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From the 1/21/2022 release of VAERS data:

Found 1,049,249 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 114 out of 10,493

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VAERS ID: 2030122 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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: Comments: Patient has not had symptoms associated with COVID-19
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.MOD20224

Write-up: shivering; Fever; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26420900) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (shivering) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) had not resolved and CHILLS (shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient not had symptoms associated with COVID-19. Patient had a really bad fever, hot to touch but shivering. Horrible experience. 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 is a regulatory case concerning a 18-year-old male patient with no medical history reported, who experienced the serious unexpected according to RA, events of Pyrexia and chills. The events occurred the day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 18-year-old male patient with no medical history reported, who experienced the serious unexpected according to RA, events of Pyrexia and chills. The events occurred the day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26421039) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment medications was not reported In the source document patient stated that patient had Severe arm pain at site of injection, unable to move properly due to pain and causing nausea from level of pain Patient has not tested positive for COVID-19 since having the vaccine Company comment: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according agency, event of pain, reported as pain at the injection site with movement impairment and nausea due to the pain. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according agency, event of pain, reported as pain at the injection site with movement impairment and nausea due to the pain. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030128 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Sweating; Fever; Headache; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26421476) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). On 31-Dec-2021, NAUSEA (Nausea) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), PYREXIA (Fever) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. It was reported that, patient developed a reaction some 12 hours after his booster Jab. He felt very hot and started sweating profusely causing him to be soaking wet and he developed a pounding headache meaning he struggled to focus or sleep. He did not tested positive for COVID-19 after taking the vaccine. He was not enrolled in clinical trial. It was reported that, his reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). This is a regulatory case concerning a 40-year-old male patient with no medical history reported, who experienced the unexpected event of hyperhidrosis and the expected events of pyrexia, headache and nausea. The events occurred on the same day after the third dose of mRNA ? 1273 vaccine, except for event hyperhidrosis which was experienced on an unknown date. Events were reported as medically significant, but nausea resolved after a day and at the time of report the other events was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 40-year-old male patient with no medical history reported, who experienced the unexpected event of hyperhidrosis and the expected events of pyrexia, headache and nausea. The events occurred on the same day after the third dose of mRNA ? 1273 vaccine, except for event hyperhidrosis which was experienced on an unknown date. Events were reported as medically significant, but nausea resolved after a day and at the time of report the other events was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2030132 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuralgia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (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 Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Nerve pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26421480) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant). At the time of the report, NEURALGIA (Nerve pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Patient was not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Treatment Medication use information was not provided by reporter. Re-challenge was reported as unknown. Company comment: This is a regulatory case concerning a 50 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according Agency, event of neuralgia. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 50 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according agency, event of neuralgia. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030161 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenopia, Headache, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal 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: MIRTAZAPINE; SUSTANON [TESTOSTERONE DECANOATE;TESTOSTERONE ISOCAPROATE;TESTOSTERONE PHENYLPROPIONATE;TESTOSTERONE; VENLAFAXIN; VENTOLIN [SALBUTAMOL]
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.MOD20224

Write-up: Nausea; Eye tired; Headache; Fever chills; This case was received via RA (Reference number: GB-MHRA-ADR 26422636) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ASTHENOPIA (Eye tired), HEADACHE (Headache) and PYREXIA (Fever chills) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included MIRTAZAPINE, SUSTANON [TESTOSTERONE DECANOATE;TESTOSTERONE ISOCAPROATE;TESTOSTERONE PHENYLPROPIONATE;TESTOSTERONE PROPIONATE], VENLAFAXINE HYDROCHLORIDE (VENLAFAXIN) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), ASTHENOPIA (Eye tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), ASTHENOPIA (Eye tired) and HEADACHE (Headache) had not resolved and PYREXIA (Fever chills) 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsure if patient had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This regulatory authority case concerns a 26-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, ASTHENOPIA, HEADACHE and PYREXIA. The event of pyrexia occurred on the same day after receiving a third dose of mRNA-1273 and was recovering and the time of the report. Other reported events occurred on the next day after vaccination and had not resolved by the time of the report. No information about previous vaccination schedule was provided. No further clinical information was disclosed for medical reviewing. Patient''s concomitant use of venlafaxine remains as a confounder for the events of nausea and headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority; Sender''s Comments: This regulatory authority case concerns a 26-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, ASTHENOPIA, HEADACHE and PYREXIA. The event of pyrexia occurred on the same day after receiving a third dose of mRNA-1273 and was recovering and the time of the report. Other reported events occurred on the next day after vaccination and had not resolved by the time of the report. No information about previous vaccination schedule was provided. No further clinical information was disclosed for medical reviewing. Patient''s concomitant use of venlafaxine remains as a confounder for the events of nausea and headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority


VAERS ID: 2030166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Coldness; Painful arm; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26422903) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FEELING COLD (Coldness) and PAIN IN EXTREMITY (Painful arm) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced FEELING COLD (Coldness) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FEELING COLD (Coldness) and PAIN IN EXTREMITY (Painful arm) 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 information was mentioned by reporter. Patient reported that 30 minutes after injection he experienced headache started, had not stopped after 24 hours. The injection arm was noticeably colder than the rest of the his body, even by other individuals after waking up, still after 12 hours it was colder. Patient had pain on injection arm, possible muscular painful to move or use under any circumstance. No treatment medication information was mentioned by reporter. Company comment: This regulatory authority case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) events of Headache, Feeling cold and Painful arm after mRNA- 1273 vaccine. The onset of the event Headache occurred 30 minutes after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and painful arm (described as pain on the injection arm) and feeling cold (described as vaccination site coldness) occurred on the following day. Headache and Vaccination site pain are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. Very limited information is available regarding clinical course. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had not symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine.Patient was not enrolled in clinical trial.


VAERS ID: 2030167 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest discomfort, Dizziness, Fatigue, Headache, Illness, Nausea, Pain, Panic attack, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: fever; Nausea; Light-headed; Headache; Belly ache; Ache; Feverish; Panic attack; Shaking; Sickness; Fatigue; Tight chest; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26422910) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (Nausea), DIZZINESS (Light-headed), HEADACHE (Headache), ABDOMINAL PAIN (Belly ache), PAIN (Ache), PYREXIA (Feverish), PANIC ATTACK (Panic attack), TREMOR (Shaking), ILLNESS (Sickness), FATIGUE (Fatigue) and CHEST DISCOMFORT (Tight chest) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 30-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ABDOMINAL PAIN (Belly ache) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), PANIC ATTACK (Panic attack) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever), HEADACHE (Headache), PAIN (Ache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Tight chest) had not resolved, NAUSEA (Nausea) and ABDOMINAL PAIN (Belly ache) was resolving and DIZZINESS (Light-headed), PYREXIA (Feverish), PANIC ATTACK (Panic attack), TREMOR (Shaking) and ILLNESS (Sickness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date was on 22-DEC-2021, Patient was not breastfeeding. No treatment medication information was mentioned by reporter The evening after the patient received second dose of Pfizer and the booster dose of Moderna, had the same reaction in the early hours of the morning - extreme nausea, fever, triggering a panic attack and followed by body aches, headaches and extreme fatigue. Patient did not experienced these symptoms after the first vaccine. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company comment: This is a regulatory case concerning a 33 year-old, female patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of pain, chest discomfort, headache, pyrexia (reported as fever and feverish), fatigue, abdominal pain, nausea, panic attack, tremor, illness and dizziness. Events were assessed as serious by the Regulatory Authority. The events occurred after the booster dose of mRNA-1273 vaccine, date of vaccination not provided. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 33 year-old, female patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of pain, chest discomfort, headache, pyrexia (reported as fever and feverish), fatigue, abdominal pain, nausea, panic attack, tremor, illness and dizziness. Events were assessed as serious by the Regulatory Authority. The events occurred after the booster dose of mRNA-1273 vaccine, date of vaccination not provided. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030177 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Ear pain, Glossodynia, Headache, Peripheral swelling, Swollen tongue
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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.MOD20224

Write-up: ear ache; swollen tongue; Earache; Sore tongue; Headache; Swollen arm; Armpit pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423122) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), SWOLLEN TONGUE (swollen tongue), AXILLARY PAIN (Armpit pain), EAR PAIN (Earache), GLOSSODYNIA (Sore tongue), HEADACHE (Headache) and PERIPHERAL SWELLING (Swollen arm) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant) and GLOSSODYNIA (Sore tongue) (seriousness criterion medically significant). On an unknown date, the patient experienced EAR PAIN (ear ache) (seriousness criterion medically significant) and SWOLLEN TONGUE (swollen tongue) (seriousness criterion medically significant). At the time of the report, EAR PAIN (ear ache) and SWOLLEN TONGUE (swollen tongue) was resolving and AXILLARY PAIN (Armpit pain), EAR PAIN (Earache), GLOSSODYNIA (Sore tongue), HEADACHE (Headache) and PERIPHERAL SWELLING (Swollen arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not currently breastfeeding. Been taking paracetamol since 1pm on 29th December. Sore arm and arm pit, effecting sleep and everyday activities. Started with Headache, Ear ache and sore/swollen tongue during the day of 31st December. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 43-year-old, female patient with no medical history, who experienced the unexpected events of axillary pain, headache, peripheral swelling, ear pain (two events), glossodynia and swollen tongue. The events occurred approximately 1 to 2 days after the third dose of mRNA-1273. As reported the patient experienced sore arm and arm pit, effecting sleep and everyday activities. Reportedly, events started with Headache, Ear ache and sore/swollen tongue during the day 2 days after third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 43-year-old, female patient with no medical history, who experienced the unexpected events of axillary pain, headache, peripheral swelling, ear pain(two events), glossodynia and swollen tongue. The events occurred approximately 1 to 2 days after the third dose of mRNA-1273. As reported the patient experienced sore arm and arm pit, effecting sleep and everyday activities. Reportedly, events started with Headache, Ear ache and sore/swollen tongue during the day 2 days after third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Illness, Muscle spasms, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (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), 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: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: head feels like it''s going to explode; Headache; Nausea; Sickness; Muscle pain; High temperature; Exhaustion; Muscle spasm; Joint pain; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423240) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (head feels like it''s going to explode), HEADACHE (Headache), NAUSEA (Nausea), ILLNESS (Sickness), MYALGIA (Muscle pain), PYREXIA (High temperature), FATIGUE (Exhaustion), MUSCLE SPASMS (Muscle spasm), ARTHRALGIA (Joint pain) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), ILLNESS (Sickness) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), PYREXIA (High temperature) (seriousness criterion disability), FATIGUE (Exhaustion) (seriousness criterion disability), MUSCLE SPASMS (Muscle spasm) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and DIZZINESS (Dizziness) (seriousness criterion disability). On an unknown date, the patient experienced HEADACHE (head feels like it''s going to explode) (seriousness criterion disability). At the time of the report, HEADACHE (head feels like it''s going to explode) had not resolved and HEADACHE (Headache), NAUSEA (Nausea), ILLNESS (Sickness), MYALGIA (Muscle pain), PYREXIA (High temperature), FATIGUE (Exhaustion), MUSCLE SPASMS (Muscle spasm), ARTHRALGIA (Joint pain) and DIZZINESS (Dizziness) 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. No Concomitant medications were reported. It was reported that head felt like it was going to explode, every joint was getting sharp stabbing pains, nausea and dizziness probably from the headache. Patient has not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No Treatment medications were reported. Company comment This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious events of HEADACHE, NAUSEA, ILLNESS, MYALGIA, PYREXIA, FATIGUE, MUSCLE SPASMS, ARTHRALGIA and DIZZINESS. The events occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious events of HEADACHE, NAUSEA, ILLNESS, MYALGIA, PYREXIA, FATIGUE, MUSCLE SPASMS, ARTHRALGIA and DIZZINESS. The events occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030184 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Lethargy, Nausea, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SILDENAFIL PFIZER; SILDENAFIL PFIZER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: chest pain; feverish; lethargic; Skin rash; Light headedness; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26423264) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PYREXIA (feverish), LETHARGY (lethargic), DIZZINESS (Light headedness), NAUSEA (Nausea) and RASH (Skin rash) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included SILDENAFIL CITRATE (SILDENAFIL PFIZER) and SILDENAFIL CITRATE (SILDENAFIL PFIZER) for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIZZINESS (Light headedness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), PYREXIA (feverish) (seriousness criterion medically significant) and LETHARGY (lethargic) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (chest pain), PYREXIA (feverish), LETHARGY (lethargic), DIZZINESS (Light headedness), NAUSEA (Nausea) and RASH (Skin rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-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. Patient had not symptoms associated with COVID-19. Patient was not pregnant. Patient was not breastfeeding. Patient last menstrual period date was 20-NOV-2021. No Medical History information was reported. The patient had constant headache, feverish and feels unwell and lethargic and she was unable to sleep. The patient feels extremely lightheaded to the point where she needs help while standing up. The patient had red circle rash around the injection site which had got bigger and exacerbated and cause chest pain and all over body pains. No treatment information was provided. The Patient was not tested positive for COVID-19 since vaccination and not enrolled in clinical trials. Company comment: This regulatory authority case concerns a 26-year-old female patient with no relevant medical history and previous administration of COVID-19 Vaccine Pfizer BioNTech, who experienced serious unexpected events of chest pain, pyrexia, lethargy, dizziness, nausea and rash, that occurred on the same day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.; Sender''s Comments: This regulatory authority case concerns a 26-year-old female patient with no relevant medical history and previous administration of COVID-19 Vaccine Pfizer BioNTech, who experienced serious unexpected events of chest pain, pyrexia, lethargy, dizziness, nausea and rash, that occurred on the same day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.


