLD SWEAT (Cold sweats) (seriousness criterion medically significant). On 31-Jul-2021, PYREXIA (Fever), CHILLS (Shivers) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) and FATIGUE (Fatigue) had not resolved and HEADACHE (Headache), COLD SWEAT (Cold sweats) and PAIN (Ache) 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 mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant treatment medication information provided. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: 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: 1575847 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Dermatitis allergic, Hypersensitivity, Illness, Pain, Pruritus, SARS-CoV-2 test, Somnolence
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: CO-CODAMOL; CHLORPHENAMINE MALEATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Lactation decreased; Nerve pain
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977295

Write-up: felt sick; had zero energy to do anything; had zero appetite; drowsy; pain; itchy; allergic reaction; Allergic skin reaction; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. The first report is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107311232369810-PDQLE. Safety Report Unique Identifier GB-MHRA-ADR 25736979. A 35-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (at the age of 35 years old) (Lot number was not known) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, Hay fever, Nerve pain. No known allergy other than mild hay fever. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient took her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunisation and experienced Itchy, allergic reaction, tearing her skin to shreds and pain. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) taken for Nerve pain; chlorphenamine maleate (BOOTS ALLERGY RELIEF ANTIHISTAMINE). The patient experienced pain on 30Jul2021, itchy on 30Jul2021, allergic reaction on 30Jul2021, allergic skin reaction on 30Jul2021, drowsy on 31Jul2021, had zero energy to do anything on an unspecified date, felt sick on an unspecified date, had zero appetite on an unspecified date. It was reported that: As the patient went for her 2nd vaccine, she told the medical staff about the reaction. They advised her to take an antihistamine & wait 30 mins in her car before she received the vaccine. After her 2nd vaccine, the allergic reaction started literally 15 minutes after being jagged. The same reaction again but this time much worse. The all body itch was so much worse & more painful, antihistamines were doing nothing to curtail it. A few hours later she became so drowsy to the point of not being able to keep open her eyes. (Anti histamines were non drowsy) Today (31Jul2021, Saturday morning the day after her jag) she had awoken to still being itchy, slightly less than yesterday however it felt like her body was on fire with pain. Every inch of her hurts badly, it''s painful to get up & walk & she had zero energy to do anything which was very unlike her. She felt sick & had zero appetite. The only thing stopping her from seeking medical attention today from a hospital was that her breathing was okay so it wouldn''t be classed as any kind of emergency. However first thing Monday morning she would be contacting her doctor. Therapeutic measures were taken as a result of pain, itchy, allergic reaction and allergic skin reaction. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of allergic skin reaction was not recovered; of pain, itchy and allergic reaction was recovering; of the other events was unknown. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100986010 to same patient same product different dosage and different event.


VAERS ID: 1575859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Drug ineffective, Hangover, Headache, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: no diagnosed illnesses
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100977026

Write-up: hangover; Diarrhea; Dizziness/dizzy; Weakness; suspected covid-19; suspected covid-19; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is , Safety Report . A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jul2021 as dose 2, single for COVID-19 immunisation. Medical history was none, no diagnosed illnesses. Concomitant medication included paracetamol. The patient experienced hangover on an unspecified date, headache on 30Jul2021, diarrhea on 31Jul2021, dizziness/dizzy on 31Jul2021, weakness on 31Jul2021, suspected covid-19 on 31Jul2021. Feeling almost like a dreadful hangover. Got incredibly dizzy whilst driving and almost came off of the road. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 30Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events hangover, diarrhea, dizziness/dizzy, weakness, suspected covid-19 was not recovered; of the event headache was recovering. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Menstruation irregular, Polymenorrhoea
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977124

Write-up: early period; pregnancy; Irregular periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311645559960-RCUZD. Safety Report Unique Identifier GB-MHRA-ADR 25737299. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jul2021 (Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced early period (polymenorrhoea) (medically significant) on an unspecified date with outcome of unknown, irregular periods (menstruation irregular) (medically significant) on 30Jul2021 with outcome of not recovered, exposure during pregnancy on an unspecified date with outcome of unknown. The clinical course was reported as follows: Early period 2 weeks apart. Same effect after 1st dose. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1575883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976756

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311846057810-JNQDM, Safety Report Unique Identifier is GB-MHRA-ADR 25737423. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. She has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced swollen lymph nodes on 30Jul2021 with outcome of not recovered. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on unspecified date. She has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Eye pain, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100976658

Write-up: aching eyes; Blurry vision; very worried; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107311934264800-RIFVN, Safety Report Unique Identifier GB-MHRA-ADR 25737489. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 07Jan2021 to 20Jan2021 and was not ongoing. The patient''s concomitant medications were not reported. The patient experienced aching eyes, blurry vision, and very worried on 30Jul2021. The clinical course was reported as follows: The patient woke up with aching eyes, went into super market and couldn''t read ingredients on a packet. He was very worried. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 08Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the blurry vision was not recovered while of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976863

Write-up: Swollen lymph nodes; BNT162B2 dose 1: 03Jun2021, dose 2: 30Jul2021; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107311947509600-K9DAL, Safety Report Unique Identifier GB-MHRA-ADR 25737506. A 36-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He had his dose 1 of BNT162B2 (lot unknown) on 03Jun2021.The patient experienced swollen lymph nodes (medically significant) on 31Jul2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1575892 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Lipodystrophy (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: MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Mental disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977021

Write-up: Breast pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107312017414460-LZKCB, safety report unique identifier is GB-MHRA-ADR 25737547. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 ( at the age of 34 years old) (Lot Number: FE1510) as single dose for COVID-19 immunisation. Medical history included lactation decreased and mental disorder from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included mirtazapine taken for mental disorder from 01Jun2018 to an unspecified date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 for COVID-19 immunisation and experienced arm started hurting. The patient experienced breast pain and swollen lymph nodes on 30Jul2021 with outcome of not recovered, reported as medically significant. Clinical course reported as follow: Arm started hurting late last night then this morning breast pain and swollen lymph nodes under arm. It was very painful and just a slight touch made it even worse. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Swelling, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977274

Write-up: sore arm; headache; large swelling under arm/armpit which is about the size of1/2 a tennis ball; large swelling under arm/armpit which is about the size of1/2 a tennis ball; swelling at injection site; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312039554690-MCBKZ. Safety Report Unique Identifier GB-MHRA-ADR 25737561. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date as single dose for COVID-19 vaccination. The patient experienced sore arm, headache on an unknown date, swelling at injection site on 30Jul2021. The clinical course was as follows: Headache, sore arm and swelling at injection site, large swelling under arm/armpit which is about the size of1/2 a tennis ball and very sore. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the event Vaccination site swelling was not recovered and was unknown for the rest events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575906 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vaccination site pruritus
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), 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: LEVONORGESTREL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Postnatal depression (excl psychosis); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977043

