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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 506 out of 8,753

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VAERS ID: 1740464 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE426 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Hyperhidrosis, Influenza like illness, Local reaction
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no history of any reaction.
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: mild fever less than 38 degree celcius; Test Date: 20210915; Test Name: Blood pressure; Result Unstructured Data: 145/92 mmHg, Elevated
CDC Split Type: ZAJNJFOC20210945002

Write-up: SEVERE LOCAL REACTION; ELEVATED BLOOD PRESSURE 145/92; FLU LIKE SYMPTOMS; SWEATING; This spontaneous report received from a health care professional concerned a 45 year old female . The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient had no history of any reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE426, expiry: MAY-2023) dose was not reported, 1 total, administered on 14-SEP-2021 at 15:30 as prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced severe local reaction, pain, redness, swelling more than 5 cm/ swelling on the injection site ,hardness/ induration at the injection site, and also also experienced elevated blood pressure145/92, flu like symptoms, fever, general body malaise and sweating. Laboratory data included: Blood pressure (NR: not provided) 145/92 mmHg and body temperature (NR: not provided) mild Fever less than 38 degree celcius. On 17-SEP-2021, the patient experienced hardness around vaccination site, swelling on injection site and redness around vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, elevated blood pressure 145/92, severe local reaction, and sweating. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210945002-Covid-19 vaccine ad26.cov2.s-Severe local reaction, elevated blood pressure 145/92, flu like symptoms and sweating. This event(s) is considered unassessable. The event(s) has an 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: 1740465 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE430 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Coma scale, Heart rate, Loss of consciousness, Oxygen saturation, Physical examination
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? 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: Hypertension
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Blood pressure; Result Unstructured Data: 211/107 mmHg; Test Date: 20210915; Test Name: Pulse rate; Result Unstructured Data: 80 beats/min; Test Date: 20210915; Test Name: Oxygen saturation; Result Unstructured Data: 99 %, 99%; Test Date: 20210915; Test Name: Physical examination; Result Unstructured Data: Unresponsivness; Comments: Both pupils constricted and unresponsive to light; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: 75 mmol/L; Test Date: 20210915; Test Name: Glasgow coma scale; Result Unstructured Data: 3/15; Comments: E1V1M1; Test Date: 20210915; Test Name: Physical examination; Result Unstructured Data: Normal; Comments: normal s1s2 , normal breath sounds; Test Date: 20210915; Test Name: Pulse rate; Result Unstructured Data: 71 beats/min
CDC Split Type: ZAJNJFOC20210945060

Write-up: COLLAPSE POST VACCINATION; This spontaneous report received from a pharmacist concerned a 49 year old female of unspecified ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hypertension. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE430, and expiry: MAY-2023) 0.5 ml, 1 total administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, 10 minute after vaccination patient collapsed and was transferred to hospital where she was resuscitated. The patient was unresponsive. The patient had secretions through mouth. In CNS(Central nervous system) examination, both the pupils constricted and unresponsive to light. The chest was clear. The patients S1S2 was normal and normal breath sounds. As per reporter, patient was suspected to have CVA (cerebrovascular accident). The patients IV opened. The patient was put on oxygen by nasal prongs and continued with suction if secretions reoccur. Laboratory data included: Blood glucose (NR: not provided) 75 mmol/L, Blood pressure (NR: not provided) 211/107 mmHg, Glasgow coma scale (NR: not provided) 3/15(E1V1M1), Oxygen saturation (NR: not provided) 99%, Pulse rate (NR: not provided) 71 beats/min, 80 beats/min. Treatment medications (dates unspecified) included: furosemide and amlodipine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapse post vaccination was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210945060-covid-19 vaccine ad26.cov2.s-collapse post vaccination. 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: 1740552 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest scan, Echocardiogram, Electrocardiogram, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: prescribed colchicine for pericaritis


VAERS ID: 1742294 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-09-15
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: SARs-COV-test; Test Result: Positive ; Test Date: 20210916; Test Name: SARs-COV-test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101240089

Write-up: Covid-19 positive in vaccinated patient; vaccination failure; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, (Lot Number: FD7959), via an unspecified route of administration on 05Jul2021 as single dose, received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE8405) via an unspecified route of administration on 26Jul2021 as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Sep2021, in a pharmacy patient tested positive antigen test and had tested positive again on 16Sep2021, in an antigen test at health centre. Patient had mild symptoms, like those of a cold: cough and mucus, without fever. Reporter assessed event as serious because of ASTL. The outcome of the event was unknown.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events COVID-19, vaccination failure and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available., Linked Report(s) : ES-PFIZER INC-202101240157 Same reporter, same event, different patients21411.


VAERS ID: 1742450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Headache, Pain, SARS-CoV-2 test
SMQs:, 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; Comments: Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217897

Write-up: Swollen armpit; Headache; Body aches; Chills; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-APPCOVID-20210916065218, Safety Report Unique Identifier GB-MHRA-ADR 25949625. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not reported), via an unspecified route of administration on 14Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected covid-19 from 29Jul2021 to 10Aug2021. The patient''s concomitant medications were not reported. The patient experienced body aches, chills and headache on 15Sep2021 and also experienced swollen armpit on 16Sep2021. It was reported that patient recently recovered from COVID-19 and got second dose of vaccine after 6 weeks of first developing symptoms/testing positive. The side effects described are from the second dose. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-COV-2 test): positive (Yes - Positive COVID-19 test) on 29Jul2021. The case was assessed as serious- medically significant. The outcome of the events body aches, swollen armpit was not resolved, events headache was resolved on 15Sep2021 and chills resolved on 16Sep2021. 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-MHRA-ADR 25949625 MHRA


VAERS ID: 1742574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Pallor, Photophobia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217907

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109152207397370-JYKXA; safety report unique identifier: GB-MHRA-ADR 25948513). A 35-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration, in Sep 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. The patient experienced bleeding (medically significant) on Sep 15, 2021. Patient has usually very light/spotting only once every few months. But within a couple of hours of the vaccination, she had a heavy period. This was her first heavy period in over 3 and a half years. Patient not enrolled in a clinical trial. The outcome of bleeding: not recovered; and other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1742580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis, Eye swelling, Ocular hyperaemia, Pruritus, SARS-CoV-2 test, Vaccination site inflammation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101217743

Write-up: Reaction around my eyes; Itchy; Redness of eyes; Eyes swollen; Interface dermatitis; 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-202109160012160470-B0Z4S, Safety Report Unique Identifier GB-MHRA-ADR 25948826. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 15Sep2021 as Dose 1, Single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine.Patient was not enrolled in clinical trial.On an unspecified date, the patient had reaction around her eyes, redness, itchy and swollen. On 15Sep2021, the patient experienced interface dermatitis.The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The reporter considered the events as serious (medically significant). The outcome of event interface dermatitis was recovering while the outcome of the other events unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101233498

Write-up: Dizzy spells; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109190816246130-DXFDC with Safety Report Unique Identifier GB-MHRA-ADR 25965915. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 14Sep2021 as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 unknown if ongoing, it was unsure when symptoms started and unsure when symptoms stopped. The patient did not have a COVID-19 test. The patient was not enrolled in the clinical trial. On 15Sep2021, 1 day after the vaccination, the patient experienced dizzy spells and it was reported as serious for being medically significant. The clinical outcome of the event dizzy spells was recovered on 16Sep2021, after the duration of 1 day. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742693 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Malaise, Migraine, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; Fatigue; Muscle ache; Malaise; Chills; Fever; Migraine; This case was received via RA (Reference number: -MHRA-ADR 25965918) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), RASH (Rash), FATIGUE (Fatigue), MYALGIA (Muscle ache), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Fever) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), MALAISE (Malaise) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 16-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 17-Sep-2021, CHILLS (Chills) had resolved. On 18-Sep-2021, MYALGIA (Muscle ache) was resolving, PYREXIA (Fever) had resolved. At the time of the report, MIGRAINE (Migraine), RASH (Rash) and FATIGUE (Fatigue) had not resolved and MALAISE (Malaise) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided Treatment medication were not reported. Patient had developed the delayed rash 8 or 9 days after first dose. Patient had developed the rash again and only one day after second dose of vaccination despite the nurse telling that it wouldn''t happen again. The patients symptoms were much worse after the second dose and had been so ill so that patient was bed bound after having it. Company Comment : This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine and malaise, and expected event Pyrexia, Rash, Fatigue Myalgia and Chills.. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was positive for the event rash. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine and malaise, and expected event Pyrexia, Rash, Fatigue Myalgia and Chills.. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was positive for the event rash. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1742700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 2 - / 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.MOD20213

Write-up: Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25965966) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 16-Sep-2021, PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Company Comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the expected event of pyrexia. The event occurred approximately 1 day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the expected event of pyrexia. The event occurred approximately 1 day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1743200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Genital haemorrhage
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: JPMODERNATX, INC.MOD20213

Write-up: Irregular bleeding; This case was received via Pharmaceutical Company (Reference number: JP-TAKEDA-2021TJP091286) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a consumer via a medical representative. On an unknown date, the patient received the 1st dose of this vaccine. On 15-Sep-2021, irregular bleeding developed. The specific symptoms, course, and treatment were unknown. A causal relationship with this vaccine was also unknown. The outcome of irregular bleeding 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.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of genital haemorrhage. The event occurred on an unknown date after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1743247 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-09-15
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Influenza, Pain, Pyrexia, SARS-CoV-2 test, Tachycardia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: RTK; Result Unstructured Data: Test Result:Positive; Test Date: 20210916; Test Name: RT-PCR; Result Unstructured Data: Test Result:Positive
CDC Split Type: MYPFIZER INC202101223248

Write-up: tested positive for RT-PCR & RTK testes on 16SEP2021; tested positive for RT-PCR & RTK testes on 16SEP2021; The patient experienced high fever on 15SEP2021; The patient experienced cough on 15SEP2021; The patient experienced flu on 15SEP2021; The patient experienced body ache on 15SEP2021; The patient experienced tachycardia on 15SEP2021; This is a spontaneous report from a contactable physician (patient) via Pfizer. A 28-years-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: EP2163) via intramuscularly in left arm on 04Mar2021 at 13:45 (at the age of 28-years-old) as single dose for COVID-19 immunization and received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: EP2163) via intramuscularly in left arm on 25Mar2021 at 10:45 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. It was reported that the Comirnaty vaccine was ineffective. The patient tested positive for RT-PCR & RTK testes on 16SEP2021 and the patient believes it could be due a close contact from patient at his workplace. On 15Sep2021, the patient experienced high fever, cough, flu, body ache and tachycardia. The patient underwent lab tests and procedures which included RTK and RT-PCR tests both results positive on 16Sep2021. Therapeutic measures were taken as a result of all the events. Treatments received for the events were Para-acetaminophen, Augmentin, Pantoprazole and Cetirizine. The outcome of all the events was not recovered.; Sender''s Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Covid-19.


VAERS ID: 1743345 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210951451

Write-up: VACCINATION FAILURE; COVID-19; This spontaneous report received from a health care professional by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-B202109-1714) on 27-SEP-2021 concerned a 24 year old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 0.5 ml, 01 total, administered on 19-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On an unspecified date, the patient experienced anosmia, ageusia, cough and headaches. On 15-SEP-2021, the patient experienced vaccination failure, covid-19, and Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive Iu (international unit )(s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-Positive RT PCR test on 15-Sep-2021 Anosmia, ageusia, cough and headaches


VAERS ID: 1744898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Malaise, Myalgia, Nausea, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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)

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: DAFALGAN
Current Illness:
Preexisting Conditions: Comments: Immunodeficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210951457

Write-up: NAUSEA; STABBING ABDOMINAL PAIN; SHIVERING; STINGING; HEADACHE; FEELING UNWELL; MUSCLE PAIN; FEVER; FATIGUE; This spontaneous report received from a consumer via Regulatory Authority (BE-FAMHP-DHH-N2021-106759) on 27-SEP-2021 was received on 27-SEP-2021 and concerned a 35 year old female of unspecified race and ethnic origin. The patient''s weight was 64 kilograms, and height was 183 centimeters. The patient''s pre-existing medical conditions included: Immunodeficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 117529J expiry: UNKNOWN) dose was not reported, 1 total administered on 14-SEP-2021 for covid-19 immunisation. Concomitant medications included paracetamol. On 15-SEP-2021, the patient experienced nausea, stabbing abdominal pain, shivering, stinging, headache, feeling unwell, muscle pain, fever and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, nausea, stabbing abdominal pain, shivering, stinging, headache, feeling unwell, muscle pain, and fever. This report was serious (Disability or Permanent Damage).