VAERS ID: 2030189 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20224

Write-up: Vomited; Headache; Ache; This case was received via RA (Reference number: GB-MHRA-ADR 26423309) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomited), HEADACHE (Headache) and PAIN (Ache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomited) was resolving and HEADACHE (Headache) and PAIN (Ache) had not resolved. 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. Concomitant and treatment medication was not provided. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Company comment: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of pain, headache and vomiting. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the third dose of mRNA-1273 vaccine. The outcome of the events pain and headache was reported as not recovered and the event vomiting as recovering. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of pain, headache and vomiting. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the third dose of mRNA-1273 vaccine. The outcome of the events pain and headache was reported as not recovered and the event vomiting as recovering. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030190 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Headache, Muscle spasms, Nausea, Neuralgia, SARS-CoV-2 test, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: AMOXICILLIN; CERELLE; PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; ELVANSE; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Nauseous; Headache; Nausea; Muscle spasm; Difficulty breathing; Muscle cramp; Nerve pain; Sensitive skin; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26423387) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain), SENSITIVE SKIN (Sensitive skin), NAUSEA (Nauseous), MUSCLE SPASMS (Muscle cramp), HEADACHE (Headache), NAUSEA (Nausea), MUSCLE SPASMS (Muscle spasm) and DYSPNOEA (Difficulty breathing) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Concomitant products included LISDEXAMFETAMINE MESILATE (ELVANSE) from 14-Apr-2021 to an unknown date for ADHD, AMOXICILLIN from 20-Dec-2021 to 25-Dec-2021 for Bacterial infection, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 28-Apr-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 27-Jun-2021 to an unknown date for COVID-19 vaccination, DESOGESTREL (CERELLE) from 12-Jan-2018 to an unknown date for Contraception, SERTRALINE from 09-Mar-2020 to an unknown date for Depression. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criteria disability and medically significant), SENSITIVE SKIN (Sensitive skin) (seriousness criteria disability and medically significant), MUSCLE SPASMS (Muscle cramp) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), MUSCLE SPASMS (Muscle spasm) (seriousness criteria disability and medically significant) and DYSPNOEA (Difficulty breathing) (seriousness criteria disability and medically significant). On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced NAUSEA (Nauseous) (seriousness criteria disability and medically significant). On 31-Dec-2021, NAUSEA (Nausea) was resolving, MUSCLE SPASMS (Muscle spasm) and DYSPNOEA (Difficulty breathing) had resolved. At the time of the report, NEURALGIA (Nerve pain) and SENSITIVE SKIN (Sensitive skin) had not resolved and NAUSEA (Nauseous), MUSCLE SPASMS (Muscle cramp) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided by the reporter. Company comment: This is a regulatory case concerning a 23 year-old, female patient with concomitant use of Desogestrel, lisdexamfetamine mesilate, sertraline and amoxicillin due to bacterial infection and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 6 months prior), who experienced the serious (due to medically important condition and disability) unexpected, according Certification, events of neuralgia, sensitive skin, nausea, muscle spasms, headache, nausea, muscle spasms and dyspnoea. Events seriousness assessed as per Regulatory Authority reporting. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine except for the event nausea that occurred on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of Desogestrel, lisdexamfetamine mesilate, sertraline and amoxicillin due to bacterial infection and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 6 months prior) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient stated initially felt fine after booster vaccine and started feeling side effects around 9 hours later. The nerve pain was felt all over body almost felt as if muscles was trying to force themselves out of skin. This pain/discomfort caused involuntary twitches/spasms. It was at this time that patient also felt nauseous and struggled to breathe. It was also stated that difficulty breathing may had been to do with the nerve pain and cramps patient was feeling everywhere. Additionally the skin felt hypersensitive to any sort of touch. The combination of these side effects prevented sleep. The following day the severity of the side effects began to subside and the headache began with varying levels of intensity that seemed to lack any sort of environmental trigger. The nerve pain and skin sensitivity persist with legs and feet being the worst which felt unable to leave bed for the majority of the day and slept for several hours in the afternoon. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding.; Sender''s Comments: This is a regulatory case concerning a 23 year-old, female patient with concomitant use of Desogestrel, lisdexamfetamine mesilate, sertraline and amoxicillin due to bacterial infection and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 6 months prior), who experienced the serious (due to medically important condition and disability) unexpected, according Certification, events of neuralgia, sensitive skin, nausea, muscle spasms, headache, nausea, muscle spasms and dyspnoea. Events seriousness assessed as per Regulatory Authority reporting. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine except for the event nausea that occurred on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of Desogestrel, lisdexamfetamine mesilate, sertraline and amoxicillin due to bacterial infection and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 6 months prior) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030196 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia, Nausea, Night sweats, Pyrexia
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? 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.MOD20224

Write-up: Joint pain; Headache; Dizziness; Night sweats; Fever; Chills; Nausea; Generalised muscle aches; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423695) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Generalised muscle aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), NIGHT SWEATS (Night sweats) and DIZZINESS (Dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and NIGHT SWEATS (Night sweats) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) was resolving and NAUSEA (Nausea), MYALGIA (Generalised muscle aches), ARTHRALGIA (Joint pain), NIGHT SWEATS (Night sweats) and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. No treatment information was provided by the reporter. Patient not tested positive for COVID-19 since had the vaccine. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not breastfeeding. Patient not had COVID 19 test Patient was not enrolled in clinical trial Company comment: This regulatory authority case concerns a 50-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PYREXIA, CHILLS, NAUSEA, MYALGIA, ARTHRALGIA, HEADACHE, NIGHT SWEATS and DIZZINESS~. The events of pyrexia, chills, nausea, myalgia and night sweats occurred on the same day after receiving a third dose of mRNA-1273. Other reported events occurred 2 days after vaccination. No information about previous vaccination schedule was provided. No further clinical information was disclosed for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 50-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PYREXIA, CHILLS, NAUSEA, MYALGIA, ARTHRALGIA, HEADACHE, NIGHT SWEATS and DIZZINESS . The events of pyrexia, chills, nausea, myalgia and night sweats occurred on the same day after receiving a third dose of mRNA-1273. Other reported events occurred 2 days after vaccination. No information about previous vaccination schedule was provided. No further clinical information was disclosed for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2030226 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (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.MOD20224

Write-up: Leg cramps; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MUSCLE SPASMS (Leg cramps) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Leg cramps) had not resolved. 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. Concomitant product use was not provided by the reporter. Patient had not symptoms associated with COVID-19. Patient was not pregnant. Patient was not breastfeeding. 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 24-year-old female patient, with no relevant medical history reported in this case, who experience the serious unexpected event of Muscle spasms. The event occurred approximately 1 day after the administration of the Second dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old female patient, with no relevant medical history reported in this case, who experience the serious unexpected event of Muscle spasms. The event occurred approximately 1 day after the administration of the Second dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030243 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Nausea, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Vomiting; Nausea; Flu; Ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424211) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), INFLUENZA (Flu), PAIN (Ache) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), INFLUENZA (Flu), PAIN (Ache) and VOMITING (Vomiting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided by the reporter. Patient reported that she had inability to do anything for 3 days after booster dose, which was absolutely horrendous side effects which were not experienced in any other jabs. Patient has not had any symptoms associated with COVID-19 nor had heart related inflammation. Patient was not currently breastfeeding. Company comment: This regulatory authority case concerns a 51-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, INFLUENZA, PAIN and VOMITING. The events of nausea, influenza and pain occurred 1 day after receiving a booster dose of mRNA-1273. The event of vomiting occurred 2 days after vaccination. None of the events had resolved by the time of the report. No information about previous vaccination schedule was provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 51-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, INFLUENZA, PAIN and VOMITING. The events of nausea, influenza and pain occurred 1 day after receiving a booster dose of mRNA-1273. The event of vomiting occurred 2 days after vaccination. None of the events had resolved by the time of the report. No information about previous vaccination schedule was provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as provided by the Regulatory Authority.


VAERS ID: 2030255 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Food aversion, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test, Taste disorder
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000312

Write-up: Nausea; Diarrhea; Impaired taste; Off label use; Interchange of vaccine products; Booster; Food aversion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201011905524830-G0Z3P (RA). Other Case identifier(s): GB-MHRA-ADR 26424314 (RA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19, patient is not pregnant (date of last menstrual period reported as 03Jul2021), patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication(s) included: CITALOPRAM taken for depression, start date: 02May2019. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; FOOD AVERSION (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Food aversion"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; DIARRHOEA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Diarrhea"; TASTE DISORDER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Impaired taste". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022): negative covid-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20224

Write-up: pain; Inflammation; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26424351) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain) and INFLAMMATION (Inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced INFLAMMATION (Inflammation) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain) and INFLAMMATION (Inflammation) 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. Patient not had symptoms associated with COVID-19. Concomitant product use was not provided by the reporter. It had inflamed a previous injection site just below this injection site. It was an injection patient suffered an extreme reaction too so this newly inflammation and pain was concerning . 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 is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according to the reporter, events of pain and inflammation. Events were assessed as serious by the Regulatory Authority. The event inflammation occurred the same day after the booster dose of mRNA-1273 vaccine and the event pain on an unknown date. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according to the reporter, events of pain and inflammation. Events were assessed as serious by the Regulatory Authority. The event inflammation occurred the same day after the booster dose of mRNA-1273 vaccine and the event pain on an unknown date. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030267 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Injection site swelling, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: swelling of injection site; headache; stomach pain; nausea; Fever chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424396) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling of injection site), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach pain), NAUSEA (nausea) and PYREXIA (Fever chills) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 09-Mar-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 29-Apr-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling of injection site) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). At the time of the report, INJECTION SITE SWELLING (swelling of injection site), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) outcome was unknown and PYREXIA (Fever chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information was mentioned by reporter. Patient had swelling of injection site, fever for 36 hours, headache, stomach pain, nausea and felt like patient was going to die. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not pregnant and was not currently breastfeeding. company comments This regulatory case concerns a 53-year-old, female patient with relevant history of Suspected COVID-19, who experienced the unexpected serious events of injection site swelling, headache, abdominal pain upper, nausea and pyrexia (seriousness criteria- medically significant for all events). after having the interchange of vaccine with a third dose of mRNA-1273 vaccine, given as I dosage form through unknown route, unknown site of administration, for an unknown indication, The event Pyrexia occurred 1 day later and all the other events occurred unknown days and time after the third dose of vaccination. Patient had swelling of injection site, fever for 36 hours, headache, stomach pain, nausea and felt like patient was going to die. Patient is not pregnant, and is not currently breastfeeding. The event pyrexia was resolving and the outcome of the other events is unknown. concomitant products included covid-19 vaccine (covid-19 vaccine astrazeneca) from 29-apr-2021 to an unknown date and covid-19 vaccine (covid-19 vaccine astrazeneca) from 20-June -2021 to an unknown date for an unknown indication. Patient previously had a lab test for covid -19 on 10 Apr 2021 and the result was Positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report, as important medical condition..; Sender''s Comments: This regulatory case concerns a 53-year-old, female patient with relevant history of Suspected COVID-19, who experienced the unexpected serious events of injection site swelling, headache, abdominal pain upper, nausea and pyrexia (seriousness criteria- medically significant for all events). after having the interchange of vaccine with a third dose of mRNA-1273 vaccine, given as I dosage form through unknown route, unknown site of administration, for an unknown indication, The event Pyrexia occurred 1 day later and all the other events occurred unknown days and time after the third dose of vaccination. Patient had swelling of injection site, fever for 36 hours, headache, stomach pain, nausea and felt like patient was going to die. Patient is not pregnant, and is not currently breastfeeding. The event pyrexia was resolving and the outcome of the other events is unknown. concomitant products included covid-19 vaccine (covid-19 vaccine astrazeneca) from 29-apr-2021 to an unknown date and covid-19 vaccine (covid-19 vaccine astrazeneca) from 20-June -2021 to an unknown date for an unknown indication. Patient previously had a lab test for covid -19 on 10 Apr 2021 and the result was Positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report, as important medical condition.


VAERS ID: 2030271 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Glomerulonephritis acute; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424405) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of GLOMERULONEPHRITIS ACUTE (Glomerulonephritis acute) in a 49-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced GLOMERULONEPHRITIS ACUTE (Glomerulonephritis acute) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS ACUTE (Glomerulonephritis acute) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No concomitant medication were reported. No treatment medication were reported. Company comment: This is a regulatory case concerning a 49-year-old, male patient with no medical history reported who experienced the unexpected serious event of Glomerulonephritis acute 15 days after the third dose of mRNA-1273 vaccine. The rechallenge and action taken with the suspect product were kept as per reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 49-year-old, male patient with no medical history reported who experienced the unexpected serious event of Glomerulonephritis acute 15 days after the third dose of mRNA-1273 vaccine. The rechallenge and action taken with the suspect product were kept as per reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030274 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006235 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Joint pain; Fatigue; Headache; Feverish; Drowsiness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424428) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Feverish) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006235) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced SOMNOLENCE (Drowsiness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, SOMNOLENCE (Drowsiness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Feverish) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter.Treatment information was not provided. Patient''s symptoms worsened everyday . Company Comment: This case concerns a 35-year-old male patient with no previous relevant medical history reported, who experienced the serious unexpected events of Somnolence, Arthralgia, Fatigue, Headache and Pyrexia. The events occurred on the same day an on the day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Patient had not tested positive for COVID-19 post vaccination.Patient was not enrolled in clinical trial.It was reported that patient had no symptoms associated with COVID-19.Patient had not tested for covid-19.Patient''s report was not related to possible inflammation of the heart (myocarditis or pericarditis).; Sender''s Comments: This case concerns a 35-year-old male patient with no previous relevant medical history reported, who experienced the serious unexpected events of Somnolence, Arthralgia, Fatigue, Headache and Pyrexia. The events occurred on the same day an on the day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2030276 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20224