Write-up: sore arm; Swollen arm; localized itching / itchy injection site; Painful arm; Tired all the time; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312144066380-ORBNF, Safety Report GB-MHRA-ADR 25737619. A 33-year-old female (not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 at age of 33-year-old as single dose for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 and unsure when symptoms started, unsure when symptoms stopped, postnatal depression (excl psychosis). Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included levonorgestrel as birth control pill from 30Aug2020; sertraline taken for postnatal depression (excl psychosis) from 20Jul2020. The patient experienced sore arm on an unspecified date, swollen arm and localized itching / itchy injection site on 31Jul2021, painful arm and tired all the time on 30Jul2021 after 3 hours. The events were considered as medically significant. Clinical course as follow: Day of injection very tired and sore arm after 3 hours. Day after injection extremely tired, swollen and sore arm and itchy injection site. Patient has not tested positive for COVID-19 since having the vaccine. The COVID-19 virus test was No - Negative COVID-19 test. The outcome of the event sore arm was unknown, of other events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575907 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Feeling hot, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977017

Write-up: Have no energy; Tiredness/felt really exhausted; Muscle ache; Painful arm; Feeling of warmth; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312146373110-9IMDY, Safety Report Unique Identifier GB-MHRA-ADR 25737623. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 30Jul2021 at the age of 36 year old as DOSE 2 , SINGLE for COVID-19 immunisation. Medical history included Lactation decreased. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported, Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Arm was aching the first day then felt really exhausted the next day even after sleeping for 10 1/2 hours. Have no energy and still can''t lift arm up due to muscle aches. The patient experienced painful arm on 30Jul2021 with outcome of not recovered, feeling of warmth on 30Jul2021 with outcome of recovering, tiredness/felt really exhausted on 31Jul2021 with outcome of not recovered, muscle ache on 30Jul2021 with outcome of not recovered, have no energy on an unspecified date with outcome of unknown. Events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Fatigue, Feeling cold, Heart rate, Lymphadenopathy, Oropharyngeal pain, Palpitations, Peripheral swelling, SARS-CoV-2 test, Tachycardia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL; SALAMOL [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Lactation decreased; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Name: Bloods; Result Unstructured Data: Test Result:Unknown results; Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: heart rate; Result Unstructured Data: Test Result:106; Test Date: 20210730; Test Name: heart rate; Result Unstructured Data: Test Result:120BPM; Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977044

Write-up: sore throat; feeling cold; Palpitations; Tachycardia; Swollen arm; Swollen lymph nodes; fell asleep as I was feeling tired; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108010000002150-5GVNU, Safety Report Unique Identifier GB-MHRA-ADR 25737704. A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased, chest pain, shortness of breath. Patient is not enrolled in clinical trial. No previous medical conditions. Patient has not had symptoms associated with COVID-19, Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included ibuprofen taken for chest pain from 30Jul2021; paracetamol taken for chest pain from 30Jul2021; salbutamol sulfate (SALAMOL) taken for shortness of breath from 15Jul2021 to 17Jul2021. The patient experienced sore throat, feeling cold, palpitations, tachycardia, swollen arm, swollen lymph nodes, fell asleep as she was feeling tired on 30Jul2021. The events were serious as medically significant. The patient underwent lab tests and procedures which included blood test, chest x-ray, electrocardiogram, heart rate: 106, heart rate on 30Jul2021: 120bpm, COVID-19 virus test on 16Jul2021 was No - Negative COVID-19 test. Clinical course as follow: Had a mild sore throat on when she woke up on morning of the 30th. Started feeling cold around midday so had a bath got out the bath and fell asleep as she was feeling tired and felt worse when she woke up. She had heart palpitations and her heart rate had gone up to 120BPM. The patient called the doctor and was told if it gets worse or does not improve go A&E. it calmed down by evening so went to sleep. Got woken up with the heart palpitations again and her heart rate was 106. The patient called 111 they sent her to UTC but they could not help so was sent to A&E where she was quickly seen to. Patient had to undergo tests as her heart rate was still too high and she was given fluids. Patient had an IV drip. Patient was later discharged and told its most likely the effects from vaccine however the issue still had not been fully resolved as she still have the same feelings on occasion even though she was back at home. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of palpitations was not recovered, of fell asleep as she was feeling tired was unknown. The outcome of sore throat, feeling cold was recovered, of other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575919 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pain in extremity, Vaccination site movement impairment
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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976774

Write-up: Arm which vaccine injected has been extremely sore (7/10); It has been painful to touch and lift or move; Pain; This is a spontaneous report from a contactable consumer received from the Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108010035445880-45MYJ, Safety Report Unique Identifier is GB-MHRA-ADR 25737716. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (age at vaccination was 27 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1 single on an unspecified date for COVID-19 immunization. The patient experienced pain on 30Jul2021 with outcome of recovering, arm which vaccine injected has been extremely sore (7/10) on an unspecified date with outcome of unknown, and it has been painful to touch and lift or move on an unspecified date with outcome of unknown. The events were reported as serious, medically significant by the health authority. Additional information: Arm which vaccine injected has been extremely sore (7/10) since about 6 hours after vaccine injected. It has been painful to touch and lift or move. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Intermenstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101009305

Write-up: bleeding; Intermenstrual bleeding; This is a Spontaneous report from two contactable Consumer downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory authority report number GB-MHRA-WEBCOVID-202108010809074620-PGSXM, with Safety Report Unique Identifier GB-MHRA-ADR 25737820. A 39-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 17Jul2021 as dose 1 single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and was not currently breastfeeding. The patient concomitant medications were not reported. The patient experienced bleeding on an unspecified date and intermenstrual bleeding on 30Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, (No - Negative COVID-19 test) on unknown date. The outcome of the event haemorrhage was unknown while outcome of the event intermenstrual bleeding was not recovered. No follow-up attempts are needed, Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1575930 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Lymphadenopathy, Myalgia, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984717

Write-up: Muscle ache; Fever/Fever chills; Swollen lymph nodes; Exhaustion; Painful arm; Armpit pain; Headache; body aches; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108010809400020-87ED0, Safety Report Unique Identifier is GB-MHRA-ADR 25737826. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 30Jul2021 (at the age of 35 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and headache. Patient has not had symptoms associated with COVID-19, was not pregnant, and not currently breastfeeding. Concomitant medication included paracetamol taken for headache. On 30Jul2021, the patient experienced muscle ache, fever/fever chills, swollen lymph nodes, exhaustion, painful arm, armpit pain, headache, and body aches. The events were reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The clinical course was reported as follows: Taken paracetamol but this didn''t help with any of the patient''s body and muscle aches or fever, only the headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event fever/fever chills was recovered on 01Aug2021, while the event headache was recovered on 31Jul2021. The outcome of the event exhaustion was recovering. The outcome of the remaining 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: 1575942 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Hypersomnia, Lymphadenopathy, Maternal exposure during pregnancy, Off label use, Pain, Pain in extremity, Product use issue, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding; Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984455