VAERS ID: 1746043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-09-15
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Polymerase chain reaction, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC202101262602

Write-up: Herpes zoster; Facial swelling; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority WEB, regulatory authority number ES-AEMPS-1006294. An adult non-pregnant female patient of unspecified age received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA8142, Expiry date: unknown) via an unspecified route of administration on 25May2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19. The patient concomitant medications were not reported. The patient was not pregnant at the administration of the vaccination. On 15Sep2021 the patient experienced herpes zoster (medically significant) and facial swelling. The patient was not hospitalized. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 17Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1746636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
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: GBPFIZER INC202101225453

Write-up: Heavy periods; painful period; was not due to start for another week; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202109160900231330-IFTUZ, Safety Report Unique Identifier GB-MHRA-ADR 25950889. A female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number was not reported), via an unspecified route of administration at single dose on 14Sep2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient reported that she used to have light periods normally but the next day after the vaccine, on 15Sep2021, the patient suffered a very heavy painful period. Patient was not due to start for another week. The events were reported as serious for being medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient had not recovered from heavy periods and painful period, while outcome of "was not due to start for another week" was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746646 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Inappropriate schedule of product administration, Loss of consciousness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225272

Write-up: passed out; felt faint; Fainting; received first dose on 26Jun2021/received second dose on 15Sep2021; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160924512930-0KZBM, Safety Report Unique Identifier GB-MHRA-ADR 25951306. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FG3712; expiration date not provided) via an unspecified route of administration on 15Sep2021 (at the age of 29-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included suspected COVID-19 from 03Jul2021 to 15Jul2021. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced ''passed out'' and felt faint on unspecified dates; fainting on 16Sep2021; ''received first dose on 26Jun2021/received second dose on 15Sep2021'' on 15Sep2021. Patient''s clinical course is as follows: Patient reported that she felt fine when she woke up in the morning, got the train to work and felt faint on the train, then passed out getting off train. Patient was thankful that it was very busy so lots of people stopped to help. Patient mentioned that she never fainted before and have felt faint but never actually passed out. The event ''received first dose on 26Jun2021/received second dose on 15Sep2021'' was assessed as non-serious; the remaining events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''positive; Yes - Positive COVID-19 test'' on 05Jul2021. Outcome of the event ''fainting'' was recovered on 16Sep2021''; outcome of the events ''passed out'' and ''felt faint'' was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746671 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Nausea, Photophobia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101225271

Write-up: weak; nausea; dizziness; Vomiting; Photophobia; temperature - hot and cold; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109161024088850-OVKIY, Safety Report Unique Identifier : GB-MHRA-ADR 25951639. A 14-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 15Sep2021 (at the age of 14 years old) as dose 1, single (At the age of 14 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient is not pregnant nor not currently breastfeeding. The patient experienced nausea, photophobia, dizziness, temperature - hot and cold, park (unclear and cannot be clarified), and vomiting on 15Sep2021; and weak on 17Sep2021. Clinical course was reported as follows: nausea within 5 mins of vaccine. Fine for 4 hours then temperature - hot and cold, park, dizziness and more nausea. Vomiting began at 6pm on and until 4am the next day. Following day weak, feel nauseous. The events were considered medically significant. The patient underwent lab tests and procedures which included COVID 19 virus test: negative on 13Sep2021. The patient was recovering from the events, nausea, photophobia, dizziness, and vomiting and outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746688 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Feeling hot, Headache, Inappropriate schedule of product administration, Nausea, Peripheral coldness, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225432

Write-up: Hand swelling; Inappropriate schedule of vaccine administered; Chest pain; Chills; Hands, feet and nose feel cold; the body and forehead feel warm; Joint ache; Nausea; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202109161113587270-PEPGW, Safety Report Unique Identifier: GB-MHRA-ADR 25951877. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Sep2021 (Lot Number: FE3380) as DOSE 2, SINGLE for COVID-19 immunisation. The patient was 27-years-old at the time of vaccination. Medical history included steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). 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 previously took Preventer inhaler beclometasone dipropionate (KELHALE) x2 daily (x1 morning; x1 night). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient had no initial symptoms within the first 6 hours. Around 12 hours later, the symptoms started. The patient experienced headache on 15Sep2021. On 16Sep2021 she had chest pain which started around 16 hours later in the right side and chills increased to feeling like she can''t get warm; hands, feet and nose feel cold; however, the body and forehead feel warm. Patient also had nausea and joint ache on 16Sep2021. The patient also experienced hand swelling on an unspecified date. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 12Sep2021. The outcome of hand swelling was recovering, the body and forehead feel warm was unknown, while the events headache, chest pain, chills, hands and feet and nose feel cold, joint ache and nausea had not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (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: GBPFIZER INC202101225474

Write-up: Lymph nodes enlarged; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202109161221306520-TBOUL, Safety Report Unique Identifier is GB-MHRA-ADR 25952260. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (lot number: Ff8222) 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, not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient experienced lymph nodes enlarged on 15Sep2021 with outcome of not recovered. Event was reported as serious by health authority (disability and medically significant). She has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.~


VAERS ID: 1746832 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Heart rate increased, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225003

Write-up: Heart rate high; Bloated feeling; Muscle ache; Injection site pain; Fever; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109170222541960-4RSYD. Safety Report Unique Identifier GB-MHRA-ADR 25956619. A 27-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/ Lot number was not reported) via an unspecified route of administration on 15Sep2021 (at the age 27-years-old) as single dose for COVID-19 immunization. Medical history included COVID-19 on 17Aug2021. Concomitant medication was not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/ Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On 15Sep2021 (after 1 day of vaccination), patient experienced fever, muscle ache and injection site pain. On 16Sep2021 (after 1 day of vaccination), patient experienced bloated feeling. On 17Sep2021 (after 2 days of vaccination), patient heart rate high. All events were medically significant. Lab test on 17Aug2021 included COVID-19 virus test : Positive. The outcome of event muscle ache, injection site pain was resolving and all other events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (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: Wheezy
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217792

Write-up: Headache; Numbness; Nausea; This is a solicited report from the regulatory authority from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202109151336259010-6UJZS, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25945557. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (Lot Number: FF2153) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included wheezing. 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. Concomitant medication included salbutamol sulfate (VENTOLIN [SALBUTAMOL SULFATE]) taken for wheezing. The patient experienced headache, numbness, and nausea on 15Sep2021. The events were considered serious: medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 13Sep2021. The outcome of numbness was not recovered while the other events were recovering. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the events headache, numbness, nausea and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1746880 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224636

Write-up: Sore throat; Headache; This is a solicited report from the regulatory authority program from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202109161119322260-KROTJ and Safety Report Unique Identifier GB-MHRA-ADR 25951864. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Sep2021 (at age of 16-years-old) as dose 1, single for COVID-19 immunisation. Medical history was not reported as none. The patient''s concomitant medications were not reported. On 15Sep2021, the patient experienced headache and sore throat. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 12Sep2021. The outcome of the events was not recovered. Additional information: Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The reporter''s assessment of the causal relationship of the ''Headache'' and ''Sore throat'' with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Headache, Oropharyngeal Pain)and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1746887 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-09-15
   Days after vaccination:114
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR; Test Result: Positive ; Comments: Nasal Swab result received on 17Sep2021
CDC Split Type: GBPFIZER INC202101223318

Write-up: Tested positive for COVID-19 by PCR on the 16th of September 2021; Tested positive for COVID-19 by PCR on the 16th of September 2021; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient of an received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 04May2021 (Lot Number: ET3620; Expiration Date: 30Jun2021) (at the age of 48-years old) as dose 1, single and intramuscular, administered in left arm on 24May2021 (Lot Number: ET1831; Expiration Date: 30Jun2021) (at the age of 48-years old) as dose 2, single for covid-19 immunisation. Medical history was none. The patient did not receive concomitant medications within 2 weeks of vaccination. 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 and since the vaccination, the patient had been tested for COVID-19. The patient first noticed the symptoms of runny nose and headache on 15Sep2021. He then tested positive for COVID-19 by PCR (polymerase chain reaction) by nasal swab on the 16Sep2021 (result received on 17Sep2021). The patient did not receive treatment for the events. The outcome of the events was recovering. Investigation conclusion for lot number: ET3620, Expiration Date: 30Jun2021: The complaint for adverse event/LOE of ''PFIZER-BIONTECH COVID-19 VACCINE'' was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET3620. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Investigation conclusion for lot number: ET1831, Expiration Date: 30Jun2021: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ''ET1831''. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1746933 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-09-15
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 antibody test; Test Result: Positive ; Test Date: 20210830; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210915; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: carries the L452R mutant strain but does not carry the N501Y or E484K mutant genes
CDC Split Type: HKPFIZER INC202101275902

Write-up: tested positive for covid-19 with no symptoms; tested positive for covid-19 with no symptoms; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: not applicable), based on information received by Pfizer (manufacturer control number: HK-Fosun-2021FOS003588), license party for bnt162b2 (COMIRNATY). The Regulatory Authority announced that as of 0.00 am, 17-Sep-2021, the RA was investigating a positive imported case of COVID-19 and two overseas cases of COVID-19. This case was created for the imported case of COVID-19. This is one of three reports received from the same reporter and this case has been linked with others. A 53-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 15Sep2021, the patient was tested positive for covid-19 with no symptoms (asymptomatic covid-19) (vaccination failure). As per the detailed information, on 21Aug2021, the patient''s blood specimen tested positive for anti-spike protein antibody (COVID-19 antibody test was negative). The patient travelled on 31Aug2021 by flight on 30Aug2021 (COVID-19 virus test was negative). The patient returned on 13Sep2021 by flight and his specimen collected upon arrival in the Regulatory Authority on the same day tested negative. Subsequently, the patient''s sample collected on 15Sep2021, which tested positive for COVID-19 (COVID-19 virus test was positive) and carried the L452R mutant strain but did not carry the N501Y or E484K mutant genes. The patient remained asymptomatic. The events were reported as serious with seriousness criteria as other medically important condition. The outcome for asymptomatic covid-19 was unknown at the time of report. Drug: Comirnaty Causality Assessments: Asymptomatic COVID-19, Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1747144 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Nausea, Somatic symptom disorder, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Anaemia; Depression (Rivotril, Tsumura 54, taking orally); Hyperphagia; Nervous
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101220526

Write-up: psychogenetic; Vomiting/vomited twice; pain at vaccination site; headache; queasy; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21126972. The patient was a 27-year and 3-month-old female (age at vaccination). Body temperature before vaccination was 36.6 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included Depression: Rivotril, Tsumura 54, both ongoing, taking orally (concomitant medication); hyperphagia and nervous; anaemia easily occurs with blood draw and injection. On 18Aug2021, after first dose of COVID-19 vaccine, queasy and vomiting were present. Originally, the patient vomits with hyperphagia and nervous. The patient told that anaemia easily occurs with blood draw and injection. Symptoms improved in about 30 minutes, so went home. On 18Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number was not provided). On 15Sep2021 at 11:05 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Sep2021 at 11:20 (15minutes after the vaccination), the patient experienced Vomiting. On 15Sep2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: Since queasy and vomiting were present after the first dose, the patient was asked to lay on bed immediately after the second dose on 15Sep2021. After about 5 minutes (11:10), the patient started to feel pain at vaccination site, headache and queasy appeared too. 15 minutes after vaccination, patient vomited twice. Since vomiting persisted, drip infusion of Primperan 10mg 1A + Normal Saline 100m were performed. Since the headache was intense, the patient took her Loxonin and stomach medicine. 30 minutes after drip infusion, headache and queasy improved. No fuzzy feeling. Family member came to pick and went home together. The reporting physician non-serious and assessed that the causality between the events and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was psychogenetic. Therapeutic measures were taken as result of all the events. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1747170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Skin abrasion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101227787

Write-up: Syncope; Left elbow abrasion; Right knee, right foot arthralgia; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 12 years old male patient on 11Sep2021 (the day of vaccination), received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration for COVID-19 immunization. On 15Sep2021 (4 days after vaccination), the patient fell down on a bicycle after school. When the patient noticed that he fell, he did not remember that there was a fence. A bicycle was pressed on the patient. The patient experienced left elbow abrasion and right knee, right foot arthralgia. According to the patient''s mother, she was not as energetic as usual. Sometimes the patient made a dissatisfaction sound. The patient''s appetite was normal. A nearby person saw the patient fell on a bicycle, so he thought the patient was hit. The person wanted to escape, and then the patient regained consciousness when he called a phone. The patient may have fallen and hit his head caused by syncope. Patient visited the hospital on 16Sep2021. The patient recovered from syncope on an unspecified date. Outcome of other reported events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events of Syncope cannot be completely excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1750916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-15
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual 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: Suspected COVID-19; Comments: Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20201005; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:not tested positive; Comments: since having the vaccine
CDC Split Type: GBPFIZER INC202101225266

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160933432350-JVIJB, Safety Report Unique Identifier is GB-MHRA-ADR 25951305. A 31-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 27Jul2021 (Lot Number: ff3319) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 28Sep2020 to 19Oct2020 (no longer ongoing). The patient had positive COVID-19 virus test on 05Oct2020. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 15Sep2021, the patient experienced heaviest period she has ever had in her life, usual levels of pain but the volume of blood was unprecedented. Patient has not tested positive for COVID-19 on unspecified date in 2021 since having the vaccine. The outcome of the event heavy periods was not recovered. The event was considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1750931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fibrin D dimer, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; SALAMOL [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000; Comments: D-dimer was not $g4000; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225170