Write-up: Vomiting; Fever; Shivering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424431) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Shivering) in a 46-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 31-Dec-2021, VOMITING (Vomiting) and CHILLS (Shivering) had resolved. On 01-Jan-2022, PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Patient not had symptoms associated with COVID-19. Patient not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. It was reported that, patient''s symptoms lasted 36 hours and were very unpleasant. Patient was not enrolled in clinical trial Treatment Medication use information was not provided by reporter. Company Comment: This is a regulatory case concerning a 46-year-old, male patient with no medical history reported, who experienced the unexpected serious events of vomiting, chills and pyrexia. The events occurred approximately on the same day after the third dose of mRNA-1273 vaccine and recovered within one to two days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 46-year-old, male patient with no medical history reported, who experienced the unexpected serious events of vomiting, chills and pyrexia. The events occurred approximately on the same day after the third dose of mRNA-1273 vaccine and recovered within one to two days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2030297 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Fatigue, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use; Exercise regular (Patient was on healthy diet.); Hay fever; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Vomiting; Diarrhea; Headache; Muscle pain; Joint ache; Fatigue; Fever chills; Breath shortness; Nausea; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle pain), ARTHRALGIA (Joint ache), FATIGUE (Fatigue), PYREXIA (Fever chills) and DYSPNOEA (Breath shortness) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 26-Aug-2021 to 31-Aug-2021. Concurrent medical conditions included Alcohol use, Non-smoker, Exercise regular (Patient was on healthy diet.) and Hay fever. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and DYSPNOEA (Breath shortness) (seriousness criterion medically significant). On 31-Dec-2021, VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint ache), PYREXIA (Fever chills) and DYSPNOEA (Breath shortness) had resolved. On 01-Jan-2022, NAUSEA (Nausea) had resolved. On 02-Jan-2022, FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment medication information was not provided by the reporter. Patient had boost jab on Thursday 30th December at 6pm, reactions was started on 31st morning at 3am, it was quick and strong, getting worse by hours. But reaction was easing off quick too, on 1st January 6pm exactly 48 hours from the time Patient received jab. Patient starting to have appetite for food and gaining most of energy back and become patient normal self again. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. Company Comment: This is a regulatory case concerning a 42-year-old patient of unknown gender with no relevant medical history, who experienced the unexpected serious events of vomiting, diarrhoea, headache, myalgia, arthralgia, pyrexia, dyspnoea, nausea and fatigue. The events occurred approximately on the same day and on the next day after the third dose of mRNA-1273 vaccine and had resolved or were resolving within one to two days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 42-year-old patient of unknown gender with no relevant medical history, who experienced the unexpected serious events of vomiting, diarrhoea, headache, myalgia, arthralgia, pyrexia, dyspnoea, nausea and fatigue. The events occurred approximately on the same day and on the next day after the third dose of mRNA-1273 vaccine and had resolved or were resolving within one to two days.. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2030301 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Headache, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (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: CLENIL MODULITE; DOXYCYCLINE; INFLUENZA VIRUS; PREDNISONE
Current Illness: Asthma (Have asthma and have had a chest infecting in last 3 months); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection (Have asthma and have had a chest infecting in last 3 months)
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: wheezing; Sneezing; Runny nose; Wheezy; Swollen glands; Coughing; Sore throat; Headache; Stiffness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424659) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), COUGH (Coughing), WHEEZING (Wheezy), LYMPHADENOPATHY (Swollen glands), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), WHEEZING (wheezing), MUSCULOSKELETAL STIFFNESS (Stiffness) and OROPHARYNGEAL PAIN (Sore throat) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Chest infection (Have asthma and have had a chest infecting in last 3 months). Concurrent medical conditions included Asthma (Have asthma and have had a chest infecting in last 3 months) and Suspected COVID-19 since 31-Dec-2021. Concomitant products included BECLOMETASONE DIPROPIONATE (CLENIL MODULITE) from 01-Nov-2020 to an unknown date for Asthma, DOXYCYCLINE from 09-Oct-2021 to 15-Oct-2021 and PREDNISONE from 12-Oct-2021 to 17-Oct-2021 for Chest infection, INFLUENZA VACCINE (INFLUENZA VIRUS) from 29-Oct-2021 to an unknown date for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced WHEEZING (Wheezy) (seriousness criterion medically significant), SNEEZING (Sneezing) (seriousness criterion medically significant) and RHINORRHOEA (Runny nose) (seriousness criterion medically significant). On an unknown date, the patient experienced WHEEZING (wheezing) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), COUGH (Coughing), WHEEZING (Wheezy), LYMPHADENOPATHY (Swollen glands), SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) had not resolved and WHEEZING (wheezing), MUSCULOSKELETAL STIFFNESS (Stiffness) and OROPHARYNGEAL PAIN (Sore throat) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-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 Treatment Medication reported. Patient reported that his headache started within 12 hours with sore arm. Headache would ease but come back towards end of pain relief period that was 4 hrs and felt tired. He slept through day due to night shift and was tired when woken up after, on doing so was coughing, had sore throat and swollen glands. He worked another night shift on 31 Dec 2021, where cough developed into a wheezing, regular headaches and also started to have regular sneezing episodes/runny nose. Headaches and coughing are regular. Lateral flow tests showed negative for COVID-19 and a PCR had been ordered. Company comment This case concerns a 29-year-old male patient, with medical history of Asthma (Have asthma and have had a chest infecting in last 3 months), who experienced the unexpected serious events of HEADACHE, COUGH, WHEEZING, LYMPHADENOPATHY, SNEEZING, RHINORRHOEA, WHEEZING, MUSCULOSKELETAL STIFFNESS and OROPHARYNGEAL PAIN. The events occurred on the same day and on the following 2 days after the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of Asthma (Have asthma and have had a chest infecting in last 3 months), remains as confounders. Patient had received INFLUENZA VACCINE 2 months prior the administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old male patient, with medical history of Asthma (Have asthma and have had a chest infecting in last 3 months), who experienced the unexpected serious events of HEADACHE, COUGH, WHEEZING, LYMPHADENOPATHY, SNEEZING, RHINORRHOEA, WHEEZING, MUSCULOSKELETAL STIFFNESS and OROPHARYNGEAL PAIN. The events occurred on the same day and on the following 2 days after the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of Asthma (Have asthma and have had a chest infecting in last 3 months), remains as confounders. Patient had received INFLUENZA VACCINE 2 months prior the administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030326 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate, Myalgia, Nausea, Neck pain, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (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 (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; ISOSORBIDE; RANOLAZINE
Current Illness: Sleep apnea
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery (Heart bypass operation eight years ago hence Ranolazine etc.); Heart attack; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: tired cold; muscle pain; racing heart; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Racing heart (tachycardia); Neck pain; Tiredness; Nausea; Heart rate; Chest pain; This case was received via the RA (Reference number: GB-MHRA-ADR 26424851) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (tired cold), MYALGIA (muscle pain), PALPITATIONS (racing heart), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)), HEART RATE (Heart rate), the first episode of CHEST PAIN (Chest pain), NECK PAIN (Neck pain), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Heart attack, Suspected COVID-19 from 07-Jan-2021 to 07-Feb-2021 and Bypass surgery (Heart bypass operation eight years ago hence Ranolazine etc.). Concurrent medical conditions included Sleep apnea. Concomitant products included RANOLAZINE from 2019 to an unknown date for Anginal pain, BISOPROLOL from 2015 to an unknown date and ISOSORBIDE for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant), the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tired cold) (seriousness criterion medically significant), MYALGIA (muscle pain) (seriousness criterion medically significant), PALPITATIONS (racing heart) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, FATIGUE (tired cold), MYALGIA (muscle pain) and PALPITATIONS (racing heart) had not resolved, FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown and HEART RATE (Heart rate), NECK PAIN (Neck pain), NAUSEA (Nausea) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient relevant medical history and concurrent conditions also included minor problems recently but nowhere near as bad as this. He was being investigated for Sleep Apnea etc. Otherwise work full time usually without any time off and generally fit for his age. It was reported that, after vaccination about 5-6 hours later Patient felt sick very tired cold etc. went to bed. Awoke a few hours later sweating (soaked) severe muscle pain, rapid heart rate, chest pain but not angina pain (more like a pulled muscle), tried to get up but felt dizzy had a bad night. Next day could not get up phoned in sick from bed (only third day off all year) spent two days not eating just drinking water etc. Finally got up on the day of reporting and although feeling better still not right thought to report the symptoms as he had night problems before but this was the worst he had for many years and nearly resulted in me calling for emergency assistance. No treatment information was provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporter relates this report to possible inflammation of the heart (myocarditis or pericarditis).; Sender''s Comments: This case concerns a 63-year-old, male patient with relevant medical history of heart attack, sleep apnea, and bypass surgery, who experienced the unexpected serious events of Fatigue, Myalgia, Palpitations, Chest Pain, Pyrexia, Dyspnea, Tachycardia, Heart rate, Neck Pain, and Nausea. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after the third dose. This patient''s underlying medical conditions remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2030329 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Skin temperature, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211115; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: This case was received via regulatory authority RA (Reference number: GB-RA-ADR 26424862) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and SKIN TEMPERATURE (Skin temperature) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 15-Nov-2021 to 19-Nov-2021. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant) and SKIN TEMPERATURE (Skin temperature) (seriousness criterion medically significant). On 31-Dec-2021, SKIN TEMPERATURE (Skin temperature) had resolved. At the time of the report, TINNITUS (Tinnitus) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant information was provided. Patient left ear has been wrong since the day after the vaccine. Patient had unbearable constant ringing in ear and felt the same temperature difficulty that experienced in previous COVID -19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No treatment information was provided. Company Comment: This case concerns a 44-year-old female subject, with a medical history of COVID-19 infection (1 month 14 days prior to 3rd dose of mRNA-1273 vaccination), who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Tinnitus and Skin temperature. The events occurred 1 day after the third dose of mRNA 1273 vaccine. No information regarding treatment medication given was available. At the time of the report, tinnitus had not resolved while unspecified problem with skin temperature, which, according to the patient, felt exactly the same as when she had COVID-19, had resolved (1 day duration). Rechallenge was not applicable as no additional dose is expected to be given. The patient''s medical history of COVID-19 infection remains a confounder. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female subject, with a medical history of COVID-19 infection (1 month 14 days prior to 3rd dose of mRNA-1273 vaccination), who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Tinnitus and Skin temperature. The events occurred 1 day after the third dose of mRNA 1273 vaccine. No information regarding treatment medication given was available. At the time of the report, tinnitus had not resolved while unspecified problem with skin temperature, which, according to the patient, felt exactly the same as when she had COVID-19, had resolved (1 day duration). Rechallenge was not applicable as no additional dose is expected to be given. The patient''s medical history of COVID-19 infection remains a confounder. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.


VAERS ID: 2030345 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Headache, Illness, Pelvic pain, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad), 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: Endometriosis
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.MOD20224

Write-up: Pelvic pain; Confused; Headache; Sickness; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26425006) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PELVIC PAIN (Pelvic pain), CONFUSIONAL STATE (Confused) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3005889) for an unknown indication. Concurrent medical conditions included Endometriosis. On 30-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On an unknown date, the patient experienced PELVIC PAIN (Pelvic pain) (seriousness criterion medically significant), CONFUSIONAL STATE (Confused) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness) and PELVIC PAIN (Pelvic pain) had not resolved, CONFUSIONAL STATE (Confused) had resolved and HEADACHE (Headache) had resolved with sequelae. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient not had symptoms associated with COVID-19. Patient was not currently breastfeeding. No concomitant medications reported. No treatment information reported.; Sender''s Comments: This case concerns a patient, with medical history (Endometriosis), who experienced the serious unexpected event(s) of illness, pelvic pain, confusional state and headache. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2030351 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20224

Write-up: Skin rash; Swelling arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425058) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and RASH (Skin rash) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and RASH (Skin rash) 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. The concomitant medications were not reported. The treatment information was not provided. Patient reported that she had rash on arm was quite hot to touch. Post vaccination patient had not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. It was reported that patient''s report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 53 year-old female patient with no reported medical history who experienced the unexpected serious events of peripheral swelling and rash which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 53 year-old female patient with no reported medical history who experienced the unexpected serious events of peripheral swelling and rash which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030354 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling hot, Feeling of body temperature change, Influenza like illness, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Asthmatic
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.MOD20224

Write-up: feeling hot; Pins and needles; Flu-like aching; Feeling hot and cold; This case was received via regulatory authority on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), INFLUENZA LIKE ILLNESS (Flu-like aching) and PARAESTHESIA (Pins and needles) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: VENTOLIN. Past adverse reactions to the above products included No adverse event with VENTOLIN. Concurrent medical conditions included Asthmatic. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING HOT (feeling hot) (seriousness criterion medically significant). At the time of the report, FEELING HOT (feeling hot), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and INFLUENZA LIKE ILLNESS (Flu-like aching) was resolving and PARAESTHESIA (Pins and needles) 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. The patient started to feel poorly from the date of the booster with feeling hot and cold. The next day patients body was aching on top of the hot/cold sweats and slowly started to ease off but have had pins and needles in both hands and arms occasionally on and off for most of the day. Started from 8am and eased off a bit by 1pm and was Still niggling now Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No concomitant medications were reported. No treatment medications were reported. Past drug included Steroid.; Sender''s Comments: This case concerns a 38-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Feeling Hot, Feeling Of Body Temperature Change, Influenza Like Illness, and Paresthesia. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19); except Paresthesia that occurred 3 days after the third dose. The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2030372 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Heavy menstrual bleeding, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Menstruation increased; Headache; Fever; Shivering; This case was received via RA (Reference number: GB-MHRA-ADR 26425235) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstruation increased), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Shivering) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 21-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstruation increased) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 01-Jan-2022, HEADACHE (Headache) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (Menstruation increased) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-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 treatment medication was reported by patient. Patient reported that period had come on early and more heavily than usual. This is a regulatory case concerning a 24-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of heavy menstrual bleeding, headache, pyrexia and chills. The events occurred within the first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given Pfizer BIONTECH COVID-19 vaccine approximately 4 and 6 months prior to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 24-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of heavy menstrual bleeding, headache, pyrexia and chills. The events occurred within the first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given Pfizer BIONTECH COVID-19 vaccine approximately 4 and 6 months prior to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030373 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-12
Onset:2021-12-30
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Poor quality sleep, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; FEXOFENADINE HYDROCHLORIDE; FLUTIFORM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fainting; Nauseated; Dizziness; Headache; Poor sleep; This case was received via RA (Reference number: GB-MHRA-ADR 26425254) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), NAUSEA (Nauseated), DIZZINESS (Dizziness), HEADACHE (Headache) and POOR QUALITY SLEEP (Poor sleep) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concomitant products included FEXOFENADINE HYDROCHLORIDE for Allergy to animal, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE (FLUTIFORM) for Asthma, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 26-Apr-2021 to an unknown date for an unknown indication. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and POOR QUALITY SLEEP (Poor sleep) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), NAUSEA (Nauseated) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 31-Dec-2021, SYNCOPE (Fainting) had resolved. On 01-Jan-2022, NAUSEA (Nauseated), DIZZINESS (Dizziness), HEADACHE (Headache) and POOR QUALITY SLEEP (Poor sleep) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not currently breastfeeding Treatment information was not provided. Reported that following the vaccine, Patient felt well until the evening. During the night patient was unable to fall asleep and remained awake for the majority of the night. Around midnight, patient began to feel nauseated but was not concerned. Over the next few hours the feeling of nausea increased until and decided to go to the bathroom at approx 3:30 am. In the bathroom patient felt nauseous and remained there for around 10 minutes.Also reported that Suddenly patient began feeling dizzy and layed down on the floor as quickly as possible. Before patient reached the floor , body became limp and patient fell to the floor as lost consciousness. Patient was in and out of consciousness for approximately 10 minutes and remained on the bathroom floor for a while but managed to gain the strength to craw and back to bed where stayed for the following day. After fainting patient continued to feel nauseated, dizzy, weak and had a headache. However, these symptoms resolved over the next 48 hours. Patient had 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. Company Comment- This is a case of Interchange of vaccine products for this 23-year-old female subject, with a medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH (7 months 16 days prior to mRNA-1273 vaccination), who experienced the serious (Seriousness criterion-Other medically important condition) expected event of Syncope and serious unexpected events of Nausea, Dizziness, Headache, and Poor quality sleep. The events Headache and Poor quality sleep occurred 18 days after the third dose of mRNA-1273 vaccine while all the other events occurred 19 days after. There is no available information regarding treatment medication. At the time of the report, all the events had resolved. Re challenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a case of Interchange of vaccine products for this 23-year-old female subject, with a medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH (7 months 16 days prior to mRNA-1273 vaccination), who experienced the serious (Seriousness criterion-Other medically important condition) expected event of Syncope and serious unexpected events of Nausea, Dizziness, Headache, and Poor quality sleep. The events Headache and Poor quality sleep occurred 18 days after the third dose of mRNA-1273 vaccine while all the other events occurred 19 days after. There is no available information regarding treatment medication. At the time of the report, all the events had resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030380 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fever chills; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425336) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills) and FATIGUE (Tiredness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever chills) and FATIGUE (Tiredness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient took Vaccine at 10:45am, patient also experienced headache from 6pm, Periodic waking during the night, Painful arm as expected. Patient has not tested positive for COVID-19 since having the vaccine, Patient has not had symptoms associated with COVID-19, Patient is not enrolled in clinical trial. Concomitant medication information was not provided by the reporter. Treatment medication information was not provided by the reporter. Company Comment This case concerns a 32-year-old female patient with no reported medical history, who experienced the serious unexpected events of Pyrexia, and Fatigue. The events of occurred the same day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report; Sender''s Comments: This case concerns a 32-year-old female patient with no reported medical history, who experienced the serious unexpected events of Pyrexia, and Fatigue. The events of occurred the same day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 2030383 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Dysmenorrhoea, Flatulence, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20224

