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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 126 out of 10,493

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VAERS ID: 2030130 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Abdominal discomfort, Fatigue, Nausea, Pain in extremity, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Feverish; Stomach upset; Pain in arm; Rash; Fatigue; 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 NAUSEA (Nausea), PYREXIA (Feverish), ABDOMINAL DISCOMFORT (Stomach upset), PAIN IN EXTREMITY (Pain in arm), RASH (Rash) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No medical history was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Mar-2021 to an unknown date for COVID-19. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach upset) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), PYREXIA (Feverish), ABDOMINAL DISCOMFORT (Stomach upset), PAIN IN EXTREMITY (Pain in arm), RASH (Rash) and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. No treatment details were added. Patient had not tested positive for COVID-19 since vaccination. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 65-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, PYREXIA, ABDOMINAL DISCOMFORT, PAIN IN EXTREMITY, RASH and FATIGUE. The event of nausea occurred on the same day after receiving a third dose of mRNA-1273. No onset date was provided for other events. All events were resolving at the time of the report. Previous vaccination schedule included at least one does of AstraZeneca COVID 19 vaccine. 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 65-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, PYREXIA, ABDOMINAL DISCOMFORT, PAIN IN EXTREMITY, RASH and FATIGUE. The event of nausea occurred on the same day after receiving a third dose of mRNA-1273. No onset date was provided for other events. All events were resolving at the time of the report. Previous vaccination schedule included at least one does of AstraZeneca COVID 19 vaccine. 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: 2030139 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; 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: Tachycardia; Fever; Sore throat; Headache; Ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26421724) 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 TACHYCARDIA (Tachycardia), PYREXIA (Fever), HEADACHE (Headache), PAIN (Ache) and OROPHARYNGEAL PAIN (Sore throat) in a 25-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 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) and PAIN (Ache) was resolving, HEADACHE (Headache) had resolved with sequelae and OROPHARYNGEAL PAIN (Sore throat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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 were not reported. No treatment information was provided by the reporter. Patient had no medical history. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not breastfeeding Patient had body ache and headache from the next day. Patient had tachycardia (140 resting rate from 12h after getting the vaccine, lasted 24hours) and fever (39 degrees initially, down to 38 after 12 hours). Patient''s ECG and blood work all normal. Slowly resolving after 36 hours. Remaining patient''s headache and body ache after 36 hours. Patient not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial. Patient had ECG, blood work and chest X-rays, results not provided. Company comment: This is a regulatory case concerning a 25 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Oropharyngeal pain, pain, tachycardia, headache and pyrexia. The event occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event oropharyngeal pain was reported as not resolved; the events pain and tachycardia as resolving and headache as resolved with sequelae. 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 25 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Oropharyngeal pain, pain, tachycardia, headache and pyrexia. The event occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event oropharyngeal pain was reported as not resolved; the events pain and tachycardia as resolving and headache as resolved with sequelae. 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: 2030141 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
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: Fever; Ache; This case was received via RA (Reference number: GB-MHRA-ADR 26421783) 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 PAIN (Ache) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 10-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and PAIN (Ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient experienced severe fever of 38.5?C during the night and arm ache started straight away at injection site. No treatment information was provided. No medical history was provided by the reporter. 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. Company comment: This is a regulatory case concerning a 27 year-old, male patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 3 months prior), who experienced the serious (due to medically important condition) unexpected, according RA, events of pain and pyrexia. Events were assessed as serious by the Regulatory Authority. The event pain occurred the same day after the booster dose of mRNA-1273 vaccine and the event pyrexia 1 day after. The outcome of the events was reported as recovering. 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 27 year-old, male patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 3 months prior), who experienced the serious (due to medically important condition) unexpected, according RA, events of pain and pyrexia. Events were assessed as serious by the Regulatory Authority. The event pain occurred the same day after the booster dose of mRNA-1273 vaccine and the event pyrexia 1 day after. The outcome of the events was reported as recovering. 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: 2030144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Chills, Dehydration, Ear pain, Emotional disorder, Fatigue, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: PFIZER BIONTECH COVID-19 VACCINE
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: Earache; Dehydration; Knee pain; Chills; General body pain; Emotional reaction; Tiredness; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26421910) 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 CHILLS (Chills), PAIN (General body pain), EMOTIONAL DISORDER (Emotional reaction), FATIGUE (Tiredness), PAIN IN EXTREMITY (Painful arm), EAR PAIN (Earache), DEHYDRATION (Dehydration) and ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 15-May-2021 to 14-Jul-2021 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 29-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), EMOTIONAL DISORDER (Emotional reaction) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), DEHYDRATION (Dehydration) (seriousness criterion medically significant) and ARTHRALGIA (Knee pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant). On 30-Dec-2021, EMOTIONAL DISORDER (Emotional reaction) had resolved. On 31-Dec-2021, CHILLS (Chills) and EAR PAIN (Earache) had resolved. At the time of the report, PAIN (General body pain) and DEHYDRATION (Dehydration) was resolving and FATIGUE (Tiredness), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Knee pain) 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 treatment information was provided. It was not expecting reactions as did not get any from the Pfizer vaccine, but they came on quick and strong. If she had been on annual leave, she would have had to take sick leave as could not move much. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial No possible inflammation of the heart (myocarditis or pericarditis). Company comment: This RA case concerns a female patient of unknown age with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 15-May-2021 to 14-Jul-2021, before current vaccination), who experienced the unexpected serious events of Chills, Pain, Emotional disorder, Fatigue, Pain in extremity, Ear pain, Dehydration and Arthralgia which occurred on same day after the third dose of mRNA-1273 vaccine except Ear pain which occurred one day later to vaccination. The outcome was reported not resolved for Arthralgia, Pain in extremity and Fatigue and was resolving for Pain and Dehydration. The benefit-risk relationship of the 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 RA case concerns a female patient of unknown age with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 15-May-2021 to 14-Jul-2021, before current vaccination), who experienced the unexpected serious events of Chills, Pain, Emotional disorder, Fatigue, Pain in extremity, Ear pain, Dehydration and Arthralgia which occurred on same day after the third dose of mRNA-1273 vaccine except Ear pain which occurred one day later to vaccination. The outcome was reported not resolved for Arthralgia, Pain in extremity and Fatigue and was resolving for Pain and Dehydration. The benefit-risk relationship of the 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 and disability.