Write-up: pain; extra sleep; Off label use/ maternal exposure via breast milk; Drug use in unapproved population/ maternal exposure via breast milk; hurt to move the arm, minor pain; Swollen lymph nodes; Armpit pain/ armpit was tender to touch; Tired all the time/tiredness; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer. This is the first of second reports. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108010929167140-4YZKH, Safety Report Unique Identifier GB-MHRA-ADR 25737876. A 31-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: fe1510), dose 2 via an unspecified route of administration on 30Jul2021 09:30 (Age at Vaccination: 31Year) as dose 2, single for COVID-19 immunisation. Medical history included fatigue from an unknown, ongoing pregnancy (currently 5 months pregnant), ongoing breast feeding, using vitamin supplementation from an unknown date. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was also reported that after first dose patient had sore arm and tiredness. On 30Jul2021 with in few hours of having vaccine the patient experienced tiredness. On 01Aug2021 the patient experienced swollen lymph nodes and armpit pain. On unspecified date patient had pain, extra sleep and pain in arm. It was reported that extra sleep was resolving slowly. In the early hours of Sunday morning patient lymph nodes began to swell under the arm that received the vaccine and the armpit was tender to the touch. It also hurt to move the arm, minor pain. The arm that did not get the injection was unaffected. Patient was exposed to the medicine second-trimester (13-28 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: (no - negative covid-19 test) on 22Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. All the events were reported as medically significant. The outcome of the event swollen lymph nodes and armpit pain was reported as not recovered, while outcome of events pain, extra sleep and tiredness was resolving. The outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100998871 Baby case


VAERS ID: 1575949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984408

Write-up: pain; neck is very swollen; Glands swollen; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108011105080280-HSTQO, Safety Report Unique Identifier GB-MHRA-ADR 25737941. A 38-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration on 29Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced pain, neck is very swollen. On 30Jul2021, the patient experienced glands swollen. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Jul2021 No - Negative COVID-19 test. My neck was very swollen on one side and the pain was awful! She can''t move it like normal and might not be able to work. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event pain was recovered, event glands swollen was not recovered and event neck is very swollen was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Fatigue, Feeling cold, Night sweats, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (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: DIOCTYL; LENALIDOMIDE; ORAMORF; PARACETAMOL; SENNA ACUTIFOLIA; ZOMORPH
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic back pain; Constipation; Immunodeficiency; Myeloma
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984710

Write-up: feeling cold; sweating/Night time sweating; Aching in knees; Diarrhoea/diarrhea/liquid bowel movements; Stomach cramps/stomach pain; Fever chills; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011123468590-QESKS. Safety Report Unique Identifier is GB-MHRA-ADR 25737974. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myeloma, immunodeficiency, constipation and chronic back pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included docusate sodium (DIOCTYL) taken for constipation from 21Feb2020 to an unspecified stop date; lenalidomide taken for myeloma from 16Apr2021 to an unspecified stop date; morphine sulfate (ORAMORF) taken for back pain from 01Nov2019 to an unspecified stop date; paracetamol taken for back pain from 13May2021 to an unspecified stop date; senna acutifolia taken for constipation from 21Feb2020 to an unspecified stop date; morphine sulfate (ZOMORPH) taken for back pain from 01Jan2021 to an unspecified stop date. The patient experienced frequent no-notice or short-notice liquid bowel movements, fever chills, fatigue, and constant stomach pain, cramps on 30Jul2021; aching in knees on 31Jul2021; feeling cold yet room temperature at 23 degrees Celsius and night time sweating on an unspecified date. The events were assessed as serious (medically significant). The patient took paracetamol and drink plenty of fluids. It was also reported that "please note: the diarrhoea and stomach cramps are NOT listed in the official side effects so have caused me distress. However some subsequent basic internet based research has indicated that around 10% of people suffer from it after Pfizer jab." Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the events feeling cold, night sweat was recovering; while not recovered for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1575956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inappropriate schedule of product administration, Influenza like illness, Mastitis, Myalgia, Off label use, Product use issue, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Functional lactation disorders (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Delivery; Lacrimal duct obstruction; Lactation decreased; Mastitis; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984724

Write-up: chills; flu like symptoms; muscle aches; fever; Mastitis; ongoing breast feeding; ongoing breast feeding; dose 1: 29May2021, dose 2: 30Jul2021; This is a spontaneous report from a contactable consumer (patient). This is a report received from the United Kingdom''s Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108011145109960-73CJJ, Safety Report Unique Identifier GB-MHRA-ADR 25737978. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: FE1510), via an unspecified route of administration in the left arm on 30Jul2021 as single dose for COVID-19 immunisation. She previously received the first dose on 29May2021 (lot number: ET8885).Medical history included lactation decreased, mastitis, ongoing breast feeding, and back pain. Text for relevant medical history and concurrent conditions: She had a baby in February (year unknown) and has been breastfeeding her with no issues such as mastitis previously, although was checked by a doctor for a blocked duct a few months ago. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not pregnant, and not enrolled in clinical trial. Concomitant medication included ibuprofen taken for back pain from 01Apr2021. The patient experienced chills, flu like symptoms, muscle aches, fever, and mastitis on 31Jul2021; maternal exposure during breast feeding on 30Jul2021. Narrative case summary and further information: Around 24 hours after the vaccine, she began having flu like symptoms - fever and chills and muscle aches. A few hours later, she noticed her left breast (she had the jab in her left arm) was red, inflamed, and sore and looked like mastitis. This could of course be coincidence but another breastfeeding friend had a similar reaction after receiving her jab the same day so she thought it was probably worth flagging. Relevant investigations or tests conducted: Waiting to get in at the doctor to confirm. She has not tested positive for COVID-19 since having the vaccine. The outcome of mastitis was not recovered, while outcome of other events was unknown. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575987 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Hypersensitivity; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100984579

Write-up: Light-headed; Headache; Pain in arm; This is a spontaneous report from a contactable consumer. This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011550480620-8SBP7 and Safety Report Unique Identifier GB-MHRA-ADR 25738182. A 31-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), via an unspecified route of administration, on 30Jul2021 (at the age of 31-year-old) at single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not a COVID-19 test. Patient is not currently breastfeeding, and she is not enrolled in a clinical trial. Concomitant medication included loratadine taken for hypersensitivity from 01Jan2021, and sertraline taken for anxiety from 01Feb2017. On 30Jul2021, the patient experienced pain in arm, light-headed, and headache. The events were reported serious as medically significant by Health Authority (HA). Clinical course was reported as follows: Headache on and off, along with light-headedness on ands off. On unknown date, a COVID-19 test was done and resulted negative. The patient had recovered from pain in arm on 01Aug2021 while the remaining events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Joint range of motion decreased, Skin reaction, Vaccination site bruising, Vaccination site inflammation, Vaccination site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Hay fever; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984670

Write-up: fatigue; Site of injection inflamed and bruised about size of baseball; Site of injection inflamed and bruised about size of baseball; site of injection hot to touch and hard to lift arm; site of injection hot to touch and hard to lift arm; Skin reaction; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011612062590-ITYMF, Safety Report Unique Identifier is GB-MHRA-ADR 25738196. A 35-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm, on 29Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased, anxiety, and hay fever. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. Concomitant medications included citalopram taken for anxiety from 01Mar2020 and fexofenadine taken for hay fever from 01Apr2010. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. The patient experienced skin reaction on 30Jul2021. The patient also experienced site of injection inflamed and bruised about size of baseball, hot to touch, and hard to lift arm. The patient also had extreme fatigue accompanied but has lessened. The outcome of skin reaction was not recovered, while for the other events was unknown. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575997 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Drug ineffective, Illness, Pain, Pyrexia, Somnolence, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:high temperature
CDC Split Type: GBPFIZER INC202100984514