Write-up: shortness of breath; chest pain; Pulmonary embolus; This is a spontaneous report from a contactable other hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202109161259545860-RLUCA, Safety Report Unique Identifier GB-MHRA-ADR 25952541. A 32-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Sep2021 as dose 2, single for COVID-19 immunisation. Medical history included non-tobacco user. Patient has not had symptoms associated with COVID-19. The patient had no history of, or current of malignancy. Concomitant medication(s) included beclometasone dipropionate (CLENIL MODULITE) taken for asthma, start and stop date were not reported and salbutamol sulfate (SALAMOL [SALBUTAMOL SULFATE]) taken for asthma, start and stop date were not reported. The patient received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced shortness of breath and chest pain. On 15Sep2021, the patient experienced pulmonary embolus. Patient admitted to hospital with chest pain and shortness of breath. Discovered to have PE. This report was related to possible blood clots or low platelet counts and the event was specified as pulmonary embolus. There was no platelet count <150 A109/L. D-dimer measured on 15Sep2021. Identification of anti-PF4 antibodies were reported as Unknown. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included fibrin d dimer: d-dimer was not $g4000 on 15Sep2021 and sars-cov-2 test: negative on an unspecified date. The outcome of the event pulmonary embolus was not recovered and unknown for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1750962 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dyspnoea, Pain, SARS-CoV-2 test, Sleep disorder, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: Test Result:Elevated; Test Date: 20210917; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101227140

Write-up: difficulty breathing; unable to sleep; Temperature elevation; Wheezy; Ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109170903138230-FMLWE, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25957731. A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Sep2021 (at the age of 25 years old) (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced difficulty breathing (medically significant) on an unspecified date with outcome of not recovered , temperature elevation (medically significant) on 15Sep2021 with outcome of recovered on 17Sep2021, wheezy (medically significant) on 15Sep2021 with outcome of not recovered , ache (medically significant) on 15Sep2021 with outcome of not recovered , unable to sleep (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab test which included sars-cov-2 test: negative on 17Sep2021. Patient has not had symptoms associated with COVID-19. Patient has 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: 1750985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226928

Write-up: Skin rash; Measly rash; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109171134474650-4RCCK, Safety Report Unique Identifier is GB-MHRA-ADR 25958398. A 20-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on Sep2021 (Lot number and expiry date not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included clinical trial participant. Patient was a clinical trial participant. Patient had not had symptoms associated with COVID-19. Concomitant medications were not reported. The patient experienced skin rash on 15Sep2021 with outcome of not recovered, and measly rash on 15Sep2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant and disabling by the health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1750996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Low platelets
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101227112

Write-up: head pain; Rash; Felt ill shivery; Felt ill shivery; This is a spontaneous report from a contactable consumer received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171221015270-3KJOE, Safety Report Unique Identifier GB-MHRA-ADR 25958793. A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (Batch/Lot Number: FE3380) as single dose for covid-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef), platelet count decreased. The patient''s concomitant medications were not reported. The patient experienced head pain on an unspecified date, rash (red rash down both arms and on my stomach and part of chest) on 17Sep2021. The patient reported she felt ill shivery day after vaccine (15Sep2021). The outcome of rash was not recovered. The outcome of the other events was unknown. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "None" No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750998 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Joint stiffness
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226828

Write-up: Jaw stiffness; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171229233500-DW26B,Safety Report Unique Identifier(GB-MHRA-ADR 25958759). A 40-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Sep2021(at the age of 40-years-old) (Lot Number: FE3380) as dose 2, single for COVID-19 immunization. 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 medical history and concomitant medications were not reported. The patient experienced jaw stiffness (assessed as medically significant) on 15Sep2021 with outcome of not recovered. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751010 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dyspnoea, Inappropriate schedule of product administration, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (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: COVID-19; Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101226877

Write-up: Breathlessness; Red rash; Fever; BNT162B2 first dose on 13Jun2021, second dose on 15Sep2021; rash; Stomach ache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171329486910-LBIZW. Safety Report Unique Identifier GB-MHRA-ADR 25959095. A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Sep2021 (Lot Number: Ff2153) (at the age of 21 years old) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 on unspecified date (not ongoing) unsure when symptoms started and stopped; and COVID-19 on 01May2021 (patient had COVID-19 virus test positive on 01May2021; Yes - Positive COVID-19 test). Patient was not pregnant at the time of vaccination; not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 via unspecified route of administration on 13Jun2021 at single dose for COVID-19 immunization. It was reported that patient received bnt162b2 first dose on 13Jun2021 and second dose on 15Sep2021. On 15Sep2021, the patient experienced fever. On 16Sep2021, the patient experienced breathlessness, and red rash (rash was hot solid and red). The patient experienced rash (unspecified) and stomachache on unspecified date in 2021. Events rash, breathlessness, red rash, fever and stomachache were reported as serious, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event fever, breathlessness and stomachache was recovering; event red rash was not recovered, while event rash was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751034 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Glossodynia, Lip haemorrhage, Lip injury, Lip pain, Lip swelling, Oral pain, Pain in jaw, SARS-CoV-2 test, Swollen tongue, Tongue discomfort
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101227048

Write-up: Swollen lips; Swollen tongue; Lips started to sting slights; Lips started to sting slights and they were bleeding; lips/seemed cut / cracked; Tongue felt as if it had been burnt and is stinging also; Tongue felt as if it had been burnt and is stinging also; mouth and jaw also ached; mouth and jaw also ached; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171629150960-IM27K, Safety Report Unique Identifier GB-MHRA-ADR 25960133. A 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FF2153), via an unspecified route of administration on 15Sep2021 (at the age of 21-year-old) 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. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient experienced swollen lips, swollen tongue, lips started to sting slights and they were bleeding, lips/seemed cut / cracked, tongue felt as if it had been burnt and was stinging also, mouth and jaw also ached on 15Sep2021. The events were reported as serious as important medical events. The clinical course of the events as reported as follows: lips started to sting slights and they were bleeding and seemed cut / cracked - blood shot almost. Tongue felt as if it had been burnt and was stinging also. Lips then began to swell and the pain got worse, mouth and jaw also ached. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 16Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751101 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Lymphadenopathy, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226684

Write-up: Swollen lymph nodes; Flu like symptoms; Vomiting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109180031481360-MNA1A. Safety Report Unique Identifier GB-MHRA-ADR 25962530. A 23-years-old female patient received second dose of bnt162b2 (PFIZER- BIOTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot number: Not reported) dose 2 via an unspecified route of administration, administered on 15Sep2021 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation. Patient did not had symptoms associated with covid-19, patient was not currently breastfeeding. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER- BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported) dose 1 via an unspecified route of administration, administered on unspecified date as dose 1, single for covid-19 immunisation. It was reported that on 15Sep2021 the patient experienced vomiting. On 16Sep2021 the patient experienced swollen lymph nodes, flu like symptoms. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 16Sep2021 the patient underwent lab tests and procedures which included covid-19 virus test which was resulted as negative (No - Negative COVID-19 test). The patient was not recovered from the event of swollen lymph nodes. The patient was recovering from the events of vomiting, flu like symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751141 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA0127 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Headache, Influenza, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: CO-CODAMOL; SERTRALINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Head injury.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101226992

Write-up: 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-202109181148344990-Z6DCS), Safety Report Unique Identifier (GB-MHRA-ADR 25964624). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FA0127), via an unspecified route of administration, on 15Sep2021, at single dose, for COVID-19 immunization. Relevant medical history included head injury from an unknown date, depression from an unknown date. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) taken for head injury from 2021 to an unspecified stop date; sertraline taken for depression from 01Oct2018 to an unspecified stop date. The patient experienced cough (medically significant) on 17Sep2021 with outcome of not recovered, headache (medically significant) on 15Sep2021 with outcome of not recovered, flu (medically significant) on 16Sep2021 with outcome of recovering, weakness (medically significant) on 15Sep2021 with outcome of not recovered and nausea (medically significant) on 16Sep2021 with outcome of not recovered. The patient has been tested for COVID-19 on an unspecified date and resulted negative.No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751205 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Diarrhoea, Fatigue, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101227110

Write-up: Bruising of leg; Nausea; Diarrhea; Fatigue extreme; Migraine; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109190021024970-TJSVQ, Safety Report Unique Identifier GB-MHRA-ADR 25965292. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose number unkown, via an unspecified route of administration on 14Sep2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, she didn''t have a COVID-19 test, she was not pregnant and was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 15Sep2021 the patient experienced migraine, nausea, diarrhea and fatigue extreme. On 16Sep2021 a bruise to left calf appeared suddenly with no trauma. At the time of the report the event diarrhea was resolving, whereas the other events had not resolved yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751232 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neck mass, SARS-CoV-2 test
SMQs:, 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 ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Neck mass; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25973027) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK MASS (Neck mass) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced NECK MASS (Neck mass) (seriousness criterion medically significant). At the time of the report, NECK MASS (Neck mass) had not resolved. 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 concomitant product was reported. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Had 3 lumps on left hand side of neck (same side as vaccine) not painful but hard and moveable 0.5-1 cm. No treatment information was reported. This case concerns a 26 year old female patient with no medical history reported, who experienced the unexpected serious event of Neck mass, within 7 days after the first dose of mRNA-1273 vaccine. Limited information regarding the event have been provided at this time. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 26 year old female patient with no medical history reported, who experienced the unexpected serious event of Neck mass, within 7 days after the first dose of mRNA-1273 vaccine. Limited information regarding the event have been provided at this time. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1751236 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-09-15
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pericarditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chest pain; Pericarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25973418) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (chest pain) and PERICARDITIS (Pericarditis) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for Vaccination. The patient''s past medical history included Acute pericarditis. Concurrent medical conditions included Asthma. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-Sep-2021 due to CHEST PAIN and PERICARDITIS. At the time of the report, CHEST PAIN (chest pain) and PERICARDITIS (Pericarditis) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Medical history included obesity. Unsure if patient had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant product usage were not provided. On 01-Jun-2021, patient had swelling of injection site. On an unknown date, laboratory test included ECG (Electrocardiogram) and result was not provided. On 15-Sep-2021, patient started with chest pain. Admitted to hospital 16-Sep-2021, diagnosed with acute pericarditis. Treated with ibuprofen and symptoms began to resolve so discharged. Still recovering. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment : This case concerns a 42-year-old, male patient with medical history of Acute pericarditis, Asthma and Obesity, who experienced the unexpected event of Chest pain and the expected event of Pericarditis. The event of Pericarditis occurred approximately 1 month 10 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as limited information was provided about the first dose. The events were considered related to the product per the reporter''s assessment. The event of Pericarditis is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old, male patient with medical history of Acute pericarditis, Asthma and Obesity, who experienced the unexpected event of Chest pain and the expected event of Pericarditis. The event of Pericarditis occurred approximately 1 month 10 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as limited information was provided about the first dose. The events were considered related to the product per the reporter''s assessment. The event of Pericarditis is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1753206 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram, Fall, Loss of consciousness, Malaise, Movement disorder, SARS-CoV-1 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EFFEXOR
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: CT; Result Unstructured Data: Test Result:unknown results; Test Date: 20210920; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: CAPFIZER INC202101266696

Write-up: Neurology assessed me the following day and admitted me to hospital stroke unit.; I felt ill; vomited; unconscious; fell to the floor.; I couldn''t speak; couldn''t move my right side at all; This is a spontaneous report from a contactable consumer or (patient) via RA. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 14Sep2021 11:00 (Batch/Lot Number: Unknown) age at vaccination of 30-years-old, as single dose (dose number unknown)for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Sep2021 (at approx. 8:45PM) the patient felt ill and vomited. Within a few minutes, the patient became unconscious and fell to the floor. A co-worker was able to get wake up and the patient was laying on right side on the floor. The patient was in and out of consciousness and co-worker was asking questions and the patient realized he couldn''t speak. The patient was screaming and trying to stay conscious. He then asked to squeeze his hand and patient couldn''t move right side at all. The paramedics arrived and assessed. The patient continued to be in and out of consciousness. The paramedics took to the hospital under a code stroke protocol. The events resulted in Emergency room/department or urgent care visit. At this point patient was conscious and could hear everything but couldn''t move my right side or speak. The patient arrived at the hospital and before being taken to CT, the ER doctor canceled the stroke protocol. The patient was given IV of benadryl then adavan but neither helped at all. All events were serious as hospitalization, disability and life- threatening conditions. Neurology assessed me the following day and admitted me to hospital stroke unit. The patient remained there until 23Sep2021 (Duration of Hospitalization 8 days) when she was released. Facility where the most recent COVID-19 vaccine was administered: Administration facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 15Sep2021, sars-cov-1 test negative on 20Sep2021 (nasal swab). The patient was not recovered from all events.