VAERS ID: 2030156 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   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: Chest X-ray, Chest pain, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, 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), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Test Result: Inconclusive ; Result Unstructured Data: Result not provided; Test Name: ECG; Test Result: Inconclusive ; Result Unstructured Data: Result not provided; Test Name: Cardiac MRI; Test Result: Inconclusive ; Result Unstructured Data: Result not provided; 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: Chest Pain; Fever; Myocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26422243) 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 CHEST PAIN (Chest Pain), PYREXIA (Fever) and MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest Pain) and PYREXIA (Fever) outcome was unknown and MYOCARDITIS (Myocarditis) was resolving. 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. On an unknown date, Chest X-ray: inconclusive (Inconclusive) Result not provided. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Result not provided. On an unknown date, Magnetic resonance imaging heart: inconclusive (Inconclusive) Result not provided. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medication provided. On the day 1 post vaccination patient had fever and on day 2 patient had chest and arm pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report of the patient related to possible myocarditis or pericarditis. The patient was admitted to hospital and was hospitalized for 3 days. The patient was seen by a cardiologist and was diagnosed with Myo-pericarditis. Patient was treated initially with NSAID which however caused him to vomit and so had been started on colchicine. On 30-Dc-2021, the cardiac troponin was raised above the peak level 8650 ng/L. ECG was carried out on an unknown date and the result include widespread concave ST changes in keeping with pericarditis. Company comment: This regulatory authority case concerns a 24-year-old male patient with no relevant medical history who experienced serious unexpected events of chest pain, pyrexia and serious expected AESI of myocarditis, that occurred approximately 2 days 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 24-year-old male patient with no relevant medical history who experienced serious unexpected events of chest pain, pyrexia and serious expected AESI of myocarditis, that occurred approximately 2 days 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: 2030171 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-12-29
   Days after vaccination:200
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: Fatigue, Headache, Q fever, SARS-CoV-2 test
SMQs:, 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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: headache; tiredness; Q-fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26422992) 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), FATIGUE (tiredness) and Q FEVER (Q-fever) in a 54-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 20-Sep-2021 to 25-Sep-2021. On 12-Jun-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced Q FEVER (Q-fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and FATIGUE (tiredness) (seriousness criterion medically significant). On 31-Dec-2021, Q FEVER (Q-fever) was resolving. At the time of the report, HEADACHE (headache) and FATIGUE (tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date reported 01-JAN-2017. Reported that Headache, tiredness, no appetite fever Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Patient is not currently breastfeeding. No concomitant medications were reported. No treatment medications were reported. Company comment This case concerns a 54-year-old female patient, with no reported medical history, who experienced the unexpected serious events of HEADACHE, FATIGUE and Q FEVER. The events occurred approximately 6 months 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 54-year-old female patient, with no reported medical history, who experienced the unexpected serious events of HEADACHE, FATIGUE and Q FEVER. The events occurred approximately 6 months 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: 2030172 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Headache, Renal pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201228; 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: kidney pain; Pain kidney; Diarrhea; Stomach ache; Headache; Light-headed; Tiredness; 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 RENAL PAIN (kidney pain), RENAL PAIN (Pain kidney), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache), DIZZINESS (Light-headed) and FATIGUE (Tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 23-Dec-2020. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RENAL PAIN (Pain kidney) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced RENAL PAIN (kidney pain) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (kidney pain), RENAL PAIN (Pain kidney), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) had not resolved and HEADACHE (Headache), DIZZINESS (Light-headed) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not currently breastfeeding. Stomach started 8 hours after vaccine, followed by diarrhea after 12 hours. Felt very lightheaded and had a constant headache for 3 days. Very tired. The diarrhea is very watery, and patient have not been keeping food and water down. Kidney pain started about 24 hours after vaccine Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Patient relevant investigations or tests conducted were reported as Urine test for a kidney infection, result negative. No treatment medications were reported. Company Comment: This case concerns a 49-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Renal pain, Diarrhoea, Abdominal pain upper, Headache, Dizziness and Fatigue. The events occurred on the day after third 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.; Sender''s Comments: This case concerns a 49-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Renal pain, Diarrhoea, Abdominal pain upper, Headache, Dizziness and Fatigue. The events occurred on the day after third 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: 2030179 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Dizziness, Headache, Hypoaesthesia, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Nausea; Numbness; Headache; Dizziness; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26423182) 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 DIZZINESS (Dizziness), NAUSEA (Nausea), HYPOAESTHESIA (Numbness) and HEADACHE (Headache) in a 52-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) (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 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea) and HYPOAESTHESIA (Numbness) had not resolved and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date was reported as 12-Jun-2021. Patient experienced redness on arm and hot and there was a lump below vaccination site. Patient had 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 case concerns a 52-year-old, female patient with no medical history reported, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of dizziness, nausea, hypoesthesia and headache. The event of dizziness occurred approximately 1 day after the third dose of mRNA-1273, while the rest of the events occurred on unknown date. As reported, patient''s arm was red and hot and there was a lump well below vaccination site. 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 52-year-old, female patient with no medical history reported, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of dizziness, nausea, hypoesthesia and headache. The event of dizziness occurred approximately 1 day after the third dose of mRNA-1273, while the rest of the events occurred on unknown date. As reported, patient''s arm was red and hot and there was a lump well below vaccination site. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
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: Arthralgia, Body temperature increased, Fatigue, Headache, Injection site pain, Pyrexia, Respiration abnormal, Respiratory rate increased, SARS-CoV-2 test, Tension headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Respiratory failure (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 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: breathing changes; high temperature; tiredness; headache; Aching joints; Breathing rate increased; Tired all the time; Tension headaches; Temperature elevation; Pain injection site; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423771) 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 RESPIRATION ABNORMAL (breathing changes), PYREXIA (high temperature), FATIGUE (tiredness), TENSION HEADACHE (Tension headaches), BODY TEMPERATURE INCREASED (Temperature elevation), ARTHRALGIA (Aching joints), HEADACHE (headache), FATIGUE (Tired all the time), INJECTION SITE PAIN (Pain injection site) and RESPIRATORY RATE INCREASED (Breathing rate increased) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Previously administered products included for Product used for unknown indication: Lansoprozale (30mg daily) since an unknown date. Past adverse reactions to the above products included No adverse reaction with Lansoprozale. On an unknown date, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criteria disability and medically significant). On 29-Dec-2021, the patient experienced TENSION HEADACHE (Tension headaches) (seriousness criteria disability and medically significant), BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criteria disability and medically significant), FATIGUE (Tired all the time) (seriousness criteria disability and medically significant) and RESPIRATORY RATE INCREASED (Breathing rate increased) (seriousness criteria disability and medically significant). On 01-Jan-2022, the patient experienced ARTHRALGIA (Aching joints) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced RESPIRATION ABNORMAL (breathing changes) (seriousness criteria disability and medically significant), PYREXIA (high temperature) (seriousness criteria disability and medically significant), FATIGUE (tiredness) (seriousness criteria disability and medically significant) and HEADACHE (headache) (seriousness criteria disability and medically significant). On 01-Jan-2022, TENSION HEADACHE (Tension headaches) and BODY TEMPERATURE INCREASED (Temperature elevation) was resolving. At the time of the report, RESPIRATION ABNORMAL (breathing changes), PYREXIA (high temperature), FATIGUE (tiredness), HEADACHE (headache) and RESPIRATORY RATE INCREASED (Breathing rate increased) was resolving and ARTHRALGIA (Aching joints), FATIGUE (Tired all the time) and INJECTION SITE PAIN (Pain injection site) 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 product use was not provided by the reporter. She had not symptoms associated with COVID-19. Patient experience high temperature for over 70 hours with a constant headache. Breathing changed. Tiredness, her whole-body aching, arm was still sore at injection site (72 hours after booster). She had not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. It was reported that, report was not related to possible inflammation of the heart (myocarditis or pericarditis). No treatment drugs were reported. Company comment:This RA case concerns a female patient of unknown age with no medical history, who experienced the unexpected serious events of Respiration abnormal, Fatigue(tiredness), Pyrexia (High temperature), Tension headache, Body temperature increased, Fatigue, (tired all the time), Arthralgia, Respiratory rate increased, and Injection site pain (Medically significant) which occurred on unknown date after the third dose of mRNA-1273 vaccine received on unknown date. The outcome was reported not resolved for Arthralgia, Fatigue (tired all the time) and Injection site pain and Respiration abnormal and was resolving for Pyrexia (high temperature), headache (headache), Fatigue (tiredness) and Respiratory rate increased. The benefit-risk relationship of the 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 RA case concerns a female patient of unknown age with no medical history, who experienced the unexpected serious events of Respiration abnormal, Fatigue(tiredness), Pyrexia (High temperature), Tension headache, Body temperature increased, Fatigue, (tired all the time), Arthralgia, Respiratory rate increased, and Injection site pain (Medically significant) which occurred on unknown date after the third dose of mRNA-1273 vaccine received on unknown date. The outcome was reported not resolved for Arthralgia, Fatigue (tired all the time) and Injection site pain and Respiration abnormal and was resolving for Pyrexia (high temperature), headache (headache), Fatigue (tiredness) and Respiratory rate increased. The benefit-risk relationship of the 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: 2030213 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Abdominal pain upper, Diarrhoea, Nausea, Pain, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: diarrhea; fever; pain; Stomachache; High temperature; Nausea; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26423966) 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 DIARRHOEA (diarrhea), PYREXIA (fever), PAIN (pain), ABDOMINAL PAIN UPPER (Stomachache), PYREXIA (High temperature) and NAUSEA (Nausea) in a 41-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) (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to 22-May-2021 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 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). On 30-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion disability). On 31-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion disability). On an unknown date, the patient experienced DIARRHOEA (diarrhea) (seriousness criterion disability), PYREXIA (fever) (seriousness criterion disability) and PAIN (pain) (seriousness criterion disability). On 01-Jan-2022, NAUSEA (Nausea) was resolving. At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), PAIN (pain) and ABDOMINAL PAIN UPPER (Stomachache) had not resolved and PYREXIA (High temperature) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Medical History information was reported. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and not breastfeeding. Patient last menstrual period date was 19-DEC-2021. Patient had pain at the immediate site, then it travelled to the chest and back between the shoulders. The patient felt like the body was battered and bruised with in 24hrs. Then the temperature shot up, had fever and excruciating tummy ache like the patient had sever tummy inflammation. The patient felt light headed and suffered with diarrhoea. Patient had 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 case concerns a 41-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of nausea, pyrexia(two events), abdominal pain upper, diarrhoea and pain, which met seriousness criteria of disability per Regulatory authority. The events occurred on the same day or up to 2 days after the third dose of mRNA-1273. As reported, patient had pain at the immediate site, then it travelled to the chest and back between the shoulders. The patient felt like the body was battered and bruised with in 24hrs. Then the temperature shot up, had fever and excruciating tummy ache like the patient had sever tummy inflammation, as reported. The patient felt light headed and suffered with diarrhoea. 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 41-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of nausea, pyrexia(two events), abdominal pain upper, diarrhoea and pain, which met seriousness criteria of disability per Regulatory authority. The events occurred on the same day or up to 2 days after the third dose of mRNA-1273. As reported, patient had pain at the immediate site, then it travelled to the chest and back between the shoulders. The patient felt like the body was battered and bruised with in 24hrs. Then the temperature shot up, had fever and excruciating tummy ache like the patient had sever tummy inflammation, as reported. The patient felt light headed and suffered with diarrhoea. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030220 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