Write-up: high temperature; Diarrhoea; Aches; Feel really sleepy; Sickness; suspected COVID-19; suspected COVID-19; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011703001010-5PSMD, Safety Report Unique Identifier GB-MHRA-ADR 25738225. A 26-year-old male (as reported) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) (at the age of 26-year-old) as single dose for COVID-19 immunization. Medical history included pregnancy (Adverse reaction did not occur as a result of an exposure during pregnancy). The patient''s concomitant medications were not reported. The patient experienced suspected COVID-19 on 30Jul2021 with outcome of not recovered, high temperature on an unspecified date with outcome of not recovered, sickness on 30Jul2021 with outcome of not recovered, diarrhea on an unspecified date with outcome of unknown, aches on an unspecified date with outcome of unknown, feel really sleepy on an unspecified date with outcome of unknown. The events were serious, medically significant. Additional information: the patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Not had a COVID-19 test. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1576017 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Inappropriate schedule of product administration, Limb discomfort
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: GBPFIZER INC202100984641

Write-up: Armpit pain; Heaviness in arm; Tiredness; First dose of BNT162B2 on 20May2021; second dose on 30Jul2021; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108011900141780-HH0C2 and Safety Report Unique Identifier is GB-MHRA-ADR 25738302. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not known, Expiry date not reported), via an unspecified route of administration on 30Jul2021 (age at vaccination updated as 28 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 via an unspecified route of administration on 20May2021 (Lot Number: Not known) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced armpit pain on 31Jul2021 with outcome of not recovered, heaviness in arm on 31Jul2021 with outcome of not recovered, and tiredness on 31Jul2021 with outcome of recovering. The events armpit pain, heaviness in arm, and fatigue were reported as serious, medically significant by the health authority. Case Narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1576045 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: EVRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Seizure anoxic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984529

Write-up: sweating; shivering; fever; chills; Diarrhea; Fever chills; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012106292160-6SPMU, Safety Report Unique Identifier GB-MHRA-ADR 25738403. A 19-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FE3380) as single dose for covid-19 immunisation (age at vaccination 19 years). Medical history included suppressed lactation , contraception and seizure anoxic. Concomitant medications included ethinylestradiol, norelgestromin (EVRA) taken for contraception from 01Mar2021 to an unspecified stop date. The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient experienced sweating (medically significant) on an unspecified date with outcome of recovering , shivering (medically significant) on an unspecified date with outcome of recovering, fever (medically significant) on an unspecified date with outcome of recovering, chills (medically significant) on an unspecified date with outcome of recovering, fever chills on 30Jul2021 with outcome of recovered on 01Aug2021, headache (medically significant) on 30Jul2021 with outcome of recovering, diarrhea (medically significant) on 01Aug2021 with outcome of recovering. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Myalgia, Pain, Pain in extremity, Pruritus, Rash, Rash erythematous
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984758

Write-up: itchy; Rash; Chills; Muscle ache; painful arm; Red rash on torso; Body ache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012314239700-6KKUL, Safety Report Unique Identifier GB-MHRA-ADR 25738485. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Jul2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. No concomitant medications, the patient was not taking any medication at the time. The patient experienced itchy on 01Aug2021, rash, chills, muscle ache, painful arm, red rash on torso and body ache on 30Jul2021. The events were reported as serious as important medical events. The clinical course was reported as follows: red rash on torso on the day after the second dose. Became more uniform on the third day and itchy. Chills and body ache the day after the second dose plus painful arm. Patient had not tested positive for COVID-19 since having the vaccine. The patient had recovered from chills and muscle ache on 31Jul2021, had not recovered from rash, the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Illness
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984504

Write-up: Sickness; Headache; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020103042970-R01TF, Safety Report Unique Identifier GB-MHRA-ADR 25738526. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FD5613) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced fatigue on 30Jul2021, and sickness and headache on 31Jul2021. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576095 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-30
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210801; 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: Dizziness; Foggy feeling in head; Exhaustion; Muscle soreness; This case was received via Agency Regulatory Authority (Reference number: 25740661) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Exhaustion) and MYALGIA (Muscle soreness) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 on 30-Jul-2021. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Exhaustion) had not resolved and MYALGIA (Muscle soreness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, 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. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter. Company Comment: 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: 1576109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Fever; This case was received via RA (Reference number: 25739924) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 01-Aug-2021, PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug information provided. No concomitant drug information provided. 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1576118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Mood altered, SARS-CoV-2 test
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Temperature elevation; Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority MHRA (Reference number: 25740510) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MOOD ALTERED (Mood change), HEADACHE (Headache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced MOOD ALTERED (Mood change) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 01-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, MOOD ALTERED (Mood change) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Body temperature: temperature elevation (High) Temperature elevation. On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided. Company comment: 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. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; 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. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576147 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shingles; This regulatory authority case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Company 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time; 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time


VAERS ID: 1576191 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-07-30
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Hyperhidrosis, Myalgia, Nausea, Pain in extremity, Pyrexia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tiredness; Nausea; Fatigue; Drowsiness; Fever chills; Headache; Muscle ache; Sweating; Armpit pain; Painful arm; This case was received via the Regulatory Authority (Reference number: 25746935) on 04-Aug-2021 and was forwarded to the company on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PYREXIA (Fever chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), SOMNOLENCE (Drowsiness), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Painful arm), MYALGIA (Muscle ache) and HYPERHIDROSIS (Sweating) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002332 and 3003608) for COVID-19 vaccination. No Medical History information was reported. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion disability) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion disability). On 31-Jul-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), FATIGUE (Fatigue) (seriousness criterion disability), SOMNOLENCE (Drowsiness) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability) and HYPERHIDROSIS (Sweating) (seriousness criterion disability). On 02-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion disability). On 02-Aug-2021, MYALGIA (Muscle ache) had resolved. On 03-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, FATIGUE (Tiredness), PYREXIA (Fever chills), AXILLARY PAIN (Armpit pain) and PAIN IN EXTREMITY (Painful arm) was resolving and HEADACHE (Headache), FATIGUE (Fatigue), SOMNOLENCE (Drowsiness) and HYPERHIDROSIS (Sweating) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication were reported. 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: 1576259 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Seizure
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), 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: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 20210730; 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: seizure; sweating; headache; nauseous; Seizures; This case was received via Regulatory Authority (Reference number: 25752825) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (Seizures), SEIZURE (seizure), HYPERHIDROSIS (sweating), HEADACHE (headache) and NAUSEA (nauseous) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (sweating) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization) and NAUSEA (nauseous) (seriousness criterion hospitalization). On 30-Jul-2021, SEIZURE (Seizures) had resolved. At the time of the report, SEIZURE (seizure), HYPERHIDROSIS (sweating), HEADACHE (headache) and NAUSEA (nauseous) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. After receiving the vaccine, there was no side effects other than tiredness for the rest of the day. Roughly around midday, felt sick so went to lie down. The patient was found on the sofa having a seizure with eyes wide open which lasted roughly for 1 min. Ambulance arrived and on the way to A&E (Accident and Emergency) had another seizure lasting for 5 seconds. The patient spent the rest of the 29-Jul-2021, in the hospital with feeling rather poorly and weak. The patient was having tests awaiting appointment at the seizure clinic. The patient had blood tests and pressure, and ECG with unknown result. No treatment information was provided by the reporter. Company Comment: 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: 1576380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-30
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardiac failure, Cardiogenic shock, Chordae tendinae rupture, Echocardiogram, Mitral valve incompetence, Myocardial infarction, Platelet count, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral regurgitation
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Cardiac angio; Result Unstructured Data: Test Result:severe cardiac failure; Test Date: 20210804; Test Name: cardiac echo; Result Unstructured Data: Test Result:severe cardiac failure; Test Name: platelet count; Result Unstructured Data: Test Result:not less than 150 - 109/L; Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014651

