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

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



Case Details (Reverse Sorted by Onset Date)

This is page 213 out of 8,010

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VAERS ID: 1720881 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Hypoaesthesia, Influenza, Pain, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; 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: Flu symptoms; Chest pain; Heart pounding; High temperature; Generalized aching; Numbness in hand; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25929141) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding), PYREXIA (High temperature), PAIN (Generalized aching) and HYPOAESTHESIA (Numbness in hand) 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 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PALPITATIONS (Heart pounding) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), PAIN (Generalized aching) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant). At the time of the report, INFLUENZA (Flu symptoms), CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and PAIN (Generalized aching) had not resolved and PYREXIA (High temperature) and HYPOAESTHESIA (Numbness in hand) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided. Company Comment: This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected events of INFLUENZA (Flu symptoms), CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding), PYREXIA (High temperature), PAIN (Generalized aching) and HYPOAESTHESIA (Numbness in hand). The events occurred on the same day (11Sep2021) after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected events of INFLUENZA (Flu symptoms), CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding), PYREXIA (High temperature), PAIN (Generalized aching) and HYPOAESTHESIA (Numbness in hand). The events occurred on the same day (11Sep2021) after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1720886 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: shivering; Lethargy; Fever; Headache; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25929276) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (shivering) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 12-Sep-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, LETHARGY (Lethargy), PYREXIA (Fever) and HEADACHE (Headache) had not resolved and CHILLS (shivering) outcome was unknown. 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. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient had the jab at 10:50am, by 19:00pm she was shivering and then having hot sweats, had such a bad headache she could not move her head and could not move her arm from the pain. Company Comment: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of lethargy, pyrexia, headache and chills. The events occurred the same day after the 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 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of lethargy, pyrexia, headache and chills. The events occurred the same day after the 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 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness.


VAERS ID: 1720893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Migraine, Nausea, 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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vomiting; Nausea; Migraine; This case was received via RA (Reference number: GB-MHRA-ADR 25929473) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), NAUSEA (Nausea) and MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 10-Mar-2019. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and MIGRAINE (Migraine) (seriousness criterion medically significant). On 12-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved and MIGRAINE (Migraine) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. On an unspecified date, patient underwent COVID-19 virus test and the results were not provided. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This report concerns a female patient who experienced unexpected serious events of migraine, nausea approximately 1 day and vomiting 2 days after the second dose of mRNA-1273. The re-challenge was unknown since there''s no information about the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This report concerns a female patient who experienced unexpected serious events of migraine, nausea approximately 1 day and vomiting 2 days after the second dose of mRNA-1273. The re-challenge was unknown since there''s no information about the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1721930 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-11
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7478 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Malaise, Oropharyngeal pain, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Test Date: 20210911; Test Name: COVID test: RT-PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101206553

Write-up: malaise; body aches; cough; sore throat; She tested positive for COVID 19; She tested positive for COVID 19; This is a spontaneous report from a contactable consumer. This consumer reported for a 29-year-old female patient. A 29-year-old non pregnant female patient (not-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot Number: FA7478) via an unspecified route of administration on 10Jun2021 (29-year-old at the time of vaccination) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Patient had no other vaccines in four weeks, no other medications in two weeks and no COVID prior vaccination. Allergies were unknown. On 11Sep2021, the patient tested positive for COVID 19. On 12Sep2021, the patient experienced malaise, body aches, cough and sore throat. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. On 11Sep2021, the patient underwent lab tests and procedures which included Nasal Swab (RT-PCR) was positive. No treatment was given for the events. The outcome of the events were recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1722123 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-11
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dizziness postural, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: dizziness; blurred vision; chest pain; Dizzy on standing; This case was received (Reference number: GB-MHRA-ADR 25933495) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VISION BLURRED (blurred vision), DIZZINESS POSTURAL (Dizzy on standing) and CHEST PAIN (chest pain) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant), VISION BLURRED (blurred vision) (seriousness criterion medically significant) and CHEST PAIN (chest pain) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizziness) and VISION BLURRED (blurred vision) outcome was unknown and DIZZINESS POSTURAL (Dizzy on standing) and CHEST PAIN (chest pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication provided. Company comment This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of dizziness, vision blurred, dizziness postural and chest pain. The event dizziness postural 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 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 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of dizziness, vision blurred, dizziness postural and chest pain. The event dizziness postural 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 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: 1724733 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191542

Write-up: Pins and needles; Difficulty breathing; Tight chest; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109111757265350-XXBRF, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25928575. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF2), via an unspecified route of administration on 11Sep2021 (at the age of 26 years old), as dose 2, single for COVID-19 immunisation. The patient''s medical history included anxiety (from an unknown date and unknown if ongoing). Historical vaccine included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for COVID-19 immunisation. Concomitant medication(s) included citalopram (CITALOPRAM) taken for anxiety (start and stop date were not reported). Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 11Sep2021, the patient experienced pins and needles, difficulty breathing and tight chest. All the events were serious (medically significant). The outcome of the event was pins and needles, difficulty breathing and tight chest was recovered with sequelae on an unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724747 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 INC202101191496

Write-up: Nausea; Diarrhea; 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-WEBCOVID-202109112333424490-ZSS56; Safety Report Unique Identifier: GB-MHRA-ADR 25928770. A 22-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Not known), via an unspecified route of administration on 11Sep2021 (age at the time of vaccination 22-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced nausea and diarrhea on 11Sep2021, about 8 hours following vaccine the patient started with both symptoms and was ongoing for some hours then. The events were assessed as medically significant. The outcome of both the events was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724753 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Feeling drunk, Hallucination, Pain, SARS-CoV-2 test, Sleep disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: FLUOXETINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Head cold; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191786

Write-up: feeling can be described as being incredibly drunk; Pains; restless sleep; fatigue; chills; hallucinations; Hallucination; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109120739104580-RL0QU. Safety Report Unique Identifier GB-MHRA-ADR 25928902. A 28-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 11Sep2021 (at the age of 28-year-old ) as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included suspected covid-19 from 01Sep2021 to 07Sep2021 and head cold from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine taken for an unspecified indication from 20Mar2021 to an unspecified stop date and paracetamol taken for head cold from 03Sep2021 to 08Sep2021. 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 experienced hallucinations, chills, feeling can be described as being incredibly drunk, fatigue, pains and restless sleep. On 11Sep2021, hallucination. It was reported that fatigue started after vaccine to be expected. Approximately 10 to 11 hours after vaccine hallucination started. Feeling could be described as being incredibly drunk, unable to walk or think despite not having had any alcohol. Confused thoughts and unsure where she was or what had happened that day. Went to bed, had chills, pains and restless sleep then hallucinations stopped by morning. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Aug2021 (Yes - Positive COVID-19 test). The outcome of event hallucination was recovered on 12Sep2021, events pains, restless sleep were unknown and other events were recovered on an unspecified date. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1724759 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Loss of consciousness, Nausea, Pyrexia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: headache; rigors; nauseated; loss of consciousness; Seizure; Fever; This case was received via RA (Reference number: GB-MHRA-ADR 25930465) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness), SEIZURE (Seizure), HEADACHE (headache), CHILLS (rigors), NAUSEA (nauseated) and PYREXIA (Fever) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant). On 12-Sep-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criteria disability and medically significant), HEADACHE (headache) (seriousness criteria disability and medically significant), CHILLS (rigors) (seriousness criteria disability and medically significant) and NAUSEA (nauseated) (seriousness criteria disability and medically significant). On 12-Sep-2021, SEIZURE (Seizure) and PYREXIA (Fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness), HEADACHE (headache), CHILLS (rigors) and NAUSEA (nauseated) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment for the events were not provided. This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure, and the expected events of headache, chills, nausea, and pyrexia. The events occurred on the day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Sender''s Comments: This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure, and the expected events of headache, chills, nausea, and pyrexia. The events occurred on the day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1724761 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscular weakness, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; ROBITUSSIN [GUAIFENESIN]; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscular pains; Muscle weakness; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25930984) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Depression. Concomitant products included SERTRALINE for Depression, PARACETAMOL and GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) for an unknown indication. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient lost grip strength, coordination, and fine motor skills in the arm that vaccination was received, also had muscular pains throughout arm, chest, and especially in armpit. Patient had not tested positive for COVID-19 since having the vaccine neither have any symptoms associated with COVID -19. Patient is not currently breastfeeding. Company Comment: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of muscle weakness, myalgia, coordination abnormal, fine motor skill dysfunction. The event muscle weakness occurred 1 day after the second dose of MRNA-1273 vaccine while the events myalgia, coordination abnormal and fine motor skill dysfunction occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. No reporter''s assessment was given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of muscle weakness, myalgia, coordination abnormal, fine motor skill dysfunction. The event muscle weakness occurred 1 day after the second dose of MRNA-1273 vaccine while the events myalgia, coordination abnormal and fine motor skill dysfunction occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. No reporter''s assessment was given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1724767 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: Headache; Fever; Ache; Sickness; Fatigue; This case was received via the RA (Reference number: GB-MHRA-ADR 25934244) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), PAIN (Ache), ILLNESS (Sickness) and FATIGUE (Fatigue) 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 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 13-Sep-2021, HEADACHE (Headache) was resolving. At the time of the report, PYREXIA (Fever) and PAIN (Ache) was resolving, ILLNESS (Sickness) had resolved and FATIGUE (Fatigue) had not 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. No concomitant medication information was provided. No treatment information was provided. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient had not had symptoms associated with COVID-19. The patient was not pregnant, and not currently breastfeeding. Company Comment: This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the unexpected event of Headache, Pyrexia, Pain, Illness and Fatigue. The events occurred approximately the same day after the 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. 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 18-year-old, female patient with no relevant medical history, who experienced the unexpected event of Headache, Pyrexia, Pain, Illness and Fatigue. The events occurred approximately the same day after the 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. 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: 1724771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101229143

Write-up: Shingles; This is a spontaneous report from two contactable Consumer downloaded from the regulatory authority-WEB. Regulatory authority report number GB-MHRA-WEBCOVID-202109141655017240-TC0VA with Safety Report Unique Identifier GB-MHRA-ADR 25939974. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, (Batch/Lot Number: unknown), via an unspecified route of administration on 10Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. The patient had experienced shingles on 11Sep2021. The event seriousness was assessed as medically significant. The outcome of the event was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1729156 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-11
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Pruritus, Rash, SARS-CoV-2 test, Thirst
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), 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: CYCLIZINE
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 INC202101196445

Write-up: sudden onset of severe rash to trunk, face and groin; Extremely itchy; Severe thirst; allergic reaction; 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-202109121854075840-JEBUK with Safety Report Unique Identifier of GB-MHRA-ADR 25929329. A 17-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 28Aug2021, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications included cyclizine (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date and unknown if ongoing. On 11Sep2021, exactly 2 weeks after vaccination, the patient experienced sudden onset of severe rash to trunk, face and groin and rash. On an unknown date in 2021, the patient experienced allergic reaction, extremely itchy, and severe thirst. The event sudden onset of severe rash to trunk, face and groin and allergic reaction were reported as serious for being medically significant. It was reported that there was no other known cause for the events but appeared to be allergic reaction because of way in which rash presented. The patient had not had these events before. On an unknown date in 2021, the patient underwent COVID-19 virus test and the result was negative. No other relevant investigations or tests were conducted. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event sudden onset of severe rash to trunk, face and groin was not resolved; while that of extremely itchy, severe thirst, allergic reaction and were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101196430

Write-up: This is a spontaneous report from a contactable consumer (the patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109121901312860-ZGDRY; safety report unique identifier: GB-MHRA-ADR 25929334). A female patient, of unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FE3380), via an unspecified route of administration, on Sep 11, 2021, single dose, for COVID-19 immunisation. Medical history not reported. The patient did not have symptoms associated with COVID-19. Patient not enrolled in a clinical trial. Concomitant medications included paracetamol for an unknown indication from Sep 10, 2021 and unknown if ongoing. On Sep 11, 2021 (on the same day of vaccination), patient had swollen lymph nodes in the armpit where the patient received the vaccine. On an unknown date in Sep 2021, patient experienced shaking, severe headache, fever, nausea, fatigue, shivering and muscles pain; all the events reported serious (medically significant). On an unknown date, patient underwent a COVID-19 virus test: negative result. The patient has not tested positive for COVID-19 since the vaccination. The outcome of swollen lymph nodes in the armpit: not recovered; while that of severe headache, shivering, shaking, fatigue, fever, muscles pain and nausea: unknown (at the time of this report). No follow-up attempts needed. No further information expected.