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

Write-up: Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423983) 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 DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug information provided. No treatment drug information provided. Patient experienced severe dizziness and was unable to do daily activities. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient''s last menstrual cycle was on 30-DEC-2021. Company comment: This case concerns a 37-year-old, female patient with no medical history reported, who experienced the unexpected event of dizziness. The event occurred approximately 1 day after the third dose of mRNA-1273. As reported the patient experienced severe dizziness unable to do daily activities. 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 37-year-old, female patient with no medical history reported, who experienced the unexpected event of dizziness. The event occurred approximately 1 day after the third dose of mRNA-1273. As reported the patient experienced severe dizziness unable to do daily activities. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030221 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Instillation site warmth, Limb discomfort, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: Patient is not pregnant,Patient is not currently breastfeeding
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: Instillation site warm feeling; Fever; Headache; Arm discomfort; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423989) 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), HEADACHE (Headache), INSTILLATION SITE WARMTH (Instillation site warm feeling) and LIMB DISCOMFORT (Arm discomfort) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 28-Mar-2020. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced INSTILLATION SITE WARMTH (Instillation site warm feeling) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, INSTILLATION SITE WARMTH (Instillation site warm feeling) and LIMB DISCOMFORT (Arm discomfort) 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 received booster at 12 pm, fever onset around 12 hours later, had headache and fever continues throughout the next day/evening/night. Around 48 hours after booster shot fever headache relents. The patient had hot red patch on arm under to the right of injection site stays inflamed. The patient was hot to touch and sore and was ongoing. 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. Patient was not pregnant, and was not currently breastfeeding. Re-challenge was reported as unknown. Company comment: This Regulatory Authority case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of pyrexia, headache, Instillation site warmth and limb discomfort. The patient developed limb discomfort on the same day she received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with fever around 12 hours later and headache throughout the next day. Complicated with a hot, red patch on her arm under to the right of injection site, hot to touch and sore. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of pyrexia, headache, Instillation site warmth and limb discomfort. The patient developed limb discomfort on the same day she received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with fever around 12 hours later and headache throughout the next day. Complicated with a hot, red patch on her arm under to the right of injection site, hot to touch and sore. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2030227 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-12-29
   Days after vaccination:260
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH AA1234 / 2 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypersensitivity, Lymph node pain, Lymphadenopathy, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 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: exhaustion; allergic reaction; Rash; Lymph node pain; Swollen lymph nodes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424089) 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 FATIGUE (exhaustion), HYPERSENSITIVITY (allergic reaction), LYMPHADENOPATHY (Swollen lymph nodes), RASH (Rash) and LYMPH NODE PAIN (Lymph node pain) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (exhaustion) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). On 01-Jan-2022, LYMPH NODE PAIN (Lymph node pain) had resolved. At the time of the report, FATIGUE (exhaustion) and HYPERSENSITIVITY (allergic reaction) had not resolved and LYMPHADENOPATHY (Swollen lymph nodes) and RASH (Rash) 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. Day 1: 29-Dec-2021: Patient had swelling under left arm (injection arm), slight ache in left arm and swelling under armpit, slight exhaustion. Patient went on a walk and had to head back since he was getting out of breath. Day 2: Further swelling under left arm, as well as under right arm, high intensity ache in left arm, and pain under armpit. Extreme exhaustion, stayed in bed. In the evening he noticed high-intensity, localised rashes on: inner upper arms, torso sides, beneath armpits, genotalia area and neck. Patient took 10mg of cetirizine hydrochloride before going to bed, since it looked like an allergic reaction. Day 3: Energy levels almost back to normal. Armpit pain almost gone, swelling still present. Rash was less dense, but far more spread-out over the whole body, including slight swelling in the face and eyelids. Rashes seemed to systematically spread from its origin points from the previous day. By the evening it was most prevalent in hands and thighs, with it having mostly cleared in other locations. Patient took another 10mg of cetirizine hydrochloride in the morning. The GP confirmed there was nothing dangerous. Day 5: 1-Jan-2022 Everything normal. Only slight visual reddening in hands. Company comment: This is a regulatory case concerning a 28-year-old, male patient with no medical history reported who experienced the unexpected serious events of Fatigue, Hypersensitivity, Lymphadenopathy, Rash and Lymph node pain. The events of Lymphadenopathy and Lymph node pain occurred one day and the event of Rash two days after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose), while the onset date of events Fatigue and Hypersensitivity was not reported. As reported, the patient''s GP confirmed there was nothing dangerous. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 28-year-old, male patient with no medical history reported who experienced the unexpected serious events of Fatigue, Hypersensitivity, Lymphadenopathy, Rash and Lymph node pain. The events of Lymphadenopathy and Lymph node pain occurred one day and the event of Rash two days after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose), while the onset date of events Fatigue and Hypersensitivity was not reported. As reported, the patient''s GP confirmed there was nothing dangerous. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030238 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Body temperature increased, Dyspnoea, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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 Date: 20211129; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: palpitations; Difficulty breathing; Palpitations aggravated; Fever; Temperature elevation; 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 PALPITATIONS (palpitations), DYSPNOEA (Difficulty breathing), PALPITATIONS (Palpitations aggravated), PYREXIA (Fever) and BODY TEMPERATURE INCREASED (Temperature elevation) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014a) 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 29-Dec-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion disability), PALPITATIONS (Palpitations aggravated) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability) and BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion disability). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion disability). On 31-Dec-2021, PYREXIA (Fever) and BODY TEMPERATURE INCREASED (Temperature elevation) had resolved. At the time of the report, PALPITATIONS (palpitations) was resolving and DYSPNOEA (Difficulty breathing) and PALPITATIONS (Palpitations aggravated) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment for the events included paracetamol for fever and antihistamine for breathing problems throughout each day. Patient experienced flu in first night with fever and temperature, difficulty breathing and getting a full breath as well as heart palpitations or noticeable random strong heartbeats. Company comment: This regulatory authority case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected serious (disability) events of Palpitations (reported as palpitations and palpitations aggravated), Dyspnoea, Pyrexia and Body temperature increased after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Very limited information was provided regarding this events. Pyrexia and Body temperature increased may be in connection with Palpitations. However, these events resolved after 2 days while palpitations and dyspnoea were ongoing. Medical consultation was not performed. Pyrexia and Body temperature increased are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of Disability was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial; Sender''s Comments: This regulatory authority case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected serious (disability) events of Palpitations (reported as palpitations and palpitations aggravated), Dyspnoea, Pyrexia and Body temperature increased after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Very limited information was provided regarding this events. Pyrexia and Body temperature increased may be in connection with Palpitations. However, these events resolved after 2 days while palpitations and dyspnoea were ongoing. Medical consultation was not performed. Pyrexia and Body temperature increased are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of Disability was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030250 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 3543 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202200000319

Write-up: Vomiting; Nosebleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202201011806284320-XUMWL. Other Case identifier(s): GB-MHRA-ADR 26424278. A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: 3543) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 10Jul2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The following information was reported: EPISTAXIS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Nosebleed"; VOMITING (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Vomiting". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Reaction does not relate to possible inflammation of the heart (myocarditis or pericarditis) No follow-up attempts are needed. No further information is expected.