Write-up: mitral regurgitation; severe cardiac failure; cardiogenic shock; rupture of chordae tendinea; Myocardial infarct; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061132171490-NIEUP, Safety Report Unique Identifier GB-MHRA-ADR 25764550. A 36-year-old male patient received second dose of BNT162B2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 05Jul2021 as dose 2, single for COVID-19 immunization. Medical history included mitral valve incompetence. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced mitral regurgitation with outcome of unknown, myocardial infarct on 30Jul2021 with outcome of recovering, severe cardiac failure with outcome of unknown, cardiogenic shock with outcome of unknown; Acute MI with severe mitral regurgitation due to rupture of chordae tendinea. The patient underwent lab tests included SARS-CoV-2 test: negative on 04Aug2021 No-Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. The report was related to possible blood clots or low platelet counts. Patient presented with severe cardiac failure and cardiogenic shock and was diagnosed with Cardiac angio and cardiac echo on 04Aug2021. The platelet count was not less than 150 - 109/L. Unknown if the D-dimer $g4000. Unknown if anti-PF4 antibodies identified. The report was considered as serious as life threatening from regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576383 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Peripheral swelling, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: TRAMADOL
Current Illness: Back pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Arm is swollen; Flu like symptoms; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Back pain: Paracetamol. Concurrent medical conditions included Back pain. Concomitant products included TRAMADOL from 1996 to an unknown date for Back pain. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). 30-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen). On 01-Aug-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, RASH (Rash) outcome was unknown and PERIPHERAL SWELLING (Arm is swollen) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient had flu like symptoms for 2 days following my Moderna vaccination, with small rashes on the vaccinated arm. Patient was fatigued and very achy everywhere. 7 days after vaccinated the arm is swollen, warm to the touch with a large rash and is aching rather than painful. Company comment: 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: 1576727 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979445

Write-up: This is a spontaneous report from a non-contactable physician. A 73-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection, Lot number not reported), via intramuscular route, administered in left arm on 30Jul2021 at 16:15 (at the age of 73-year-old) (the day of vaccination) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s medical history and concomitant medications were not reported. It was unknown that since the vaccination, whether the patient had been tested for COVID-19 or not. On 30Jul2021 at 16:45, (30 minutes after the vaccination), the patient experienced cardiac failure acute. The patient was hospitalized on an unknown date for the same reported event. The patient was treated with unspecified diuretics. The outcome of the event was recovering. The reporter classified the event as serious (Hospitalized) and stated the event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information and the close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of acute cardiac failure cannot be totally excluded. The case will be reassessed if additional information becomes available such as relevant underlying medical history and concomitant medications if any. 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: 1576994 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809679

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095301] concerned a 65 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 18:50, the patient experienced elevated blood pressure (BP). Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021, the following information was updated and incorporated into case narrative: seriousness criteria for elevated blood pressure was updated as other medically important condition.; Sender''s Comments: V1: This Version was created to amend previously reported information. Seriousness criteria for event elevated BP was updated as other medically important condition. 20210809679-COVID-19 VACCINE AD26.COV2.S- Elevated BP. This event is considered unassessable. The event 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.


VAERS ID: 1576998 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809807

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095236] concerned a 39 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 13:18, the patient experienced elevated blood pressure of 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021 .Upon review following information was amended: seriousness upgraded to serious (elevated blood pressure), narrative updated.; Sender''s Comments: V1: Following information was amended in this version: seriousness level of event (elevated BP) was updated to serious from non-serious. 20210809807-covid-19 vaccine ad26.cov2.s -Elevated BP. This event is considered unassessable. The event 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.


VAERS ID: 1577002 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809893

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095255] concerned a 53 year old female. The patient''s weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported, 1 total administered on 30-JUL-2021 as prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 11:31, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from non serious to serious.; Sender''s Comments: V1: 20210809893- Covid-19 vaccine ad26.cov2.s-Elevated BP. This event is considered unassessable. The event 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.


VAERS ID: 1577003 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg
CDC Split Type: PHJNJFOC20210809935

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095323] concerned a 55-year-old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 18:20 hours, the patient''s blood pressure (BP) was elevated and was measured to be at 200/100 mm/Hg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended. This case was reassessed as serious.; Sender''s Comments: V1 Version created for amendment. This case was reassessed as serious. 20210809935-COVID-19 VACCINE AD26.COV2.S-Elevated BP: 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: 1577005 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg
CDC Split Type: PHJNJFOC20210810033

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-30009533] concerned a patient of unspecified age, sex, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 21:40 hours, the patient''s blood pressure (BP) was elevated and was measured to be at 190/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: Seriousness of Event elevated blood pressure upgraded to serious.; Sender''s Comments: V2-Version created to amend previously reported information and case was reassessed as serious. 20210810033-COVID-19 Vaccine AD26.COV2.S-Elevated BP. This event is considered un-assessable. The event 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.


VAERS ID: 1577008 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210810072

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095288] concerned a 61 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 16:45, the patient experienced elevated blood pressure of 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021 .Upon review following information was amended: seriousness upgraded to serious (elevated blood pressure), narrative updated.; Sender''s Comments: V1:Following information was amended in this version: seriousness level of event (elevated Blood pressure) was updated to serious from non-serious. 20210810072-covid-19 vaccine ad26.cov2.s -Elevated Bloodpressure. Follow-up received regarding Other Information:Seriousness for event of Elevated blood pressure upgraded to serious and narrative updated.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: 1577033 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: High
CDC Split Type: PHJNJFOC20210823964

Write-up: COUGH; CHILLS; FEVER; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA,PH-PHFDA-300097072] concerned a 71 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A,expiry: unknown) dose was not reported, frequency time 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021,at 16:00 the patient developed cough, experienced chills and had fever and was hospitalized on an unspecified date. Laboratory data included: Body temperature (NR: not provided) High. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, fever, and chills. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210823964-COVID-19 VACCINE AD26.COV2.S-cough. This event is considered unassessable. The event 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. 20210823964-COVID-19 VACCINE AD26.COV2.S -fever and chills. These events are labeled per RSI and are therefore considered potentially related.