VAERS ID: 1729211 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure via breast milk, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Neonatal exposures via breast milk (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101198233

Write-up: Vaccine exposure via breast milk; Vomiting projectile; This is a spontaneous report from a contactable consumer (parent) or other non HCP. This is the second of 2 reports. The first report is a report received from the Regulatory Agency, report number GB-MHRA-WEBCOVID-202109120029572720-C03IZ, Safety Report Unique Identifier GB-MHRA-ADR 25928791. Reporter had received the vaccine and was breastfeeding 18-months-old baby. This case pertains to 18-months-old baby (the patient). A 18-months-old patient of an unspecified gender received second doe of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via transmammary route on 10Sep2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. On 11Sep2021, 1 day after second dose patient experienced vomiting projectile, vaccine exposure via breast milk. Her breastfed 18-months-old began projectile vomiting 11 hours after she had her second jab. The vomiting lasted approximately 11 hours, with a very quick recovery for toddler. The reporter considered the event vomiting projectile as serious (medically significant). The outcome of event vomiting projectile was resolved on 11Sep2021. outcome other evets was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101191553 Original Case : 202101191553


VAERS ID: 1729255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-09-11
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
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: 20210707; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:positive for anti-spike protein antibody
CDC Split Type: HKPFIZER INC202101223219

Write-up: CONFIRMED CASE OF COVID-19; CONFIRMED CASE OF COVID-19; This is a spontaneous report from a non-contactable healthcare professional downloaded from the Regulatory Authority (Regulatory authority report number: not provided),based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003557), license party for bnt162b2 (COMIRNATY). As of 0:00 am, 13-Sep-2021, DH announced that 1 additional confirmed case of COVID-19 after Comirnaty vaccination A 26-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 17May2021 as single dose and first dose on 26Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had confirmed case of COVID-19 and exhibited drug ineffective on 11Sep2021. On 11Sep2021, the patient had symptoms and was confirmed as COVID-19. The adverse event confirmed case of COVID-19 was considered as Important Medical Event. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive for anti-spike protein antibody on 07Jul2021. The outcome of the events was unknown. The causality assessment per reporter and company was possible Follow-up closed, no further information is possible.


VAERS ID: 1729429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Exposure during pregnancy, Extra dose administered, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (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: 20210911; Test Name: PCR Covid test; Test Result: Positive
CDC Split Type: ILPFIZER INC202101192970

Write-up: 35 weeks pregnant after the 3rd vaccine/positive PCR; 35 weeks pregnant after the 3rd vaccine/positive PCR; 35 weeks pregnant after the 3rd vaccine/positive PCR; 35 weeks pregnant after the 3rd vaccine/positive PCR; This is a spontaneous report from a contactable nurse (the patient) and a consumer. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE, dose 2 via an unspecified route of administration on an unspecified date as DOSE 2,SINGLE, dose 3 via an unspecified route of administration on an unspecified date as DOSE 3,SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced 35 weeks pregnant after the 3rd vaccine. On 11Sep2021 positive PCR test. The outcome of events was unknown. No Follow-Up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event COVID-19, Drug ineffective, Extra dose administered and Exposure during pregnancy cannot be excluded. .


VAERS ID: 1729666 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: blood pressure; Result Unstructured Data: Test Result:70s; Comments: 15 minutes after vaccination.
CDC Split Type: JPPFIZER INC202101192212

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable physician received from regulatory authority. Regulatory authority report number is v21126544. A 49-year and 8-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 11Sep2021 11:05 at the age of 49-year old (Batch/Lot Number: FD0349; Expiration Date: 31Oct2021) as dose 2, single for covid-19 immunisation. 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 anaphylactic shock on 11Sep2021 11:20 with outcome of recovered on 11Sep2021. The course of the event was as follows: On 11Sep2021 at 11:20 (15 minutes after the vaccination), feels poorly appeared. When attached the monitor, blood pressure was 70s, intravenous drip received. After about an hour of improvement using a blood-raising agent, symptoms improved. For an about 1 hour, feels poorly improved as well. The patient underwent lab tests and procedures which included blood pressure: 70s on 11Sep2021 (15 minutes after vaccination). The reporting physician classified the event as serious (Medically significant) and assessed that the event was related to bnt162b2. The reporting physician commented as follows: Diagnosed as Anaphylactic shock for COMIRNATY vaccine.


VAERS ID: 1729693 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dysphoria, Heart rate, Heart rate decreased, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ETHYL ICOSAPENTATE; AMLODIPINE; CARBOCISTEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Blood pressure decreased; Result Unstructured Data: Test Result:73/50 mmHg; Test Date: 20210911; Test Name: Pulse; Result Unstructured Data: Test Result:37
CDC Split Type: JPPFIZER INC202101196352

Write-up: Vagal reaction; dysphoria; Blood pressure decreased to 73/50; Pulse was 37; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution . A 55-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, administered via intramuscular route, in left arm on 11Sep2021 11:30, at 55 years of age, (Batch/Lot Number: FH0151; Expiration Date: 31Dec2021) as single dose for COVID-19 immunization. Medical history included hypertension, dyslipidaemia and bronchitis chronic, all from an unknown date. The patient had no allergies to medications, food, or other products. Concomitant medications included ethyl icosapentate, amlodipine and carbocisteine, all taken for an unspecified indication, since an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021 at 11:40 (10 minutes after the vaccination), the patient experienced dysphoria. Blood pressure decreased to 73/50. Pulse rate was 37. The patient gradually recovered through bed rest and fluid infusion. The patient was taken to the emergency hospital just in case. On 11Sep2021 at 11:45 (15 minutes after the vaccination), the patient experienced vagal reaction. The reporter stated the events results in Doctor or other healthcare professional office/clinic visit. The outcome of events was recovering with treatment including fluid infusion. No follow up attempts are possible. No further information is expected.


VAERS ID: 1729705 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia (Being treated for fibromyalgia at another institution, stable)
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Body temperature; Result Unstructured Data: Test Result:around 38 Centigrade; Comments: pyrexia of around 38 degrees centigrade.
CDC Split Type: JPPFIZER INC202101219093

Write-up: numerous small skin eruptions on the face and entire body/Many rashes were noted on the body; Anaphylaxis; pyrexia of around 38 degrees centigrade; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21126891. A 50-year and 3-month-old female patient received first dose bnt162b2 (COMIRNATY; Formulation: Solution for injection; Lot Number: FF3620; Expiration Date: 30Nov2021) via an unspecified route of administration on 11Sep2021 at 13:30 (the day of vaccination, age at vaccination was 50 years old) as dose 1, single for covid-19 immunisation. Body temperature before vaccination was not provided. There were 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 medical history includes fibromyalgia from an unknown date and unknown if ongoing (being treated for fibromyalgia at another institution, stable). The patient''s concomitant medications were not reported. On the afternoon of 11Sep2021, unknown hour and minute (the day of vaccination), the patient experienced anaphylaxis. Patient experienced pyrexia of around 38 degrees centigrade on 11Sep2021 and numerous small skin eruptions on the face and entire body/many rashes were noted on the body on 13Sep2021. The course of the event was as follows: On 11Sep2021, at evening of the day of vaccination, the patient experienced pyrexia of around 38 degrees centigrade. The patient took LOXONIN, and the pyrexia subsided. Around 13Sep2021, however, the patient began to experience numerous small skin eruptions on the face and entire body. On 14Sep2021, the patient visited an Emergency Medical Center and was prescribed antihistamine. Without any improvement, the patient presented to clinic on 15Sep2021. Many rashes were noted on the body. The patient was followed up with oral medication. The patient underwent lab test which included body temperature around 38 centigrade on 11Sep2021. Therapeutic measures were taken as a result of anaphylaxis, pyrexia of around 38 degrees centigrade with Loxonin, numerous small skin eruptions on the face and entire body/many rashes were noted on the body with antihistamine and oral medication. The outcome of the event pyrexia was recovering; anaphylaxis was unknown and numerous small skin eruptions on the face and entire body/Many rashes were noted on the body was reported as not resolved. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729731 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Head discomfort, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol allergy (Drug allergy (Alcohol)); Dermatitis atopic; Irritable bowel syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; Heaviness of head; Queasy; This case was received via the RA (Reference number: 2021TJP091859) on 11-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0021674), and reported to the RA by a physician, was received via the RA (Ref, v21126543). The patient was on her period. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 11-Sep-2021, 10:32, the patient received 1st dose of the vaccine. At 10:40, heaviness of head and queasy were present. The patient suddenly experienced anaphylaxis, and it progressed rapidly. At 11:00, discomfort in lower abdomen, nasal congestion, and nasal discharge were present. At 11:15, sodium L-lactate ringer''s solution 500 mL was administered. At 11:20, hydroxyzine hydrochloride 25 mg was administered. At 11:30, methylprednisolone sodium succinate 125 mg was administered. At 11:34, adrenaline 0.3 mg was administered, and the symptoms were resolving. Vital signs were stable constantly. The patient was transported by ambulance to a hospital. The outcome of heaviness of head, queasy, and anaphylaxis was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Anaphylaxis was suspected because the symptoms were resolving after administration of adrenaline.; Sender''s Comments: This case concerns a 31 year-old, female patient with medical history of dermatitis atopic and drug allergy, who experienced the expected event of Anaphylactic reaction and the unexpected events of head discomfort and nausea. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1729734 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP093124) on 11-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a physician, was received by the Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021672), and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21126535). Peripheral nerve disorder was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 11-Sep-2021, at 10:20, the patient received the 1st dose of the vaccine. Just after the vaccination, peripheral nerve disorder occurred. The patient had numbness in the left hand and unpleasant sensation in the left forearm. The outcome of peripheral nerve disorder was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19-year-old, female patient with no medical history, who experienced the unexpected events of Neuropathy peripheral. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter assessed the event as Not Related to the product. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1729735 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

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

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

Write-up: Loss of consciousness; vasovagal reflex; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP093152) on 11-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0021675), and reported to the RA by a physician, was received via the RA (Ref, v21126553). Loss of consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 11-Sep-2021, at 14:12, the patient received the 1st dose of the vaccine. At 14:25, vasovagal reflex developed while the patient was sitting. The patient had giddiness and lost consciousness for about 10 seconds. Subsequently, the symptoms resolved. The outcome of loss of consciousness and vasovagal reflex 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 19-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1729736 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / UNK - / OT

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

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

Write-up: Loss of consciousness; Bradycardia; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP093153) on 11-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021679), and reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21126564). Loss of consciousness and bradycardia were assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 11-Sep-2021, at 16:27, the patient received the 1st dose of the vaccine. Immediately after the vaccination, vasovagal reflex developed. The patient experienced sleepiness and difficulty breathing and then lost consciousness for 10 seconds. Bradycardia and decreased blood pressure were noted. Subsequently, recovery of the symptoms was confirmed. The outcome of vasovagal reflex, loss of consciousness, and bradycardia 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 22-year-old male patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness and Bradycardia 1 day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as no rechallenge was done. The event causality was considered no reasonable plausibility to the vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1729737 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder; This case was received (Reference number: 2021TJP093154) on 11-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a physician, was received by Moderna''s adverse reaction reporting site (TASK0021677), and this case, initially reported to the physician, was received (Ref, v21126557). Peripheral nerve disorder was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 11-Sep-2021, at 14:43, the patient received the 1st dose of the vaccine. At 14:55, peripheral nerve disorder occurred. The patient had numbness in the left forearm. Subsequently, the patient was recovering from the event. The outcome of peripheral nerve disorder was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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 20 -year-old, female patient with no relevant medical history, who experienced the unexpected event of peripheral neuropathy. The event occurred approximately 12 minutes after the first dose of Moderna COVID-19 Vaccine. The patient had numbness in the left forearm. Subsequently, the patient was recovering from the event. The rechallenge was not applicable, as the events happened after the first dose and action taken was reported as not applicable. The reporter assessed the event as not related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per provide information is source document.