VAERS ID: 1755019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-15
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Vaginal haemorrhage
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: GBPFIZER INC202101244934

Write-up: bleeding; Vaginal bleeding; This is a spontaneous report from a contactable other hcp downloaded from the /-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109162044484670-LYZ9W. A 32-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FF3319, expiration date unspecified), via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient is not currently breastfeeding. Patient has not had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced bleeding. On 15Sep2021, the patient developed vaginal bleeding. The patient has never been tested positive for covid-19 since the vaccination. The outcome of the event bleeding was reported as recovering, while the outcome of the event vaginal bleeding was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755036 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Headache, Hyperhidrosis, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
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 INC202101226564

Write-up: Swollen lymph nodes; Sweating; Feeling cold; Swollen arm; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109180906541200-B0Q4S. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FE8087), via an unspecified route of administration on 15Sep2021 (at the age of 32-year-old) as dose 2, single for COVID-19 immunisation. Patient was not currently breastfeeding (at the time of report). The patient medical history was not reported. Patient had not symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 15Sep2021, patient experienced swollen arm and headache. On 16Sep2021, she had swollen lymph nodes, sweating and felt cold. The case was assessed as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clini-cal trial. Not had a COVID-19 test. Outcome of the event headache was resolved on 16Sep2021; sweating and felt cold was resolved on 17Sep2021; and swollen lymph nodes and swollen arm was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstruation irregular, Muscle spasms
SMQs:, Dystonia (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226610

Write-up: cramps; very painful cramps; Irregular menstruation; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109180923147210-BFSYM, Safety Report Unique Identifier GB-MHRA-ADR 25964468. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 13Sep2021 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient med-ical history was not reported. Patient had no symptoms associated with COVID-19, Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. The patient''s concomitant med-ications were not reported. The patient took previously dose one of bnt162b2 via an unspecified route of administration on unspecified date (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced very painful cramps on unspecified date and irregular menstruation/ Unexpected spotting on 15Sep2021. The seriousness of events was assessed as medically significant. The clinical outcome of event irregular menstruation was not recovered and other events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-15
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate decreased, Heart rate irregular, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Heart rate decreased; Result Unstructured Data: Test Result:irregular; Test Date: 20210915; Test Name: Heart rate decreased; Result Unstructured Data: Test Result:irregular
CDC Split Type: GBPFIZER INC202101233736

Write-up: palpitations; irregular heart beat; Pulse irregular; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-202109192111307850-Q2GOD, Safety Report Unique Identifier GB-MHRA-ADR 25966337. A 45-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 27Aug2021 (Batch/Lot Number: FF3319) as DOSE 1, 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, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced palpitations (medically significant) on an unspecified date with outcome of unknown, irregular heart beat (medically significant) on an unspecified date with outcome of unknown, pulse irregular (medically significant) on 15Sep2021 with outcome of not recovered. The patient underwent lab tests and procedures which included heart rate decreased: irregular on unknown date, heart rate decreased: irregular on 15Sep2021. 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: 1755276 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Fatigue, Hypoaesthesia, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101226460

Write-up: swelling in the eye began; numbness in the fingers; fatigue; pain at the injection site; muscle pain; This is a spontaneous report from a contactable consumer. A 23-year-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration at the age of 23-year-old on 15Sep2021 08:00 as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications was none. On 16Sep2021, evening after the injection patient experienced fatigue, pain in the injection site, muscle pain, numbness in the fingers. The day after the vaccination on 16Sep2021, swelling in the eye began and was visiting the doctor on 17Sep2021 and received treatment with an ointment of steroids and antibiotics. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1755619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101228985

Write-up: Angioedema of the upper lip; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number PT-INFARMED-V202109-1682. A 13-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 14Sep2021 (Batch/Lot Number: FG6273) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and no concomitant medications was not reported. The patient experienced angioedema of the upper lip on 15Sep202. Specific treatment of unknown ADRs was taken. According to the additional monitoring list as of 16Sep2021, the medicine is included (last updated on 29Jul2021, EMA/245297/2013 Rev. 91). Outcome of the event was recovering. The reporters assessment of the causal relationship of the (Lip angioedema) with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Migraine, Nausea, Pyrexia, Stomatitis, Vertigo
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: 39.2 C
CDC Split Type: ROJNJFOC20210959921

Write-up: NAUSEA; MIGRAINE; CHILLS; FEVER; STOMATITIS; VERTIGO; This spontaneous report received from a consumer via a Regulatory Authority (RO-NMA-2021-SPCOV12669) was received on 30-SEP-2021 and concerned a 19 year old male of unknown race and ethnicity. The patient''s weight was 68 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: unknown) 1 dosage forms, frequency 1 total administered on 14-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 15-SEP-2021, the patient experienced nausea, migraine, chills, fever, stomatitis and vertigo. Laboratory data included: Body temperature (NR: not provided) 39.2 Celsius. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, migraine, chills, fever, stomatitis, and vertigo. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1756452 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE426 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Skin induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies, no drug abuse/ illicit drug use and no illness at the time of vaccination. The patient experienced no adverse events following any previous vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210954439

Write-up: CELLULITE WAS POSSIBLY SETTING IN; HARD TO TOUCH; This spontaneous report received from a health care professional (nurse) concerned a 32 year old male of unknown ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non-smoker, and patient had no known allergies, no drug abuse/ illicit drug use and no illness at the time of vaccination. The patient experienced no adverse events following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE426 and expiry: MAY-2023) 0.5 ml, frequency 1 total, administered on 15-SEP-2021 at 11:00 to deltoid muscle of left arm for prophylactic vaccination. The product was properly stored from receipt to administration in a temperature condition of 2-8 Degrees Celsius. The vaccine was removed one time from storage for 5 minutes. No concomitant medications were reported. On 15-SEP-2021, 6 hours post vaccination at 17:00, the patient experienced swelling of left arm below elbow. It was hard and hot to touch (cellulite was possibly setting in). The patient was referred to a hospital as cellulite was possibly setting in and for circulation assessment (referred for diagnostics). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard to touch and cellulite was possibly setting in was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210954439-COVID-19 VACCINE AD26.COV2.S ? Cellulite was possibly setting in and hard to touch . 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: 1756463 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0581 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Flushing, Haemoglobin, Haemoglobin decreased, Heart rate, Laboratory test, Loss of consciousness, Oxygen saturation, Respiratory rate
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blackout (patient had similar reaction 3 years ago when he pierces the ear); Flushed (patient had similar reaction 3 years ago when he pierces the ear)
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: BP; Result Unstructured Data: Test Result:123/83 mmHg; Comments: pre vaccination; Test Date: 20210915; Test Name: BP; Result Unstructured Data: Test Result:104/69 mmHg; Comments: post vaccination; Test Date: 20210915; Test Name: Temperature; Result Unstructured Data: Test Result:36.2; Comments: post vaccination; Test Date: 20210915; Test Name: HB; Result Unstructured Data: Test Result:11.7; Comments: post vaccination; Test Date: 20210915; Test Name: pulse; Result Unstructured Data: Test Result:114; Comments: bpm pre vaccination; Test Date: 20210915; Test Name: pulse; Result Unstructured Data: Test Result:81; Comments: bpm post vaccination; Test Date: 20210915; Test Name: GM; Test Result: 4.6 mol; Comments: post vaccination; Test Date: 20210915; Test Name: o2 sats; Test Result: 99 %; Comments: room air post vaccination; Test Date: 20210915; Test Name: RESPIRATION; Result Unstructured Data: Test Result:20; Comments: bpm post vaccination
CDC Split Type: ZAPFIZER INC202101231338

Write-up: Blackout; Flushed feeling; haemoglobin (HB): 11.7 (post vaccination); This is a spontaneous report from a contactable physician. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Sep2021 13:18 (Batch/Lot Number: EY0581; Expiration Date: Nov2021) (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included flushed feeling and black out (reported as had a similar experience 3 years ago when he pierced his ears). The patient''s concomitant medications were not reported. On 15Sep2021, the patient experienced blackout and flushed feeling. The patient underwent lab tests and procedures on 15Sep2021 which included blood pressure (BP): 123/83 mmhg (pre vaccination) and 104/69 mmhg (post vaccination), temperature: 36.2 (post vaccination), haemoglobin (HB): 11.7 (post vaccination), pulse: 114 bpm (pre vaccination) and 81 bpm (post vaccination), GM: 4.6 mol (post vaccination), oxygen saturation: 99 % on room air (post vaccination), and respiration: 20 bpm (post vaccination). On unspecified date, the patient recovered from black out and flushed feeling while outcome of the other event was unknown.


VAERS ID: 1757967 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31045BD / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Off label use
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Constipation
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101234366

Write-up: brutal diarrhea/ completely liquid; reactions to the third dose; reactions to the third dose; This is a spontaneous report from a contactable consumer (patient''s daughter) via Regulatory Authority. A 93-year-old female patient received 3rd dose (booster) of BNT162B2 (COMIRNATY, Lot Number: 31045BD), via an unspecified route of administration on 15Sep2021 08:30 (at the age of 93-year-old) as single dose for COVID-19 immunisation. Medical history included huge constipation. Concomitant medications were not reported. The reporter informed that she saw an article about covid reactions to the third dose and called to report the mother''s reaction. She informed that the patient had a brutal diarrhea (on 16Sep2021 03:00), she had no pain, fever, pain in her arm, nothing, only the diarrhea that lasted about 10 hours and it was completely liquid. The reporter informed that she gave food that she could hold (diarrhea) for the patient, and that she did not even have colic, only diarrhea. She informed that she did not think it was anything related to food, as she had been taking care of her mother''s food for years. She informed that the patient had been vaccinated on 15Sep2021 at around 8:30 am and at night she started to have diarrhea, around 3 am she called the reporter informing that she needed to go to the bathroom. She informed that the patient usually had a huge constipation and as she had no change in her diet, she believed she was from the vaccine. Patient received treatment for diarrhea. The event diarrhea was reported as serious (Medically Significant). The outcome of the event diarrhea was recovered on 16Sep2021 13:00, of other events was unknown.


VAERS ID: 1758086 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Back pain, Chest pain, Chromaturia, Cough, Malaise, Oropharyngeal pain, Pain, Productive cough, Pruritus, Urine analysis abnormal, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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 INC202101227076

Write-up: Back pain; Cough increased; Sore throat; cough sputum; brown urine; body pain; Unwell; Chest pain; Abdominal pain; Joint pain; Urine abnormal; Pain at site of injection; Itching all over/Itching both Hands; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171726485300-REYVI. Safety Report Unique Identifier GB-MHRA-ADR 25960422. A 39-year-old non pregnant female patient received bnt162b2 (Pfizer BioNTech covid-19 vaccine), via an unspecified route of administration on 15sep2021 (lot number: fe3380) as dose 1, single (at the age of 39-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for covid-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient was pregnant at the time of vaccination. Patient is not currently breastfeeding. On 15Sep2021, The patient experienced itching all over/itching both hands, pain at site of injection, On 16Sep2021, chest pain, abdominal pain, joint pain, urine abnormal, unwell, brown urine, body pain, on 17Sep2021 back pain, cough increased, sore throat, cough sputum and Couldn''t get out of bed. Therapeutic measures were taken as a result of above events with paracetamol and antihistamine. The outcome for the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1758205 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-15
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome
SMQs:, Myocardial infarction (narrow)

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

Write-up: Acute coronary syndrome; This case was received via Regulatory Authority (Reference number: -TAKEDA-2021TJP095728) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the (Ref, v21126882). On an unknown date, the patient received the 1st dose of the vaccine. On 11-Aug-2021, the patient received the 2nd dose of the vaccine. On 15-Sep-2021, at 01:00, chest pain developed. At visit to the hospital, catheterization was performed. There were 75% stenosis and plaque in Seg.6, indicating acute coronary syndrome. The patient was admitted to the hospital. The outcome of acute coronary syndrome 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.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 37 year old male patient with no relevant medical history ,who experienced the serious unexpected event of Acute coronary syndrome. The event occurred 1 month 5 days after second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed.The reporter assessed the event as related to the product.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1760428 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUE1 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asthenia, Back pain, Chills, Decreased appetite, Dyschezia, Fear of death, Gait disturbance, Insomnia, Myalgia, Pain, Polymyalgia rheumatica, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101250244

Write-up: Polymyalgia rheumatica; going to toilet is a torture; pain causes brutal anxiety in addition; Then lack of strength; Today most severe muscle pain in the whole back and all muscles; I was afraid to die; No appetite; evening fever; chills; pain and back lumbar 3 downwards to both groins forwards; No sleep; no walking possible; Brutal pain with the slightest movement, Bad pain in the whole body; This is a spontaneous report from a contactable consumer or other non hcp. This is a report based on information received by Pfizer. A 72-year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: SCUE1), via an unspecified route of administration on 15Sep2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient experienced polymyalgia rheumatica, no appetite, going to toilet was a tortur, pain causes brutal anxiety in addition, then lack of strength, most severe muscle pain in the whole back and all muscles and was afraid to die. On 15Sep2021, the patient experienced pain and back lumbar 3 downwards to both groins forwards, no sleep, no walking possible, brutal pain with the slightest movement, bad pain in the whole body, evening fever, chills. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain and back lumbar 3 downwards to both groins forwards, no walking possible, brutal pain with the slightest movement, bad pain in the whole body, today most severe muscle pain in the whole back and all muscles. Event Polymyalgia rheumatica assess as medically significant. Outcome of the events was not recovered except the event Polymyalgia rheumatica it was unknown.