VAERS ID: 1577061 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824410

Write-up: SYNCOPE; FATIGUE; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300096900] concerned a 48 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, dose was not reported and batch number: UNKNOWN), 1 Total administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, at 23:00, the patient experienced fatigue and headache. On 31-JUL-2021, at 11:00, the patient experienced syncope. On an unspecified date, the patient was hospitalized due to syncope. It was unknown if patient got discharge from hospital or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, fatigue, and headache. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0; 20210824410-Covid-19 vaccine ad26.cov2.s-Syncope. 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: 1577071 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, Elevated; Test Name: Blood pressure; Result Unstructured Data: 140/100 mmHg; Comments: Prevaccination
CDC Split Type: PHJNJFOC20210824489

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095806] concerned a 62 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. On unspecified date, the pre vaccination Laboratory data included: Blood pressure (NR: not provided) 140/100 mmHg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient''s BP (Blood Pressure) was elevated and the measurement was 200/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition); Sender''s Comments: V0:20210824489-COVID-19 VACCINE AD26.COV2.S-Elevated BP. 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: 1577076 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824549

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095855] concerned a 60 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at18:13 hours, the patient experienced elevated blood pressure. The patient''s blood pressure reading was 200/110 mmHg, patient was administered clonidine 75micrograms at 18:20 hours for treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210824549 -COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. 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: 1577083 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / 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: PHJNJFOC20210824711

Write-up: FAINTING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096631] concerned a 43 year old male of an unspecified race and ethnic origin.. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A and expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 14:20 the patient had fainted. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824711-Covid-19 vaccine ad26.cov2.s-Fainting. 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: 1577089 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/90 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824838

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095861] concerned a 60 year old female with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported with frequency 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 18:09 the patient experienced elevated bp (blood pressure) for which the measurements were 200/90 mmHg post vaccination. Then at 18:10 she was treated with clonidine 75 microgram. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated bp (blood pressure). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210824838 - JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated blood pressure. This event is considered unassessable. The event 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.


VAERS ID: 1577096 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824894

Write-up: RIGHT LEG WEAKNESS AND HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097152] concerned a 69 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported,1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 18:00, the patient experienced right leg weakness and headache, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right leg weakness and headache. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210824894-Covid-19 vaccine ad26.cov2.s-Right leg weakness and headache(LLT: Headache). This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1577102 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Heart rate, Hot flush, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Heart rate; Result Unstructured Data: 116; Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824965

Write-up: ELEVATED BP; HOT FLUSHES; CHEST DISCOMFORT; TACHYCARDIA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095696] concerned a 58 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 in total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 10:45, the patient had elevated blood pressure (BP), hot flushes, chest discomfort, and tachycardia. Laboratory data included: Blood pressure (NR: not provided) 190/110 mmHg, and Heart rate (NR: not provided) 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP), hot flushes, chest discomfort, and tachycardia. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824965-Covid-19 vaccine ad26.cov2.s-Elevated BP. 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: 1579170 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Muscular weakness, Paraesthesia, Pyrexia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UTROGESTAN
Current Illness: Lactose intolerance (Fructose and lactose intolerance)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: Has passed the COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210826134

Write-up: GROGGY; WEAKNESS IN THE RIGHT LEG, I LIMP, IT HURTS AND TREMBLES WHEN I TRY IT.; RIGHT TOES NUMBNESS, FROM THE BIG TOE TO THE ONE PREVIOUS TO THE PINKY TOE, IT TURNS INTO PAIN AFTER WALKING FOR ABOUT 20 MINUTES; JOINT PAIN, KNEES AND HANDS; FEVER; FATIGUE WITH LOW-GRADE FEVER IN THE AFTERNOONS, NEED TO SLEEP.; This spontaneous report received from a consumer via a Regulatory Authority [Regulatory Authority, ES-AEMPS-970101] concerned a 63 year old female. The patient''s weight was 57 kilograms, and height was 157 centimeters. The patient''s past medical history included, covid-19 (on JAN-2021). Concurrent conditions included, lactose intolerance (Fructose and lactose intolerance), and other pre-existing medical conditions included COVID-19, which patient has passed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number, XE393 expiry, unknown) dose was not reported on 28-JUL-2021 at left arm for covid-19 vaccination. Concomitant medications included 60 soft pill of Utrogestan (200 mg) (twice a day, 10 days per month) for menopausal symptoms. On 30-JUL-2021, the patient experienced groggy, weakness in the right leg, patient limped, it hurt and trembled when patient tried it, right toes numbness, from the big toe to the one previous to the pinky toe, it turned into pain after walking for about 20 minutes, patient also experienced joint pain of knees and hands, fever and fatigue with low-grade fever in the afternoons, patient needed to sleep. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 28-JUL-2021. The patient had not recovered from fever, groggy, weakness in the right leg, i limp, it hurts and trembles when i try it., right toes numbness, from the big toe to the one previous to the pinky toe, it turns into pain after walking for about 20 minutes., fatigue with low-grade fever in the afternoons, need to sleep and joint pain, knees and hands. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20210826134-Covid-19 vaccine ad26.cov2. s Groggy- This event is considered unassessable. The event 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 events. 20210826134-covid-19 vaccine ad26.cov2. s Weakness in the right leg, Right toes numbness, Fatigue, Fever, Joint pain. This events are labeled per the institute and is therefore considered potentially related.


VAERS ID: 1579312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3317 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Lymphoma, SARS-CoV-2 test
SMQs:, Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), 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: Pregnancy; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984636

Write-up: lymph nodes; lymph nodes in the armpit and it swell and feels painful; Lymphoma; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011603243420-HZYXX, Safety Report Unique Identifier is GB-MHRA-ADR 25738198. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jul2021 (Lot Number: FF3317) as single dose for COVID-19 immunisation. Medical history included pregnancy from an unknown date. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced lymph nodes on an unspecified date and lymphoma on 30Jul2021. It was reported that patient have lymph nodes in the armpit and it swell and feels painful. The events were reported as serious (disability). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test with No - Negative COVID-19 test result on 23Jul2021. The patient had not recovered from lymphoma while outcome of the other events unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579327 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Pyrexia, SARS-CoV-2 test, Sweating fever
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100992461

Write-up: Nausea; Headache; Dizziness; Fever chills; Sweating fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202108022009066330-EVGJY. Safety Report Unique Identifier GB-MHRA-ADR 25743470. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FD8813), via an unspecified route of administration on 30Jul2021 (at the age of 27-years) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. Concomitant medication included citalopram. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. The patient experienced nausea, headache, dizziness, fever chills, and sweating fever; all on 30Jul2021. The patient had negative COVID-19 virus test on an unspecified date. The outcome of headache was recovered on 01Aug2021, while for the other events was recovered on 31Jul2021. The events were considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579376 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Neck mass, Neck pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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: I have a lump on my neck bone; Neck aches; Muscle ache; Neck stiff; Headache; This case was received via MHRA (Reference number: ADR 25759026) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiff), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 29-Jul-2021 to an unknown date for Pain. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiff) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced NECK MASS (I have a lump on my neck bone) and NECK PAIN (Neck aches). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck stiff) and MYALGIA (Muscle ache) had not resolved, HEADACHE (Headache) had resolved with sequelae and NECK MASS (I have a lump on my neck bone) and NECK PAIN (Neck aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter Company Comment: 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: 1579416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune system disorder, Lip ulceration, Pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101029465

Write-up: severe pain; lip ulcer; the vaccine triggered the immune system; This is a spontaneous report from a contactable consumer (patient''s mother) via Drug Safety Unit. A 13-years-old female (unknown if pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number unknown), unknown dose via an unspecified route of administration on 27Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced severe pain, lip ulcer and vaccine triggered the immune system. The outcome of all the events was unknown.