VAERS ID: 1729740 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Presyncope, Visual impairment
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Vasovagal reflex; Dimmed vision; Possibility of anaphylaxis; This case was received via regulatory authority (Reference number: 2021TJP093278) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a vaccinator (other than a physician), was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK0021689), and reported to the regulatory authority by a vaccinator (other than a physician), was received via the regulatory authority (Ref, v21126586). On 11-Sep-2021, at 11:00, the patient received the 1st dose of this vaccine. At 11:05, anaphylaxis possibly developed suddenly. At 11:30, vasovagal reflex developed. Queasy and dimmed vision were noted. Lactated ringer''s solution 500 mL, d-chlorpheniramine maleate 1A, and famotidine 1A were administered in bed. Improvement was confirmed, and when the patient walked home, queasy developed again. Adrenaline 0.3 mg was injected intramuscularly in bed, but the symptoms did not improve. The patient was raced to a hospital and was hospitalized. On 12-Sep-2021, the patient had queasy but was discharged from the hospital at the patient''s request. On 13-Sep-2021, it was confirmed that the symptoms were resolving. The outcome of possibility of anaphylaxis, vasovagal reflex, and dimmed vision was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: This case concerns a 16-year-old, male patient with no medical history, who experienced the expected event of Anaphylactic reaction. The event occurred immediately within 30 minutes after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also experienced serious events of Presyncope and Visual impairment. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 16-year-old, male patient with no medical history, who experienced the expected event of Anaphylactic reaction. The event occurred immediately within 30 minutes after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also experienced serious events of Presyncope and Visual impairment. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1731007 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Nasopharyngitis, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (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: Comments: No known comorbidities.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210945336

Write-up: PYREXIA; CHILLS; COMMON COLD; PAIN PHARYNX; ARTHRALGIA; This spontaneous report received from a consumer via Regulatory Authority (AT-BASGAGES-2021-048778) on 23-SEP-2021 concerned a 24 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no known comorbidities. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: X3423 and expiry: unknown) dose was not reported, 1 total administered on 11-SEP-2021 for unknown indication. No concomitant medications were reported. On 11-SEP-2021, the patient experienced pyrexia (39.6 degrees celsius), chills, common cold, pain pharynx and arthralgia (joint pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pyrexia, chills, common cold, pain pharynx, and arthralgia. This report was serious (Other Medically Important Condition).; Reporter''s Comments: I was "fully vaccinated" with company Johnson''s vaccine on 11.9.2021 at 11:00. At about 6 in the evening I had joint pain followed by chills and fever ? 39,6 degrees; rhinitis and neck pain came during the night. That continued on an on/off basis until about Monday, 13.9.21 when I started feeling better. I was completely "healthy/symptom-free" on Wednesday 15.9.


VAERS ID: 1731098 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7206 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysgeusia, Headache, Interchange of vaccine products, Nausea, Off label use
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart murmur (Heart murmur as a child, unsure if it still exists); Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101206045

Write-up: This Pfizer dose was the second Pfizer vaccination but her third vaccination overall/ initially had the Astra Zeneca Vaccine as her first dose; This Pfizer dose was the second Pfizer vaccination but her third vaccination overall/ initially had the Astra Zeneca Vaccine as her first dose; Severe headache lasting 1 day; Metallic taste in mouth; nausea/ felt nauseous; lightheaded; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old female patient (pregnant: no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose (reported as this Pfizer dose was the second Pfizer vaccination but her third vaccination overall) via an unspecified route of administration, administered in left arm on 10Sep2021 at 03:15 (Batch/Lot Number: FD7206) as single dose for covid-19 immunisation. Medical history included heart murmur from an unknown date (Heart murmur as a child, unsure if it still exists), penicillin from an unknown date. The patient''s concomitant medications were not reported. The patient previously received the Astra Zeneca Vaccine (COVID-19 VACCINE ASTRAZENECA, initially had the Astra Zeneca Vaccine as first dose) on an unspecified date for covid-19 immunisation; the BNT162B2 (DOSE 2 (INITIAL PFIZER DOSE), SINGLE) on an unspecified date for covid-19 immunisation. The patient experienced metallic taste in mouth lasting 3 days, severe headache lasting 1 day, nausea/ felt nauseous, lightheaded, all on 11Sep2021 at 11:00. No hospitalization and no treatment received for the events. Nausea/lightheaded occasionally the following day. One evening episode followed a trip to the bathroom to urinate. Felt nauseous so the patient sat down with a bottle of water in her left hand. Suddenly the bottle tipped forward and although she knew she was being drenched by the water she could not immediately correct the action. She looked down and saw the bottle and she saw her left hand move slightly as she tried to right the bottle. Only after approximately 1/2 the bottle was emptied did she manage to lift the bottle. This lasted for a few seconds. Immediately following this episode it felt like her left ear had an ear plug inserted as the conversation from a family member sounded muted. This lasted a few seconds then corrected itself. I still felt nauseous/lightheaded for another 20 minutes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Severe headache lasting 1 day and Metallic taste in mouth was recovered in Sep2021, for events nausea/ felt nauseous and lightheaded was were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732532 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Fatigue, Feeling abnormal, Headache, Nausea, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (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: Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Comida 19 pcr test; Test Result: Negative ; Comments: Techniques: Nasal Swab; prior vaccination; Test Date: 2021; Test Name: SARS-Cov-2 test; Result Unstructured Data: Test Result:Unknown; Comments: Since the vaccination
CDC Split Type: DEPFIZER INC202101193318

Write-up: partially short facial paralysis; Headache; Palpitations; Nausea; Tiredness; Brain feels foggy; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority. A non-pregnant 44-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered on the left arm on 10Sep2021 17:00 (Batch/Lot number: not reported) (at the age of 44 years old) as dose 2, single for COVID-19 immunisation. The vaccine was administered in a Public Health Clinic. The patient''s medical history included penicillin allergy (reported as penicillin). Concomitant medications were reported as none (List of any other medications the patient received within 2 weeks of vaccination: None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2, administered on the left arm on 04Aug2021 16:00 (Batch/Lot number: not reported) (at the age of 43 years old) for COVID-19 immunisation. On 11Sep2021 11:00, the patient experienced partially short facial paralysis, headache, palpitations, nausea, tiredness, and brain feels foggy. The event partially short facial paralysis is serious (medically significant). The patient underwent lab tests and procedures which included SARS-CoV-2 test (reported as "Comida 19 pcr test") on 10Sep2021: Negative (Techniques: Nasal Swab; prior vaccination) and SARS-CoV-2 test on an unspecified date in 2021: Unknown (Since the vaccination). The patient did not receive any treatment. The events did not result in any of the following: results in death, life-threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect, and hospitalization prolonged. The outcome of the events was not recovered. The lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 1732882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Culture urine, Dizziness, Dyspnoea, Electrocardiogram, Headache, Heart rate, Heart rate increased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: urine sample; Result Unstructured Data: Test Result:unknown result; Test Name: Ecg; Result Unstructured Data: Test Result:unknown result; Test Name: Elevated heart rate; Result Unstructured Data: Test Result:120; Comments: 1st day; Test Name: Elevated heart rate; Result Unstructured Data: Test Result:irregular heart rate; Comments: 2nd day
CDC Split Type: GBPFIZER INC202101196506

Write-up: breathlessness; Fever; Heart rate increased; Chest pain; Felt faint; Throbbing headache; This is a spontaneous report from a contactable consumer or other non hcp. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is RA-APPCOVID-20210912134118. Safety Report Unique Identifier: RA-ADR 25929105. A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ff2153), via an unspecified route of administration on 10Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient''s medical history included contraception from 12Sep2019 to an unknown date. Patient''s concomitant medications included desogestrel, ethinylestradiol (GEDAREL) taken for contraception from 12Sep2019 to an unspecified stop date. Neither the patient had symptoms associated with COVID-19 nor had a COVID-19 test. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient experienced breathlessness on an unspecified date and fever, heart rate increased, chest pain, felt faint and throbbing headache on 11Sep2021. Elevated heart rate of 120 resting the day after. On the 2nd day heart rate normal when laying down but elevated to 115 when standing. Breathlessness, faint feeling and temp of 39. Chest pain/tightness. All the events were reported as medically significant. The patient underwent lab tests and procedures which included body temperature was 39 centigrade, culture urine and electrocardiogram with unknown on an unspecified date, heart rate was 120 on 1st day, heart rate: irregular heart rate on 2nd day when laying down but elevated to 115 when standing on an unspecified date. The outcome of breathlessness was recovered on an unspecified date, fever, heart rate increased, chest pain, felt faint was not recovered, while outcome of throbbing headache was recovering. No follow-up attempts are needed. No further information is expected


VAERS ID: 1732941 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Discomfort, Nausea, Pain in extremity, Pyrexia, Restlessness, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETASONE DIPROPIONATE; FEXOFENADINE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196519

Write-up: restlessness; general non-specific discomfort; general shakes; shivers; Leg pain; Nausea; Fever; Restless; 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-202109120846026350-PWVVL, Safety Report Unique Identifier GB-MHRA-ADR 25928930. A 26-year-old male patient received second dose of bnt162b2 (Pfizer BioNTech covid-19 vaccine, solution for injection, lot number: Ff2153), via an unspecified route of administration on 11sep2021 (at the age of 26 years old), as dose 2, single for covid-19 immunization. Historical vaccine was taken for first dose of bnt162b2 (Pfizer BioNTech covid-19 vaccine, 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 immunization. Medical history included rhinitis allergic from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. Concomitant medications included beclomethasone dipropionate taken for rhinitis allergic, asthma from Mar2021 to an unspecified stop date; fexofenadine taken for rhinitis allergic from Mar2021 to an unspecified stop date; salbutamol taken for asthma from Mar2021 to an unspecified stop date. Patient has not had symptoms associated with covid-19; not had a covid-19 test. Patient has not tested positive for covid-19 since having the vaccine. Patient is not enrolled in clinical trial. On an unspecified date patient experienced restlessness, general non-specific discomfort, general shakes, shivers, on 11Sep2021 restless, on 12Sep2021 leg pain, nausea, fever.Patient reported restlessness and general non-specific discomfort started overnight, followed by a wave of nausea in the morning and leg pain presumably after general shakes and shivers from discomfort. The outcome of restlessness was recovering, leg pain, restless, nausea, fever was not recovered, general non-specific discomfort, general shakes, shivers was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733004 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Heart rate, Inappropriate schedule of product administration, Nausea, Restlessness, Syncope, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: Heartbeat; Result Unstructured Data: Test Result:70-80 bpm; Comments: normal
CDC Split Type: GBPFIZER INC202101196474

Write-up: Fainting; Nausea; Skin cold clammy; Thirsty; patient received the 2nd dose of bnt162b2 on 11Sep2021 and the 1st dose on 22Jul2021; Restless in night; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory Authority report number GB-MHRA-WEBCOVID-202109122023182960-WLHX6, Safety Report Unique Identifier GB-MHRA-ADR 25929401. An 18-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FE3380) via an unspecified route of administration on 11Sep2021 about 11 am, at the age of 18 years, as dose 2, single COVID-19 immunisation. The patient did not have any relevant medical history, it was reported that patient was healthy with no previous history of fainting. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient had not had a COVID-19 test. Concomitant medications were not reported. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunisation. On 11Sep2021, the patient was restless in night. On 12Sep2021, the patient experienced fainting, nausea, skin cold and clammy and thirsty. The clinical course was reported as follows: The patient administered vaccine about 11am on 11Sep2021 and the patient was fine for rest of the day but restless in night and got up to go to bathroom at 4am on 12Sep2021. The patient fainted briefly in bathroom, found on floor shortly afterwards. The patient recovered consciousness, fainted again a few minutes later. The patient felt skin cold and clammy and felt nauseous. Heartbeat normal was about 70-80 bpm. The patient had no prior history of fainting. The patient was given water as he was thirsty, plus paracetamol and reassurance. The patient felt recovered by midday 12Sep2021 after sleep and another dose of paracetamol. The patient had not tested positive for COVID-19, since the vaccination. The case is serious medically significant. It was also reported that the patient received the 2nd dose of bnt162b2 on 11Sep2021 and the 1st dose on 22Jul2021 which was considered inappropriate schedule of vaccine administered. The clinical outcome of the events fainting, nausea, skin cold and clammy, restless in night, and thirsty was recovered on 12Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733007 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Loss of consciousness, Palpitations, SARS-CoV-2 test, Seizure
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196399

Write-up: Palpitations; Fit (non-epileptic); Lost consciousness/kept losing consciousness; Come over hot; This is a spontaneous report from a contactable consumer, the patient. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109122138161760-PKXMM with Safety Report Unique Identifier GB-MHRA-ADR 25929434. A 31-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Sep2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not-applicable (N/A). The patient was not pregnant and was not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. Concomitant medications were not reported. On 11Sep2021, the patient experienced palpitations, lost consciousness/kept losing consciousness, and started to fit (non-epileptic) while in doctor surgery and it lasted 6 hours; all were reported as serious for being medically significant and causing hospitalization. It was reported that the patient came over hot. On 11Sep2021, the patient underwent a COVID-19 virus test and the result was negative. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event fit (non-epileptic) was resolved on 11Sep2021 after the duration of 6 hours; the outcome of the event lost consciousness/kept losing consciousness was resolving; the outcome of event palpitations was not resolved while the outcome of the event come over hot was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733031 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Disturbance in attention, Feeling abnormal, Feeling of body temperature change, Headache, Hyperhidrosis, Insomnia, Loss of consciousness, Lymphadenopathy, Malaise, Myalgia, Nausea, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vaccination site pruritus
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infected insect bite
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205572