VAERS ID: 2030272 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 discomfort, Chills, Fatigue, Hyperhidrosis, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 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: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: shivering; sweating; Migraine; Fever; Tight chest; Shivers; Tiredness; This case was received via RA (Reference number: GB-MHRA-ADR 26424423) 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 CHILLS (shivering), HYPERHIDROSIS (sweating), MIGRAINE (Migraine), PYREXIA (Fever), CHEST DISCOMFORT (Tight chest), CHILLS (Shivers) and FATIGUE (Tiredness) in a 24-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 from 29-Dec-2021 to 01-Jan-2022. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Apr-2021 to an unknown date 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 29-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering) and HYPERHIDROSIS (sweating) had not resolved, MIGRAINE (Migraine), PYREXIA (Fever), CHEST DISCOMFORT (Tight chest) and CHILLS (Shivers) had resolved and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-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 her initial vaccine the patient had similar side effects, her second had none and for her booster dose she had sever flu like side effects, sweating/shivering/migraine/tired/loss of appetite/sick feeling and achy Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No treatment information was reported. Patient last menstrual period date was 29-DEC-2021 Patient is not pregnant,Patient is not currently breastfeeding Company comment: This Regulatory Authority case concerns a 24-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of chills (reported as "shivering" and "shivers"), hyperhidrosis, migraine, pyrexia, chest discomfort and fatigue. The patient developed severe flu like side effects, like sweating, shivering, migraine, tiredness, loss of appetite, sick feeling and ache on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. The patient received as first and second dose of her COVID-19 vaccination schedule two doses AstraZeneca''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. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 24-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of chills (reported as "shivering" and "shivers"), hyperhidrosis, migraine, pyrexia, chest discomfort and fatigue. The patient developed severe flu like side effects, like sweating, shivering, migraine, tiredness, loss of appetite, sick feeling and ache on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. The patient received as first and second dose of her COVID-19 vaccination schedule two doses AstraZeneca''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. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2030273 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Headache, Mouth swelling, Pyrexia, SARS-CoV-2 test, Swollen tongue, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: swollen tongue; wheezy; headache; Swollen mouth; Chest aching; High temperature; Frontal headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424427) 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 SWOLLEN TONGUE (swollen tongue), WHEEZING (wheezy), HEADACHE (headache), HEADACHE (Frontal headache), MOUTH SWELLING (Swollen mouth), CHEST PAIN (Chest aching) and PYREXIA (High temperature) 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 29-Dec-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced CHEST PAIN (Chest aching) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced MOUTH SWELLING (Swollen mouth) (seriousness criterion medically significant). On an unknown date, the patient experienced SWOLLEN TONGUE (swollen tongue) (seriousness criterion medically significant), WHEEZING (wheezy) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, SWOLLEN TONGUE (swollen tongue), WHEEZING (wheezy), HEADACHE (headache) and HEADACHE (Frontal headache) had not resolved, MOUTH SWELLING (Swollen mouth) was resolving and CHEST PAIN (Chest aching) and PYREXIA (High temperature) had 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. Patient was not pregnant, Patient was not currently breastfeeding. Patient last menstrual period date was 21-Dec-2021. Concomitant product use was not provided by the reporter. Patient had headache within 2 hours of booster, high temperature, swollen tongue, chest aching and felt wheezy. Only symptom remaining was headache when moving and swollen tongue . 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 43-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Swollen tongue, Wheezing, Headache, Mouth swelling, Chest pain and Pyrexia. The events occurred on the same day and on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). No treatment information was provided. 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.; Sender''s Comments: This case concerns a 43-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Swollen tongue, Wheezing, Headache, Mouth swelling, Chest pain and Pyrexia. The events occurred on the same day and on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). No treatment information was provided. 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: 2030289 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Blister, Breast swelling, Headache, Heart rate, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Blister; Swollen lymph nodes; Headache; Breast swelling; Heart rate; High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424528) 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 LYMPHADENOPATHY (Swollen lymph nodes), HEART RATE (Heart rate), BLISTER (Blister), PYREXIA (High temperature), HEADACHE (Headache) and BREAST SWELLING (Breast swelling) in a 49-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 29-Dec-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and BREAST SWELLING (Breast swelling) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced BLISTER (Blister) (seriousness criterion medically significant). On 01-Jan-2022, HEART RATE (Heart rate) was resolving. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and BLISTER (Blister) had not resolved, PYREXIA (High temperature) had resolved and HEADACHE (Headache) and BREAST SWELLING (Breast swelling) 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. Patient received jab at 9:30am on 29-Dec-2021, during the evening got severe headache and high temperature lasted until morning of 31/12/2021,still had mild headache on 1/1/2022, armpit was very swollen and side of breast , red patch on arm at site of injection which was blistered and filled with fluid. Had no issues with last 2 jabs but will never have Moderna again. Because the patient felt like was dying. Will never accept a Moderna jab again . Never had any health issues in patent''s whole life for active runner and felt like disabled. Patient was not enrolled in clinical trial. Patient asked why the arm blistered and full of water, this was not acceptable for an injection, patient didn''t felt on administering at the pharmacy. A follow up was requested No concomitant medications reported No treatment medications provided Date of LMP: 10-DEC-2021 Company Comment: This is a regulatory case concerning a 49-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Lymphadenopathy, Heart rate, Blister, Pyrexia, Headache and Breast swelling. The events Heart rate and Pyrexia occurred on the same day, the events Headache and Breast swelling occurred 1 day after, swollen lymph nodes occurred 2days after and Blister occurred 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 49-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Lymphadenopathy, Heart rate, Blister, Pyrexia, Headache and Breast swelling. The events Heart rate and Pyrexia occurred on the same day, the events Headache and Breast swelling occurred 1 day after, swollen lymph nodes occurred 2days after and Blister occurred 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to important medical condition.