Write-up: bloating; flatulence; Painful periods; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425379) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (bloating), FLATULENCE (flatulence) and DYSMENORRHOEA (Painful periods) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL DISTENSION (bloating) (seriousness criterion medically significant) and FLATULENCE (flatulence) (seriousness criterion medically significant). At the time of the report, ABDOMINAL DISTENSION (bloating), FLATULENCE (flatulence) and DYSMENORRHOEA (Painful periods) 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 provided. Patient has not had symptoms associated with COVID-19. Patient had magnified sharp period pains before and during, painful flatulence, bloating, reddish bruise on arm which was itchy. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No treatment medication reported. COMPANY COMMENT: This is a Regulatory case concerning a 39-old female patient with no clinical history who experienced the unexpected events of ABDOMINAL DISTENSION, FLATULENCE and DYSMENORRHOEA The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a Regulatory case concerning a 39-old female patient with no clinical history who experienced the unexpected events of ABDOMINAL DISTENSION, FLATULENCE and DYSMENORRHOEA The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2030387 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Contusion, Dizziness, Ear pain, Fatigue, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Fever; Earache; Nausea; Fatigue; Confusion; Bruising; Dizzy spells; This case was received via regulatory authority on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), EAR PAIN (Earache), CONFUSIONAL STATE (Confusion), CONTUSION (Bruising), DIZZINESS (Dizzy spells), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) from 08-Jun-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), CONTUSION (Bruising) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 01-Jan-2022, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Headache), EAR PAIN (Earache) and CONTUSION (Bruising) had not resolved and CONFUSIONAL STATE (Confusion), DIZZINESS (Dizzy spells), NAUSEA (Nausea) and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Began with bruising on left hand (injection was given in left arm). By evening patient began experiencing dizziness and confusion. patient awoke the following morning with a severe headache, mild fever, body ache, brain fog and extreme fatigue. Puffiness in the face and acne from day 2. Headaches seem to come in waves and are similar to sinus attacks but worse. Painful to look at lights and accompanied by a painful ear ache, sometimes also stomach ache and nausea. By day 3 patient have begun finding bruises that are beginning to develop on left leg. Patient Still suffering with confusion and mind fog, with mild bouts of dizziness. Patient has not tested positive for COVID-19 since having the vaccine. Treatment medication were not reported. No possible inflammation of the heart (myocarditis or pericarditis) was reported. This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of headache, pyrexia, ear pain, confusional state, contusion, dizziness, nausea and fatigue. The events occurred within first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of COVID-19 vaccine NRVV AD approximately 5 and 6 months prior to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of headache, pyrexia, ear pain, confusional state, contusion, dizziness, nausea and fatigue. The events occurred within first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of COVID-19 vaccine NRVV AD approximately 5 and 6 months prior to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Bruxism; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425465) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BRUXISM (Bruxism) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced BRUXISM (Bruxism) (seriousness criterion medically significant). At the time of the report, BRUXISM (Bruxism) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, 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 medications were reported. No treatment medication were provided The patient experienced severe bruxism for 2 nights following booster jab. He has not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious event of Bruxism. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious event of Bruxism. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030448 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure via breast milk, Insomnia, Irritability, Poor feeding infant
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200011545

Write-up: Breast feeding problem (infant); uncharacteristically unsettled and irritated; Not sleeping; Breast feeding problem (infant); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Agency Regulatory Authority. An infant patient was exposed to BNT162b2 (COMIRNATY), transmammary, administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The mother''s vaccination history included: BNT162b2 (Dose 1), for COVID-19 immunisation; BNT162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: EXPOSURE VIA BREAST MILK (medically significant), outcome "unknown", POOR FEEDING INFANT (medically significant) with onset 30Dec2021, outcome "not recovered" and all described as "Breast feeding problem (infant)"; IRRITABILITY (medically significant), outcome "unknown", described as "uncharacteristically unsettled and irritated"; INSOMNIA (medically significant), outcome "unknown", described as "Not sleeping". Clinical course: Baby uncharacteristically unsettled and irritated. Not sleeping. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101882790 mother case


VAERS ID: 2030796 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Illness, Influenza like illness, Migraine, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Sickness; Appetite lost; Flu-like aching; Shivering; Migraine; Tiredness; Sweating; This case was received via the regulatory RA (Reference number: GB-MHRA-ADR 26422732) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ILLNESS (Sickness), MIGRAINE (Migraine), FATIGUE (Tiredness), DECREASED APPETITE (Appetite lost), INFLUENZA LIKE ILLNESS (Flu-like aching) and CHILLS (Shivering) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), FATIGUE (Tiredness), DECREASED APPETITE (Appetite lost), INFLUENZA LIKE ILLNESS (Flu-like aching) and CHILLS (Shivering) had not resolved and ILLNESS (Sickness) and MIGRAINE (Migraine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. After the vaccine patient had an achy arm, on the night of the 30/12/21 she had shivers and felt very hot and cold. Her body felt very achy and she was very tired. Patient then went to bed and had a migraine, so she took paracetamol and used tiger balm to help me sleep. She was sweating a lot through the night and woke up still very tired the next day. Patient then slept until midday, tried to have some food, but before she got around to actually eating it she was throwing up. Patient now feeling very hot and tired still. Patient has not tested positive for COVID-19 since having the vaccine 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 No concomitant medication were reported. Company Comment: This case concerns a 19-year-old, female subject with no relevant medical history, who experienced the serious (Seriousness criterion-Other medically important condition) unexpected events of Hyperhidrosis, Illness, Migraine, Fatigue, Decreased appetite, Influenza-like illness, Chills, Pain in extremity, and Vomiting. The events Illness, Decreased appetite, and Vomiting occurred 1 day after the third dose of mRNA-1273 vaccine, while all the other events occurred on the same day after vaccination. The patient took Paracetamol and used Tiger balm. COVID-19 virus test was negative. At the time of the report, events illness and migraine were resolving while all the other events were not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old, female subject with no relevant medical history, who experienced the serious (Seriousness criterion-Other medically important condition) unexpected events of Hyperhidrosis, Illness, Migraine, Fatigue, Decreased appetite, Influenza-like illness, Chills, Pain in extremity, and Vomiting. The events Illness, Decreased appetite, and Vomiting occurred 1 day after the third dose of mRNA-1273 vaccine, while all the other events occurred on the same day after vaccination. The patient took Paracetamol and used Tiger balm. COVID-19 virus test was negative. At the time of the report, events illness and migraine were resolving while all the other events were not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030800 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Pyrexia, Rash erythematous, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: High temperature; Headache; Hives; Red rash; Fever; Dizziness; This case was received via RA (Reference number: GB-MHRA-ADR 26424233) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), HEADACHE (Headache), URTICARIA (Hives), RASH ERYTHEMATOUS (Red rash), PYREXIA (Fever) and DIZZINESS (Dizziness) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 30-Apr-2020. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and URTICARIA (Hives) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature), HEADACHE (Headache), URTICARIA (Hives) and PYREXIA (Fever) had not resolved and RASH ERYTHEMATOUS (Red rash) and DIZZINESS (Dizziness) 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date was 1-JAN-2022. No concomitant and treatment medications were not provided. On 30 Dec 2021, the patient experienced very sore arm and had dull headache. On 31 Dec 2021, she had queasiness and lightheaded and felt very hot but temperature reading normal. On 01 Jan 2022, early hours had high temperature and intense pain in ribs. She felt like prickly heat rash coming everywhere and intense headache, hives began on chest and back. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.. Company comment: This regulatory case concerns a 27-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of PYREXIA, HEADACHE, URTICARIA, PYREXIA, RASH ERYTHEMATOUS and DIZZINESS. The event DIZZINESS occurred on the following day of the third dose of the mRNA-1273 vaccine. The events PYREXIA and RASH ERYTHEMATOUS occurred after two days of the third dose of the mRNA-1273 vaccine. The events PYREXIA, HEADACHE and URTICARIA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 27-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of PYREXIA, HEADACHE, URTICARIA, PYREXIA, RASH ERYTHEMATOUS and DIZZINESS. The event DIZZINESS occurred on the following day of the third dose of the mRNA-1273 vaccine. The events PYREXIA and RASH ERYTHEMATOUS occurred after two days of the third dose of the mRNA-1273 vaccine. The events PYREXIA, HEADACHE and URTICARIA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2030803 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005888 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Peripheral swelling, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL; ZELLETA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Nausea; Swelling of leg; Pulmonary embolus; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26424575) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PERIPHERAL SWELLING (Swelling of leg) and PULMONARY EMBOLISM (Pulmonary embolus) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005888) for an unknown indication. Concomitant products included DESOGESTREL (ZELLETA) for Contraception, LAMOTRIGINE (LAMICTAL) for Epilepsy petit mal. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolus) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of leg) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea) and PERIPHERAL SWELLING (Swelling of leg) had not resolved and PULMONARY EMBOLISM (Pulmonary embolus) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-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 medical history was reported. It was stated that the patient experienced high level pain. Patient was admitted to A&E for bloods, pain relief and blood thinner programme. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report was not related to possible inflammation of the heart (myocarditis or pericarditis). Treatment information was not provided. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Company comment: This regulatory case concerns a 39-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of SWELLING and NAUSEA, and the serious unexpected AESI of PULMONARY EMBOLISM. The event PULMONARY EMBOLISM occurred after three days of the third dose of mRNA-1273. The events SWELLING and NAUSEA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed the day before of the third dose of mRNA-1273. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 39-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of SWELLING and NAUSEA, and the serious unexpected AESI of PULMONARY EMBOLISM. The event PULMONARY EMBOLISM occurred after three days of the third dose of mRNA-1273. The events SWELLING and NAUSEA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed the day before of the third dose of mRNA-1273. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 2030804 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
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.MOD20224

Write-up: Impetigo; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424596) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of IMPETIGO (Impetigo) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was reported. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced IMPETIGO (Impetigo) (seriousness criterion medically significant). At the time of the report, IMPETIGO (Impetigo) 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. Patient has not had symptoms associated with COVID-19. Patient suspect Vaccine start date was reported as 17-Oct-1992. Patient had his vaccine on Tuesday by Thursday morning patient face was covered in a rash he was seen by a GP who prescribed antibiotics after three days of taking the antibiotics it started to spread to patient hands and patient saw another GP who signed him off work for three weeks and gave him another cream to use on top of the antibiotics Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Company comment: This Regulatory Authority case concerns a 29-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of impetigo. The patient developed face rash 2 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Regulatory authority reported vaccination date as 17 October 1992. He was prescribed with antibiotics and after three days of taking them, it spread to his hands for what he saw another doctor who signed him off work for three weeks and gave him a cream to use on top of the antibiotics. It was reported that the patient received a dose of Biontech''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This Regulatory Authority case concerns a 29-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of impetigo. The patient developed face rash 2 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Regulatory authority reported vaccination date as 17 October 1992. He was prescribed with antibiotics and after three days of taking them, it spread to his hands for what he saw another doctor who signed him off work for three weeks and gave him a cream to use on top of the antibiotics. It was reported that the patient received a dose of Biontech''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030872 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-12-30
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20224

Write-up: Right leg pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Right leg pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Right leg pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Right leg pain) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter Patient reported that On 15-aug-2021 he received first dose of Moderna vaccine and On 18-Nov-2021 received the second dose of Moderna vaccine On 29-Dec-2021 patient returned to the outpatient department of Hematology Oncology and the patient complained that his right leg had swelled and became more and more serious in the last month. The doctor suspected that this is VITT caused by the vaccine, and the patient was referred to the emergency department for CTA and hospitalization. The patient treatment changed from warfarin to apixaban 5 mg BID. Company Comment: This case refers to a 61-year-old male patient with no known medical history who experienced the unexpected event of Pain in extremity approximately 6 weeks after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 61-year-old male patient with no known medical history who experienced the unexpected event of Pain in extremity approximately 6 weeks after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2031087 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20224

Write-up: vomiting; Abdominal pain; This case was received via RA (Reference number: GB-MHRA-ADR 26423048) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and ABDOMINAL PAIN (Abdominal pain) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion medically significant). On 30-Dec-2021, ABDOMINAL PAIN (Abdominal pain) had resolved. At the time of the report, VOMITING (vomiting) had resolved. 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. Concomitant medication was not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Last menstrual period date was reported as 10-Dec-2021. Patient received booster vaccination of Moderna received at around midday on 29-Dec-2021 and woke with abdominal pain at 5:30am on 30-Dec-2021. Abdominal pain then increased throughout the morning with some vomiting and diarrhoea. Pain was so severe that patient called 111 and were referred to Urgent Care Centre to be checked. Urine, heart rate, blood pressure and abdomen tests were performed. All checks were fine so patient was sent home as pain was subsiding. Abdominal pain then stopped at around 6pm. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Re-challenge was reported as unknown. Company Comment: This case concerns a 44-year-old, female subject with no relevant medical history, who experienced the serious (Seriousness criteria- Other medically important condition) unexpected events of Vomiting and Abdominal pain. The abdominal pain occurred 1 day after the booster dose of mRNA-1273 vaccine while vomiting occurred unknown number of days after. Pain was so severe that patient called 111 and were referred to Urgent Care Centre where urine, heart rate, blood pressure and abdomen were checked and were all fine. COVID-19 virus test was negative. At the time of the report, both the events had resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old, female subject with no relevant medical history, who experienced the serious (Seriousness criteria- Other medically important condition) unexpected events of Vomiting and Abdominal pain. The abdominal pain occurred 1 day after the booster dose of mRNA-1273 vaccine while vomiting occurred unknown number of days after. Pain was so severe that patient called 111 and were referred to Urgent Care Centre where urine, heart rate, blood pressure and abdomen were checked and were all fine. COVID-19 virus test was negative. At the time of the report, both the events had resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2031225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Haematoma, Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pruritus, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (She was on Asthma Inhalers (Did not state which ones)); Overweight (Was on a weight management diet.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ARPFIZER INC202200004113

Write-up: she fainted; the third dose of Pfizer was applied; the third dose of Pfizer was applied; the third dose of Pfizer was applied; began to feel bad; headache; hematoma; bruises; began to itch all over her body; had hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): EX-2022-01156603- -APN-DGA#ANMAT (RA). A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: She was on Asthma Inhalers (Did not state which ones); "Overweight" (unspecified if ongoing), notes: Was on a weight management diet. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (she had previously received the Astra Zeneca vaccine), for Immunisation. The following information was reported: SYNCOPE (medically significant) with onset 30Dec2021, outcome "unknown", described as "she fainted"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "the third dose of Pfizer was applied"; MALAISE (non-serious) with onset 30Dec2021, outcome "unknown", described as "began to feel bad"; HEADACHE (non-serious) with onset 30Dec2021, outcome "unknown", described as "headache"; HAEMATOMA (non-serious) with onset 30Dec2021, outcome "unknown", described as "hematoma"; CONTUSION (non-serious) with onset 30Dec2021, outcome "unknown", described as "bruises"; PRURITUS (non-serious) with onset 30Dec2021, outcome "not recovered", described as "began to itch all over her body"; URTICARIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "had hives". The event "she fainted" was evaluated at the physician office visit. Clinical course: Patient had previously received the Astra Zeneca vaccine. She received the vaccine on 30Dec2021 and commented that an hour and a half after the application she began to feel bad, she thought it was because she was in a very confined place, she went to a more ventilated place and began to feel a headache, in the end she fainted, so they had to take her to the physician by ambulance and there the physician told her that this was normal with the vaccine. The patient commented that she now had bruises and hematoma on her body from the fall. Additionally, she commented, that day she soon began to itch all over her body and now she had hives (it had not been resolved). Medical History reported as Asthma and overweight. Patient was on Asthma Inhalers (she did not state which ones) and was on a weight management diet. Third Dose reported as Pfizer; Date: 30Dec2021; Batch: F (?) L7309 (She was not sure about the first letter). Follow up attempts completed. No further information expected.