Write-up: hot and cold; Aching; concentration loss; passed out; sweating; spaced out; Enlarged lymph nodes (excl infective); Injection site itching; Pins and needles; Feeling unwell/Feeling sick; Chills; Nauseous; Generalised joint pain; Headache; Muscle pain; Insomnia; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109130839190910-BLTQT. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number FF2153, expiration date unspecified), via an unspecified route of administration on 11Sep2021 as DOSE 2, SINGLE for covid-19 immunization (44 year when vaccinated). Medical history included Infected insect bite. Concomitant medication included clarithromycin (CLARITHROMYCIN) taken for Infected insect bite from 23Aug2021 to 28Aug2021. The patient previously took penicillin and experienced adverse reaction. On 11Sep2021, the patient experienced insomnia. On 12Sep2021, the patient developed enlarged lymph nodes (excl infective), injection site itching, pins and needles, feeling unwell and sick, chills, nauseous, generalized joint pain, headache and muscle pain. On an unknown date, the patient experienced passed out, sweating, spaced out, hot and cold, concentration loss. Day of injection felt fine and felt fine until middle of the night. Woke feeling sick and excessive sweating giddy and going hot and cold. Felt aching all over and like he could hardly move. These symptoms although lessoning was making him feel unwell and feel totally spaced out. Patient could not focus or concentrate on work or anything else at moment. He had not had as much as a cold in over 2 years, but this has really knocked me for six. He passed out after the having the first injection but had no other symptoms after first jab. On 03Jul2021, the patient had lab test for SarS-CoV-2 infection test and result were negative. Patient has not tested positive for COVID-19 since having the vaccine. Seriousness for the events reported as medically significant. The outcome for the events passed out, sweating, spaced out, pins and needles, nauseous were reported as resolving, and not resolved for enlarged lymph nodes (excl infective), insomnia, injection site itching, feeling unwell/feeling sick, chills, generalised joint pain, headache, muscle pain and for 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. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101213662 Original Case : 202101205572 (Same patient and drug, different dose and event)


VAERS ID: 1733039 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Arthritis (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: GBPFIZER INC202101205600

Write-up: Neuropathy; Joint pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131017199270-DC4YO, Safety Report Unique Identifier GB-MHRA-ADR 25930905. A 31-year-old non-pregnant female 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 11Sep2021 as dose 1, single (Age at vaccination: 31-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not currently breastfeeding. On 11Sep2021, The patient experienced neuropathy and joint pain. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of the events neuropathy and joint pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained; No further information is expected.


VAERS ID: 1733055 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Gastric antral vascular ectasia, Influenza like illness, Rash, Rash pruritic, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205592

Write-up: given; 48 hours after vaccine; itchy rash; fatigue; Rash; Flu like symptoms; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131248202640-IZYK8. [Safety Report Unique Identifier: GB-MHRA-ADR 25931665] A 32-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number was not provided), via an unspecified route of administration on 11Sep2021 (At the age of 32-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient historical vaccine BNT162B2 as DOSE 1 SINGLE for COVID-19 immunization was reported. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. On an unspecified date the patient experienced given, 48 hours after vaccine events were assessed as medically significant, itchy rash, fatigue. On 13Sep2021 patient experienced rash and flu like symptoms on 11Sep2021. It was reported that Flu like symptoms on the evening vaccine was given, which resolved within a few hours. Fatigue the day after the vaccine but otherwise fine.48 hours after vaccine, developed a red and itchy rash on neck, tummy and back. Outcome of recovered while rash was Not recovered and Flu like symptoms was recovered on 11Sep2021 No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1733069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Ocular discomfort, SARS-CoV-2 test
SMQs:, Glaucoma (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205590

Write-up: left eye/dull with a small bit of pain; no visual marks around the eye,just hurts by touch/Eye pain; left eye/ feeling very sensitive; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131610198180-GAL4B, Safety Report Unique Identifier GB-MHRA-ADR 25932728. A 28-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: FE8087 and Expiration date was unknown), via an unspecified route of administration on 31Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Completely good medical history. Patient has not had symptoms associated with COVID-19. The patient had experienced left eye, feeling very sensitive and no visual marks around the eye, just hurts by touch/eye pain on an unspecified date in 2021. On 11Sep2021 the patient had experienced left, eye dull with a small bit of pain. The events seriousness was assessed as medically significant. Patient do not take any other medication, patient left eye had been feeling very sensitive and dull with a small bit of pain. Patient had never had this sensation before, it was getting more sensitive and painful by the day. No visual marks around the eye, just hurts by touch. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): no - negative covid-19 test on an unspecified date. The outcome of the events left eye, feeling very sensitive, no visual marks around the eye , just hurts by touch/eye pain was unknown and left, eye dull with a small bit of pain was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neuralgia
SMQs:, Peripheral neuropathy (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: OMEPRAZOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205383

Write-up: Nerve pain; 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-202109132053399790-MF39G with Safety Report Unique Identifier of GB-MHRA-ADR 25934428. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Sep2021, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of this report. The patient was not enrolled in clinical trial. Concomitant medications included omeprazole (OMEPRAZOL) for an unknown indication, from an unknown date and unknown if ongoing. On 11Sep2021, the patient experienced nerve pain, which was reported as serious for being medically significant. The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event nerve pain was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733099 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via RA (Reference number: GB-MHRA-ADR 25946125) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in September 2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. 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. No concomitant medications were reported by the reporter. The patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. It was reported that the patient was admitted with troponin of 4069. No treatment information was provided by the reporter. Company comment This case concerns 25 year old male who experienced myocarditis 1 day after receiving the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns 25 year old male who experienced myocarditis 1 day after receiving the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.


VAERS ID: 1733451 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Headache, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
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: 20210911; Test Name: BP; Result Unstructured Data: Test Result:72/42; Comments: At 10:25; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:76/69; Comments: At 10:30; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:90/49; Comments: At 11:15; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:111/69; Comments: At 11:30; Test Date: 20210911; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210911; Test Name: Pulse; Result Unstructured Data: Test Result:60; Comments: At 10:25; Test Date: 20210911; Test Name: Pulse; Result Unstructured Data: Test Result:57; Comments: At 10:30; Test Date: 20210911; Test Name: Pulse; Result Unstructured Data: Test Result:60; Comments: At 11:15; Test Date: 20210911; Test Name: Pulse; Result Unstructured Data: Test Result:63; Comments: At 11:30; Test Date: 20210911; Test Name: SpO2; Test Result: 99 %; Comments: At 10:30
CDC Split Type: JPPFIZER INC202101192947

Write-up: Vasovagal reflex; Giddiness; Headache; BP: 72/42; BP: 76/69; BP: 90/49; This is a spontaneous report from a contactable other health care professional. This is a report received from the regulatory authority report number is v21126548. A 15-year-old (also reported as 15-year and 9-month-old) female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 11Sep2021 10:10 (Lot number: FF9944; Expiration date: 30Nov2021), at age 15 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history was reported as none. Concomitant medications were not reported. 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). Body temperature before vaccination on 11Sep2021 was 36.7 degrees Centigrade. On 11Sep2021 at 10:25 (15 minutes after vaccination), the patient experienced vasovagal reflex (headache). The course of the event was as follows: At 10:10 (the same day of vaccination), the patient received the first dose of vaccination. At 10:25 (15 minutes after vaccination), giddiness appeared. Bed rest. Contacted doctor and nurse. Vital signs measurements by the nurse showed blood pressure (BP): 72/42 and heart rate (P): 60. IV drip was carried out according to the doctor''s instruction (SOLDEM 3A 500ml). At 10:30 (20 minutes after vaccination), vital signs measurements were BP: 76/69, P: 57 and oxygen saturation (SpO2): 99%. At 11:15 (1 hour 5 minutes after vaccination), vital signs measurements were BP: 90/49 and P: 60. At 11:30 (1 hour 20 minutes after vaccination), vital signs measurements were BP: 111/69 and P: 63. Vital stabled, giddiness symptom recovered. The patient went home accompanied by parent. In addition, the patient orally took a pack of Fexofenadine tablets 60 mg. On 11Sep2021 11:30, the outcome of BP: 72/42; BP: 76/69; BP: 90/49 was recovered. On 11Sep2021 (the same day of vaccination), the outcome of the remaining events was recovered. The reporter classified the event as non-serious (as reported) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown.


VAERS ID: 1737908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-11
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101216586

Write-up: 3-4 weeks after the 2nd vaccination, on Saturday, on 11Sep, his female partner had a thrombosis on her right leg and is currently taking Fragmin; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient reported that 3 to 4 weeks after the second vaccination, on Saturday 11Sep2021, the patient had a thrombosis on her right leg and was currently taking Fragmin. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1737981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Chest pain, Fall, Orbital haematoma
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210947376

Write-up: ORBITAL HAEMATOMA; THORAX PAIN; FALL; BLOOD PRESSURE DROPPED; This spontaneous report received from a consumer via Regulatory Authority (DE-PEI-CADR2021180248) on 24-SEP-2021 and concerned a 60 year old female. The patient''s weight was 82 kilograms, and height was 167 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C18-01 expiry: UNKNOWN) dose was not reported,1 total, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced orbital haematoma, thorax pain, fall (chest bruise, ambulance) and blood pressure dropped. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from orbital haematoma, thorax pain, fall, and blood pressure dropped. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1738712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Neck pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101216332

Write-up: Shoulder pain; Neck pain; Back pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109111506392130-PBASM. Safety Report Unique Identifier: GB-MHRA-ADR 25928375. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 10Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 as DOSE 1, SINGLE for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 11Sep2021, the patient experienced shoulder pain, neck pain and back pain. Seriousness criteria was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 25Feb2021 (Yes - Positive COVID-19 test). Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738714 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (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: GBPFIZER INC202101196461

Write-up: Joint pain; Muscle pain; Chills/shivering; Sweating; Headache; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is -MHRA-WEBCOVID-202109120806468250-RUP5S with Safety Report Unique Identifier of -MHRA-ADR 25928912. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Sep2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and did not have a COVID-19 test. The patient was not pregnant and was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 11Sep2021, the patient experienced joint pain, muscle pain, chills/shivering, sweating, headache and tiredness; all the events were reported as serious for being medically significant. The patient did not test positive for COVID-19 since having the vaccine. The clinical outcome of the events chills/shivering and sweating were resolved on an unknown date in Sep2021 while that of the events joint pain, muscle pain, headache and tiredness were resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1738722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Confusional state, Discomfort, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196426

Write-up: stomach pain; Chest pain; Tightness in chest.; tired; Very uncomfortable/ Clothes felt tight; confused; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109122058519370-NLEQA, Safety Report Unique Identifier GB-MHRA-ADR 25929419. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF 2153) via an unspecified route of administration on 09Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 11Sep2021, 48 hours after the vaccine, the patient experienced chest pain, tiredness, stomach pain, tightness in chest, felt tired, very uncomfortable/ clothes felt tight and confused. The events, stomach pain and chest pain were reported as serious for being medically significant. The clinical course was reported as follows: 48 hours after the vaccine, the patient felt tired and then she had tightness in her chest.as well as chest pain. The patient had stomach pain. She was very uncomfortable for 1.5 hours; could not lie down; a bit confused and her clothes felt tight. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The patient recovered from very uncomfortable/ clothes felt tight on an unspecified date in Sep2021 while clinical outcome of the events stomach pain, tightness in my chest, confused, chest pain and tired was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Fatigue, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101205579

Write-up: Armpit pain; Fever; Ache; Tiredness; This is a spontaneous report from a contactable consumer. This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109130856588110-EJNQ5. Safety Report Unique Identifier GB-MHRA-ADR 25930470. A 33-year-old non pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection), dose 2 via an unspecified route of administration on 11Sep2021 with unspecified Batch/Lot number as dose 2, single for COVID-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included ethinylestradiol, norgestimate (LIZINNA) taken for contraception, start and stop date were not reported. Historical vaccine included (BNT162B2), dose 1 via an unspecified route of administration on unknown date for COVID-19 immunisation. The patient experienced armpit pain on 12Sep2021, fever on 12Sep2021, ache on 12Sep2021, tiredness on 11Sep2021. Tiredness within hours of taking the vaccine. Awoke with fever, muscular aches and very sore, swollen armpit on the arm the vaccine was given. All events are 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 body temperature: unknown. The outcome of the event fever was recovered on unspecified date and other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   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: Fatigue, Rash, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill; Stevens-Johnson syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205514

Write-up: stevens-johnson syndrome; Rash; Tiredness; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131941057790-MUBW7, Safety Report Unique Identifier GB-MHRA-ADR 25933937. A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Sep2021 as dose 2, single for COVID-19 immunization. Medical history included stevens-johnson syndrome in the past, and birth control pill. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication(s) included desogestrel (CERELLE) taken for birth control pill. On an unspecified date, the patient experienced stevens-johnson syndrome, and on 11Sep2021, patient had tiredness, on 13Sep2021, rash. The events were considered as serious (medical significant). The outcome of events rash, tiredness was not recovered and stevens-johnson syndrome was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1738755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Liver function test, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Osteonecrosis (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LFT; Test Result: Positive ; Comments: LFTs are positive; Test Name: PCR; Test Result: Negative ; Comments: have all covid symptoms YET PCR negative; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101205612