VAERS ID: 2030293 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Insomnia, 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: Insomnia; This case was received via RA (Reference number: GB-MHRA-ADR 26424560) 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 INSOMNIA (Insomnia) in a 30-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 29-Dec-2021, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Insomnia) 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 is not currently breastfeeding. Concomitant medications were not provided. Treatment medication was not provided Patient experienced Insomnia - trouble sleeping. Also happened after second dose of Pfizer injection Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This Regulatory Authority case concerns a 30-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Insomnia. The patient developed insomnia on the same day she received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that she previously received as her second dose of her COVID-19 vaccination schedule a dose of Pfizer''s Biontech''s COVID-19 vaccine, and she experienced the same event after that dose. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 30-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Insomnia. The patient developed insomnia on the same day she received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that she previously received as her second dose of her COVID-19 vaccination schedule a dose of Pfizer''s Biontech''s COVID-19 vaccine, and she experienced the same event after that dose. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2030307 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Stiff neck; Headache; Aching joints; Tiredness; Painful arm; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26424723) 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 MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), ARTHRALGIA (Aching joints) and FATIGUE (Tiredness) in a 47-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) (COVID-19 VACCINE ASTRAZENECA) from 08-May-2021 to 03-Jul-2021 for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) had resolved. On 02-Jan-2022, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved, ARTHRALGIA (Aching joints) was resolving. At the time of the report, HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had taken paracetamol and rested which has helped resolve most of the reactions, however the headache although mild seems to have moved from the back of the head to top right hand side, if patient lean forward get a sharp pain. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment - This regulatory authority case concerns a 47 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of musculoskeletal stiffness, pain in extremity, headache, arthralgia and fatigue.The events occurred on the same day after the third dose of mRNA-1273 vaccine, except musculoskeletal stiffness which occurred 2 days after. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 47 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of musculoskeletal stiffness, pain in extremity, headache, arthralgia and fatigue.The events occurred on the same day after the third dose of mRNA-1273 vaccine, except musculoskeletal stiffness which occurred 2 days after. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030311 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2021-12-29
   Days after vaccination:376
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: Pruritus, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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: Medical History/Concurrent Conditions: Clinical trial participant
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: itching; Hives; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424749) 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 PRURITUS (itching) and URTICARIA (Hives) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 18-Dec-2020, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion medically significant). At the time of the report, PRURITUS (itching) was resolving and URTICARIA (Hives) 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. Patient not had symptoms associated with COVID-19. Concomitant product use was not provided by the reporter. Re-occurring uticaria suspected pressure trigger for breakouts. Limited responsiveness to antihistamines (over the counter and prescription). Symptoms may reduce for a few hours but will then flare up again. Emollient and steroid cream reduce the stinging/itching feeling on affected areas. Next flare ups often in different areas. Patient had now been prescribed pregnisolone as well so far with no effect. Patient had not tested positive for COVID-19 since having the vaccine. Patient was clinical trial participant. Company Comment: This case concerns a 33 year-old male patient with a history of clinical trial participation who experienced the unexpected serious events of urticaria which occurred (reportedly) 1 year 12 days after the third dose of mRNA-1273 vaccine and the unexpected serious event of pruritis which occurred on an unknown date relative to vaccination. The medical history of clinical trial participation remains a confounder for the events. 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 33 year-old male patient with a history of clinical trial participation who experienced the unexpected serious events of urticaria which occurred (reportedly) 1 year 12 days after the third dose of mRNA-1273 vaccine and the unexpected serious event of pruritis which occurred on an unknown date relative to vaccination. The medical history of clinical trial participation remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030321 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00002A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, Illness, Influenza like illness, Pyrexia, SARS-CoV-2 test, Tremor, Urinary incontinence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: shaking; i even lost control over my bladder; Sickness; Flu like symptoms; High temperature; Hallucination; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424799) 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 HALLUCINATION (Hallucination), TREMOR (shaking), URINARY INCONTINENCE (i even lost control over my bladder), ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (High temperature) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 00002A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 30-Aug-2021. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant) and URINARY INCONTINENCE (i even lost control over my bladder) (seriousness criterion medically significant). On 30-Dec-2021, HALLUCINATION (Hallucination), ILLNESS (Sickness) and PYREXIA (High temperature) had resolved. On 31-Dec-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, TREMOR (shaking) and URINARY INCONTINENCE (i even lost control over my bladder) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Dosage text :Dose 3b Patient had never felt so ill. Patient even lost control over her bladder, She did not know what she was doing. Patient could not stop shaking and was freezing cold even though she had a temperature. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. This is a regulatory case concerning a 56-year-old female patient with relevant medical history of suspected COVID-19, who experienced the serious per reported severity unexpected events of hallucination, tremor, urinary incontinence, illness, influenza like illness and pyrexia. The events of hallucination, illness, influenza like illness and pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine administration and the events of tremor, urinary incontinence occurred on unknown day. 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 event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 56-year-old female patient with relevant medical history of suspected COVID-19, who experienced the serious per reported severity unexpected events of hallucination, tremor, urinary incontinence, illness, influenza like illness and pyrexia. The events of hallucination, illness, influenza like illness and pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine administration and the events of tremor, urinary incontinence occurred on unknown day. 