VAERS ID: 2032636 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL4222 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Oedema, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202200000070

Write-up: slight increase in edema; axillary lymphadenopathy appeared in the same arm where the dose was applied; Fever; myalgia; arthralgia; pain at the application site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 32 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 14:15 (Lot number: FL4222) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 31Dec2021 07:00, outcome "not recovered", described as "axillary lymphadenopathy appeared in the same arm where the dose was applied"; OEDEMA (medically significant) with onset 01Jan2022, outcome "unknown", described as "slight increase in edema"; PYREXIA (non-serious) with onset 30Dec2021, outcome "unknown", described as "Fever"; MYALGIA (non-serious) with onset 30Dec2021, outcome "unknown", described as "myalgia"; ARTHRALGIA (non-serious) with onset 30Dec2021, outcome "unknown", described as "arthralgia"; VACCINATION SITE PAIN (non-serious) with onset 30Dec2021, outcome "unknown", described as "pain at the application site". The events "axillary lymphadenopathy appeared in the same arm where the dose was applied" and "slight increase in edema" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of lymphadenopathy. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since vaccination. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events lymphadenopathy ,edema and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2032997 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Immunisation, SARS-CoV-2 test
SMQs:, Guillain-Barre 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
CDC Split Type: GBPFIZER INC202200000624

Write-up: less energy; Booster; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-APPCOVID-20220101134250. Other Case identifier(s): GB-MHRA-ADR 26424054. A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue"; ASTHENIA (medically significant), outcome "unknown", described as "less energy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: Unsure if patient has had symptoms associated with COVID-19. Extreme fatigue whenever waking up, less energy ever since having the booster. No other side effects. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033002 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Headache, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, Rhinorrhoea, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Difficulty breathing; Phlegm; Polyp NOS (Operated for polyps 8-9 years ago); Postnasal drip; Upper respiratory tract congestion
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:High; Comments: Started with high fever; Test Name: Body temperature; Result Unstructured Data: Test Result:Low; Comments: Turned into a low fever
CDC Split Type: GBPFIZER INC202200003545

Write-up: Unable to sleep through the night; Headache; Cough; Runny nose; Off label use; Interchange of vaccine products; Booster; Chills; Started with high fever, later turned into lower fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-APPCOVID-202201021451313150-QWMVU. Other Case identifier(s): GB-MHRA-ADR 26424973. A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Unsure if patient had symptoms associated with COVID-19. Patient 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. Relevant medical history included: "Upper respiratory tract issues" (unspecified if ongoing); "Breathing difficulties" (unspecified if ongoing); "Excess phlegm production" (unspecified if ongoing); "Polyp" (unspecified if ongoing), notes: Operated for polyps 8-9 years ago; "Postnasal drip" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chills"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Started with high fever, later turned into lower fever"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; COUGH (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Cough"; RHINORRHOEA (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Runny nose"; SLEEP DISORDER (medically significant), outcome "unknown", described as "Unable to sleep through the night". The patient underwent the following laboratory tests and procedures: body temperature: high, notes: Started with high fever; low, notes: Turned into a low fever. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033112 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Genital haemorrhage, Headache, Hyperhidrosis, Immunisation, Maternal exposure during pregnancy, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: CITALOPRAM; FOLIC ACID; INFLUENZA VIRUS; PARACETAMOL
Current Illness: Pregnancy (Estimated due date: 29Jul2022)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101886040

Write-up: Bleeding genital; Ache; Headache; Lucid dreams; Nausea; Sweating; Maternal exposure during pregnancy; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112310402251340-5BRDO (MHRA). Other Case identifier: GB-MHRA-ADR 26418912 (MHRA). A 31 year-old female patient (pregnant) received BNT162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pregnancy" (ongoing), notes: Estimated due date: 29Jul2022; "Mental disorder" (unspecified if ongoing); "Folic acid supplementation" (unspecified if ongoing). Date of last menstrual period was 02Oct2021. The patient was 12 weeks pregnant at the time of exposure to BNT162b2, paracetamol. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby on 09Jul2022. Patient was not currently breastfeeding. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medications included: CITALOPRAM taken for mental disorder; FOLIC ACID taken for vitamin supplementation; INFLUENZA VIRUS taken for pregnancy; PARACETAMOL, start date: 30Dec2021 (indication was reported as "drug side effect"). Vaccination history included: BNT162b2 (DOSE 1), for COVID-19 immunisation; BNT162b2 (DOSE 2), for Covid-19 immunisation. The following information was reported: GENITAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "Bleeding genital"; PAIN (medically significant), outcome "not recovered", described as "Ache"; HEADACHE (medically significant), outcome "not recovered", described as "Headache"; ABNORMAL DREAMS (medically significant), outcome "not recovered", described as "Lucid dreams"; NAUSEA (medically significant), outcome "not recovered", described as "Nausea"; HYPERHIDROSIS (medically significant), outcome "not recovered", described as "Sweating"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 30Dec2021, outcome "unknown", described as "Maternal exposure during pregnancy". The patient also experienced IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster". Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Angioedema; Arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Urticaria cold
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000489

Write-up: Painful arm at the injection site; fever; chills; Swollen lymph nodes; Booster; Interchange of vaccine products; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112310858391050-E5WET. Other Case identifier(s): GB-MHRA-ADR 26420141. A 37-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 09:50 (Batch/Lot number: unknown) as dose 3 (booster) single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "Palindromic Arthritis" (unspecified if ongoing); "Cold induced urticaria" (unspecified if ongoing); "angioodema" (unspecified if ongoing); "Anaphylaxis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 30Dec2021 09:50, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; PYREXIA (medically significant) with onset 31Dec2021 03:00, outcome "not recovered", described as "fever"; CHILLS (medically significant) with onset 31Dec2021 03:00, outcome "not recovered", described as "chills"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "Painful arm at the injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient had Painful arm at the injection site. Fever and chills began approx 3:00am 31Dec2021. Painful and swollen lymph nodes under the left arm, where vaccine was received. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient last menstrual period date: 17Dec2021. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Gastrooesophageal reflux disease, Hyperhidrosis, Immunisation, Insomnia, Movement disorder, Muscle twitching, Myalgia, Pain, Peripheral swelling, Throat irritation, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (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 INC202200000441

Write-up: trembling/Shaking; twitching; severe pain throughout body/very sore; Burning sensation in lower throat; difficult to move; Muscle ache; Muscle twitch; Chills/Shivering; Sweating; Insomnia; Swollen arm; Acid reflux (oesophageal); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112311030082090-WJQQX (RA). Other Case identifier(s): GB-MHRA-ADR 26420874 (RA). A 33-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; TREMOR (medically significant), outcome "recovering", described as "trembling/Shaking"; MUSCLE TWITCHING (medically significant), outcome "recovering", described as "twitching"; MYALGIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Muscle ache"; MUSCLE TWITCHING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Muscle twitch"; CHILLS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chills/Shivering"; HYPERHIDROSIS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sweating"; INSOMNIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Insomnia"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm"; GASTROOESOPHAGEAL REFLUX DISEASE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Acid reflux (oesophageal)"; PAIN (medically significant), outcome "unknown", described as "severe pain throughout body/very sore"; THROAT IRRITATION (medically significant), outcome "unknown", described as "Burning sensation in lower throat"; MOVEMENT DISORDER (medically significant), outcome "unknown", described as "difficult to move". Clinical course: The patient woke up at 1:00am with severe pain throughout body, shaking / trembling / twitching and felt cold. Even with additional layers still felt cold. Burning sensation in lower throat. Sweating (bed sheets damp). Arm was swollen (arm of injection) and difficult to move, very sore. Couldn''t sleep felt wide awake. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033156 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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...); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000500

Write-up: Swelling arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112311119423790-YTJ7J (RA). Other Case identifier(s): GB-MHRA-ADR 26420906 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i... The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, LOT NUMBER UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 2, LOT NUMBER UNKNOWN), for COVID-19 immunisation. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant), outcome "recovering", described as "Swelling arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Tension headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; PROPRANOLOL; EZETIMIBE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic headaches; High cholesterol; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000537

Write-up: severe headache; Tension headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112311234317340-5Q4NT. Other Case identifier(s): GB-MHRA-ADR 26421488. AA 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Chronic headaches" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroidectomy, start date: 01Oct2014; PROPRANOLOL taken for headache, start date: 01May2016; EZETIMIBE taken for blood cholesterol increased, start date: 01Nov2021. Vaccination history included: Comirnaty (Dose 1), administration date: 17Feb2021, for Covid-19 immunisation; Comirnaty (Dose 2), administration date: 07May2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "not recovered", described as "severe headache"; TENSION HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Tension headache". Therapeutic measures were taken as a result of headache, tension headache. Clinical course: Patient was not having symptoms associated with COVID-19 Not had COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. The patient was taking Ibuprofen and paracetamol not helping for Severe headache. Patient was not enrolled in clinical trial. LMP: 21Dec2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033173 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Loss of consciousness, Nausea, SARS-CoV-2 test, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000640

Write-up: loss of consciousness; nausea; Fainting; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112311237062640-ZTP3X (RA). Other Case identifier: GB-MHRA-ADR 26421507 (RA). A 21-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant), outcome "not recovered", described as "loss of consciousness"; SYNCOPE (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Fainting"; NAUSEA (medically significant), outcome "not recovered", described as "nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were not taken as a result of loss of consciousness, nausea. Clinical course: nausea and loss of consciousness for a few seconds. No other treatment. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033178 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202200000421

Write-up: Palpitations; Feeling sick; Fever; Off label use; Interchange of vaccine products; Booster; Generalised muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112311257327610-HILW8. Other Case identifier(s): GB-MHRA-ADR 26421603. A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Generalised muscle aches"; PALPITATIONS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Palpitations"; MALAISE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Feeling sick"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient had no symptoms associated with COVID-19. The patient was not currently breastfeeding. Patient last menstrual period date was 30Nov2021. The patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033183 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-01
Onset:2021-12-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
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: COVID-19 VACCINE ASTRAZENECA; FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20220128)
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.MOD20224

Write-up: stillbirth; Maternal exposure during pregnancy; Stillbirth NOS; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26421728) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of STILLBIRTH (stillbirth), STILLBIRTH (Stillbirth NOS) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 42-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Pregnancy (Estimated due date: 20220128). Concomitant products included FOLIC ACID for Folic acid supplementation, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Jul-2021 to an unknown date for an unknown indication. In December 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 28-Jan-2022. On 30-Dec-2021, the patient experienced STILLBIRTH (Stillbirth NOS) (seriousness criteria hospitalization, medically significant and congenital anomaly). On an unknown date, the patient experienced STILLBIRTH (stillbirth) (seriousness criteria hospitalization, medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria hospitalization, medically significant and congenital anomaly). The delivery occurred on an unknown date, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth w Congenital Anomaly. At the time of the report, STILLBIRTH (stillbirth) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and STILLBIRTH (Stillbirth NOS) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient attended hospital due to absent fetal movements. Baby was found to have no heartbeat. No other abnormalities on scan. No other maternal illness. Patient had normal BMI, no hypertension. Patient was induced for stillbirth. Patient was exposed to ''the medicine'' during the first trimester (1 to 12 weeks). Details of scans or investigations: Normal growth on scans. Normal anomaly scan. Normal BP. GTT normal. Patient''s 1st baby had cardiac abnormality which was successfully surgically treated postnatally. Patient has not had symptoms associated with COVID-19. Patient was not breast feeding. This regulatory case concerns a 42-year-old, female patient with relevant medical history of concomitant administration of the AstraZeneca COVID-19 vaccine, exposure to ''the medicine'' during the first trimester (1 to 12 weeks) of pregnancy and unspecified Cardiac abnormality of the first baby, who experienced vaccine exposure during pregnancy and the unexpected, serious events of stillbirth (LLT: stillbirth) and stillbirth (LLT: stillbirth NOS). The mother received the third dose of the Moderna mRNA-1273 vaccine on an unspecified date in Dec2021. The event stillbirth NOS occurred 29 days after administration of the third dose of the Moderna mRNA-1273 vaccine. The patient had normal BMI and normal blood pressure, and had normal Glucose Tolerance Test result. Details of investigations showed that the baby had normal growth and normal anomaly scan. However, on an unspecified date, the patient was admitted to the hospital due to absent fetal movements and the baby was found to have no heartbeat. The patient was then induced for stillbirth. The history of concomitant administration of the AstraZeneca COVID-19 vaccine, exposure to ''the medicine'' during the first trimester of pregnancy and unspecified Cardiac abnormality of the first baby remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 42-year-old, female patient with relevant medical history of concomitant administration of the AstraZeneca COVID-19 vaccine, exposure to ''the medicine'' during the first trimester (1 to 12 weeks) of pregnancy and unspecified Cardiac abnormality of the first baby, who experienced vaccine exposure during pregnancy and the unexpected, serious events of stillbirth (LLT: stillbirth) and stillbirth (LLT: stillbirth NOS). The mother received the third dose of the Moderna mRNA-1273 vaccine on an unspecified date in Dec2021. The event stillbirth NOS occurred 29 days after administration of the third dose of the Moderna mRNA-1273 vaccine. The patient had normal BMI and normal blood pressure, and had normal Glucose Tolerance Test result. Details of investigations showed that the baby had normal growth and normal anomaly scan. However, on an unspecified date, the patient was admitted to the hospital due to absent fetal movements and the baby was found to have no heartbeat. The patient was then induced for stillbirth. The history of concomitant administration of the AstraZeneca COVID-19 vaccine, exposure to ''the medicine'' during the first trimester of pregnancy and unspecified Cardiac abnormality of the first baby remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033184 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000847

Write-up: Heartburn; Painful arm; Nausea; High temperature; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112311324149770-O7FIV (MHRA). Other Case identifier(s): GB-MHRA-ADR 26421736 (MHRA). A 14 year-old female patient received BNT162B2 (COMIRNATY), administration date: 30Dec2021 (Lot number: FN5254) at the age of 14 years as dose 2, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Painful arm"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "High temperature"; DYSPEPSIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Heartburn". The patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, and was not enrolled in a clinical trial. It was reported that the reaction did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Oct2021) yes - positive COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033191 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pharyngeal swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000721