Write-up: arm pain; Bone pain; This is a spontaneous report from a contactable consumer or other non (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109132108021630-LEMWH, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25934578. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot Number: FE3380), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 Inconclusive test. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot Number: not reported), via an unspecified route of administration on 27Apr2021 as dose 1, single for COVID-19 immunization and experienced pain in arm and bone pain in full length of left arm ever since. Affects me daily. Reported to local surgery, nothing done. On 11Sep2021, after second vaccination the patient experienced bone pain and on unspecified date experienced arm pain. It was reported that after 2nd dose, arm pain has increased even more. LFTs are positive, have all Covid symptoms yet PCR negative. On an unspecified date, the patient underwent lab tests which included liver function test was positive (LFTs are positive), sars-cov-2 test was inconclusive test and sars-cov-2 antibody test was negative (have all Covid symptoms yet PCR negative). The outcome of event for arm pain was unknown and for bone pain was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738765 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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 INC202101211370

Write-up: Shortness of breath; I noticed a shortness of breath occur when I started to walk up stairs or exert myself, which got gradually worse, but not debilitating.; Fever; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109140816008880-MYONW. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25937279. A 20-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Sep2021, (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number was not reported), as dose 1, single for COVID-19 immunization. On 13Sep2021, the patient experienced shortness of breath. On 11Sep2021, the patient had fever. It was also reported that she suffered an intense but short-lasting fever the night after. However, when he went back to work the day after, he noticed a shortness of breath occur when he started to walk upstairs or exert himself (dyspnoea exacerbated), which got gradually worse, but not debilitating. No notable chest pains or palpitations occurred. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test negative, No - Negative COVID-19 test. On 12Sep2021, the outcome of the event fever was reported as resolved, dyspnoea was not recovered and dyspnoea exacerbated was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738780 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Muscle twitching, Neuralgia, Pain, Renal pain, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211509

Write-up: Shooting pain; Kidney pain; Numbness in leg; Nerve pain; Muscle twitching; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109141037052410-ZNKJT, Safety Report Unique Identifier GB-MHRA-ADR 25938249. A 39-year-old female patient (not pregnant at the time of vaccination) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Lot Number: FF2153), via an unspecified route of administration on 11Sep2021 (at the age of 39-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not on breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. The patient had experienced shooting pain, kidney pain, numbness in leg, nerve pain, muscle twitching on 11Sep2021. The events seriousness was assessed as medically significant. The patient had severe shooting pains that would came on very sudden, for example in pt legs, in the lower back on the right hand side, up patient arms and it was incredibly painful and had never experienced pain like it. It also caused muscle twitching and numbness. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): no-negative COVID-19 test on an unspecified date. The outcome of the events shooting pain was recovering and kidney pain, numbness in leg, nerve pain, muscle twitching was not recovered. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1738784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Limb discomfort, Pain in extremity, Pruritus, SARS-CoV-2 test, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Anxiety; Menstrual cramps
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211465

Write-up: Injection site swelling; dose 1 of BNT162B2 taken on 26Jun2021 and dose2 of BNT162B2 taken on 11Sep2021; itching; numbness; hard to lift the arm up; pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109141118178180-EDVFH, Safety Report Unique Identifier GB-MHRA-ADR 25938308. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 11Sep2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization Medical history included Menstrual cramps and anxiety. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The concomitant medications included ibuprofen taken for Menstrual cramps, start and stop date were not reported; mirtazapine taken for anxiety, start and stop date were not reported. The patient previously tookbnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as dose1, single for covid-19 immunization. The patient experienced injection site swelling on 12Sep2021, itching, numbness, hard to lift the arm up, pain in arm on an unspecified date in 2021. The patient received dose 1 of bnt162b2 taken on 26Jun2021 and dose 2 of bnt162b2 taken on 11sep2021. It was reported that Initially minor swelling, after two days grew to about 10cm wide, with site itching and numbness. Makes it hard to lift the arm up (also due to pain in arm). The patient underwent lab tests and procedures which included COVID-19 virus test No - Negative COVID-19 test on 14Sep2021. The outcome of injection site swelling was not recovered while outcome of rest all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Myocardial injury, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211426

Write-up: Heart injury; His heart feels sore and painful. He never had heart pain in his life previously.; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141852585610-QG7SU. Safety Report Unique Identifier [GB-MHRA-ADR 25940644]. A 20-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 02Sep2021 as dose 1, single for covid-19 immunization. The medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 11Sep2021, the patient experienced heart injury. His heart felt sore and painful. He never had heart pain in his life previously. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on an unspecified date. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: 2021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101217831

Write-up: Itchy skin; Facial droop; This is a spontaneous report from a contactable Consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151715368540-AMTMN, Senders (Case) Safety Report Unique Identifier GB-MHRA-ADR 25946809. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: FF2153) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 11Sep2021, the patient experienced facial droop and on 12Sep2021, 1 day after second dose of vaccine, the patient experienced itchy skin. 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. On an unspecified date in 2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of the event facial droop was resolving, while the event itchy skin was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-09-11
   Days after vaccination:123
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: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217651

Write-up: Very, very heavy and long periods; Extremely painful periods; Periods irregular; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109160539355730-QYAZT with Safety Report Unique Identifier of GB-MHRA-ADR 25949219. A female patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced periods irregular and extremely painful periods. On 11Sep2021, the patient experienced very, very heavy and long periods which lasted longer than 8 days. Events periods irregular; very, very heavy and long periods were reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event very, very heavy and long periods was not recovered whereas that of the event periods irregular and extremely painful periods was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738994 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dental paraesthesia, Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Tingling teeth; Sore throat; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25961058) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), DENTAL PARAESTHESIA (Tingling teeth), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started) on 12-Sep-2021. Concomitant products included MIRTAZAPINE and SERTRALINE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), DENTAL PARAESTHESIA (Tingling teeth) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 12-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, DENTAL PARAESTHESIA (Tingling teeth) and OROPHARYNGEAL PAIN (Sore throat) had resolved and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company comment This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected event of Pyrexia, Dental paraesthesia, Oropharyngeal pain and Fatigue. The event occurred after administration of mRNA-1273. (Date and dose sequence of the vaccine are not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected event of Pyrexia, Dental paraesthesia, Oropharyngeal pain and Fatigue. The event occurred after administration of mRNA-1273. (Date and dose sequence of the vaccine are not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1739432 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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: Anaphylactic reaction, Body temperature, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown Centigrade
CDC Split Type: JPPFIZER INC202101206436

Write-up: anaphylaxis; Dyspnoea; light-headed feeling; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number is v21126739. A 20-year-old (reported as 20-year and 8-month-old) female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 11Sep2021 at about 16:25 (as reported) (at the age of 20-year-old) as dose 1, single dose for COVID-19 immunisation. Body temperature before vaccination was unknown. The patient''s medical history was unknown. The patient''s concomitant medications were not reported. On 11Sep2021 at about 16:30 (5 minutes after the vaccination) (as reported), the patient experienced light-headed feeling and dyspnea. On 11Sep2021 (the same day of the vaccination), the patient was admitted to the hospital for suspected anaphylaxis. On 12Sep2021 (1 day after the vaccination), the patient was discharged from the hospital. The course of the event was as follows: about 5 or 10 minutes after vaccination (as reported), light-headed feeling and dyspnoea occurred. At the vaccination place, the patient was administrated adrenaline injection via intramuscular, and transported to the hospital. The reporting physician classified the event as serious (caused hospitalization from 11Sep2021 to 12Sep2021) and assessed that the causality between the event and BNT162b2 as unassessable. On 12Sep2021 (1 day after the vaccination), the outcome of the events was resolved. The reporting physician commented as follows (reporter''s comment): with only the information that this hospital had, whether it was anaphylaxis or not was unable to assess. But the possibility of anaphylaxis could not be denied. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: With only the information that this hospital had, whether it was anaphylaxis or not was unable to assess. But the possibility of anaphylaxis could not be denied.


VAERS ID: 1740497 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fibromyalgia
SMQs:

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

Write-up: Myalgia; This case was received via Regulatory Authority (Reference number: 2021TJP094352) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority (RA) by a nurse, was received via the RA (Ref, v21126679). The patient was being treated for fibromyalgia and anemia. On 11-Sep-2021, at 20:15, the patient received the 1st dose of this vaccine. At 20:20, 5 minutes after the vaccination, the patient had headache and lay down on bed. The patient had weakness of the left hand, eye tracking difficulty, difficulty in evaluating nystagmus, paralysis on the left upper and lower limb, and JCS-1 or almost clear. The attending physician judged that detailed examination with HCT was urgently required and requested emergency care, and the patient was taken to the hospital with the physician. On an unknown date, the patient was examined at several medical institutions and was diagnosed with myalgia of unknown cause. The patient visited a pain clinic and was on steroid therapy at the moment. The outcome of myalgia was unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of fibromyalgia. The event fibromyalgia occurred the same day after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the first dose. The event were considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1740635 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden hearing loss
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210951317

Write-up: SUDDEN HEARING LOSS; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-044330) on 27-SEP-2021 and concerned a 22 year old male of unknown race and ethnicity. The patient''s weight was 108 kilograms and height was 190 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: unknown) 1 dosage forms, 1 total, administered on 11-SEP-2021 for covid-19 vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced sudden hearing loss. The patient was hospitalized on an unspecified date Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 11-SEP-2021. The patient had not recovered from sudden hearing loss. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).


VAERS ID: 1742215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pneumonia, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: DEJNJFOC20210947768

Write-up: PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS LEG; PNEUMONIA; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021179825) was received on 24-SEP-2021 and concerned a 66 year old female of unspecified race and ethnicity. The patient''s weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported , batch number: unknown expiry: unknown ) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-SEP-2021, the patient experienced pulmonary embolism, deep vein thrombosis leg, pneumonia, and was hospitalized (date unspecified). 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 pulmonary embolism, deep vein thrombosis leg, and pneumonia. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: Sind bei Ihnen oder der betroffenen Person Allergien bekannt? Wenn ja, welche?NeinAngaben zu Risikofaktoren oder Vorerkrankungen- / Schmerzen im Bein und Atemprobleme


VAERS ID: 1742410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210951573

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-NY20214399) on 27-SEP-2021 and concerned a 64 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total administered on 23-JUL-2021 for covid-19 vaccination. The drug start period was 51 days and drug last period was 51 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-SEP-2021, the patient experienced vaccination failure, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination failure. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint.


VAERS ID: 1742476 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:High; Comments: High temperature; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101223073

Write-up: Headache; Muscle pain; High temperature; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority-WEB, Regulatory authority number GB-MHRA-WEBCOVID-202109121649251350-QXFXF. Safety Report Unique Identifier GB-MHRA-ADR 25929230. A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection), dose 2 via an unspecified route of administration on 11Sep2021 (at the age of 28 years) (Batch/Lot: unknown) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot: unknown) as dose 1, single for COVID-19 immunization. Patient did not had symptoms associated with COVID-19, Patient was not pregnant, Patient was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. On 11Sep2021, after receiving the second dose the patient experienced muscle pain, high temperature, headache on 12Sep2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative and Body temperature: High on an unspecified date. The events were serious medically significant. The outcome of the event high temperature was not recovered, and other events were recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217931

Write-up: pain; Swelling of armpit; This is a spontaneous report from a contactable non-health care professional. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151005022490-HZ5HP, safety report unique identifier is GB-MHRA-ADR 25944563. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient experienced swelling of armpit on 11Sep2021, and pain on an unspecified date. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event swelling was recovering, while pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1742554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Parosmia, SARS-CoV-2 test, Taste disorder
SMQs:, Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Pneumonia; Supraventricular tachycardia (Heart condition- Supreventricular Tachichardia)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217893

Write-up: Taste abnormality; Altered smell sensation; Diarrhoea; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151543239340-DSJUQ. Safety Report Unique Identifier GB-MHRA-ADR 25946429. A 37-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: unknown), via an unspecified route of administration on 09Sep2021 as single dose for COVID-19 immunization. Medical history included pneumonia from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing Taking other treatments or medicines, not listed above, known to lower the immune response, supraventricular tachycardia from an unknown date and unknown if ongoing Heart condition- Supreventricular Tachichardia. Heart condition- Supreventricular Tachichardia. Patient has not had symptoms associated with COVID-19. The patients concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: unknown), via unspecified route on an unspecified date as single dose for COVID-19 immunization. The patient had experienced diarrhoea on 11Sep2021 and taste abnormality, altered smell sensation on 14Sep2021. Acid like diareah constantly for atleast 5 days. On 5th day developed a strange sensation in the sensory organs in the head Region ie strange sense of smell and taste at same time, almost medical, at random points throughout the day. This sensation was almost felt behind the eyes. The events seriousness was assessed as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): negative on an unspecified date No - Negative COVID-19 test. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea
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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101224690