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 event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030322 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: Arthralgia, Asthenia, Fatigue, Muscular weakness, Myalgia, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211220; 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: Weakness; Nausea; Tremor; Shoulder pain; Tremor muscle; Muscular weakness; Fatigue; Localised muscle pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424798) 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 ASTHENIA (Weakness), NAUSEA (Nausea), TREMOR (Tremor), ARTHRALGIA (Shoulder pain), TREMOR (Tremor muscle), MYALGIA (Localised muscle pain), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Localised muscle pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced TREMOR (Tremor muscle) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), TREMOR (Tremor) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 31-Dec-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ASTHENIA (Weakness), NAUSEA (Nausea), TREMOR (Tremor), ARTHRALGIA (Shoulder pain), TREMOR (Tremor muscle), MYALGIA (Localised muscle pain) and MUSCULAR WEAKNESS (Muscular weakness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-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 experienced fatigue and nausea just day after he received the booster. The patient had arm pain at site of injection and arm pit with reduced mobility from day 2 through day 4. On day 5 patient had tiredness and shoulder pain, weakness, and reduced mobility. On day 6 had ongoing continuous pain like shoulder muscles are fully flexed. He experienced muscle tremor every time any load is applied to arm for daily tasks and still ongoing.Patient was not tested positive for COVID-19 since vaccination. Patient was not enrolled in clinical trials. No concomitant medications were reported. No treatment information was reported. Company Comment: This case concerns a 46-year-old male patient, with no medical history reported, who experienced the unexpected and serious events of Asthenia, Tremor, Arthralgia, Myalgia, Nausea, Muscular weakness, and Fatigue. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred within the first day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in the . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 46-year-old male patient, with no medical history reported, who experienced the unexpected and serious events of Asthenia, Tremor, Arthralgia, Myalgia, Nausea, Muscular weakness, and Fatigue. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred within the first day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in the . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030327 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: Heavy menstrual bleeding, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heavy periods; Menstrual cycle shortened; This case was received via RA (Reference number: GB-MHRA-ADR 26424846) 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 (Heavy periods) and POLYMENORRHOEA (Menstrual cycle shortened) in a 27-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) 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 29-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant) and POLYMENORRHOEA (Menstrual cycle shortened) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy periods) had resolved and POLYMENORRHOEA (Menstrual cycle shortened) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-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 treatment medication was provided. She had the booster vaccine on the evening of 28th December, her menstrual period arrived on 29th December, approximately 1week to 10 days earlier than expected. This also occurred following her second vaccine (pfizer) but I did not report it at this time. Her period was also more painful (cramping) than usual, to the extent that she altered usual daily activities to rest, although she does already suffer quite bad cramping. Her periods had been as usual in the interim. Patient was not enrolled in clinical trial. 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 heavy menstrual bleeding and polymenorrhoea. The events occurred on the next day 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 27-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of heavy menstrual bleeding and polymenorrhoea. The events occurred on the next day 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: 2030357 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211112; 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: Back pain; Swollen glands; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425095) 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 BACK PAIN (Back pain) and LYMPHADENOPATHY (Swollen glands) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 12-Nov-2021 to 20-Nov-2021. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Back pain) had not resolved and LYMPHADENOPATHY (Swollen glands) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-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. Patient was not pregnant. Patient was not breastfeeding. Concomitant medication was not provided. Treatment information was not reported. 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). Company Comment: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced the unexpected and serious events of Back pain and Lymphadenopathy. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in the RA. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced the unexpected and serious events of Back pain and Lymphadenopathy. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in the RA. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030381 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-29
   Days after vaccination:13
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: Pruritus, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; 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: itchy; Itchy rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425362) 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 RASH PRURITIC (Itchy rash) and PRURITUS (itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Itchy rash) had not resolved and PRURITUS (itchy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-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 concomitant medication information was reported. Patient had rash started on legs, moving about body - legs, stomach, neck, under arms. Rash is very itchy and sore. Pharmacist had suggested antihistamine tablets and Daktacort hydrocortison cream. Patient had not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 41-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Rash pruritic and Pruritus. The events occurred 13 days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The events could be in connection between each other. 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.; Sender''s Comments: This case concerns a 41-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Rash pruritic and Pruritus. The events occurred 13 days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The events could be in connection between each other. 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: 2030384 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: Contusion, Dermatitis, Heat oedema, Hypersensitivity, Nausea, SARS-CoV-2 test, Skin reaction
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PAROXETINE HYDROCHLORIDE; VITAMIN B12 NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Fibromyalgia; Vitamin B12 deficiency
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: allergic reaction; Bruising of arm; Skin inflammation; Heat oedema; Skin reaction; Nausea; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26425419) 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 HYPERSENSITIVITY (allergic reaction), CONTUSION (Bruising of arm), DERMATITIS (Skin inflammation), HEAT OEDEMA (Heat oedema), SKIN REACTION (Skin reaction) and NAUSEA (Nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Fibromyalgia, Anxiety and Vitamin B12 deficiency. Concomitant products included PAROXETINE HYDROCHLORIDE from 01-Dec-1991 to an unknown date for Anxiety, CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from 01-Jun-2016 to an unknown date for Fibromyalgia syndrome, ELASOMERAN (COVID-19 VACCINE MODERNA), ELASOMERAN (COVID-19 VACCINE MODERNA), INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Dec-2021 to an unknown date and VITAMIN B12 NOS from 01-Jan-2017 to an unknown date 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 29-Dec-2021, the patient experienced CONTUSION (Bruising of arm) (seriousness criterion medically significant), DERMATITIS (Skin inflammation) (seriousness criterion medically significant), HEAT OEDEMA (Heat oedema) (seriousness criterion medically significant), SKIN REACTION (Skin reaction) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (allergic reaction) had not resolved and CONTUSION (Bruising of arm), DERMATITIS (Skin inflammation), HEAT OEDEMA (Heat oedema), SKIN REACTION (Skin reaction) and NAUSEA (Nausea) 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. Painful large red area on upper arm but below the injection site, saw GP as it was hot and hard to touch, felt bruised a swell as feeling nausea, GP prescribed fusibet antibiotics cream, and said was allergic reaction to vaccine, therefore she was concerned about having further booster vaccines. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial This is a regulatory case concerning a 50-year-old female patient with no relevant medical history, who experienced the serious per reported severity unexpected events of contusion, dermatitis, heat oedema, skin reaction, nausea and hypersensitivity. The events occurred 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 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 relevant medical history, who experienced the serious per reported severity unexpected events of contusion, dermatitis, heat oedema, skin reaction, nausea and hypersensitivity. The events occurred 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030390 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Headache, Influenza, Maternal exposure during breast feeding, Myalgia, Oropharyngeal pain, Palpitations, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