VAERS ID: 1760499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Epilepsy, Loss of consciousness, Neurological examination
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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: Body temperature; Result Unstructured Data: Test Result:37.1; Test Name: Neurological examination; Result Unstructured Data: Test Result:Normal
CDC Split Type: ESPFIZER INC202101239606

Write-up: This is a spontaneous report from a contactable physician, regulatory authority number ES-AEMPS-1003328. A 16-year-old male patient received the second dose of bnt162b2 (Covid19 Pfizer) via an unknown route of administration on 14Sep2021 (Lot Number: unknown) as DOSE 2, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (Covid19 Pfizer) on an unknown date as DOSE 1, SINGLE for Covid-19 immunisation. The patient experienced generalised epileptic seizure and loss of consciousness (events reported as serious as medically significant) on 15Sep2021. The patient underwent lab tests and procedures which included body temperature was 37.1; neurological examination: normal. Therapeutic measures were taken. Events outcome was recovered on 15Sep2021. The clinical course was reported as follows: Additional information of adverse reactions: Epileptic seizures this morning, generalized, loss of consciousness, generalized hypertonia, ocular revulsion and guttural noises. Duration 2-3 minutes, he has been administered oral midazolam and has subsided, subsequently drowsiness. Temperature 37.1, yesterday 2nd dose of vaccine. In treatment with Perampanel 6mg and Atomoxetine 40mg, they report good compliance. Normal neurological examination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760709 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hypertensive crisis, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Crisis hypertensive; Vaccination site reaction; Headache; Myalgia; Pyrexia; This case was received via Agency (Reference number: FR-AFSSAPS-TO20217972) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of HYPERTENSIVE CRISIS (Crisis hypertensive) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 15-Sep-2021, the patient experienced HYPERTENSIVE CRISIS (Crisis hypertensive) (seriousness criterion medically significant), VACCINATION SITE REACTION (Vaccination site reaction), HEADACHE (Headache), MYALGIA (Myalgia) and PYREXIA (Pyrexia). At the time of the report, HYPERTENSIVE CRISIS (Crisis hypertensive), VACCINATION SITE REACTION (Vaccination site reaction), HEADACHE (Headache), MYALGIA (Myalgia) and PYREXIA (Pyrexia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Intramuscular) and mRNA-1273 (Spikevax) (Unknown Route) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medications were provided. No Treatment Medications were provided. Company Comment: This case concerns a 55 year old female patient with no relevant medical history ,who experienced the serious unexpected event of Hypertensive crisis .The event occurred one day after first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Translation received on 30-09-2021 and does not contain any new information.; Sender''s Comments: This case concerns a 55 year old female patient with no relevant medical history ,who experienced the serious unexpected event of Hypertensive crisis .The event occurred one day after first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1760722 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (I have long term covid, with a heart condition from it); Heart disorder (I have long term covid, with a heart condition from it); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101242837

Write-up: Dizziness; Headache; BNT162B2 [Dose 1: 24Jul2021, Dose 2: 15Sep2021]; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109200844148480-APYBB. Safety Report Unique Identifier GB-MHRA-ADR 25967078. A 27-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 15Sep2021 (at the age of 27-years-old) (Batch/Lot Number: FE8087, expiration date: not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected covid-19 from 27Nov2020 to an unspecified date (unsure when symptoms stopped), COVID-19 and heart condition from an unknown date (I have long term covid, with a heart condition from it). The patient''s concomitant medications were not reported. Patient was not pregnant and was not currently breastfeeding at the time of vaccination. Historical vaccine included previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 24Jul2021 (Batch/Lot Number: unknown, expiration date: not reported) as DOSE 1, SINGLE for COVID-19 immunization. Inappropriate schedule of vaccine administered occurred on 15Sep2021. The patient experienced dizziness and headache on 16Sep2021. Patient stated It was hard to explain but it felt like a rush from her head down to her feet then she went dizzy for a minute or so, weather she was standing or sat down, headache had not gone at all and dizziness comes and goes around 25/30 times a day. 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 COVID-19 virus test (sars-cov-2 test): positive (Yes - Positive COVID-19 test) on an unspecified date. The case was assessed as serious- medically significant (headache and dizziness). The outcome of the events headache and dizziness was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Dizziness, Electrocardiogram, Fatigue, Malaise, Palpitations, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101242834

Write-up: generally unwell; feeling lightheaded; tired; Heart racing; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109201143155660-AML0Z. Safety Report Unique Identifier GB-MHRA-ADR 25967798. A 38-years-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection, Lot Number: Fe8087) via an unspecified route of administration on 06Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 Immunisation. The patient experienced generally unwell, feeling lightheaded, tired on an unspecified date and heart racing on 15Sep2021. Additional information: Generally fit and healthy no long term managed conditions. Woke up to heart racing, after for days feeling lightheaded and tired and generally unwell. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test), electrocardiogram: unknown results on an unspecified date, blood test: unknown results on an unspecified date, blood pressure measurement: unknown results on an unspecified date. The outcome of heart racing was recovering. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1760821 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101242925

Write-up: Lymph nodes enlarged; Near fainting; Headache; This is a spontaneous report from a contactable consumer. This is the report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109202140038440-DDBNE, Safety Report Unique Identifier GB-MHRA-ADR 25971537. A 30-year-old non-pregnant female patient received Second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection; Lot number: unknown), via an unspecified route of administration on 15Sep2021(age at vaccination: 30-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included suspected COVID-19 from an unknown date and unknown if ongoing Unsure when symptoms started Unsure when symptoms stopped. The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) on an unspecified date for COVID-19 immunization. The patient''s concomitant medications were not reported. On 15Sep2021 the patient had near fainting (presyncope) and, headache. On 17Sep2021 the patient experienced lymph nodes enlarged (lymphadenopathy). Patient was not enrolled in clinical trial. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. The outcome of event Headache was not recovered and event of (lymphadenopathy) was recovering, (Near fainting) was recovered on 15 Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760911 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eyelids pruritus, Nasopharyngitis, Oropharyngeal pain, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Comments: No medical history information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Cold symptoms; Itching; Eyelids itchy sensation of; Sore throat; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25996040) on 26-Sep-2021 and was forwarded to Moderna on 26-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EYELIDS PRURITUS (Eyelids itchy sensation of), NASOPHARYNGITIS (Cold symptoms), OROPHARYNGEAL PAIN (Sore throat), PRURITUS (Itching) and PYREXIA (Fever) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history information was reported. Concomitant products included ESCITALOPRAM from 2014 to an unknown date for Depression. On 15-Sep-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 dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 15-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 17-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 20-Sep-2021, the patient experienced EYELIDS PRURITUS (Eyelids itchy sensation of) (seriousness criterion medically significant) and PRURITUS (Itching) (seriousness criterion medically significant). On 21-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms) (seriousness criterion medically significant). On 16-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, EYELIDS PRURITUS (Eyelids itchy sensation of) and PRURITUS (Itching) was resolving and NASOPHARYNGITIS (Cold symptoms) and OROPHARYNGEAL PAIN (Sore throat) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information provided by the reporter included antihistamine which was advised by the pharmacy. The patient stated that the itching began early on 20-Sep-2021, which became worse by the following day and sought advice from pharmacy who advised to take antihistamine. The patient reported that the Itchy on eyelids reduced/stopped by late on 24-Sep-2021 leaving behind the dry and flaky skin and stated that the itching around/under chin was ongoing, causing spots/scabs and irritation. It was also reported that the patient was not pregnant and was not currently breastfeeding. Also, the patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Reportedly, the patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This case concerns a 32 year old female patient with no relevant medical history,who experienced the serious unexpected events of Eyelids pruritus, Nasopharyngitis, Oropharyngeal pain, Pruritus and Pyrexia . The event Pyrexia occurred on the same day,Eyelids pruritus and Pruritus after 5 days,Nasopharyngitis after 6 days and Oropharyngeal pain, after 2 days following second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed.The benefit-risk relationship of mRNA-1273 is not affected by this report.Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 32 year old female patient with no relevant medical history,who experienced the serious unexpected events of Eyelids pruritus, Nasopharyngitis, Oropharyngeal pain, Pruritus and Pyrexia . The event Pyrexia occurred on the same day,Eyelids pruritus and Pruritus after 5 days,Nasopharyngitis after 6 days and Oropharyngeal pain, after 2 days following second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed.The benefit-risk relationship of mRNA-1273 is not affected by this report.Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1761088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Allergic rhinoconjunctivitis (Seasonal allergic rhinoconjunctivitis. Sensitization to grass, trees, rye, cats (RAS ?); Seasonal allergy (Seasonal allergic rhinoconjunctivitis. Sensitization to grass, trees, rye, cats (RAS ?)
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior cruciate ligament tear (Cruciate ligament tear); Thrombosis leg (Condition after muscle vein thrombosis of the left lower leg (M. gastrocnemius medialis) after cruciate ligament tear 05 ....); Comments: Seasonal allergic rhinoconjunctivitis. Sensitization to grasses, trees, rye, cats (RAST + Prick 10/2010). Condition after muscle vein thrombosis of the left lower leg (M. gastrocnemius medialis) after cruciate ligament tear 05.01.2016
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Platelet count; Result Unstructured Data: 60 G/I; Test Date: 20210915; Test Name: ELISA; Result Unstructured Data: platelet factor 4 ELISA negative; Test Date: 20210915; Test Name: MRI brain; Result Unstructured Data: normal; Test Date: 20210920; Test Name: Platelet count; Result Unstructured Data: again in the reference range
CDC Split Type: ATJNJFOC20211004992

Write-up: IMMUNE THROMBOCYTOPENIA; This spontaneous report received from a physician via Regulatory Authority (Vaccines, AT-BASGAGES-2021-048655) on 04-OCT-2021 concerned a 24 year old male of unspecified race and ethnicity. The patient''s weight was 64 kilograms, and height was 166 centimeters. The patient''s past medical history included: thrombosis leg, and anterior cruciate ligament tear, and concurrent conditions included: seasonal allergy, and allergic rhinoconjunctivitis, and other pre-existing medical conditions included: Seasonal allergic rhinoconjunctivitis. Sensitization to grasses, trees, rye, cats (RAST + Prick 10/2010). Condition after muscle vein thrombosis of the left lower leg (M. gastrocnemius medialis) after cruciate ligament tear 05.01.2016. The patient was previously treated with rivaroxaban. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 11-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 15-SEP-2021, the patient experienced immune thrombocytopenia, and was hospitalized (date unspecified). Laboratory data included: ELISA (NR: not provided) platelet factor 4 ELISA negative, MRI brain (NR: not provided) normal, and Platelet count (NR: not provided) 60 G/I. On 20-SEP-2021, Laboratory data included: Platelet count (NR: not provided) again in the reference range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from immune thrombocytopenia. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1761121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Clonic convulsion, Nausea
SMQs:, Acute pancreatitis (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)

Life Threatening? No
Birth Defect? No
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 INC202101243379

Write-up: Clonic convulsion; Nausea; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 624839. A 17-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection; Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced clonic convulsion and nausea on 15Sep2021. The clinical outcome of events was recovering. No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.


VAERS ID: 1761160 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pain in extremity, Vaccination site reaction
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244462

Write-up: Deep vein thrombosis; Injection site reaction; Pain in extremity; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627167. A 47-years-old female patient received bnt162b2 (COMIRNATY mRNA, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 15Sep2021 the patient experienced deep vein thrombosis, injection site reaction and pain in extremity. The outcome of all the events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Flushing, Haematochezia, Headache, Lethargy, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101282409

Write-up: Haematochezia; discomfort; flushing; headache; lethargy; Myalgia; nausea; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Australian Regulatory Authority, Regulatory Authority. Regulatory authority report number is 627496. A 22-year-old male patient received a dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Sep2021, the patient experienced haematochezia, discomfort, flushing, headache, lethargy, myalgia, and nausea. The clinical outcomes of the haematochezia, discomfort, flushing, headache, lethargy, myalgia, and nausea were recovering. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1762423 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211005492

Write-up: Lung embolism; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, DE-PEI-202100200073) on 04-OCT-2021 concerned a 38-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, route of administration, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 22-AUG-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 15-SEP-2021, the patient experienced lung embolism. On an unspecified date, the patient was hospitalized for event. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung embolism. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1762976 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Headache, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252627

Write-up: Dizziness; Headache; Loss of balance; Ringing in ears; Interchange of vaccine products; Off label use; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109220736003630-DVLZ5. Safety Report Unique Identifier GB-MHRA-ADR 25977492. A 56-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot Number: FF2153), via an unspecified route of administration on 15Sep2021 (at the age of 56 years) as DOSE 2, (initial pfizer dose)SINGLE for COVID-19 immunisation. Unsure, if patient has had symptoms associated with COVID-19. The patient previously received COVID-19 Vaccine AstraZeneca, dose 1 on 25Jan2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that on 21Sep2021, the patient experienced dizziness, headache, loss of balance, ringing in ears. On 15Sep2021, off label use. interchange of vaccine products. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test was negative (No-Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Th e outcome of event for dizziness, headache, loss of balance and ringing in ears was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1763250 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Hypotension, Loss of consciousness, Myalgia, Nausea, Tremor, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-787726) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS, VERTIGO, HYPOTENSION, TREMOR, ASTHENIA, MYALGIA, FATIGUE, NAUSEA and HEADACHE in a 53-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 15-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criteria disability and medically significant), VERTIGO (seriousness criterion disability), HYPOTENSION (seriousness criterion disability), TREMOR (seriousness criterion disability), ASTHENIA (seriousness criterion disability), MYALGIA (seriousness criterion disability), FATIGUE (seriousness criterion disability), NAUSEA (seriousness criterion disability) and HEADACHE (seriousness criterion disability). At the time of the report, LOSS OF CONSCIOUSNESS, VERTIGO, HYPOTENSION, TREMOR, ASTHENIA, MYALGIA, FATIGUE, NAUSEA and HEADACHE outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products used were not provided by the reporter. Treatment medications were not provided by the reporter. Reporter stated that patient received second dose on the previous evening which is on 14-Sep-2021. On 15-Sep-2021, patient''s Blood pressure was reported as 90/65. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up information included no new information. On 24-Sep-2021: Translation received on 30-Sep-2021 included: Patient lab data, Vaccine dose number were added.; Reporter''s Comments: Adverse reaction related to the 2nd dose of the Moderna vaccine.; Sender''s Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness, vertigo, hypotension, tremor, asthenia, myalgia, fatigue, nausea and headache. The events occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1763393 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Hypotension, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: blood pressure; Result Unstructured Data: Test Result:low
CDC Split Type: ITPFIZER INC202101285344