Write-up: Painful periods/ awful period pains; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109160755429710-VTWGO, Safety Report Unique Identifier GB-MHRA-ADR 25950286. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 19Aug2021, as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding. Concomitant medication included propranolol (MANUFACTURER UNKNOWN) for anxiety for a day on 19Aug2021. On 11Sep2021, 23 days after vaccination, the patient experienced painful periods/ period on time but the most awful period pains that woke her up; the event painful periods was reported as serious for being medically significant. The patient took painkillers and hot water bottle but did nothing to help. The patient did not have a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event painful periods/ awful period pains was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743074 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling cold, Grip strength, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Investigation, Joint range of motion decreased, Muscular weakness, Skin discolouration
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), 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: Medical History/Concurrent Conditions: Food allergy.
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210911; Test Name: Grip strength; Result Unstructured Data: Test Result:41.7/18.9 kg; Comments: right 41.7 kg, left 18.9 kg; Test Date: 20210913; Test Name: Grip strength; Result Unstructured Data: Test Result:45.5/17.8 kg; Comments: right 45.5 kg, left 17.8 kg; Test Name: Hughes Functional Grading Scale; Result Unstructured Data: Test Result:scores in the worst phase of disease; Comments: scores in the worst phase of disease until this report was Healthy
CDC Split Type: JPPFIZER INC202101207241

Write-up: flexion and extension of the left forearm were poor (about 50% compared to the right); Feeling cold; cannot hold anything with left hand; bluish skin; Guillain-Barre syndrome; Numbness of the left fingertip/ numbness was widespread; Grip strength decreased was observed (right 41.7 kg, left 18.9 kg); This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number is v21126748. A 33-year and 8-month-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF9944; Expiration Date: 30Nov2021), via an unspecified route of administration, administered in Arm Left (reported as left shoulder) on 11Sep2021 12:00 (the day of vaccination, at the age of 33-year and 8-month-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.6 degrees Centigrade on 11Sep2021. Medical history included food allergies (apple, wheat) from an unknown date. There were 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): Food allergies (apples, wheat). It was unknown that the patient had family history. The patient''s concomitant medications were not reported. On 11Sep2021 13:00 (after 1 hour of vaccination), the patient experienced Guillain-barre syndrome, numbness of the left fingertip/ numbness was widespread, grip strength decreased was observed (right 41.7 kg, left 18.9 kg). On 12Sep2021 (1 day after the vaccination), the patient experienced feeling cold, cannot hold anything with left hand, bluish skin. On 13Sep2021 (2 days after the vaccination), the patient experienced flexion and extension of the left forearm were poor (about 50% compared to the right). The course of the event was as follows: On 11Sep2021, there was no abnormality at the time of vaccination (first time) on the left shoulder. numbness of the left fingertip appeared from one hour later. The patient visited the clinic on the same day. At that time, grip strength decreased was observed (right 41.7 kg, left 18.9 kg). On 12Sep2021, the patient cannot hold anything with left hand, also the patient had bluish skin and feeling cold. On 13Sep2021, the patient had a second clinic visit, grip strength (right 45.5 kg, left 17.8 kg). The flexion and extension of the left forearm were poor (about 50% compared to the right). The patient skin color had recovered, but numbness was widespread. The patient suspected Guillain-Barre syndrome and was referred to the hospital. The events resulted in physician office visit. The outcome of event bluish skin was recovered on an unspecified date in 2021 whereas the outcome of all other events was not recovered at the time of this report. Questionnaire for Guillain Barre syndrome (GBS) case were as follows: Clinical symptoms was unknown. The Hughes Functional Grading Scale scores in the worst phase of disease until this report was Healthy. Course of disease was that the patient was referred to the hospital for requesting careful examination. Electrophysiological study and Cerebrospinal fluid test were not performed. There were differential diagnosis. Imaging examination (Magnetic resonance imaging (MRI) and Autoantibody test were also not performed. It was unknown that the patient had preceding infection. The reporting other health professional classified the events as serious (Medically significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743091 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Blood pressure; Result Unstructured Data: Test Result:86/50; Comments: 12:05; Test Date: 20210911; Test Name: Blood pressure; Result Unstructured Data: Test Result:103/60; Comments: 12:25; Test Date: 20210911; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101208813

Write-up: vagal reflex /Vasovagal reflex; Cold sweat; BP was 86/50; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126730. The patient was a 39-year-old female. Body temperature before vaccination was 36.5 degrees Centigrade on 11Sep2021. On 11Sep2021 at 11:49 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) (at the age of 39 years old) via an unspecified route of administration as a single dose for COVID-19 immunization. On the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was reported as Pollinosis. Concomitant medications were not reported. On 11Sep2021at 12:05 (16minutes after the vaccination), the patient experienced vasovagal reflex. On 11Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: At 12:05, the patient experienced symptom of cold sweat. BP was 86/50. Lactec 100ml via intravenous drip for 30 minutes was given. At 12:25, BP was 103/60. At 13:00, the symptom recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was not allergy but vagal reflex. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1743172 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Body temperature decreased, Heart rate, Hyperhidrosis, Oxygen saturation, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
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: 20210911; Test Name: BP; Result Unstructured Data: Test Result:100/60; Comments: at sitting position 14:52; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:11illegible number/70; Comments: at 14:57; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:120/68; Comments: at 15:18; Test Date: 20210911; Test Name: BP; Result Unstructured Data: Test Result:114/60; Comments: at 16:00; Test Date: 20210911; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210911; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Test Date: 20210911; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: at 16:00; Test Date: 20210911; Test Name: P; Result Unstructured Data: Test Result:78; Comments: 14:52; Test Date: 20210911; Test Name: P; Result Unstructured Data: Test Result:97; Test Date: 20210911; Test Name: P; Result Unstructured Data: Test Result:78; Comments: at 15:18; Test Date: 20210911; Test Name: SpO2; Test Result: 96 %; Comments: at 15:0illegible time; Test Date: 20210911; Test Name: SpO2; Test Result: 99 %; Comments: at 15:18
CDC Split Type: JPPFIZER INC202101223091

Write-up: 37.4 centigrade; 35.4 centigrade; BP at sitting position was 100/60; pallor facial; Sweaty; This is a spontaneous report from a contactable other health professional received from the regulatory authority. Regulatory authority report number is v21126731. A 21-year-old (reported as 21-year and 3-month-old) female patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FF2782; Expiration Date: 30Nov2021), via an unspecified route of administration on 11Sep2021 at 14:40 at 21-year-old as single dose for covid-19 immunisation. Body temperature before vaccination was 36.6 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 11Sep2021 at 14:50 (10 minutes after the vaccination), the patient experienced sweaty and pallor facial. The course of the event was as follows: On 11Sep2021 at 14:40, the 1st vaccination against Novel Coronavirus was performed. At 14:50, sweaty and pallor facial. At 14:52, BP at sitting position was 100/60, P 78. At 14:57, BP 11(illegible number)/70, the patient lied down on a bed and was treated with LACTEC 500 ml. At 15:00, the consciousness was lucid, and the patient could respond. At 15:0(illegible time), SpO2 96%, P 97, 35.4 centigrade. At 15:18, BP 120/68, SpO2 99%, P 78. At 16:00, BP 114/60, 37.4 centigrade. On 11Sep2021 (the day of vaccination), the outcome of the events was recovered. The reporting other health professional classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting other health professional commented as follows: The patient was strained prior to the vaccination.


VAERS ID: 1743233 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
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: Asthenia, Gait inability, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), 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: Medical History/Concurrent Conditions: Pollinosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Suspected Guillain-Barre-like reaction; Feelings of weakness; Gait inability; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP095967) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported by a physician, was received via the PMDA (Ref, v21127089). Guillain-Barre-like reaction was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccine. On 10-Sep-2021, at 19:15, the patient received the 2nd dose of this vaccine feelings of weakness and gait inability developed. Guillain-Barre-like reaction was suspected. On 16-Sep-2021, at present, muscle strength almost resolved (to around the level of 10-Sep-2021). Symptoms were resolving. The outcome of feelings of weakness, gait inability, and suspected Guillain-Barre-like reaction was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred the following day the second dose of Moderna COVID vaccine was administered. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Moderna COVID vaccine in not affected by this report.


VAERS ID: 1745793 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Nephrolithiasis, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101197643

Write-up: Developed a UTI/possible kidney stone; Developed a UTI/possible kidney stone; This is a Spontaneous case received from a non-contactable consumer (patient). A 19-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19) via an unspecified route of administration, administered in left arm, as a single dose, on an unspecified date (lot number unknown), at age of 19-year-old of vaccination, for COVID-19 immunisation. The patient''s medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Sep2021, the patient developed a urinary tract infection (UTI) and possible kidney stone. The events required doctor or other healthcare professional office/clinic visit and were treated with antibiotics. The patient was recovering from the events at the time of reporting. No follow-up attempts are possible. Lot/ Batch number cannot be obtained. No further information is expected.


VAERS ID: 1746543 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
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: Dizziness, Headache, Hot flush, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Hot flushes; Vomiting; Dizzy spells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25929346) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), HOT FLUSH (Hot flushes), VOMITING (Vomiting) and DIZZINESS (Dizzy spells) in a 21-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced HOT FLUSH (Hot flushes) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization) and DIZZINESS (Dizzy spells) (seriousness criterion hospitalization). On 12-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, HEADACHE (Headache), HOT FLUSH (Hot flushes), VOMITING (Vomiting) and DIZZINESS (Dizzy spells) 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 medication details were reported. No treatment medication details was reported. Patient has not had symptoms associated with COVID-19. Company Comment: This case concerns a 21-year-old male hospitalized with serious unexpected events of hot flush, dizziness, vomiting, and headache. Latency within 24 hours after first dose mRNA-1273. Events reported as not resolved. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 21-year-old male hospitalized with serious unexpected events of hot flush, dizziness, vomiting, and headache. Latency within 24 hours after first dose mRNA-1273. Events reported as not resolved. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1746655 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-11
   Days after vaccination:7
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: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225226

Write-up: cramps; Heavy period; Painful and heavy period which was a week late; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160935321300-YUR5K, Safety Report Unique Identifier GB-MHRA-ADR 25951294. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunisation. Medical history included covid-19 from 09Jan2020 to 26Jan2020. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient was a healthy teenage girl with no other illness or conditions, and not had a COVID-19 test. The patient experienced cramps and heavy period on an unspecified date. On 11Sep2021, the patient experienced painful periods. Cramps and painful periods were reported as serious for being medically significant. Clinical course of the events were as follows: Painful and heavy period which was a week late. So painful that she was crying with cramps and paracetamol and ibuprofen did not take away the pain. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of heavy period and "a week late" was unknown; patient had not recovered from cramps at the time of the report; recovered from painful periods on 16Sep2021 (outcome also reported as recovering). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746898 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation delayed, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Skin warm, Vaccination site erythema
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), Tendinopathies and ligament 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101240378

Write-up: Late period; Period pains; Heavy periods; Arm has also been in pain; Skin warm; Swollen arm; Armpit pain; Painful arm; Red circle around my jab; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report received from the regulatory authority . The regulatory authority report number is GB-MHRA-WEBCOVID-202109161336493450-ECIGP, Safety Report Unique Identification Number: GB-MHRA-ADR 25952844. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ff8222) via an unspecified route of administration, at single dose, on 11Sep2021, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously, on 25Jun2021, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD5613) at single dose, for COVID-19 immunization. On an unspecified date, after the first dose, the patient experienced late period, period pains and heavy periods. After the second dose, the patient experienced pain in arm described as "arm has also been in pain" (medically significant) on an unspecified date with outcome of recovering, skin warm (medically significant) on an unspecified date with outcome of not recovered, swollen arm (medically significant) on an unspecified date with outcome of not recovered, armpit pain (medically significant) on an unspecified date with outcome of not recovered, painful arm (medically significant) on an unspecified date with outcome of not recovered, late period (medically significant) on an unspecified date with outcome of recovered with sequelae, period pains (medically significant) on an unspecified date with outcome of not recovered, heavy periods (medically significant) on an unspecified date with outcome of recovered. The adverse events were described as "After the second vaccination patient''s arm has also been in pain, it''s now been five days and now changes in arm. You can see a massive red circle around my jab, it''s hot, swollen, feels hard and in pain, the pain and swelling are also reaching up to my armpit as well. The period affects started after the first vaccination and are still ongoing". The patient has been tested for COVID-19 on an unspecified date and resulted negative. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101224825 Same patient different dose/events


VAERS ID: 1747208 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Consciousness decreased; Vagal reflex; This case was received via The Regulatory Authority (Reference number: 2021TJP096486) on 20-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, reported by a physician, was received by The Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021791). Consciousness decreased was assessed as serious. On 11-Sep-2021, the patient received the 1st dose of this vaccine. At 17:05, during follow-up, vagal reflex developed without syncope. The patient complained of feeling poorly, pallor facial, numbness in the limbs, and slight grogginess. BP 95/64. At 17:15, the patient''s symptoms improved. The patient''s symptoms subsequently resolved. The outcome of vagal reflex and consciousness decreased was reported as resolved. Follow-up investigation will be made. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 38 year-old female patient with no reported medical history, who experienced the unexpected serious event of Depressed level of consciousness. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event coding and seriousness criteria of Medically significant maintained for consistency with assessment, however description noted no syncope.