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

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Heart palpitations; Racing heart (tachycardia); Maternal exposure during breast feeding; Sore throat; Chest pain; Flu; Headache; Muscle ache; Heart pounding; This case was received via RA (Reference number: GB-MHRA-ADR 26425536) 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 (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart pounding), OROPHARYNGEAL PAIN (Sore throat), the first episode of CHEST PAIN (Chest pain), INFLUENZA (Flu), HEADACHE (Headache), MYALGIA (Muscle ache) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. Concurrent medical conditions included Breast feeding. On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced 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), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown, PALPITATIONS (Heart pounding) and OROPHARYNGEAL PAIN (Sore throat) had not resolved and INFLUENZA (Flu), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced flu symptoms including nausea, chills, mucus in chest/throat and blocked nose. On 2-JAN-2022 patient had her LMP. Relevant concomitant medications were not reported. Treatment information was not provided; Sender''s Comments: This case concerns a 26-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Fatigue, Chest Pain, Pyrexia, Palpitations, Tachycardia, Oropharyngeal Pain, Influenza, Headache, Myalgia, and Maternal Exposure during breast Feeding. The events of palpitations, myalgia, headache, and influenza occurred approximately 1 day after the first dose of mRNA-1273 (Moderna covid-19 vaccine); oropharyngeal pain and chest pain occurred 4 days after the first dose; while fatigue, tavhycardia occurred at an unspecified interval after first dose. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2030401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Abdominal pain, Back pain, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009320

Write-up: myocarditis; Tummy ache; Low back pain; 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 Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201032146456600-6JNN1 (RA). Other Case identifier(s): GB-MHRA-ADR 26430386 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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. 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 29Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; ABDOMINAL PAIN (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Tummy ache"; BACK PAIN (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Low back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: yes - positive covid-19 test. Clinical course: 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: 2030482 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FN3643 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885629