VAERS ID: 1579535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac murmur, Muscle spasms, Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad), Pulmonary hypertension (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 INC202100992507

Write-up: cramps; felt my left pectoral muscle (where my heart is located) twitch; Heart murmur; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021051579950-7H8D0, Safety Report Unique Identifier is GB-MHRA-ADR 25740074. A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. The patient experienced cramps on an unspecified date and heart murmur on 30Jul2021. Additional case narrative: He had his jab on the 26th July 2021 and he was fine for a couple of days and then he felt his left pectoral muscle (where his heart is located) twitch and felt like it was having mini cramps every now and then 2 or 3 every 5-10 minutes. No relevant investigations or tests conducted. He has not tested positive for COVID-19 since having the vaccine. The outcome of heart murmur was not recovered, recovering for cramps while outcome of muscle twitching was unknown. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579539 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Confusional state, Fatigue, Headache, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: CLENIL MODULITE; FLUOXETIN; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression; Esophageal acid reflux; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991899

Write-up: Armpit pain; Confusion; Injection site pain; Headache; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021109508770-GHOBF. Safety Report Unique Identifier is GB-MHRA-ADR 25740227. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 30Jul2021 (at the age of 40 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased, asthma, depression, and esophageal acid reflux. Patient has not had symptoms associated with COVID-19, was not pregnant, and not currently breastfeeding. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma; fluoxetine hydrochloride (FLUOXETIN) taken for depression from 2005; and omeprazole (OMEPRAZOL) taken for esophageal acid reflux from 2019. On 30Jul2021, the patient experienced headache, fatigue, and injection site pain. On 31Jul2021, the patient experienced confusion, and experienced armpit pain on 01Aug2021. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event armpit pain was not recovered, the outcome of the event injection site pain was recovered on 31Jul2021, and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1579549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (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: GBPFIZER INC202100992488

Write-up: Pain back; Stomach pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202108022210525070-DI2WM; Safety Report Unique Identifier: GB-MHRA-ADR 25744017. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jul2021 (Batch/Lot Number: Not known; Expiry date: Not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced stomach pain on 30Jul2021 and pain back on 02Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were assessed as medically significant. Outcome of events pain back and stomach pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579593 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Cough, Depression, Dyspnoea, Heavy menstrual bleeding, Influenza, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? 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: Depression; Lactation decreased; UTI
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu; Cough; Fever; Heavy periods; Depression; Taste loss; Shortness of breath; This case was received via Regulatory Authority (Reference number: ADR 25769933) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), AGEUSIA (Taste loss), DYSPNEA (Shortness of breath), HEAVY MENSTRUAL BLEEDING (Heavy periods), INFLUENZA (Flu), COUGH (Cough) and PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Depression, Lactation decreased and UTI. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced AGEUSIA (Taste loss) (seriousness criterion disability) and DYSPNEA (Shortness of breath) (seriousness criterion disability). On 31-Jul-2021, the patient experienced DEPRESSION (Depression) (seriousness criterion disability). On 06-Aug-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion disability). On an unknown date, the patient experienced INFLUENZA (Flu) (seriousness criterion disability), COUGH (Cough) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). At the time of the report, DEPRESSION (Depression), AGEUSIA (Taste loss) and DYSPNEA (Shortness of breath) had not resolved, HEAVY MENSTRUAL BLEEDING (Heavy periods) outcome was unknown and INFLUENZA (Flu), COUGH (Cough) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Past medication included 5 day dose of antibiotics for suspected UTI which was taken a month before second vaccine. Patient had her period early which was painful. She had massive increase in depression noticed. Concomitant product, Treatment information were not provided by the reporter.; 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. Based on biological implausibility the event of Influenza causality is assessed as not applicable in related to mRNA-1273.


VAERS ID: 1579844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperpyrexia, Hypothermia, Physical deconditioning
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (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: JPTAKEDA2021TJP068352

Write-up: High fever; Hypothermia; Physical deconditioning; This case was received (Reference number: 2021TJP068352) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case was reported by a vaccine recipient via the Drug Information Center. High fever and Hypothermia was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of the vaccine. On 26-Jul-2021, the patient received the 2nd dose of the vaccine. On 30-Jul-2021, the patient experienced physical deconditioning and high fever. On an unknown date, the patient experienced the symptom of hypothermia of basal body temperature decreased to 34.5 degrees Celsius. On an unknown date, the patient visited an internal medicine. The outcome of physical deconditioning, high fever, and hypothermia was unknown. No follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: 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: 1579846 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP068427

Write-up: Myocarditis; Pyrexia; This case was received via (Reference number: 2021TJP068427) on 03-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case was reported by a physician via a medical representative. On 29-Jul-2021, the patient received the vaccine (unknown number of doses). On 30-Jul-2021, the patient experienced pyrexia of 39.0 degrees Celsius. On 31-Jul-2021, the patient experienced pyrexia of 37.5 degrees Celsius. On 01-Aug-2021, in the morning, the patient experienced chest pain. The patient called an ambulance and was transported to a medical institution. The patient was admitted to the ICU. On an unknown date, the patient received examinations at the hospital. On 02-Aug-2021, the patient was diagnosed with myocarditis and was tested negative on PCR test. At 14:00, pyrexia resolved. The outcome of pyrexia was reported as recovered. The outcome of myocarditis was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Causal relationship of the events with the vaccine was unable to be assessed because the reporting physician did not examine the patient face-to-face.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.


VAERS ID: 1579847 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP068471

Write-up: Myocarditis (queasy feeling, vomiting, chest pain); This case was received via Regulatory Authority (Reference number: 2021TJP068471) on 03-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case was reported by a physician via the Drug Information Center. On an unknown date, the patient received the 1st dose of the vaccine. On 29-Jul-2021, the patient received the 2nd dose of the vaccine. On 30-Jul-2021, around the night, queasy feeling developed. On 31-Jul-2021, the patient experienced vomiting several times and had squeezing chest pain. Around 02:00, the patient was transported by ambulance and was hospitalized. On an unknown date, myocardial infarction was suspected, and a catheterization was performed at the medical institution, but no abnormality was found. The patient was diagnosed with myocarditis. The outcome of myocarditis (queasy feeling, vomiting, and chest pain) was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient was diagnosed with myocarditis. The possibility of viral myocarditis is under investigation at a cardiovascular department.; 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.