VAERS ID: 1747307 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
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: 20210912; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC202101214248

Write-up: Headache; Myalgia; Fever: 40.5 to 42 degrees Celcius; This is a spontaneous report from a contactable Consumer or other non-HCP downloaded from the regulatory authority-WEB NL-LRB-00683928. A 13-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number and Expiry date: unknown, at the age of 13 years), dose 2 via an unspecified route of administration on 11Sep2021 as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number and Expiry date: unknown), dose 1 via an unspecified route of administration on 18Aug2021 as dose 1, 0.3 ml single for covid-19 immunisation. The patient experienced hyperpyrexia within 1 day on 11Sep2021 following administration of covid-19 vaccine Pfizer injection fluid and headache, myalgia 1 day after start on 12Sep2021. The patient underwent lab tests and procedures which included hyperpyrexia: 40.5 to 42 centigrade on 12Sep2021. The outcome of the events was not recovered. Health Authority comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 18Aug2021. BSN available: yes. COVID19. Previous COVID-19, infection: No. No follow-up attempts possible. No further information expected.


VAERS ID: 1750690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Superficial vein thrombosis
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicose vein
Preexisting Conditions: Comments: Varicose veins, monitored by an angiologist
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210956721

Write-up: SUPERFICIAL THROMBOPHLEBITIS OF LEG; This spontaneous report received from a pharmacist by a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-BR20213492) on 29-SEP-2021 concerned a 58-year-old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: varicose vein, and other pre-existing medical conditions included: Varicose veins, monitored by an angiologist. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-03 expiry: unknown) 1 dosage forms, 01 total, administered on 05-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced superficial thrombophlebitis of leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from superficial thrombophlebitis of leg. This report was serious (Other Medically Important Condition).


VAERS ID: 1750885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Illness, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226577

Write-up: chest tightness; Sickness; Headache; very painful stabbing cramps.; extremely heavy painful period; extremely heavy painful period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00260865. Safety Report Unique Identifier GB-MHRA-ADR 25954137. A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ Lot Number: FE8087) via parenteral route of administrtaion on 04Sep2021, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Sep2021 (after 7 days of vaccination), patient experienced extremely heavy painful period. On an unspecified date, patient experienced chest tightness, very painful stabbing cramps, sickness and headache. All events were medically significant. The outcome of event extremely heavy painful period was not resolved and for all other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vulval 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: LEVOTHYROXINE SODIUM; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101227070

Write-up: Vulval bleeding; 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-202109142204443820-ZPJRO, Safety Report Unique Identifier is GB-MHRA-ADR 25941800. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number FE3380) as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Unsure if patient had symptoms associated with COVID-19. She had not had a COVID-19 test. Concomitant medications included levothyroxine sodium and ethinylestradiol/ levonorgestrel (RIGEVIDON), both from unspecified date. On 11Sep2021 the patient experienced vulval bleeding reported as serious with medically significant criterion. Patient was not enrolled in clinical trial. The outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1750956 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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: Abdominal pain upper, Dizziness, Dyspnoea, Inappropriate schedule of product administration, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101226590

Write-up: Stomach ache; First dose of BNT162B2 on 17Jul2021, second dose on 11Sep2021; Heart racing; Breathlessness; Lightheadedness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170825144160-TAQP9, and Safety Report Unique Identifier is GB-MHRA-ADR 25957666. A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number was not reported), via an unspecified route of administration on 11Sep2021 (at the age of 23-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 21Jun2021 and ongoing. Patient was positive for COVID in Jun2021. Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jul2021 for COVID-19 immunisation. The patient experienced heart racing on 11Sep2021, breathlessness on 11Sep2021, lightheadedness on 11Sep2021, and stomach ache on 13Sep2021. The events ''heart racing, breathlessness, lightheadedness and stomach ache'' were reported as serious, other medically important condition. The patient underwent lab test which included COVID-19 virus test: Yes - Positive COVID-19 test in Jun2021. Additional information: Not triggered by anything specific - heart racing happens at least twice a day and lasts anywhere between 10- 40 minutes. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events ''heart racing, breathlessness, lightheadedness and stomach ache'' was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751056 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226694

Write-up: Period pains; 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-202109171847030840-4PUNB. Safety Report Unique Identifier GB-MHRA-ADR 25960848. A 17-year-old (age at vaccination) non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Sep2021 (Lot Number: FF2153) (At the age of 17 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient was not pregnant, Patient was not currently breastfeeding. Patient is not enrolled in clinical trial. The patient experienced period pains on 17Sep2021, heavy periods on 11Sep2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dysmenorrhoea, Menstruation delayed, Muscle spasms, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101227016

Write-up: leg cramps; Abdominal cramping; delay of period; Period pains; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109172113173020-DNIHI. Safety Report Unique Identifier GB-MHRA-ADR 25961550. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 on 04Aug2021, unsure when symptoms stopped. On 06Aug2021 the patient was tested positive for COVID-19 . Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications were not reported. On an unspecified date the patient experienced leg cramps and abdominal cramping and delay of period, on 11Sep2021 period pains was reported. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of period pains was recovering, the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751125 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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: Blood pressure measurement, Chills, Oxygen saturation, Poor quality sleep, Pruritus, Pyrexia, Rash, Rash pruritic, SARS-CoV-2 test, Urine analysis, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Unknown result; Test Name: oxygen level; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Urine; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC202101226527

Write-up: itchy; rash; Itchy rash; Poor sleep; Fever; Shivering; Injection site pain; Itch burning; This is a spontaneous report from a contactable consumer. This is a report received from a Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109180845387090-DMAGK, Safety Report Unique Identifier GB-MHRA-ADR 25964452. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection; Batch/ Lot Number: Ff2153) via an unspecified route of administration, administered in arm as single dose on 11Sep2021 (at the age of 39-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection; Batch/ Lot number: not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 11Sep2021 (on the day of vaccination), patient experienced itch burning and injection site pain. On 12Sep2021 (after 1 day of vaccination), patient had fever and shivering. On 13Sep2021 (after 2 days of vaccination), patient experienced itchy rash and poor sleep. On an unspecified date, patient experienced itchy and rash. All events were medically significant. Treatment (unspecified) was received for itchy, rash and itchy rash. Clinical course of events includes; the rash appear on the forearm that had injection, not long ago the other forearm started to have rash. The rash was extremely itchy and burning. Whatever ointment was put on it was still extremely itchy. The rash continue developing up to left arm. A day later, notice a rash on the top of ankle of right. A day later, noticeable rash/ spot appeared on thigh of the left leg. There was rash on both hand forth finger. There was another patch of rash appear on right thigh. Lab test on 12Sep2021, included COVID-19 virus test: No, Negative and on an unspecified date, included blood pressure measurement, oxygen saturation and urine analysis; all had unknown result. The outcome for events itchy, rash, itchy rash, itch burning was not resolved, poor sleep was resolving, fever and shivering was resolved on 13Sep2021 and injection site pain was resolved on 14Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751136 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-11
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: Suspected COVID-19.
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 INC202101226631

Write-up: Prolonged heavy periods; 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-202109181059522080-MN83Y, Safety Report Unique Identifier GB-MHRA-ADR 25964569. A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunization. Medical history included suspected covid-19 from 04Sep2021 and ongoing. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication(s) included dihydrocodeine; paracetamol; pregabalin; fluoxetine hydrochloride (PROZAC); all taken for an unspecified indication, start and stop date were not reported and influenza vaccine (INFLUENZA VIRUS) taken for influenza immunisation, start and stop date were not reported. On 11Sep2021, the patient experienced prolonged heavy periods. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: (No - negative covid-19 test) on an unspecified date. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   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 FE3180 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226825

Write-up: dizziness; vomiting; dizzy; spinning; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202109181716586230-GYVM4, Safety Report Unique Identifier: GB-MHRA-ADR 25964963. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Sep2021 (Lot Number: FE3180) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history: none. The patient''s concomitant medications were not reported. 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 received vaccine on 09Sep2021 (Thursday) late afternoon. The patient reported room was spinning on 11Sep2021 (Saturday) morning upon waking. Patient was vomiting throughout Saturday due to dizziness (onset date not reported). The patient was prescribed Cinnarizine - started taking these Sunday (12Sep2021) afternoon which resolved the vomiting but remained in bed until Wednesday to minimize dizzy spells. The patient was feeling dizzy (onset date not reported) upon moving her head to the right side until the morning of 18Sep2021. The events were considered serious: disability, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The event dizzy recovered on 18Sep2021, vomiting, and dizziness recovered on an unspecified date. The outcome of spinning was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751344 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Vertigo
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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: FERRO-GRAD
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-MINISAL02-784916) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (VERTIGO, NAUSEA AND FAINTING), NAUSEA (VERTIGO, NAUSEA AND FAINTING) and VERTIGO (VERTIGO, NAUSEA AND FAINTING) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 vaccination. Concomitant products included FERROUS SULFATE (FERRO-GRAD) for an unknown indication. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 11-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (VERTIGO, NAUSEA AND FAINTING) (seriousness criterion medically significant), NAUSEA (VERTIGO, NAUSEA AND FAINTING) (seriousness criterion medically significant) and VERTIGO (VERTIGO, NAUSEA AND FAINTING) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (VERTIGO, NAUSEA AND FAINTING), NAUSEA (VERTIGO, NAUSEA AND FAINTING) and VERTIGO (VERTIGO, NAUSEA AND FAINTING) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Company comment - This case concerns a 23-year-old female patient with no relevant medical history ,who experienced the serious unexpected events of Loss of consciousness, Nausea and Vertigo . The events occurred two days 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 21-Sep-2021: Translation received on 28-Sep-21, which contains no new information. Only translation on event verbatim.; Sender''s Comments: This case concerns a 23-year-old female patient with no relevant medical history ,who experienced the serious unexpected events of Loss of consciousness, Nausea and Vertigo . The events occurred two days 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: 1751357 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-11
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Heart rate, Heart rate increased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210911; Test Name: Heart sound accelerated; Result Unstructured Data: increased heart rate
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-785757) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS , PYREXIA and HEART RATE INCREASED in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Subcutaneous) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced CHILLS (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant) and HEART RATE INCREASED (seriousness criterion medically significant). At the time of the report, CHILLS , PYREXIA and HEART RATE INCREASED was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Heart rate: increased (High) increased heart rate. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. It was reported that fever of 39, patient experienced uncontrollable tremors throughout the body and the second dose of the Moderna COVID-19 vaccine injected on the afternoon. Company Comment: This case concerns a 19 year old female with no reported history who experienced the serious, unlisted events of Pyrexia, Chills and Heart rate increased. The events occurred the day after the second dose of Spikevax. Re-challenge is not applicable as it is the second dose and unknown for the first dose as no information is reported. Benefit risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the RA; however, based on medical judgement and the lack of evidence in the source documents of seriousness from a clinical or regulatory standpoint the events are considered non-serious. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28-Sep-21 contains I narrative updated. On 23-Sep-2021: Non-Significant Follow-up received on 23-SEP-2021:contains No new information.; Sender''s Comments: This case concerns a 19 year old female with no reported history who experienced the serious, unlisted events of Pyrexia, Chills and Heart rate increased. The events occurred the day after the second dose of Spikevax. Re-challenge is not applicable as it is the second dose and unknown for the first dose as no information is reported. Benefit risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the RA; however, based on medical judgement and the lack of evidence in the source documents of seriousness from a clinical or regulatory standpoint the events are considered non-serious.