Write-up: Throat swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112311352065490-MD7YC (MHRA). Other Case identifier(s): GB-MHRA-ADR 26421843 (MHRA). A 19 year-old male patient received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGEAL SWELLING (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Throat swelling". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033193 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Ear pain, Eye pain, Immunisation, Interchange of vaccine products, Musculoskeletal pain, Neck pain, Off label use, Pain in extremity, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000476

Write-up: Booster; Off label use; Interchange of vaccine products; Tremor; Shoulder pain; Neck pain; Ear pain; Eye pain; Back pain; sharp pain on my left side arm; sharp pain on my left side arm, shoulder , shoulder blade; felt week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEB-COVID-202112311400522170-WZAXG. Other Case identifier(s): GB-MHRA-ADR 26421916. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9706) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 30Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (hospitalization) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; TREMOR (hospitalization) with onset 30Dec2021, outcome "recovered with sequelae", described as "Tremor"; ARTHRALGIA (hospitalization) with onset 30Dec2021, outcome "not recovered", described as "Shoulder pain"; NECK PAIN (hospitalization) with onset 30Dec2021, outcome "not recovered", described as "Neck pain"; EAR PAIN (hospitalization) with onset 30Dec2021, outcome "not recovered", described as "Ear pain"; EYE PAIN (hospitalization) with onset 30Dec2021, outcome "not recovered", described as "Eye pain"; BACK PAIN (hospitalization) with onset 30Dec2021, outcome "not recovered", described as "Back pain"; PAIN IN EXTREMITY (hospitalization) with onset 30Dec2021, outcome "unknown", described as "sharp pain on my left side arm"; MUSCULOSKELETAL PAIN (hospitalization) with onset 30Dec2021, outcome "unknown", described as "sharp pain on my left side arm, shoulder , shoulder blade"; ASTHENIA (hospitalization) with onset 30Dec2021, outcome "unknown", described as "felt week". The events "tremor", "shoulder pain", "neck pain", "ear pain", "eye pain", "back pain", "sharp pain on my left side arm", "sharp pain on my left side arm, shoulder , shoulder blade" and "felt week" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The patient had a booster on her left arm within a 5 min by onset of a coarse tremor of left arm, head and hand. As a result left arm was difficult to use and felt week. Following 10 min had a sharp pain on her left side arm, shoulder, shoulder blade and neck. Patient had taken to A&E. Patient last menstrual period date: 06Dec2021. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033198 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000366

Write-up: Booster; Painful arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112311419013430-YOVE6 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26421954 (regulatory authority). A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Painful arm". Clinical course: 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. Patient''s report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033209 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE; PARACETAMOL; IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000638

Write-up: Hives across jawline, smaller than on forehead; Itching all over body; torso, legs, arms and face; Booster; Giant hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112311511578050-KDOSR. Other Case identifier(s): GB-MHRA-ADR 26422277. A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE; PARACETAMOL; IBUPROFEN. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Giant hives"; URTICARIA (non-serious), outcome "not recovered", described as "Hives across jawline, smaller than on forehead"; PRURITUS (non-serious), outcome "unknown", described as "Itching all over body; torso, legs, arms and face". Therapeutic measures were taken as a result of angioedema, urticaria, pruritus. Clinical Course: Patient has not 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. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033223 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein increased, Immunisation, Interchange of vaccine products, Lethargy, Lymphopenia, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COPD; Spinal stenosis; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:40 degrees; Test Name: CRP; Result Unstructured Data: Test Result:Raised; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000623

Write-up: Interchange of vaccine products; Booster; lymphopenic; lethargic; High temperature; Off label use; This is a spontaneous report received from a contactable reporter(s) (Physician) from not seen. Regulatory number: GB-MHRA-WEBCOVID-202112311654288960-YBQUC. Other Case identifier(s): GB-MHRA-ADR 26422788. A 70 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; LYMPHOPENIA (medically significant) with onset 31Dec2021, outcome "unknown", described as "lymphopenic"; LETHARGY (medically significant) with onset 31Dec2021, outcome "unknown", described as "lethargic"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "High temperature". Initially post vaccine, following day the patient was very lethargic, family struggling to rouse patient in morning and ambulance called. The patient underwent the following laboratory tests and procedures: body temperature: 40 degrees; c-reactive protein increased: raised; sars-cov-2 test: positive, notes: Yes - Positive COVID-19 test. The patient had temperature of 40 degrees with amb crew, lymphopenic with raised CRP on bloods. clinical course:Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. The report dose not relate to possible blood clots or low platelet counts and possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033229 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Limb discomfort, Myalgia, Off label use, Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test, Tenderness, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000524

Write-up: pins and needles/Pins and needles in lower limbs; headache; First arm tenderness; Heavy legs; Fever - a lot of sweating; Off label use; Interchange of vaccine products; Booster; Shooting pain/Shooting pain down leg to ankle (right); Coldness; Fever; Localized tingling; Muscle pain; Thirst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311755347060-YWGF8 (RA). Other Case identifier(s): GB-RA-ADR 26422964 (RA). A 33-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 8Apr2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 21Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant), outcome "not recovered", described as "pins and needles/Pins and needles in lower limbs"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shooting pain/Shooting pain down leg to ankle (right)"; FEELING COLD (medically significant) with onset 30Dec2021, outcome "recovering", described as "Coldness"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fever"; PARAESTHESIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Localized tingling"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle pain"; THIRST (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Thirst"; TENDERNESS (medically significant), outcome "unknown", described as "First arm tenderness"; LIMB DISCOMFORT (medically significant), outcome "unknown", described as "Heavy legs"; HYPERHIDROSIS (medically significant), outcome "unknown", described as "Fever - a lot of sweating". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical Course: Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 4429561532 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asthenia, Axillary pain, Blood pressure increased, Blood pressure measurement, Dizziness, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Blood pressure high (brought on by pre-eclampsia.); Pre-eclampsia
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: Blood pressure; Result Unstructured Data: Test Result:Raised; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000601

Write-up: Raised blood pressure; Painful arm; Armpit pain; Weakness/ fading; Fever; Flu-like aching; Off label use; Interchange of vaccine products; Booster; felt dizzy; anxious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311815398500-SI8CK (RA). Other Case identifier(s): GB-RA-ADR 26423041 (RA). A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: 4429561532) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: brought on by pre-eclampsia.; "pre-eclampsia" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure abnormal, start date: 31Dec2021, stop date: 01Dec2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose: 1), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose:2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant) with onset 2021, outcome "recovering", described as "felt dizzy"; BLOOD PRESSURE INCREASED (medically significant) with onset 31Dec2021, outcome "recovering", described as "Raised blood pressure"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "recovering", described as "Painful arm"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Armpit pain"; ASTHENIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Weakness/ fading"; PYREXIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Fever"; INFLUENZA LIKE ILLNESS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Flu-like aching"; ANXIETY (medically significant) with onset 2021, outcome "unknown", described as "anxious". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (31Dec2021) raised; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of blood pressure increased with atenolol. Clinical course: Patient was felt dizzy, anxious, weak, wrong, fading. same when she previously had pre-eclampsia / high blood pressure. BP medication seems to have brought levels down, doctor made no reference to myocarditis. Doctor advised to go back on BP medication. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report is not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033233 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FIC9700 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000538

Write-up: Off label use; Interchange of vaccine products; Booster; Headache; Fatigue; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112311818359840-1TBJO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26423017 (MHRA). A 21 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FIC9700) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: Patient''s report did not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19, Patient is not currently breastfeeding. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033240 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Myocarditis, Palpitations, Paraesthesia, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest x ray; Result Unstructured Data: Test Result:Unknown results; Test Name: ECGs; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000560

Write-up: Palpitation; Breathlessness; Tingling feet/hands; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); pericarditis; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311912467450-FWNM9 (RA). Other Case identifier(s): GB-RA-ADR 26423106 (RA). A 31-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "pericarditis"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Palpitation"; DYSPNOEA (medically significant) with onset 30Dec2021, outcome "recovered", described as "Breathlessness"; PARAESTHESIA (medically significant) with onset 30Dec2021, outcome "recovered", described as "Tingling feet/hands"; PYREXIA (medically significant) with onset 2021, outcome "unknown", described as "Fever"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)". The events "pericarditis", "myocarditis", "palpitation", "breathlessness", "tingling feet/hands", "fever", "shortness of breath", "heart palpitations" and "racing heart (tachycardia)" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (30Dec2021) no - negative covid-19 test. Therapeutic measures were taken as a result of palpitations, dyspnoea, paraesthesia, pyrexia, dyspnoea, palpitations, tachycardia. The clinical reported as racing heart suddenly while seated and inactive. Tingly hands and breathlessness. Went to A and E and was given tests and ECGs. Discharged with instructions to book 24hr heart trace through GP referral. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial The report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The diagnosis was made by a medical professional (cardiologist, GP etc) was A&E doctor. Treatment was given with fluid because of symptoms. Imaging carried out such was chest x ray. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000547

Write-up: fever; nausea; Diarrhea; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311918286720-GHLER (RA). Other Case identifier(s): GB-RA-ADR 26423104 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pregnant" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 01; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 02; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "not recovered", described as "fever"; NAUSEA (medically significant), outcome "not recovered", described as "nausea"; DIARRHOEA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Diarrhea". Clinical course: Pregnant patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Diarrhea fever and nausea. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report does not relate to possible inflammation of the heart. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Immunisation, Interchange of vaccine products, Myalgia, Night sweats, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000530

Write-up: Off label use; Interchange of vaccine products; Booster; Fever; Headache; High temperature; Muscle ache; Night sweats; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112312002470840-STJPN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26423174 (MHRA). A 30 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-1), for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose-2), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fever"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "High temperature"; MYALGIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Muscle ache"; NIGHT SWEATS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Night sweats"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovered with sequelae", described as "Diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. The symptoms started during the night after having the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected. .


VAERS ID: 2033247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Limb discomfort, Lymphadenopathy, Nausea, Pain in extremity, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000600

Write-up: tiredness; Booster; Nausea; Pins and needles; Swollen lymph nodes; felt more heavy; Arm started to ache/sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112312013451080-IBFF0. Other Case identifier(s): GB-MHRA-ADR 26423205. A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; PARAESTHESIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pins and needles"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; LIMB DISCOMFORT (medically significant) with onset 30Dec2021, outcome "unknown", described as "felt more heavy"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "unknown", described as "Arm started to ache/sore"; FATIGUE (medically significant), outcome "recovering", described as "tiredness". Arm started to ache around 3 hours after injection (booster) gradually felt more heavy and sore the remainder of the day. Woke the next morning with extreme tiredness and pins and needles from injection site down arm and towards fingers. Nausea started around 24 hours after booster, still currently on going. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033249 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Immunisation, Pharyngeal swelling, SARS-CoV-2 test, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN B12 FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vitamin B12 deficiency (VITAMIN B12)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000612

Write-up: Booster; Throat swelling non-specific; Tongue swelling non-specific; Coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Regulatory number: GB-RA-WEBCOVID-202112312020294790-HRH23 (RA). Other Case identifier(s): GB-RA-ADR 26423202 (RA). A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Vitamin B12 deficiency", start date: 17Dec2021 (unspecified if ongoing), notes: VITAMIN B12. Concomitant medication(s) included: VITAMIN B12 FORTE taken for vitamin b12 deficiency, start date: 17Dec2021. Vaccination history included: Comirnaty (Dose 1), for Covid-19 immunisation; Comirnaty (Dose 2), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PHARYNGEAL SWELLING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Throat swelling non-specific"; SWOLLEN TONGUE (medically significant) with onset 30Dec2021, outcome "recovered", described as "Tongue swelling non-specific"; COUGH (medically significant) with onset 30Dec2021, outcome "recovered", described as "Coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: As reacted to previous vaccine, advised to take 2 antihistamine prior to booster. Approx 15mins after booster my arm went tingly and I had an itchy feeling in my throat. Tongue started to swell and began to cough. Took further antihistamine and observed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: No report related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Immunisation, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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 INC202200000762

Write-up: palpitations/ heart palpitations; shortness of breath/ slight shortness of breath randomly occur for several weeks; Generalized chest pain; Booster; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory number is GB-RA-WEBCOVID-202112312130125580-2YCKE (RA) and the Other Case identifier is GB-RA-ADR 26423243 (RA). The reporter is the patient. A 32-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 30Dec2021 (batch/lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Vaccination history included: Comirnaty (first dose (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 Immunization, reactions: "Shortness of breath" and "Heart palpitations"; Comirnaty (second dose (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 Immunization, reactions: "Shortness of breath" and "Heart palpitations." The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown" described as "Booster"; CHEST PAIN (medically significant) with onset 31Dec2021, outcome "not recovered" described as "Generalized chest pain"; PALPITATIONS (medically significant), outcome "not recovered" described as "palpitations/ heart palpitations"; DYSPNOEA (medically significant), outcome "not recovered" described as "shortness of breath/ slight shortness of breath randomly occur for several weeks." The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): negative, notes: No - Negative COVID-19 test. The clinical course was reported as follows: Heart palpitations and slight shortness of breath randomly occur for several weeks following each vaccination I have had. All three have been the Pfizer Vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No." No follow-up attempts are possible; information about the batch/ lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200016956 same patient/product, different dose/event


VAERS ID: 2033285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Breast swelling, Breast tenderness, Immunisation, Interchange of vaccine products, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lipodystrophy (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20201119; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000747

Write-up: Pain and swelling in the armpit; Pain and swelling in the armpit; pain, swelling and tenderness of breast; pain, swelling and tenderness of breast; Interchange of vaccine products; Booster; Breast pain female; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312221494440-OPT4K. Other Case identifier GB-MHRA-ADR 26423283. A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("DOSE 1; MANUFACTUERER UNKNOWN"), for COVID-19 immunisation, reaction(s): "No adverse event"; Covid-19 vaccine ("DOSE 2; MANUFACTUERER UNKNOWN"), for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; BREAST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Breast pain female"; AXILLARY PAIN (medically significant), SWELLING (medically significant), outcome "unknown" and all described as "Pain and swelling in the armpit"; BREAST SWELLING (medically significant), BREAST TENDERNESS (medically significant), outcome "unknown" and all described as "pain, swelling and tenderness of breast". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2020) positive, notes: Yes - Positive COVID-19 test. Additional Information: Patient has not had symptoms associated with COVID-19. Patient is not pregnant, is not currently breastfeeding. Pain and swelling in the armpit on side where vaccine was administered along with pain, swelling and tenderness of breast on the same side as vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033290 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Delirium, Fatigue, Hypoaesthesia, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, Pain in extremity, Pyrexia, Renal pain, SARS-CoV-2 test, Somnolence, Sweating fever, Urine output decreased, Vertigo
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: CODEINE; EVOREL CONTI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia syndrome; HRT; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000708