Write-up: I have been very ill for days, problems with low blood pressure; I have been very ill for days, problems with maximum weakness; I have been very ill for days, problems with fever; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-791820. A 35-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via intramuscular route, administered in left arm on an unspecified date (Lot Number: FG6273) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15Sep2021, the patient stated I have been very ill for days, problems with low blood pressure, fever, maximum weakness. Actions taken (Vitamins) - Impact on quality of life (8/10). The events were serious (Life threatening). The patient underwent lab tests and procedures which included blood pressure measurement: low on 15Sep2021. Therapeutic measures were taken as a result of fever, maximum weakness and low blood pressure. The outcome of fever, maximum weakness and low blood pressure was not recovered, at the time of this report. Sender Comment: We do not agree with the seriousness criteria of the reporter, as, from the IME-LIST, the reported events do not fall within the clinically relevant conditions, so much so that they are defined as serious. Additional information from source document: Description as reported: I have been very ill for days, problems with low blood pressure, fever, maximum weakness


VAERS ID: 1763422 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Fall, Heart rate, Heart rate decreased, Loss of consciousness, Oxygen saturation, Pallor, Peripheral coldness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: blood pressure; Result Unstructured Data: Test Result:90/60 s; Comments: At 13:17; Test Date: 20210915; Test Name: blood pressure; Result Unstructured Data: Test Result:116/78 mmHg; Comments: At 13:19; Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination.; Test Date: 20210915; Test Name: Pluse; Result Unstructured Data: Test Result:54; Comments: /min; Test Date: 20210915; Test Name: SPO2; Test Result: 99 %; Comments: At 13:17; Test Date: 20210915; Test Name: SPO2; Test Result: 100 %; Comments: At 13:19
CDC Split Type: JPPFIZER INC202101236971

Write-up: (Pluse) 54/min; (blood pressure) 90/60s; Loss of consciousness; fell off the chair and onto the floor; Pallor facial; Fingers cold feeling of; shock; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127221. A 19-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 15Sep2021 13:10 (at the age of 19-years-old) (Lot Number: FH0151; Expiration Date: 31Dec2021) as single dose for covid-19 immunisation. Medical history was none. Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. The patient experienced loss of consciousness on 15Sep2021 13:15 (5 minutes after the vaccination), shock on 15Sep2021, fell off the chair and onto the floor on 15Sep2021 13:15, pallor facial on 15Sep2021 13:15, fingers cold feeling of on 15Sep2021 13:15, blood pressure 90/60s on 15Sep2021 13:17, (pluse) 54/min on 15Sep2021 13:19. The course of the event was as follows: At 13:15, Loss of consciousness occurred and the patient fell off the chair and onto the floor. Pallor facial and Fingers cold feeling of occurred. At 13:17, let the patient lie on the bed. After being called, the patient can open the eyes and respond (no Dyspnoea occured). The lower limbs were raised, and Intramuscular injection of Noradrenalin 0.3mg was performed outside the right thigh. Monitor was put on, (blood pressure) 90/60s, SPO2 99%. At 13:19, route was ensured by normal saline solution 500ml, 116/78 mmHg, (Pluse) 54/min, SPO2 100%. (illegible characters). At 15:00, the patient went to a nearby hospital and was hospitalized for the purpose of observation. Therapeutic measures were taken as a result of all events. On 15Sep2021 (the same day of the vaccination), the outcome of the events was recovered on 15Sep2021. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Consciousness disturbance transient (for seconds), although the patient had a state of shock, the symptoms recovered. No follow-up attempts are possible, no further information is expected.; Reporter''s Comments: Consciousness disturbance transient (for seconds), although the patient had a state of shock, the symptoms recovered.


VAERS ID: 1763874 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Hypotension, Loss of consciousness, Pyrexia, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: This case was initially received via regulatory authority(Reference number: IT-MINISAL02-788230) on 24-Sep-2021. The most recent information was received on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), HYPOTENSION, TREMOR, CHILLS, VOMITING and PYREXIA. At the time of the report, LOSS OF CONSCIOUSNESS, HYPOTENSION, TREMOR, CHILLS, VOMITING and PYREXIA outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. The event LOSS OF CONSCIOUSNESS was classified as non-serious by RA, however, as per IME and medical judgment is upgraded to serious. The rest of events are non-serious, as per RA and medical judgement. Company Comment: This case concerns a 23-year-old female subject, with no relevant medical history, who experienced the unexpected serious event of LOSS OF CONSCIOUSNESS. The event occurred after receiving a dose of Spikevax vaccine. The rechallenge was not applicable as there is only information about one dose disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Initial translation received on 29-Sep-2021 included no new information. On 28-Sep-2021: Additional information received on 28-Sep-2021: Events upgraded to serious and and product indication updated.; Sender''s Comments: This case concerns a 23-year-old female subject, with no relevant medical history, who experienced the unexpected serious event of LOSS OF CONSCIOUSNESS. The event occurred after receiving a dose of Spikevax vaccine. The rechallenge was not applicable as there is only information about one dose disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1763877 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Bruise of the larynx; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP098078) on 24-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021860), and reported to the Agency Regulatory Authority by a physician, was received via the RA (Ref, v21127627). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 15-Sep-2021, at 13:14, the patient received the 1st dose of this vaccine. At 13:15, immediately after the vaccination, vasovagal reflex developed, and the patient lost consciousness. The patient regained consciousness immediately but had no memory of the event. Laryngeal area was bruised. The patient was raced to a hospital. CT and MRI showed no abnormalities. The patient was hospitalized for 1 day just in case. On 16-Sep-2021, recovery of the symptoms was confirmed. The outcome of vasovagal reflex, loss of consciousness, and bruise of the larynx was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. 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 21-year-old, male patient with no relevant medical history, who experienced the unexpected events of loss of consciousness, contusion and presyncope. The events loss of consciousness, contusion and presyncope occurred 1 minute after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the first dose. Vasovagal reaction associated with the anxiety of receiving a vaccination remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1764506 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Headache, Injection site reaction, Myalgia, Pain, 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? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No consumption of alcohol, tobacco or drugs. Known allergies: fucidin (ointment) and cats.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20211002646

Write-up: INJECTION SITE REACTION; FEELING HOT AND COLD; PAIN; SHIVERING; ARTHRALGIA; FEVER; MYALGIA; HEADACHE; This spontaneous report received from a consumer via Regulatory Authority (regulatory authority, BE-FAMHP-DHH-N2021-107092) on 01-OCT-2021 concerned a 25-year-old male. The patient''s weight was 71 kilograms, and height was 183 centimeters. The patient''s pre-existing medical conditions included: No consumption of alcohol, tobacco or drugs. Known allergies included: fucidin (ointment) and cats. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: unknown) dose was not reported, 01 total, administered on 15-SEP-2021 for Covid-19 immunisation. No concomitant medications were reported. On 15-SEP-2021, the patient experienced injection site reaction, fever, was feeling hot and cold (fever and chills during the night after the day of administration), pain (soreness), shivering (chills), arthralgia (joint pain), myalgia (muscle pain) and headache. Treatment included, one paracetamol (1g), multiple intakes (number unspecified) separated by several hours, until headache disappeared. Headache and soreness lasted a little bit less than 24 hours the day after the administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site reaction, feeling hot and cold, pain, shivering, arthralgia, fever, myalgia, and headache on 16-SEP-2021 (around 24 hours). This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - Yes, one paracetamol (1g), multiple intakes separated by several hours, until headache disappeared. Evolution of the ADR - Recovery : around 24 hours ADR description - 1) Fever and chills during the night following the day of administration 2) Headache and soreness during a little bit less than 24 hours the day after the administration. Information about the time relationship (ADR) - 1) Fever and chills during the night following


VAERS ID: 1766060 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005243 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Angioedema, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Anaphylactic reaction; Edema Quincke''s; This case was received via regulatory authority on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) and ANGIOEDEMA (Edema Quincke''s) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005243) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening) and ANGIOEDEMA (Edema Quincke''s) (seriousness criterion life threatening). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and ANGIOEDEMA (Edema Quincke''s) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 21-year-old, male patient with no relevant medical history, who experienced the unexpected event of Angioedema and expected event of Anaphylactic reaction. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 30 -Sep -2021 and does not contain any new information.; Sender''s Comments: This case concerns a 21-year-old, male patient with no relevant medical history, who experienced the unexpected event of Angioedema and expected event of Anaphylactic reaction. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1766218 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Dizziness, Ear pain, Fatigue, Feeling cold, Feeling hot, Headache, Limb discomfort, Myalgia, Neck pain, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: FLUOXETIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252573

Write-up: Earache; Dizzy spells; Suspected COVID-19; Tiredness; Pain joint; Pain muscle; Headache; Feeling cold; Feeling hot; Neck pain; Armpit pain; Arm discomfort; This is a spontaneous report from a contactable consumer. This report was received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109210941116250-CYNQK. Safety Report Unique Identifier GB-MHRA-ADR 25973515. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Sep2021 at the age of 48 years old (Lot Number: Ff8222) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (FLUOXETIN) taken for an unspecified indication, start and stop date were not reported. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced arm discomfort on 15Sep2021; neck pain and armpit pain on 16Sep2021; headache, tiredness, pain joint, pain muscle, feeling cold, feeling hot and suspected COVID-19 all on 17Sep2021, earache and dizzy spells both on 18Sep2021. The patient reported that she just felt no energy, aching all over especially arm and armpit and so tired. The events were reported as serious (medically significant). 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 15Sep2021. The patient recovered from feeling cold, earache, dizzy spells, on an unspecified date while patient was recovering from headache, arm discomfort, tiredness while patient has not recovered from pain joint, pain muscle, neck pain, feeling hot, armpit pain and suspected COVID-19. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1766227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101252454

Write-up: Painful periods; Heavy periods; period was slightly delayed; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109220714144050-SFY3M. Safety Report Unique Identifier GB-MHRA-ADR 25977383. A 37-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date with unspecified Batch/Lot number as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient previously received the dose 1 of BNT162B2 on an unspecified date (batch/lot number not reported) for COVID-19 immunisation. On 15Sep2021, the patient experienced painful periods, heavy periods and period was slightly delayed. The patient recovered from the events of painful periods on 19Sep2021, heavy periods and period was slightly delayed on 20Sep2021. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test, on an unspecified date. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Period was slightly delayed, and unusually heavy and painful. 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: 1766238 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dizziness, Dyspepsia, Fatigue, Feeling hot, Heart rate abnormal, Lethargy, Malaise, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101258890

Write-up: Chest burning; ongoing breast feeding; ongoing breast feeding; Heartburn; Heart rate; Dizziness; Tiredness; Lethargic; Weakness; Feeling hot; Light-headed; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. This reporter reported for both mother and child. This is the mother case. The regulatory authority report number: GB-MHRA-WEBCOVID-202109221112261350-VA85H, Safety Report Unique Identifier: GB-MHRA-ADR 25978895. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Sep2021 (at the age of 39-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing breast feeding. The patient had no other medical history. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced heartburn, heart rate (abnormal), dizziness, tiredness, lethargic, weakness, feeling hot, light-headed, and feeling unwell on 15Sep2021; and chest burning on 17Sep2021. The events were considered serious: medically significant. The patient took paracetamol and then felt slightly better. She went to GP and was awaiting to do blood test and ECG. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 20Sep2021. The outcome of heartburn, heart rate, dizziness, tiredness, lethargic, weakness, feeling hot, light-headed, feeling unwell, and chest burning was not recovered. 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-202101264754 baby report


VAERS ID: 1766272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202101265127

Write-up: abdominal pain; breathlessness; chest pain; aches and pains in torso region; Pain chest; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109231201075160-1IMCH. Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25983125. A 22-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unknow date for Covid-19 immunisation. It was reported that patient has not tested positive for COVID-19 since having the vaccine nor had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not enrolled in clinical trial and was fit and healthy prior to vaccine. On 15Sep2021, patient experienced pain chest. On an unknown date, patient had abdominal pain, breathlessness, chest pain and aches and pains in torso region. The events were considered serious as medically significant events. The clinical course reported as follows, Chest pain, abdominal pain and breathlessness. Normal ECG and chest xray. Fit and healthy prior to vaccine, now lots of aches and pains in torso region. The patient underwent lab tests and procedures which included blood test with unknown results, chest x-ray and electrocardiogram which were normal. At the time of report, patient was not recovered from the event pain chest while outcome of aches and pains in torso region was unknown. The outcome of rest events was recovered on an unspecified date. No follow-up attempts were possible; information about lot/batch number could not be obtained.