VAERS ID: 1751563 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959478

Write-up: CHILLS; APPETITE LOST; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107780] concerned an 84 year old female 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: unknown, and expiry: unknown) dose was not reported, 1 total administered on 12-AUG-2021 for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-SEP-2021, the patient experienced appetite lost, and body malaise. On 12-SEP-2021, the patient experienced chills. On 13-SEP-2021 the symptoms were persistent. On an unspecified date, the patient was hospitalized, 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 was recovering from body malaise, appetite lost, and chills. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210959478- covid-19 vaccine ad26.cov2.s- appetite lost. 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). 20210959478- covid-19 vaccine ad26.cov2.s -body malaise, chills. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1752932 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Bone pain, Chest pain, Migraine, Myalgia, Pyrexia, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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-MINISAL02-787215) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA, MIGRAINE, PYREXIA, CHEST PAIN, RASH PRURITIC, ABDOMINAL PAIN, MYALGIA and BONE PAIN in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced ARTHRALGIA (seriousness criterion hospitalization), MIGRAINE (seriousness criterion hospitalization), PYREXIA (seriousness criterion hospitalization), CHEST PAIN (seriousness criterion hospitalization), RASH PRURITIC (seriousness criterion hospitalization), ABDOMINAL PAIN (seriousness criterion hospitalization), MYALGIA (seriousness criterion hospitalization) and BONE PAIN (seriousness criterion hospitalization). At the time of the report, ARTHRALGIA, MIGRAINE, PYREXIA, CHEST PAIN, RASH PRURITIC, ABDOMINAL PAIN, MYALGIA and BONE PAIN was resolving. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case concerns a 36-year-old male patient with no relevant medical history, who experienced the unexpected serious events of Arthralgia, Migraine, Arthralgia, Migraine, Chest pain, Rash pruritic, Abdominal pain, Myalgia Bone. The events occurred 1 day after unspecified dose of Spikevax. The rechallenge was not applicable as there is no information regarding the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 23-SEP-21 does not contain any new information.; Reporter''s Comments: Non conosciute; Sender''s Comments: This case concerns a 36-year-old male patient with no relevant medical history, who experienced the unexpected serious events of Arthralgia, Migraine, Arthralgia, Migraine, Chest pain, Rash pruritic, Abdominal pain, Myalgia Bone. The events occurred 1 day after unspecified dose of Spikevax. The rechallenge was not applicable as there is no information regarding the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1754715 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   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 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101228817

Write-up: Convulsion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB with regulatory authority number ES-AEMPS-999653. A 12-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in the left arm on 10Sep2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient received the first dose of bnt162b2 (COMIRNATY) on 20Aug2021 (Batch/Lot number: Unknown) for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient had covid in the past. On 11Sep2021, the patient experienced convulsion which resulted in hospitalization in 2021. The outcome of the event was recovered on 11Sep2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1754934 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214025 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthmatic crisis
SMQs:, Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INORIAL
Current Illness: Allergy; Asthma (treated by a pulmonologist); Grass allergy; Hypersensitivity; Mite allergy (Allergies to dust mites); Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Asthmatic crisis; This case was received via regulatory authority(Reference number: FR-AFSSAPS-TO20217955) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHMATIC CRISIS (Asthmatic crisis) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214025) for COVID-19 vaccination. Concurrent medical conditions included Allergy, Asthma (treated by a pulmonologist), Pollen allergy, Hypersensitivity, Grass allergy and Mite allergy (Allergies to dust mites). Concomitant products included BILASTINE (INORIAL) for an unknown indication. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ASTHMATIC CRISIS (Asthmatic crisis) (seriousness criterion medically significant). At the time of the report, ASTHMATIC CRISIS (Asthmatic crisis) was resolving. Treatment information was not reported. Company Comment: This case concerns a 36-year-old female patient with relevant medical history of Allergy, Asthma , Pollen allergy, Hypersensitivity, Grass allergy and Mite allergy (Allergies to dust mites), who experienced the unexpected serious event of Asthmatic crisis.The event occurred approximately 5 days after the first dose of Spikevax.The rechallenge is unknown since there''s no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29 Sep 2021 wherein relevant medical history, medicinal product. Dosage text and suspect drug substance name.; Sender''s Comments: This case concerns a 36-year-old female patient with relevant medical history of Allergy, Asthma , Pollen allergy, Hypersensitivity, Grass allergy and Mite allergy (Allergies to dust mites), who experienced the unexpected serious event of Asthmatic crisis.The event occurred approximately 5 days after the first dose of Spikevax.The rechallenge is unknown since there''s no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Inappropriate schedule of product administration, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101233640

Write-up: Joint pain; Muscle pain; inappropriate schedule of vaccination administered; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109200709179090-ENVCI, Safety Report Unique Identifier (GB-MHRA-ADR 25966643). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2153, Expiry date was not reported), via an unspecified route of administration on 11Sep2021 as Dose 2, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 21Jul2021 at Dose 1, Single for COVID-19 immunization. The patient reported inappropriate schedule of vaccination administered on 11Sep2021 and experienced muscle pain on 14Sep2021, joint pain on 15Sep2021. The events caused hospitalization, medically significant. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was muscle pain and joint pain was not resolved. No follow-up attempts were needed. No further information was expected.


VAERS ID: 1755274 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   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 FG9019 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle rigidity, Nausea, Seizure, Skin discolouration
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (narrow), 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 (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101287734

Write-up: seizure; felt nauseous; she turned almost green; body went rigid; This is a spontaneous report from a non-contactable consumer via a company representative. A 15-year-old non-pregnant female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: FG9019), via an unspecified route of administration in the left arm on 11Sep2021 (at the age of 15-years-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FG3716) for COVID-19 immunization in the left arm on 19Aug2021 (at the age of 15-years-old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Sep2021, the patient felt nauseous, turned almost green, her body went rigid, and her body went rigid for a few seconds before having a seizure. The clinical course was as follows: A few moments after receiving the second dose, the patient felt nauseous. She turned almost green, and her body went rigid for a few seconds before having a seizure. She was moved into a different room where she was laid down flat and continued the episode for about another two minutes. After another few moments, she returned to normal. This had never happened before with other vaccines and she was not prone to taking episodes. The patient did not receive treatment for feeling nauseous. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was unknown. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1755337 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest pain, Fall, Neck pain, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-786774) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN, NECK PAIN, VOMITING, BACK PAIN, SYNCOPE, and FALL in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-Sep-2021, the patient experienced CHEST PAIN, NECK PAIN, VOMITING, BACK PAIN (seriousness criterion hospitalization), SYNCOPE (seriousness criterion hospitalization) and FALL (seriousness criterion hospitalization). At the time of the report, CHEST PAIN, NECK PAIN, VOMITING, and BACK PAIN was resolving and SYNCOPE and FALL outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product usage were not provided. Treatment details were not provided. 10 minutes after the 1st Moderna dose, Patient experienced sudden heart pain, fainting, falling to the ground, hit head, and broke two teeth. Vomited several times, pain in the spine and in the neck. Patient had perfect health. This case concerns a 19-year-old male patient with no relevant medical history, who experienced the serious unexpected events of Chest pain, Neck Pain, Vomiting, Back Pain, Fall, and Syncope. The events occurred on the same day after Spikevax dose number unknown. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes on 23-Sep-2021 translation Received on 27-SEP-21 as live follow up includes Significant information (Event added) in inarrative. On 28-Sep-2021 Follow up received as live follow up contains no new information.


VAERS ID: 1756462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-11
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure measurement, Headache, Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (broad), Arthritis (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: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:180/77
CDC Split Type: ZAPFIZER INC202101228705

Write-up: BP 180/77; Joint pain; Mild headache; Mild body aches; Numb leg (left); This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on Aug2021 for covid-19 immunization. Medical history included diabetes mellitus. The patient''s concomitant medications were not reported. The patient previously took insulin human insulin human injection/isophane (ACTRAPHANE). On 11Sep2021, the patient experienced joint pain, mild headache, mild body aches, numb leg (left) and bp reading was 180/77. The patient underwent lab tests and procedures which included blood pressure measurement: 180/77. Treatment was given with Nifedipine as a result of bp 180/77. Outcome of the events were recovering. No further information was available at the time of this report; Sender''s Comments: Based on available information, there is reasonable possibility of causal association between the event Blood pressure abnormal and the suspect drug BNT162B2.


VAERS ID: 1757683 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Acute myocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25989112) on 26-Sep-2021 and was forwarded to Moderna on 26-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient who was normally fit and well, developed sudden onset of chest pain 3 days after second dose of vaccination. Troponin significantly elevated, cardiac Magnetic resonance imaging confirmed signs of acute myocarditis. No apparent or identifiable causes for myocarditis. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This case concerns a male patient with no relevant medical history, who experienced the expected, serious and AESI event of myocarditis. The event occurred 3 days after second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a male patient with no relevant medical history, who experienced the expected, serious and AESI event of myocarditis. The event occurred 3 days after second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757691 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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 European Medicines Agency (Reference number: IT-MINISAL02-788504) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA and FATIGUE in a 39-year-old female patient who received mRNA-1273 (Spikevax) for Myocarditis and COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced DYSPNOEA (seriousness criterion disability) and FATIGUE (seriousness criterion disability). At the time of the report, DYSPNOEAand FATIGUE had not resolved. Patient stated that since the second dose of the Moderna vaccine she feel dyspnea, air hunger, tiredness. No previous disease No concomitant medication details was provided. No treatment medication details was provided. Indication for Use in Case given as Myocarditis Company Comment: This case concerns a 39-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and fatigue. The time to onset from vaccination was not reported, as vaccination date is not reported. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-sep-2021 event verbatim updated. Reporter''s comment updated. added in I-narrative supplement.; Sender''s Comments: This case concerns a 39-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and fatigue. The time to onset from vaccination was not reported, as vaccination date is not reported. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1757805 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 2 - / OT

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

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

Write-up: Miocardiopericardite; This case was received via regulatory authority on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Miocardiopericardite) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunization. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-Sep-2021, the patient experienced MYOCARDITIS (Miocardiopericardite) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Miocardiopericardite) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Laboratory data included C-reactive protein, Echocardiogram conducted on 14-SEP-2021 result were not provided. The first dose was administered on 06-AUG-2021, batch number 30044992. Patient received the first dose on 06 Aug 2021 with batch number 3004492. Company Comment : This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29 Sep 2021 and action taken, dose number was updated, narrative was updated with first dose details.; Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1758415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Ear pain, Fatigue, Headache, Lymph gland infection, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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? 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: Gastric bypass; Penicillin allergy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101238800

Write-up: Ear pain; Dizziness; Fatigue; Feeling unwell; Myalgia; joint pain; Inflamed glands; Headache; Shivering; Fever; Nausea; Injection site reaction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-106612. A 34-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 vaccination. Medical history included penicillin allergy, gastric bypass. The patient''s concomitant medications were not reported. The patient experienced ear pain, dizziness, fatigue, feeling unwell (malaise), myalgia, joint pain (arthralgia), inflamed glands (lymph gland infection), headache, shivering, fever, nausea, and injection site reaction on 11Sep2021. This case was reported as serious due to disability. No treatment received. The outcome of events was not recovered. Reporter Comment: Treatment - No Evolution of the ADR - Worsening : Headache ADR description - Earache Inflamed glands Dizzy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Worsening : Headache ADR description - Earache Inflamed glands Dizzy


VAERS ID: 1759928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   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 FG9428 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts (allergy to eggs and nuts); Animal protein allergy (allergy to eggs and nuts); Dermatitis atopic
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:Abnormal; Comments: Study compatible with posteriorly located acute myocarditis. Nondilated left ventricle with normal systolic function.
CDC Split Type: ESPFIZER INC202101239594

Write-up: Acute myocarditis; This is a spontaneous report from a contactable physician downloaded from the REGULATORY AUTHORITY-WEB, regulatory authority number ES-AEMPS-1004180. A 14-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Sep2021 (Batch/Lot Number: FG9428) as single dose for covid-19 immunisation. Medical history included allergy to eggs and nuts, dermatitis atopic. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY Lot number FF2832 on 20Aug2021. The patient experienced acute myocarditis on 11Sep2021. The event was serious with hosp and medically significant The patient underwent lab tests and procedures which included magnetic resonance imaging heart: Abnormal. Study compatible with posteriorly located acute myocarditis. Nondilated left ventricle with normal systolic function on 14Sep2021. The outcome of the event was resolved on 16Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760927 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
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: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20211004344

Write-up: ALLERGIC REACTION; This spontaneous report received from a physician via a Regulatory Authority, GR-GREOF-20218417) was received on 01-OCT-2021 and concerned a patient of unspecified age, sex, 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 was not reported) dose, start therapy date were not reported for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included levothyroxine. On 11-SEP-2021, the patient experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on 11-SEP-2021. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender''s Comments: Birth day of the patient reported.


VAERS ID: 1760983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-11
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101228843

Write-up: Breathing difficult; This is a report from a Non-Interventional Study report from the observational study regulatory agency study source. A physician reported that a 53 years-old female subject received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY, Solution for injection), Lot# FG4686, dose number unknown as single dose via intramuscular route for COVID-19 immunization. On 11Sep2021 the subject experienced breathing difficult, which was assessed as medically significant. The outcome of the event at the time of the report was recovering. The reporter''s assessment of the causal relationship of the reported event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the Company causality assessment. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dyspnoea 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


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