Write-up: Renal pain; Urine output decreased; pain in arm; fever; achy; Off Label use; interchange of vaccine products; Booster; delirium; Pain in limb; Chills; Nausea; Sweating fever; Numbness in hand; Aching joints; Acute rotatory vertigo; Exhaustion; Sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112312307214110-0VIVX. Other Case identifier(s): GB-MHRA-ADR 26423304. A 49 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HRT" (unspecified if ongoing); "Fibromyalgia syndrome" (unspecified if ongoing); "Suspected COVID-19", start date: 30Dec2021 (unspecified if ongoing). Concomitant medication(s) included: CODEINE taken for fibromyalgia, start date: 15Aug2021; EVOREL CONTI taken for hormone replacement therapy, start date: 16Sep2011. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-1, Primary Immunization series complete), administration date: 12Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose-2, Primary Immunization series complete), administration date: 16Jul2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; DELIRIUM (medically significant) with onset 30Dec2021, outcome "unknown", described as "delirium"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pain in limb"; CHILLS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Chills"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nausea"; SWEATING FEVER (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Sweating fever"; HYPOAESTHESIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Numbness in hand"; ARTHRALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Aching joints"; VERTIGO (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Acute rotatory vertigo"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Exhaustion"; SOMNOLENCE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Sleepy"; RENAL PAIN (medically significant), outcome "unknown", described as "Renal pain"; URINE OUTPUT DECREASED (medically significant), outcome "unknown", described as "Urine output decreased"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "pain in arm"; PYREXIA (medically significant), outcome "unknown", described as "fever"; PAIN (medically significant), outcome "unknown", described as "achy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Aching joints, acute rotary vertigo, chills, delirium, exhaustion, nausea, numbness in hand, pain in arm, pain in limb, sleepy, sweating fever. The nausea started immediately. Within 4 hours she had a fever, was sweating and achy. She spent 16 hours in delirium and excruciating pain that woke her every 10 - 30 minutes. Within 24 hours of vaccine, she had pain in her kidneys and have only urinated twice. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Gastritis; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000658

Write-up: Armpit pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable Consumer from the regulatory number: GB-RA-WEBCOVID-202112312337121940-1QUUG (RA). Other Case identifier(s): GB-RA-ADR 26423308 (RA). A 40 year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 04Apr2020, stop date: 01Jun2020; "Depression" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). The patient had not had a COVID-19 test. Patient was not pregnant (Patient last menstrual period date was 10Nov2021). Patient was not currently breastfeeding. Concomitant medications included: INFLUENZA VIRUS taken for immunisation, administration date 11Dec2021; CITALOPRAM taken for depression; OMEPRAZOLE taken for gastritis. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1), administration date: 01Jun2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (DOSE 2), administration date: 01Sep2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Armpit pain". Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033294 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000677

Write-up: Swelling of injection site/Swelling on injection site; Painful to touch; large red bump spanning 2-3 inches in diameter from injection site; Warm to touch; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112312339565940-AENZI (RA). Other Case identifier(s): GB-RA-ADR 26423307 (RA). A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef... The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE SWELLING (medically significant), outcome "not recovered", described as "Swelling of injection site/Swelling on injection site"; VACCINATION SITE PAIN (medically significant), outcome "not recovered", described as "Painful to touch"; VACCINATION SITE ERYTHEMA (medically significant), outcome "not recovered", described as "large red bump spanning 2-3 inches in diameter from injection site"; VACCINATION SITE WARMTH (medically significant), outcome "not recovered", described as "Warm to touch". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) no - negative covid-19 test. Clinical course: Happened with second dose also: large red bump spanning 2-3 inches in diameter from injection site. Warm to touch. Painful to touch. Swelling on injection site. Started almost immediately. Dose two reaction took nearly a week to pass. Booster dose seems to be getting worse 24 hours later. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter considered the report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Contusion, Headache, Immunisation, Interchange of vaccine products, Mobility decreased, Motion sickness, Nausea, Off label use, Pain in extremity, Vaccination site bruising
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000607

Write-up: considerable bruising to arm; motion sickness; Sore arm; Sore arm to the extent use of arm is limited.; Considerable bruising to arm, not just vaccination site; Headache; Bruising; Nausea; Loss of balance; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112312349297170-TQV2I (RA). Other Case identifier(s): GB-RA-ADR 26423321 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 25Feb2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CONTUSION (medically significant), outcome "not recovered", described as "considerable bruising to arm"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; CONTUSION (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Bruising"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; BALANCE DISORDER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Loss of balance"; MOTION SICKNESS (medically significant), outcome "unknown", described as "motion sickness"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Sore arm"; MOBILITY DECREASED (medically significant), outcome "unknown", described as "Sore arm to the extent use of arm is limited."; VACCINATION SITE BRUISING (medically significant), outcome "unknown", described as "Considerable bruising to arm, not just vaccination site". Clinical course: The reporter stated that loss of balance resulted in a fall. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Immunisation, Lymphadenopathy, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000596

Write-up: Swollen lymph nodes; Bruising; Booster; Feverish; Swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201010013295520-4PC41. Other Case identifier(s): GB-MHRA-ADR 26423327. A male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Feverish"; PERIPHERAL SWELLING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen arm"; CONTUSION (medically significant) with onset 31Dec2021, outcome "recovering", described as "Bruising". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test.Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033304 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Bone swelling, Dizziness, Immunisation, Interchange of vaccine products, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Off label use, SARS-CoV-2 test, Vaccination site pain, Wrong technique in product usage process
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000774

Write-up: Pain in left collar bone; left collar bone and swelling; Swollen lymph nodes/left collar bone and swelling, while feeling around the area for lumps; stiff in the shoulders and neck; slightly dizzy; nauseous; Nurse thinks she hit a nerve when giving me the booster, which hurt a lot; Nurse thinks she hit a nerve when giving me the booster, which hurt a lot; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201010153043530-L4LJS (RA). Other Case identifier: GB-MHRA-ADR 26423378 (RA). A 35-year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3, (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN) and (DOSE 2, MANUFACTURER UNKNOWN) both given for COVID-19 immunization. Then, received the booster dose of received bnt162b2 (COMIRNATY), on 30Dec2021 as off label use and interchange of vaccine products. It was stated that the nurse thought she hit a nerve when giving him the booster, which hurt a lot. The patient mentioned it was fine to drive but felt a little nauseous and very slightly dizzy later in the day. He slept fine that night, went to work all day on 31Dec2021 but felt a little stiff in the shoulders and neck, was feeling general side effects that were to be expected. But it was not until the night of 31Dec2021, he noted pain just above his left collar bone and swelling, while feeling around the area for lumps (swollen lymph nodes) and had a lot of pain and still do. He called EMS for advice and was told a clinician will call him back and was still waiting. Event of swollen lymph nodes was reported as serious (medically significant). The patient had negative sars-cov-2 test on that same day of 31Dec2021. Outcome of the event of swollen lymph nodes and bone pain as not recovered while unknown for the remaining events. The patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Immunisation, Myalgia, Pain, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:oscillates around 37.3
CDC Split Type: GBPFIZER INC202200000673

Write-up: increase in body temperature occurred later; body pain; Slight temperature; Swollen arm; Generalised muscle aches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201010249424980-6WPJM (RA). Other Case identifier(s): GB-MHRA-ADR 26423405 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE, start date: Nov2021. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Jun2021, for COVID-19 immunisation, reaction(s): "No adverse event"; Bnt162b2 (DOSE 2), administration date: Aug2021, for COVID-19 immunisation, reaction(s): "No adverse event". Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; BODY TEMPERATURE INCREASED (medically significant), outcome "recovering", described as "increase in body temperature occurred later"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm"; MYALGIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Generalised muscle aches"; PAIN (medically significant), outcome "unknown", described as "body pain"; PYREXIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Slight temperature". The patient underwent the following laboratory tests and procedures: body temperature: oscillates around 37.3. Therapeutic measures were taken as a result of immunisation, body temperature increased, peripheral swelling, myalgia, pain, pyrexia. Clinical course: The most disturbing are the muscle/body pains, which started within 24 hrs from the vaccine. Increase in body temperature occurred later, and it oscillates around 37.3. She used paracetamol which helped and had to rest as she felt poorly. she did not have similar reaction to the first 2 doses of the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter considered the report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033311 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Heart rate increased, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Palpitations, Pyrexia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000291

Write-up: off label use; Interchange of vaccine products; booster; dizzy; Pain legs; Heart rate high; Palpitations; High temperature; Headache; Tinnitus; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201010812443890-SVGQS (RA). Other Case identifier: GB-MHRA-ADR 26423699 (RA). A 58-year-old female patient received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Lot number: Unknown) at the age of 58 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Unknown manufacturer) for COVID-19 Immunization and Covid-19 vaccine (Dose 2, Single; Unknown manufacturer) for COVID-19 Immunization. The patient didn''t had symptoms associated with COVID-19 and not had a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in a clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "dizzy"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Pain legs"; HEART RATE INCREASED (medically significant) with onset 30Dec2021, outcome "recovering", described as "Heart rate high"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Palpitations"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "High temperature"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache" and TINNITUS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tinnitus". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033314 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20211231; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000573

Write-up: Headache; Chest pain; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201010842033400-QMQV6 (RA). Other Case identifier(s): GB-MHRA-ADR 26423726 (RA). A 33 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Fever"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Headache"; CHEST PAIN (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Chest pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) no - negative covid-19 test. Clinical course: Adverse reaction did not occur as a result of an exposure during pregnancy. Patient has not tested positive for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033318 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Liver function test, Lymphadenopathy, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL; FEXOFENADINE HYDROCHLORIDE; RIZATRIPTAN BENZOATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine prophylaxis; Migralepsy; Multiple allergies
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: LFT; Test Result: Negative ; Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000643

Write-up: Left arm vaccination site currently still very tender; Swollen lymph nodes / Swelling in armpit; Off label use; Booster; interchange of vaccine products; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202201010951318660-XRZM5 (RA). Other Case identifier(s): GB-RA-ADR 26423858 (RA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Dec2021 15:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine prophylaxis" (unspecified if ongoing); "Multiple allergies" (unspecified if ongoing); "Migralepsy" (unspecified if ongoing). Concomitant medication(s) included: CANDESARTAN CILEXETIL taken for migraine prophylaxis; FEXOFENADINE HYDROCHLORIDE taken for multiple allergies; RIZATRIPTAN BENZOATE taken for migraine-triggered seizure, start date: 25Dec2021, stop date: 25Dec2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE), administration date: 29Mar2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (DOSE 2, SINGLE), administration date: 15Jun2021, for COVID-19 immunisation. Patient is not pregnant, Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021 15:00, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 30Dec2021 15:00, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021 15:00, outcome "unknown", described as "interchange of vaccine products"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes / Swelling in armpit "; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; VACCINATION SITE PAIN (medically significant), outcome "not recovered", described as "Left arm vaccination site currently still very tender". The patient underwent the following laboratory tests and procedures: liver function test: (31Dec2021) negative; sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of lymphadenopathy, headache. Clinical course included booster vaccination at approx 3pm on 30Dec2021. Left arm vaccination site currently still very tender. Swelling in armpit (same side as booster vaccine) - appeared the same evening, now it currently measures 6.2cm in length by 4.2cm in width. Patient did LFT test approx. 30 hours after vaccine (31Dec2021) as felt very peculiar, result was negative. Patient had taken paracetamol but it hadn''t helped the swelling. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033321 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Back pain, Chills, Headache, Immunisation, Injection site erythema, Interchange of vaccine products, Lymphadenopathy, Malaise, Myalgia, Nausea, Neck pain, Night sweats, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000613

Write-up: Enlarged lymph nodes (excl infective); Muscle pain; Back pain; Armpit pain; Nausea; Chills; Feeling unwell; Feeling of total lack of energy; Night sweat; Neck pain; Headache; Injection site redness; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011007117180-6HB5C. Other Case identifier(s): GB-MHRA-ADR 26423854. A 26 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for covid-19 immunization; Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Enlarged lymph nodes (excl infective)"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; INJECTION SITE ERYTHEMA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Injection site redness"; MYALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Muscle pain"; NECK PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Neck pain"; BACK PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Back pain"; NIGHT SWEATS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Night sweat"; AXILLARY PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Armpit pain"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; CHILLS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chills"; MALAISE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Feeling unwell"; ASTHENIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Feeling of total lack of energy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical Course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033326 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site erythema, Heart rate increased, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes, Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Application site redness; Nausea; Heart rate high; Feverish; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26423869) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of APPLICATION SITE ERYTHEMA (Application site redness), NAUSEA (Nausea), HEART RATE INCREASED (Heart rate high) and PYREXIA (Feverish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 31-Jan-2021 to 16-Feb-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 24-Apr-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced APPLICATION SITE ERYTHEMA (Application site redness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEART RATE INCREASED (Heart rate high) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Feverish) had resolved. On 01-Jan-2022, HEART RATE INCREASED (Heart rate high) had resolved. At the time of the report, APPLICATION SITE ERYTHEMA (Application site redness) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) Yes, Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment : This RA case concerns a patient with unknown age , unknown gender, with no relevant medical history reported, vaccinated with Covid 19 vaccine Astra Zeneca as primary series for two doses. who experienced, Serious ( medically significant ) , unexpected events of application site erythema, nausea, heart rate increased and pyrexia . These events occurred one day post vaccination with the 3d dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine) . This patient also turned out to be SARS COV 2 test positive two days post vaccination with the 3rd dose of mRNA-1273 vaccine . The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a patient with unknown age , unknown gender, with no relevant medical history reported, vaccinated with Covid 19 vaccine Astra Zeneca as primary series for two doses. who experienced, Serious ( medically significant ) , unexpected events of application site erythema, nausea, heart rate increased and pyrexia . These events occurred one day post vaccination with the 3d dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine) . This patient also turned out to be SARS COV 2 test positive two days post vaccination with the 3rd dose of mRNA-1273 vaccine . The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report


VAERS ID: 2033329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE [SERTRALINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000498

Write-up: Swollen lymph nodes; Headache; Tiredness; Ache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011115385950-D6RJ5. Other Case identifier(s): GB-MHRA-ADR 26423912. A 30-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. The last menstrual period date of the patient was 03Dec2021. Concomitant medication(s) included: SERTRALINE [SERTRALINE HYDROCHLORIDE] taken for depression. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Headache"; FATIGUE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Tiredness"; PAIN (medically significant) with onset 31Dec2021, outcome "recovering", described as "Ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: The patient experienced left armpit very swollen and painful. Very tried day after vaccine. Patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Immunisation, Interchange of vaccine products, Intermenstrual bleeding, Mood swings, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Depression (excl suicide and self injury) (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SAYANA PRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic (Allergic to penecillin & eurythromyvin anibiotic groups.); Contraception; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211107; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000585