VAERS ID: 1766344 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inflammation, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101265245

Write-up: inflammation; Unilateral leg swelling; 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-202109232355420250-OKZU1, Safety Report Unique Identifier GB-MHRA-ADR 25987119. A 37-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Batch/Lot Number: ff2153), dose 1 via an unspecified route of administration on 15Sep2021 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding continued inflammation and swelling since patient had the vaccine. Patient is not enrolled in clinical trial. The patient experienced inflammation on an unspecified date and unilateral leg swelling on 15Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on 13Sep2021. Patient had not been tested positive for COVID-19 since having the vaccine. The events were reported as serious (disability and Medically significant). The outcome of the event inflammation was unknown and unilateral leg swelling was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1766434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Electrocardiogram, Headache, Pyrexia, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), 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: Test Date: 20210915; Test Name: body temperature; Result Unstructured Data: Test Result:37.8; Test Date: 20210915; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal
CDC Split Type: ITPFIZER INC202101256784

Write-up: In the evening of 15Sep2021 syncopal episode preceded by blurred vision; Onset of headache from the morning of 15Sep2021, from the afternoon fever 37.8; Onset of headache from the morning of 15Sep2021, from the afternoon fever 37.8; In the evening of 15Sep2021 syncopal episode preceded by blurred vision; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-789054. A 14-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: FF2382, Expiration date: 31Dec2021), intramuscular on 14Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were unknown. The patient experienced in the evening of 15sep2021 syncopal episode preceded by blurred vision and onset of headache from the morning of 15sep2021, from the afternoon fever 37.8. The patient underwent lab tests and procedures which included body temperature which showed 37.8 result on 15Sep2021 and electrocardiogram which showed normal result on 15Sep2021. The outcome of the events was recovered on 15sep2021. Health authority comment: Syncopal episode occurred 24 hours after vaccine administration indicated, rapid (10 ") and spontaneous resolution. Normal Electrocardiogram. Other symptoms: headache and fever No follow-up attempts possible. No further information expected


VAERS ID: 1766501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Physical examination, Pyrexia, Supraventricular tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: ECG; Result Unstructured Data: Test Result:change; Comments: Paroxysmal supraventricular tachycardia; Test Date: 20210915; Test Name: Physical examination; Result Unstructured Data: Test Result:unknown
CDC Split Type: ITPFIZER INC202101262533

Write-up: 48h after the second dose pfizer cardioverted paroxysmal supraventricular tachycardia with verapamil and intravenous adenosine fever; 48h after the second dose pfizer cardioverted paroxysmal supraventricular tachycardia with verapamil and intravenous adenosine fever; This is a spontaneous report from a contactable physician downloaded from A Regulatory Authority IT-MINISAL02-789402 received via regulatory authority. A 13-year-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FF2382), via an unspecified route of administration on 13Sep2021 as dose, 2 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15Sep2021, in timeframe between vaccination and starting of symptoms was 2 days, the patient experienced 48h after the second dose pfizer cardioverted paroxysmal supraventricular tachycardia with verapamil and intravenous adenosine fever. The patient underwent lab tests and procedures which included ECG: changes, paroxysmal supraventricular tachycardia and Physical examination: unknown on 15Sep2021. Therapeutic measures were taken as a result of all events and treatment included with cardioverted with Verapamil and Adenosine IV with resolution. Patient went to emergency room. Events seriousness assess as hospitalization. Outcome of the events was recovered on 15Sep2021. Sender Comment: 16Sep2021 RLFV (Local Center of Pharmacovigilance): requested to the reporter batch number, confirmation of vaccination date, hospital clinical documentation. 17Sep2021 feedback for batch number and date of vaccination, clinical documentation is awaited. Follow-up attempts are completed. No further information is expected. ; Reporter''s Comments: 13-year-old patient. second dose Pfizer vaccine on 13Sep. On 15Sep fever and palpitations. Arrives in emergency room, ECG performed: TPSV(Paroxysmal supraventricular tachycardia), cardioverted with Verapamil and Adenosine IV with resolution


VAERS ID: 1766563 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-15
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Glossoptosis, Movement disorder, Oropharyngeal pain, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: Before vaccination.; Test Date: 20210915; Test Name: body temperature; Result Unstructured Data: Test Result:around 37 Centigrade
CDC Split Type: JPPFIZER INC202101259685

Write-up: Consciousness disturbed; Pyrexia of around 37 degrees Centigrade; Pharyngodynia; Body difficulty in moving; glossoptosis; This is a spontaneous report from a contactable other healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is v21127507. A 71-year and 5-month-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 13:30 (Batch/Lot number was not reported) (at the age of 71-year and 5-months-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was reported none. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 15Sep2021 at 22:13 (61 days after the vaccination), the patient experienced consciousness disturbed. On 15Sep2021 (61 days after the vaccination), the patient was admitted to the hospital and discharged on unspecific date. Date of outcome and the outcome of the event were not provided. The course of the event was as follows: The last check time the patient was found to be safe was 15Sep2021, 20:00. On 15Sep2021 22:13 (also reported as early morning), the patient experienced pyrexia of around 37 degrees centrigrade and pharyngodynia, then rested at home. At around 22:13, the patient experienced body difficulty in moving, and subsequently showed consciousness disturbed (glossoptosis). With an emergency call, the patient was transferred to the same hospital by reporter''s hospital doctor car. The patient was hospitalized for the events from 15Sep2021 to unspecified date. The outcome of the events was unknown. The reporting other HCP classified the event as serious(caused hospitalization from 15Sep2021 to unspecific date) and assessed that the causality between the event and bnt162b2 as un-assessable. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1766583 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Hypersensitivity, Oropharyngeal discomfort, Pharyngeal oedema, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: BP; Result Unstructured Data: Test Result:156/84; Test Date: 20210915; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101261394

Write-up: allergic pharyngeal oedema/pharyngeal oedema; BP 156/84; Pharynx strange sensation of; feeling of respiratory tract stenosis; dyspnoea; allergy due to ingredient of vaccination; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21127556. A 46-year-old female patient (reported as 46-year and 9-month-old) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Sep2021 15:40 (Batch/Lot Number: FF9942; Expiration Date: 30Nov2021) (at the age of 46 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy (shrimp). Body temperature before vaccination was 37.0 degrees Centigrade. The patient''s concomitant medications were not reported. On 15Sep2021 at 16:00 (20 minutes after the vaccination), the patient experienced allergic pharyngeal oedema. On 15Sep2021 (the day of vaccination), the patient was admitted to the hospital. On 16Sep2021 (1 day after the vaccination), the patient was discharged from the hospital. The outcome of the event was recovered. The course of the event was as follows: 10-15 minutes (as reported) after the vaccination, symptoms associated with pharyngeal oedema appeared. (BP 156/84). Pharynx strange sensation of, feeling of respiratory tract stenosis and dyspnoea developed. Pharynx symptoms disappeared quickly via injection of BOMIN 0.3mg and DECADRON 1.9mg. The patient was hospitalized for only overnight on the day of the vaccination and received the observation. The patient was discharged after confirming that the symptoms would not worsen again. The reporting physician classified the event as serious (caused Hospitalized from 15Sep2021 to 16Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that the symptom was allergy due to ingredient of vaccination. Only pharyngeal oedema, no conjunctival symptoms, no nasal symptoms, no skin symptoms and no gastrointestinal symptoms. (Not anaphylaxis). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: It was considered that the symptom was allergy due to ingredient of vaccination. Only pharyngeal oedema, no conjunctival symptoms, no nasal symptoms, no skin symptoms and no gastrointestinal symptoms. (Not anaphylaxis).


VAERS ID: 1766703 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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: 20210915; Test Name: blood pressure; Result Unstructured Data: Test Result:180/80
CDC Split Type: PHPFIZER INC202101259523

Write-up: Elevated BP/blood pressure measurement: 180/80; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number PH-PHFDA-300106166. An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 15Sep2021 (batch/lot number: FD5996) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Sep2021 10:30, the patient experienced elevated bp. The patient underwent lab tests and procedures which included blood pressure measurement: 180/80 on 15Sep2021. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1766705 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3004960 / UNK - / OT

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: blood pressure; Result Unstructured Data: Test Result:190/100
CDC Split Type: PHPFIZER INC202101259538

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Food and Drug Administration. Regulatory authority report number: PH-PHFDA-300106159. A 48-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 15Sep2021 (Batch/Lot Number: 3004960) as dose number unknown, single (at the age of 48-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated blood pressure (BP) on 15Sep2021 at 09:20. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 15Sep2021. The outcome of the event was resolving. No follow up attempts are possible. No further information is expected.


VAERS ID: 1767695 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 immunisation, Chest pain, Electrocardiogram, Myocarditis, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: ECG; Result Unstructured Data: ST-elevation; Test Date: 202109; Test Name: Troponin NOS; Result Unstructured Data: High
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00051783) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS and COVID-19 IMMUNISATION in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002616) for Vaccination. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included No adverse event with Comirnaty. On 15-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2021, the patient experienced COVID-19 IMMUNISATION (seriousness criterion hospitalization). On 15-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). In 2021, COVID-19 IMMUNISATION was resolving. On 21-Sep-2021, MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Electrocardiogram: st-elevation (High) ST-elevation. In September 2021, Troponin: high (High) High. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION. No concomitant medications reported No treatment medications provided Company Comment: This is a case of revaccination with different Covid-19 vaccine for this 17-year-old, female patient with no relevant medical history, who experienced the unexpected event of chest pain and expected event of myocarditis. The events chest pain and myocarditis occurred 1 day after the administration of labeled dose number two of mRNA-1273 vaccine. The rechallenge was not applicable because the patient previously received other brand of Covid-19 vaccine (Comirnaty). The patient''s age and vaccine history of receiving of other brand of Covid-19 vaccine (Comirnaty) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translated document Received on 30-sep-2021 contains information from verbatim added to the narrative; Sender''s Comments: This is a case of revaccination with different Covid-19 vaccine for this 17-year-old, female patient with no relevant medical history, who experienced the unexpected event of chest pain and expected event of myocarditis. The events chest pain and myocarditis occurred 1 day after the administration of labeled dose number two of mRNA-1273 vaccine. The rechallenge was not applicable because the patient previously received other brand of Covid-19 vaccine (Comirnaty). The patient''s age and vaccine history of receiving of other brand of Covid-19 vaccine (Comirnaty) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1769130 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H048A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (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: DEPFIZER INC202101262357

Write-up: Pericarditis; Pericardial effusion; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100194929. A 30-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Sep2021 (Batch/Lot Number: 1H048A) as a single dose, for covid-19 immunisation . First vaccination with Comirnaty on 05Aug (1D020A). Medical history and concomitant medications were not reported. On 15Sep2021 the patient experienced pericarditis, pericardial effusion. Supported by echocardiography and serology. Myocardial infarction and myocarditis were excluded. The patient''s outcome was: not recovered/not resolved for Pericarditis, not recovered/not resolved for Pericardial effusion. No follow-up attempts possible. No further information expected. Information on lot# already obtained.


VAERS ID: 1769218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101262803

Write-up: Chest pain/Spontaneous chest pain of increasing intensity; Tiredness; Syncope/fainting; feeling of leaving the inside to the outside of the chest that causes breathing problems; feeling of leaving the inside to the outside of the chest that causes breathing problems; Myalgia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1006520. A 29-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 14Sep2021 (Batch/Lot Number: FF2832) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced chest pain, tiredness, syncope and myalgia on 15Sep2021. The events chest pain, tiredness and syncope were assessed as medically significant. Spontaneous chest pain of increasing intensity and feeling of leaving the inside to the outside of the chest that causes breathing problems and fainting, all in a matter of a couple of minutes (15Sep2021). Rapid recovery after fainting and complete disappearance of pain not reappearing until the date of submission of this form Therapeutic measures were taken as a result of chest pain and myalgia which included paracetamol. The outcome of the event syncope was recovered on 15Sep2021 while the other events were recovering. No follow up attempts are possible. No further information is expected.