VAERS ID: 1579849 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069626

Write-up: Anaphylactic shock (dyspnea, consciousness disturbance, cold sweat, decreased blood pressure); This case was received via agency (Reference number: 2021TJP069626) on 04-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician via a medical representative, and reported to the Agency by a physician, was received via the (Ref, v21122431). On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 30-Jul-2021, at 11:20, the patient received the 1st dose of the vaccine. At 11:23, the patient experienced dyspnea, consciousness disturbance, and cold sweat. Blood pressure decreased to 60/- mmHg. SpO2 was 94 (room air). After intramuscular injection of 0.3 mg of adrenaline, the symptoms quickly improved, and BP was 105/66 with SpO2 of 99 (room air). The patient was considered to experience anaphylactic shock and was transported by ambulance. The outcome of anaphylactic shock (dyspnea, consciousness disturbance, cold sweat, and decreased blood pressure) was unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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.


VAERS ID: 1579855 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Clonic convulsion, Contusion, Haematoma, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071819

Write-up: Syncope; Clonic convulsion; Bruise of head; Head hematoma (internal hemorrhage); Vasovagal reaction; This case was received via regulatory authority on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21122691). On an unknown date, the Vasovagal reaction patient received the 1st dose of this vaccine. On an unknown date, body temperature before the 2nd dose vaccination: unknown. On 30-Jul-2021, at 14:04, the patient received the 2nd dose of this vaccine. At 14:07, the patient had syncope and clonic convulsions for several seconds after vaccination. The patient suffered a bruised head. The patient''s level of consciousness recovered spontaneously thereafter. It is thought to be a vasovagal reaction. A hematoma was found in the patient''s head, and the patient was urgently transferred. The outcome of syncope, clonic convulsion, bruise of head, head hematoma (internal hemorrhage), vasovagal reaction was unknown. Follow-up investigation will be made.; Reporter''s Comments: It is thought to be a vasovagal reaction. There were head bruise and internal hemorrhage, and it was made to be the urgently transport.; 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: 1579859 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Hyperventilation, Pyrexia, Seizure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071827

Write-up: Transient convulsion; Hyperpnoea; Pyrexia; Chills; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP071827) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician, was received by Takeda Pharmaceutical Company Limited via Moderna''s adverse reaction reporting site (TASK0020647). Transient convulsion was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of the vaccine. On 30-Jul-2021, at 14:30, the patient received the 2nd dose of the vaccine. At 15:00, the patient experienced pyrexia of 38.5 degrees Celsius 30 minutes after the vaccination. Although there was a possibility of transient convulsion associated with chills, the symptoms did not improve after observation and were accompanied by hyperpnea. Therefore, the patient received treatment at a hospital. The outcome of pyrexia, chills, transient convulsion, and hyperpnea was reported as recovered. Follow-up investigation will be impossible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 29-year-old female hospitalized with a serious unexpected event of seizure, and non-serious pyrexia, chills, and hyperventilation. Event latency 30 minutes after second dose mRNA-1273. Events resolved. Based on 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.


VAERS ID: 1579861 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: JPTAKEDA2021TJP071831

Write-up: Bradycardia; Vasovagal reaction; This case was received via Regulatory Authority (Reference number: 2021TJP071831) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020657). Bradycardia was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 30-Jul-2021, at 09:10, the patient received the 1st dose of this vaccine. At 09:15, several minutes after the vaccination, the patient had facial pallor, and decreased blood pressure and bradycardia developed. The symptoms were judged as vasovagal reaction. The patient recovered after bed rest. The outcome of vasovagal reaction and bradycardia was reported as recovered. Follow-up investigation will be impossible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: 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: 1579879 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-30
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy (banana); House dust allergy (house dust); Seafood allergy (crustacean)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071920

Write-up: Anaphylaxis (redness, pruritus, dyspnoea, blood pressure decreased); This case was received via Pharmaceuticals (Reference number: 2021TJP071920) on 31-Jul-2021 and was forwarded to Moderna on 12-Aug-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21122676). On 22-Jun-2021, at 11:45, the patient received the 1st dose of this vaccination. The patient had a generalized pruritus and dyspnoea after the vaccination. On an unknown date, body temperature before the vaccination: unknown. On 30-Jul-2021, at 12:02, the patient received the 2nd dose of this vaccination. At 12:05, the patient developed skin redness, pruritus, dyspnoea, and a decrease in blood pressure down to 70 range. Anaphylaxis was considered. The symptoms improved with adrenaline and antihistamine. The patient was hospitalized. The outcomes of anaphylaxis (redness, pruritus, dyspnoea, blood pressure decreased) was resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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.


VAERS ID: 1579946 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Allergy to nuts; Dust allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: echo; Result Unstructured Data: Test Result:thrombosis; Comments: Inflammation and blood clot in vein: thrombosis
CDC Split Type: NLPFIZER INC202101026451

Write-up: Pain in my right leg/thrombosis; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number NL-LRB-00656419. A 26-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Patient age at vaccination was 26-year-old. Medical history included allergy: hazelnuts, cats, dust, pollen. Patient did not have previous COVID-19 infection. Historical vaccine included 1st dose of BNT162B2 on 26Jun2021 for COVID-19 immunisation and experienced dizziness. The patient''s concomitant medications were not reported. The patient experienced deep vein thrombosis leg (life threatening) following administration of covid-19 vaccine on 30Jul2021. Deep vein thrombosis leg started 5 hours after starting BNT162B2. Clinical course was reported as a few hours after the vaccination patient got pain in right leg below knee, a few hours later it was hard, red and warm. After a doctor''s visit and ultrasound, it was determined that patient a thrombosis. Deep vein thrombosis leg was treated with anticoagulant injections. Patient underwent ultrasound on 30Jul2021 result was that an infection had developed and a blood clot was stuck in vein. Blood thinner injections prescribed by the doctor. The patient had not recovered from deep vein thrombosis leg. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected.; Reporter''s Comments: ADR: A few hours after the vaccination I got pain in my right leg below my knee, a few hours later it was hard, red and warm. After a doctor''s visit and ultrasound, it was determined that I have a thrombosis BSN available: yes confounding factors, allergy: Hazelnuts, cats, dust, pollen Previous COVID-19 infection: No diagnostic procedures: Ultrasound, result is that an infection has developed and a blood clot is stuck in my vein. Blood thinner injections prescribed by the doctor.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101039227 same patient/drug, different dose/event


VAERS ID: 1580048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-30
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101026745

Write-up: Faint; Nausea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-068237. A 36-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 29Jun2021 (Lot Number: FD4555) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced faint on an unspecified date, nausea on 30Jul2021. The clinical course was as follows: The nausea developed the day after vaccination. The feeling of nausea caused the man to faint for 30 seconds and fall into a bookshelf. The man has reported hospitalisation but no further details were provided. The events were assessed as serious, life threatening, hospitalization. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1581939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Respiratory distress, Stridor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101007394

Write-up: Anaphylactic reaction; Respiratory distress; Abdominal pain; Stridor; This is a spontaneous report from a contactable other health professional via the Administration (TGA). Regulatory authority report number is 595262. A 44-years-old female patient received unknown dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced abdominal pain, anaphylactic reaction, respiratory distress and stridor. The outcome of events abdominal pain, anaphylactic reaction, respiratory distress and stridor was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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