Write-up: bleeding; menstrual cramps; mood swings; Intermenstrual bleeding; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011143110900-AC6RV. Other Case identifier(s): GB-MHRA-ADR 26423949. A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 05Nov2021, stop date: 16Nov2021; "Allergic to eurythromyvin anibiotic groups" (unspecified if ongoing), notes: Allergic to penecillin & eurythromyvin anibiotic groups.; "Contraception" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for influenza immunisation, administration date 06Dec2021; SAYANA PRESS taken for contraception, start date: 21Dec2021 (ongoing). Past drug history included: Penicillin for allergy. Vaccination history included: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 2, single), administration date: Jun2021, for COVID-19 immunisation, reaction(s): "tender breasts", "cramps", "bleeding", "periods resumed", "mood swings". The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HAEMORRHAGE (medically significant), outcome "recovering", described as "bleeding"; DYSMENORRHOEA (non-serious), outcome "recovering", described as "menstrual cramps"; MOOD SWINGS (non-serious), outcome "recovering", described as "mood swings"; INTERMENSTRUAL BLEEDING (non-serious) with onset 01Jan2022, outcome "not recovered", described as "Intermenstrual bleeding". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Nov2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient had booster 2 days ago, currently experiencing menstrual cramps and heavy bleeding (not breakthrough bleeding as would be expected with a newish form of contraception). This also occurred following contraction of Covid-19, 5 days after positive PCR experienced heavy menstrual bleeding whilst on the pill mid-packet. After second Astra-Zeneca jab in Jun2021, periods resumed with all usual symptoms, cramps, bleeding, tender breasts and mood swings despite having a contraceptive implant which was less than 2 years in situ. Had implant removed as was concerned it was not providing contraceptive cover and wanted a form of contraception that prevents period as have successfully used in the past. Patient was not currently breastfeeding. Patient last menstrual period date: 12Nov2021.The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Reaction: Report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033347 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Hyperhidrosis, Lethargy, Malaise, Pain, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000843

Write-up: dizzy; generally unwell; Lethargic; sweating; chills; General body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011251366310-QKZXC. Other Case identifier(s): GB-MHRA-ADR 26424016. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Dec2021 (Lot number: FN5254) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "Arthritis" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication(s) included: NAPROXEN taken for arthritis. The following information was reported: PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "General body pain"; DIZZINESS (medically significant), outcome "unknown", described as "dizzy"; MALAISE (medically significant), outcome "unknown", described as "generally unwell"; LETHARGY (medically significant), outcome "unknown", described as "Lethargic"; HYPERHIDROSIS (medically significant), outcome "unknown", described as "sweating"; CHILLS (medically significant), outcome "unknown", described as "chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033348 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000835

Write-up: Off label use; interchange of vaccine products; Booster; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201011259422420-GGQZI. Other Case identifier: GB-MHRA-ADR 26424012. A 33-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes". The patient underwent the following laboratory test: COVID-19 virus test: (28Dec2021) no - negative covid-19 test. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033352 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000735

Write-up: Painful lump above collar bone; Swollen lymph nodes; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011307465870-QF0UK. Other Case identifier: GB-MHRA-ADR 26424021. A 33 year-old female patient received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; BONE DISORDER (medically significant), outcome "unknown", described as "Painful lump above collar bone". It was reported that the painful lump above collar bone was on same side as vaccine given. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Migraine, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211221; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000795

Write-up: Migraine headache; Feverish; Painful arm; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011348050290-HLXCN. Other Case identifier: GB-MHRA-ADR 26424065. A female patient received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. Patient has not had symptoms associated with COVID-19. The following information was reported: Off label use, interchange of vaccine products and booster, all medically significant with onset 30Dec2021, outcome "unknown"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Migraine headache"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Feverish"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Painful arm". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (21Dec2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000256

Write-up: pins and needles; rash; Injection site lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from . Regulatory number: GB-MHRA-WEBCOVID-202201011559275600-SQZTK. Other Case identifier(s): GB-MHRA-ADR 26424164. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Folic acid; Iron; Contraceptive. The following information was reported: PARAESTHESIA (medically significant), outcome "not recovered", described as "pins and needles"; VACCINATION SITE MASS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Injection site lump"; RASH (medically significant), outcome "unknown", described as "rash". It was reported Covid arm symptoms minus rash, pins and needles in fingers, stitch like paint (as reported). The patient had no symptoms associated with COVID-19, not had a COVID-19 test and not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033395 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Cold sweat, Immunisation, Interchange of vaccine products, Lymphadenopathy, Night sweats, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroidectomy (Full thyroidectomy Aug 2020 On levothyroxine 125mg and lucette)
Allergies:
Diagnostic Lab Data: Test Date: 20211204; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000315

Write-up: night sweats; breast pain; painfully enlarged axillary lymph node ( left - same as injection site ); Enlarged lymph nodes (excl infective); Painful arm; Cold sweat; off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201011752423740-FQATY. Other Case identifier(s): GB-MHRA-ADR 26424277. A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Dec2021 (Lot number: fN3543) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing), notes: Full thyroidectomy Aug 2020 On levothyroxine 125mg and lucette. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; NIGHT SWEATS (medically significant), outcome "not recovered", described as "night sweats"; BREAST PAIN (medically significant), outcome "not recovered", described as "breast pain"; LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "painfully enlarged axillary lymph node ( left - same as injection site )"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Enlarged lymph nodes (excl infective)"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Painful arm"; COLD SWEAT (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Cold sweat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Dec2021) no - negative covid-19 test. Therapeutic measures were not taken as a result of night sweats, breast pain, lymphadenopathy, lymphadenopathy, pain in extremity, cold sweat. Clinical course: Painfully enlarged axillary lymph node (left - same as injection site), left arm pain (as if bursting), left breast pain, severe night sweats (without fever). Lasting a few days after the vaccine was given. No treatment received, no painkillers taken. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033397 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Immunisation, Interchange of vaccine products, Off label use, Peripheral swelling, Pruritus, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOXYCYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear infection; Suspected COVID-19; Vaccination
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000302

Write-up: Swollen arm; Redness; off label use; Interchange of vaccine products; booster; Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011757004650-HN99A. Other Case identifier(s): GB-MHRA-ADR 26424283. A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 15Nov2021, stop date: 27Nov2021; "Ear infection" (unspecified if ongoing); "Vaccination" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE taken for ear infection, start date: 23Dec2021, stop date: 29Dec2021; INFLUENZA VIRUS taken for immunisation, administration date 13Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1), administration date: 24Mar2021, for Vaccination; Covid-19 vaccine astrazeneca (dose 2), administration date: 02Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; PRURITUS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Itching"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm"; ERYTHEMA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Redness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033398 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Hypoaesthesia, Immunisation, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000333

Write-up: Sharp shooting pains behind shin into foot; Numbness; Pain in foot; Pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011816203530-KUDL2. Other Case identifier(s): GB-MHRA-ADR 26424285. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient was not breastfeeding. Patient last menstrual period date was 15Dec2021. Patient not had symptoms associated with COVID-19 Not had a COVID-19 test. Vaccination history included: Bnt162b2 (DOSE NUMBER: 1), for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER: 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pain"; BONE PAIN (medically significant), outcome "unknown", described as "Sharp shooting pains behind shin into foot"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "Numbness"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Pain in foot". Since the vaccination, the patient w not tested positive for COVID-19. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Axillary pain, Chest pain, Decreased appetite, Fatigue, Headache, Immunisation, Musculoskeletal chest pain, Myalgia, Myocarditis, Nausea, Pain in extremity, Palpitations, Pericarditis, Pyrexia, Renal pain, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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 INC202200000376

Write-up: Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); Chest pain; Fever; pericarditis; myocarditis; Fever; Joint ache; Muscle ache; Painful arm; Headache; Armpit pain; Rib pain; Appetite lost; Nausea; Kidney pain; Pancreatic pain; Chest pain; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011931464670-KOY20. Other Case identifier(s): GB-MHRA-ADR 26424329. A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2. primary immunization series completed with BNT162B2.), administration date: 06Aug2021, for COVID-19 Immunization; Bnt162b2 (Dose 1: primary immunization series completed with BNT162B2.), administration date: Jun2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; PYREXIA (medically significant) with onset 31Dec2021, outcome "not recovered", ARTHRALGIA (medically significant) with onset 31Dec2021, outcome "recovered" and all described as "Joint ache"; MYALGIA (medically significant) with onset 31Dec2021, outcome "recovered", described as "Muscle ache"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "recovering", described as "Painful arm"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovered", described as "Headache"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Armpit pain"; MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Rib pain"; DECREASED APPETITE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Appetite lost"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; RENAL PAIN (medically significant) with onset 31Dec2021, outcome "recovering", described as "Kidney pain"; ABDOMINAL PAIN UPPER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pancreatic pain"; CHEST PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chest pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain "; PYREXIA (medically significant), outcome "unknown", described as "Fever"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis". Clinical course: 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. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Symptoms was not led to hospital stay. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000449

Write-up: started off with soreness at injection site; pain in armpit; Swollen lymph nodes; off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201012004293420-O4CN3. Other Case identifier(s): GB-MHRA-ADR 26424343. A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (medically significant), outcome "recovering", described as "started off with soreness at injection site"; AXILLARY PAIN (medically significant), outcome "recovering", described as "pain in armpit"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive, notes: Yes - Positive COVID-19 test. The clinical course was as follows: Started off with soreness at injection site, now pain in armpit which I''m assuming is caused by lymph nodes. It is painful and swollen. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000434

Write-up: Rash; Swelling; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201012004527560-2G7MW. Other Case identifier(s): GB-MHRA-ADR 26424337. A 35-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; RASH (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Rash"; SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swelling". Clinical course- Patient has not tested positive for COVID-19 since having the vaccine. Patient is 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033412 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9994 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac infection, Chest pain, Dyspnoea, Immunisation, Palpitations, SARS-CoV-2 test, Syncope, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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 ; Comments: No - Negative COVID-19 test; Test Name: troponin; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202200000462

Write-up: Chest pain; Shortness of breath; Heart palpitations; Fainting; inflammation of the heart; Booster; Acute chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201012010189950-FI0UR (RA). Other Case identifier(s): GB-MHRA-ADR 26424346 (RA). A 23 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FL9994) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Acute chest pain"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; CARDIAC INFECTION (medically significant), outcome "unknown", described as "inflammation of the heart". Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did nit lead to a hospital stay. The patient was diagnosed with inflammationThe patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test; troponin: normal. No follow-up attempts are possible. No further information is expected. .


VAERS ID: 2033413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Fatigue, Immunisation, Lymphadenopathy, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; OMEPRAZOL; PARACETAMOL; PROPRANOLOL
Current Illness: Anxiety disorder; Cold; GERD
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000496

Write-up: Very swollen under arm and very sore; Very swollen under arm and very sore; Aching joints; Fatigue; Painful arm; Swollen lymph nodes; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201012014240720-HRL6C (RA). Other Case identifier(s): GB-MHRA-ADR 26424360 (RA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination and was not currently breastfeeding. Relevant medical history included: "GERD" (ongoing); "Cold" (ongoing); "Anxiety disorder" (ongoing); "Contraception" (unspecified if ongoing). Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included: CERAZETTE [DESOGESTREL] taken for contraception; OMEPRAZOL taken for gastrooesophageal reflux disease; PARACETAMOL taken for nasopharyngitis; PROPRANOLOL taken for anxiety disorder, start date: 2019. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 13May2021, for COVID-19 immunisation, reaction(s): "Very swollen under arm", "very sore"; Bnt162b2 (DOSE 2), administration date: 16Jul2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of product administration". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Painful arm"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; ARTHRALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Aching joints"; FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Fatigue"; AXILLARY PAIN (medically significant), SWELLING (medically significant), outcome "unknown" and all described as "Very swollen under arm and very sore". Clinical course: Patient was not tested positive for COVID-19 since the vaccination. This report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200017837 same patient, different dose/events;GB-PFIZER INC-202200017838 same patient, different dose/events


VAERS ID: 2033415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000456

Write-up: Swelling of lymph nodes under arm that had the vaccine; Migraine; Swelling; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201012016469610-6Z13I (RA). Other Case identifier(s): GB-MHRA-ADR 26424348 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Migraine"; SWELLING (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swelling"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swelling of lymph nodes under arm that had the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033423 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Fatigue, Headache, Immunisation, Lethargy, Myalgia, Nausea, Night sweats, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: temperature; Result Unstructured Data: Test Result:High temperature; Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000604

Write-up: Appetite lost; Weakness; Fever; Shivers; Tiredness; Booster; High temperature; Night sweat; Nausea; Headache; Lethargy; Fever chills; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201012114244990-BTLHG. Other Case identifier(s): GB-MHRA-ADR 26424401. A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), administration date: 27Jun2021, for covid-19 immunization, reaction(s): "High temperature", "Night sweat", "Nausea", "Headache", "Lethargy", "Fever chills", "Muscle ache", "Appetite lost", "Weakness", "Fever", "Shivers", "Tiredness"; Comirnaty (Dose 02), administration date: 21Aug2021, for covid-19 immunization, reaction(s): "High temperature", "Night sweat", "Nausea", "Headache", "Lethargy", "Fever chills", "Muscle ache", "Appetite lost", "Weakness", "Fever", "Shivers", "Tiredness", "inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "High temperature"; NIGHT SWEATS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Night sweat"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; LETHARGY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Lethargy"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever chills"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle ache"; DECREASED APPETITE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Appetite lost"; ASTHENIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Weakness"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shivers"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: body temperature: (30Dec2021) high temperature; sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Additional information: Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient last menstrual period date was 01Mar2021. All symptoms have happened from each vaccine also though the 3rd dose have been the worst followed by the first then second. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PFIZER INC-202200017295 same drug/patient, different dose/event;GB-PFIZER INC-202200017296 same drug/patient, different dose/event


VAERS ID: 2033432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Exercise lack of, Immunisation, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000271

Write-up: Swollen arm; Painful armpit; worsens with movement so unable to exercise as usual; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201012209392280-QGYJG (RA). Other Case identifier(s): GB-MHRA-ADR 26424441 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 Immunisation; Comirnaty (Dose 2, single), for COVID-19 Immunisation. Patient has not had symptoms associated with COVID-19. It was reported Two days after vaccine woken up with really swollen, puffy painful armpit on vaccine side only, worsens with movement so unable to exercise as usual. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen arm"; AXILLARY PAIN (medically significant) with onset 01Jan2022, outcome "unknown", described as "Painful armpit"; EXERCISE LACK OF (medically significant) with onset 01Jan2022, outcome "unknown", described as "worsens with movement so unable to exercise as usual". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033436 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, Electrocardiogram, Immunisation, Investigation, Menstruation irregular, Night sweats, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ecg; Result Unstructured Data: Test Result:Unknown Results; Test Name: Ecg; Result Unstructured Data: Test Result:Unknown Results; Test Name: hormonal test; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202200000236

Write-up: erratic periods; Indigestion; Night sweat; booster; Palpitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201012223069530-EZJKE (MHRA). Other Case identifier(s): GB-MHRA-ADR 26424454 (MHRA). A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient was healthy. Patient has not had symptoms associated with COVID-19 and 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. The patient''s LMP (last menstrual period) was on 22Dec2021. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation, reaction(s): "Erratic periods", "Heart palpitations"; Bnt162b2 (dose 2, single), for COVID-19 immunisation, reaction(s): "Heart palpitations". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; DYSPEPSIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Indigestion"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Palpitation"; NIGHT SWEATS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Night sweat"; MENSTRUATION IRREGULAR (medically significant), outcome "unknown", described as "erratic periods". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results; unknown results; investigation (hormonal tests): unknown results. Patient had heart palpitations same as previous two vaccines. Patient had erratic periods, previously had very regular with period. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200017439 same patient/reporter/drug, different dose/events;GB-PFIZER INC-202200017438 same patient/reporter/drug, different dose/events


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