VAERS ID: 1769376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F038A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diabetes mellitus inadequate control, Hyperglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101261413

Write-up: Diabetes mellitus inadequate control; Hyperglycaemia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213485. A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: 1F038A), via intramuscular on 14Sep2021 as dose 1, single for covid-19 immunisation. Medical history included type 1 diabetes mellitus. The patient concomitant medications were not reported. It was reported that 12 hours after the vaccination, appearance of a destabilization of insulin-dependent diabetes with hyperglycaemia on 15Sep2021. Temporary increase in insulin therapy with a favourable outcome. Therapeutic measures were taken as a result of diabetes mellitus inadequate control and hyperglycaemia. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1769538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Menstruation irregular, Migraine
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101266625

Write-up: Ovulation migraine; headaches; Irregular periods; 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-APPCOVID-20210925090815, Safety Report Unique Identifier GB-MHRA-ADR 25994403. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included clinical trial participant from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding The patient experienced irregular periods on 15Sep2021, ovulation migraine on an unspecified date, headaches on an unspecified date. The outcome of irregular periods was not recovered, of the other events was unknown. Narrative case summary and further information: Irregular menstrual cycle symptoms. Changes to length and flow. Ovulation migraine and headaches since first vaccine, worse since the second- more migraine like symptoms. Clinical trial participant Study details. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1769552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia
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: COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia (hx crohns proctitis alopecia after immunosuppressive meds); Comments: hx crohns proctitis alopecia after immunosuppressive meds
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101266557

Write-up: Alopecia; This is a spontaneous report from a contactable physician received from the regulatory authority .The regulatory authority report number is GB-MHRA-TPP11624463C999536YC1631694582257.Safety Report Unique Identifier GB-MHRA-ADR -25990677 A 18-years-old male patient received (BNT162B2), via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included alopecia from an unknown date and unknown if ongoing hx crohns proctitis alopecia after immunosuppressive meds. Concomitant medications included colecalciferol taken for ill-defined disorder from 13Mar2019 to an unspecified stop date. On 15Sep2021 the patient experienced alopecia with outcome of unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Alopecia


VAERS ID: 1769563 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pruritus, Rash, Tinnitus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hearing impairment (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101265139

Write-up: itchy; tinnitus; raised areas of skin; Hives; Ear ringing; Inappropriate schedule of vaccine administered; 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-202109231348543980-5NFFO], Safety Report Unique Identifier [GB-MHRA-ADR 25984112]. A 50-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: FF8222) via an unspecified route of administration on 15Sep2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history included chronic fatigue syndrome. Concomitant medications were not reported. Patient had no symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 15Sep2021, the patient experienced inappropriate schedule of vaccine administered. On an unspecified date, the patient experienced itchy, tinnitus, raised areas of skin and ear ringing on 19Sep2021, hives on 22Sep2021. Ear ringing strongly in one ear started first thing on the 19Sept2021 (tinnitus) and has not improved. Hives on skin developed rapidly in the night three days later, large areas around torso, under skin of both arms and one patch of leg. Raised areas of skin, some bright red and some itchy. Called NHS and took antihistamine (piriton) and by the morning it was resolved. This was my second yellow flag as these further symptoms developed. The outcome of event inappropriate schedule of vaccine administered was unknown and itchy, hives, raised areas of skin with outcome of recovered and tinnitus, ear ringing with outcome of not recovered. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101275505 Same patient, Different dose and event


VAERS ID: 1769714 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hyperhidrosis, Migraine, Migraine with aura, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Migraine with aura; Stress; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101266358

Write-up: Migraine aura; Migraine headache; Vomiting; Fatigue extreme; Excess sweating; This is a spontaneous report from a contactable consumer (patient). This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109251340070290-MCI3U. Safety Report Unique Identifier GB-MHRA-ADR 25995555. A 31-year-old non pregnant female patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration on 15Sep2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included stress, asthma but this was very well controlled and she only need to use an inhaler a couple of times a year, and migraine with aura in the past, but they are often triggered by something, either illness or stress, and she tend to have at most one a year; all from an unspecified date and suspected COVID-19 from 22Mar2020 to 27Mar2020. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding and not had a COVID-19 test. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced no adverse event. On 16Sep2021, the patient experienced migraine aura, migraine headache, vomiting, fatigue extreme and on 15Sep2021 the patient experienced excess sweating. The outcome of the event vomiting was resolved with sequelae on 16Sep2021, events migraine with aura, migraine headache, was resolved on 17Sep2021, event excess sweating was not resolved on an unspecified date and event fatigue extreme was resolved on 19Sep2021. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.


VAERS ID: 1769751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram, Computerised tomogram thorax, Cough, Fibrin D dimer, Pain in extremity, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan of my chest; Result Unstructured Data: Test Result: Unknown results; Test Name: CTPA; Result Unstructured Data: Test Result: Unknown results; Comments: I have a blood clot on my lung; Test Name: Ddimer; Result Unstructured Data: Test Result: Unknown results; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101266493

Write-up: chest pain; pains in my calves; cough; Pulmonary embolism; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109252215530300-EMWPF. Safety Report Unique Identifier GB-MHRA-ADR 25997584. A 31-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccine received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, The patient experienced chest pain, pains in my calves and cough. On 15Sep2021, The patient experienced pulmonary embolism. Patient stated that patient had ongoing pains in his calves for the 2-3 weeks and then suddenly developed chest pain last night with a cough. Patient had a CT scan of his chest and Patient have a blood clot on his lung. Doctors are also worried. Patient may have clots elsewhere. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted reported as CTPA, Ddimer. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on, computerised tomogram thorax: unknown results on I have a blood clot on my lung, fibrin d dimer: unknown results on, sars-cov-2 test: negative on No - Negative COVID-19 test. The outcome of the event chest pain was recovered on an unspecified date, pulmonary embolism was not recovered and pains in my calves and cough was unknown. No follow-up attempts are possible; mention about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1769783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-15
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Rheumatoid arthritis, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101294570

Write-up: painful thumb joints; Joint stiff; could hardly walk; Rheumatoid arthritis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109291024177960-1WNEX, Safety Report Unique Identifier GB-MHRA-ADR 26008636. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot number was not reported) on an unspecified date for Covid-19 immunization. It was reported that patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 15Sep2021, the patient experienced rheumatoid arthritis. On an unknown date, patient had most severe painful thumb joints in both hands which patient had never before for which patient see the GP last week and she referred her to a rheumatology specialist, and she also had joint stiff. The events were considered serious as medically significant events. Patient stated that in morning after the second vaccination, she could hardly walk as her ankle joints were stiff and painful. This was still the case some mornings but resolves within about 10 min after getting up. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative. On an unknow date, the event Joint stiff was resolved 10 min after getting up and patient was recovering from the event painful thumb joints. At the time of report, patient was not recovered from the event rheumatoid arthritis. The outcome of could hardly walk was unknown. No follow-up attempts were possible; information about lot/batch number could not be obtained


VAERS ID: 1769931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101284770

Write-up: Blood pressure increase, values around 150 maximum and 100 minimum.; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-791795. A 45-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FG4686), dose 1 intramuscular on 31Aug2021 09:51 at 0.3 ml as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 15Sep2021, It was reported: Blood pressure increase, values around 150 maximum and 100 minimum. She never had high blood pressure problems and she do not take medications. Actions taken (Visit to GP. No other problems are detected). Impact on quality of life (3/10). Outcome of the event was not recovered. Health authority comment: vaccine administration at 9.51 am; lot and expiration and saline solution not available; time of reconstitution not available, vaccine not available; symptoms appeared after 15 days. No follow-up attempts possible. No further information is expected.


VAERS ID: 1769941 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Generalised oedema, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101259963

Write-up: the oedema had begun to spread to the right hand, face, feet and whole body/the left arm that was vaccinated appeared symptoms of oedema; the oedema had begun to spread to the right hand, face, feet and whole body; the oedema had begun to spread to the right hand, face, feet and whole body; mild pyrexia symptoms; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 15Sep2021 (at the age of 55-years-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced the oedema had begun to spread to the right hand, face, feet and whole body on 16Sep2021. The left arm that was vaccinated appeared symptoms of oedema on 16Sep2021. The patient also had mild pyrexia symptoms on 15Sep2021. The outcome of the event mild pyrexia symptoms was unknown, and the outcome of the other events were not recovered. The clinical course was reported as follows: After completing the second vaccination, the left arm that was vaccinated appeared symptoms of oedema about the second day. The patient thought the symptoms of oedema would disappear immediately, but it was now the 9th day, and the oedema had begun to spread to the right hand, face, feet and the whole body. There was not recovered. On the second day after vaccination, only the left arm developed such symptoms. Gradually after that, the wife also said, "It looks like a person who has changed.", the face oedema was so severe that the eyes that were originally double eyelids swelled into single eyelids. There is no chronic disease, the patient check-up before the first vaccination, and checked all of them. There was absolutely nothing wrong with the liver. The oedema was so severe that the wife said that it was like a person who has changed. It does reduce the oedema or it would reduce the oedema. When it came to reducing the oedema, it was slightly better, and the eyes had returned to double eyelids around noon, but the hands and feet were swollen to no wrinkles as soon as they were clenched. And the symptom of oedema to the extent that the knee was bent like a towel was held for a whole week, the patient was wondering what''s the matter? The second vaccination was given on 15Sep2021, and the first vaccination did not even had fever. Because after the second vaccination, only mild pyrexia symptoms appeared that night, the patient was still thinking that it was okay, it turned out to be like this. The oedema had spread and lasted for 9 days. Did this have anything to do with vaccination? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1770047 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005692 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Fall; Facial bruises; Vasovagal reflexes; This case was received via Regulatory Authority (Reference number: 2021TJP100713) on 30-Sep-2021 and was forwarded to Moderna on 06-Oct-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021994), and reported to the Agency Regulatory Authority by a physician, was received via the RA (Ref, v21128404). Loss of consciousness was assessed as serious by the RA. On an unknown date, body temperature before vaccination: 36.5 degrees Celsius. On 15-Sep-2021, at 10:40, the patient received the 1st dose of this vaccine. At 10:50, about 10 minutes after the vaccination, the patient lost consciousness, fell down and bruised the left face. Blood pressure decreased and pulse decreased. The patient recovered consciousness in the recovery position and was able to talk. The patient''s general condition was confirmed no allergic symptoms. Although blood pressure and pulse continued to decrease, oxygenation was favorable. They were considered to be vasovagal reflex. The patient recovered after about an hour of follow-up, and no apparent pain developed. After consultation with the patient''s family, the patient was referred to the emergency department for consultation. Head CT was performed. Intracranial haemorrhage and facial bone fracture were not observed, and the patient was diagnosed with vasovagal reflex and facial bruise. The symptoms subsequently resolved. The outcome of loss of consciousness, fall, facial bruises, and vasovagal reflexes was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 33 year old male patient with no medical history, who experienced the unexpected serious event of Loss of consciousness , within the same day after the first dose of mRNA-1273 vaccine. The HCP reporter consider the causality as No reasonable possibility. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1770256 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-09-15
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: erythema multifomre; This regulatory authority case was reported by a pharmacist and describes the occurrence of ERYTHEMA MULTIFORME (erythema multifomre) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced ERYTHEMA MULTIFORME (erythema multifomre) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (erythema multifomre) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment medication was not provided. Company Comment: This case concerns a 67-year-old, female subject with no relevant medical history reported, who experienced the unexpected event of ERYTHEMA MULTIFORME. The event occurred two months after the dose of Spikevax. The rechallenge was not applicable since the number of doses is unknown by the report of regulatory authority. The benefit-risk relationship of Spikevax is not affected by this report. Very limited information regarding this event has been provided at this time.; Sender''s Comments: This case concerns a 67-year-old, female subject with no relevant medical history reported, who experienced the unexpected event of ERYTHEMA MULTIFORME. The event occurred two months after the dose of Spikevax. The rechallenge was not applicable since the number of doses is unknown by the report of regulatory authority. The benefit-risk relationship of Spikevax is not affected by this report. Very limited information regarding this event has been provided at this time.


VAERS ID: 1770300 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Limb injury, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; Chest pain; Muscle ache; Arm injury; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25977219) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), CHEST PAIN (Chest pain), MYALGIA (Muscle ache) and LIMB INJURY (Arm injury) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and LIMB INJURY (Arm injury) (seriousness criterion medically significant). On 19-Sep-2021, FATIGUE (Tiredness), CHEST PAIN (Chest pain), MYALGIA (Muscle ache) and LIMB INJURY (Arm injury) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-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 medications were not reported. Treatment medications were not reported. This case concerns a 32 year-old, male patient with no relevant medical history, who experienced the unexpected events of Fatigue, Chest pain, Myalgia, and Limb injury. The events occurred less than a day after a dose of MODERNA COVID-19 VACCINE, dose number unknown. Rechallenge was unknown due to lack of information regarding dose number and recurrence of the event. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Events assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: This case concerns a 32 year-old, male patient with no relevant medical history, who experienced the unexpected events of Fatigue, Chest pain, Myalgia, and Limb injury. The events occurred less than a day after a dose of MODERNA COVID-19 VACCINE, dose number unknown. Rechallenge was unknown due to lack of information regarding dose number and recurrence of the event. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Events assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1771035 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Migraine, Nausea, Paraesthesia, Vertigo
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow)

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-790479) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This Regulatory Authority case was reported by an other health care professional and describes the occurrence of MIGRAINE VERTIGO, PARAESTHESIA, NAUSEA and APHASIA in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced MIGRAINE (seriousness criterion hospitalization), VERTIGO (seriousness criterion hospitalization), PARAESTHESIA (seriousness criterion hospitalization), NAUSEA (seriousness criterion hospitalization) and APHASIA (seriousness criterion hospitalization). At the time of the report, MIGRAINE, VERTIGO, PARAESTHESIA NAUSEA and APHASIA had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. On 15-Sep-2021, CAT was performed and result was not provided. 4 minutes after the administration of the Moderna vaccine, extremely painful piercing migraine, tingling and consequent paresthesia of the face and limbs, aphasia, nausea, vertigo and disorientation. company comment: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine, vertigo, aphasia and paresthesia of the face and limbs. The event occurred approximately 1 day after the first dose of Spikevax.The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation received on 01-OCT-2021 contain significant information that include I narrative updated.; Sender''s Comments: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine, vertigo, aphasia and paresthesia of the face and limbs. The event occurred approximately 1 day after the first dose of Spikevax.The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


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