Write-up: Nosebleed; 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 parent. Regulatory number: GB-MHRA-WEBCOVID-202112301238327710-QZGD3 (RA). Safety Report Unique Identifier: GB-MHRA-ADR 26415608 (RA). A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3643) at the age of 13 years as dose 2, 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), for COVID-19 IMMUNISATION. The following information was reported: EPISTAXIS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Nosebleed". Clinical course: Reporter''s son suffered 5 nosebleeds hours after having his 2nd vaccination. He also had one in the night & another again this morning. He doesn''t normally suffer from severe nosebleeds. 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. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2030493 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   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: SARS-CoV-2 test, Sinusitis
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: Blood pressure high (on medication); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
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: Sinusitis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425434) 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 SINUSITIS (Sinusitis) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and Blood pressure high (on medication). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced SINUSITIS (Sinusitis) (seriousness criterion medically significant). At the time of the report, SINUSITIS (Sinusitis) 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 product use was not provided by the reporter. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment: This is a regulatory authority case concerning a 26-year-old, female patient with relevant medical history of immunodeficiency, who experienced the unexpected serious event of sinusitis. The event sinusitis occurred 2 days after the third dose of mRNA-1273 vaccine administration with negative Covid-19 test result. No reported treatment information. The outcome of the event was not resolved from the time of last observation. The medical history of immunodeficiency remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 26-year-old, female patient with relevant medical history of immunodeficiency, who experienced the unexpected serious event of sinusitis. The event sinusitis occurred 2 days after the third dose of mRNA-1273 vaccine administration with negative Covid-19 test result. No reported treatment information. The outcome of the event was not resolved from the time of last observation. The medical history of immunodeficiency remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030521 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-12-29
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron, moreover,; Comments: carried the Variant of Concern Omicron, moreover, the patient had identical genetic sequences with another 3 patients who were confirmed as COVID-19 and highly similar to another 2 patients who were confirmed as COVID-19; Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200030751

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007646. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority). The regulatory authority report number is not applicable. A 76-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 07-Jul-2021 and 28-Jul-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient was a non-household family member of the earlier confirmed imported case (confirmed to be carrying Omicron mutant strain) and he was epidemiologically linked with it. On 28-Dec-2021, the patient tested negative. On the same day, he was sent to the quarantine centre for quarantine. On 29-Dec-2021, the patient tested preliminarily positive with a Ct value larger than 30 involving N501Y and T478K mutant strains. On an unknown date, the whole genome sequencing analysis conducted by the Regulatory Authority confirmed that the patient carried the Variant of Concern Omicron, moreover, the patient had identical genetic sequences with another 3 patients who were confirmed as COVID-19 and highly similar to another 2 patients who were confirmed as COVID-19. The patient was asymptomatic and confirmed as COVID-19 with mutant strain of N501Y + T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K/imported case with Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 31-Dec-2021, 01-Jan-2022, 02-Jan-2022, 04-Jan-2022 and 05-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drug: Comirnaty Causality Assessments: Asymptomatic COVID-19, Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200020676 same reporter/product, different event/patient


VAERS ID: 2030522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-12-29
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron, moreover,; Comments: carried the Variant of Concern Omicron, moreover, the patient had identical genetic sequences with another 3 patients who were confirmed as COVID-19 and highly similar to another 2 patients who were confirmed as COVID-19; Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in community testing centre; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200030977

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007647. This is a spontaneous report received from a non-contactable HCP received via Department of Health (RA). The regulatory authority report number is not applicable. A 34-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 13-Jun-2021 and 04-Jul-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 28-Dec-2021, the patient went to a community testing centre for test and tested negative. On 29-Dec-2021, he developed cough and he attended the Emergency Department of Hospital on 30-Dec-2021. His specimen collected tested preliminarily positive with a Ct value of about 30 involving N501Y and T478K mutant strains. On an unknown date, the whole genome sequencing analysis conducted by the RA''s Branch confirmed that the patient carried the Variant of Concern Omicron, moreover, the patient had identical genetic sequences with another 3 patients who were confirmed as COVID-19 and highly similar to another 2 patients who were confirmed as COVID-19. The patient was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse events ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K/imported case with Variant of Concern Omicron'' were considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 31-Dec-2021, 01-Dec-2022, 02-Jan-2022, 03-Jan-2022, 04-Jan-2022 and 05-Jan-2022. This case was split from AER 2021FOS007596 due to same reporter/product, different event/patient. This case was split to AER 2022FOS000016, 2022FOS000032, 2022FOS000033, 2022FOS000034, 2022FOS000035, 2022FOS000036, 2022FOS000037, 2022FOS000038, 2022FOS000039, 2022FOS000040, 2022FOS000041, 2022FOS000042, 2022FOS000043, 2022FOS000044, 2022FOS000045, 2022FOS000046, 2022FOS000047, 2022FOS000048 due to same reporter/product, different event/patient. This case was cross-linked with above cases. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech RA. Drug: Comirnaty Causality Assessments: COVID-19, Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200016785 same reporter/product, different event/patient


VAERS ID: 2030523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-29
   Days after vaccination:13
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: Asymptomatic COVID-19, Gene sequencing, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 20211220; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211225; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative, upon arrival in the Temporary Specimen C; Comments: upon arrival in the Temporary Specimen Collection Centre at International Airport; Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive, with a Ct value of about 25 involving N5
CDC Split Type: HKPFIZER INC202200030746

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable healthcare professional from Regulatory Authority via License Party (BioNTech SE). Regulatory number: Not available (department of health (DH)). Other Case identifier: HK-Fosun-2021FOS007648 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. A 47-year-old male patient started to receive three doses of Tozinameran (COMIRNATY) (lot number: unknown) on 17-Mar-2021, 07-Apr-2021 and 16-Dec-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient was a co-worker of an earlier confirmed imported case (confirmed to be carrying Omicron mutant strain). On 20-Dec-2021, the patient tested negative for COVID-19. On 22-Dec-2021, he departed for the United States (US) by flight. On 25-Dec-2021, he arrived from the via flight. His specimen collected upon arrival in the Temporary Specimen Collection Centre at International Airport tested negative for COVID-19. On 27-Dec-2021, the patient tested negative. On 28-Dec-2021, he was sent to the quarantine centre for quarantine. On 29-Dec-2021, he tested preliminarily positive with a Ct value of about 25 involving N501Y mutant strain. On an unknown date, the whole genome sequencing analysis conducted by the DH''s Public Health Laboratory Services Branch confirmed that the patient carried the Variant of Concern Omicron. He was asymptomatic and confirmed as COVID-19 with mutant strain of N501Y. The adverse events ''confirmed case of COVID-19/imported case with mutant strain of N501Y/imported case with Variant of Concern Omicron'' were considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 31-Dec-2021, 01-Jan-2022 and 02-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. This source also attached to AER 2022FOS000756 since same patient, different dosage of vaccination and different event. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: The events asymptomatic COVID-19 and vaccination failure were considered as possibly related to COMIRNATY per reporter and per Company (BioNTech SE).; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200020676 same reporter/product, different event/patient;HK-PFIZER INC-202200030749 same patient, different dosage of vaccination and different event


VAERS ID: 2030697 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-27
Onset:2021-12-29
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8760 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: PHPFIZER INC202200001288

Write-up: Tested positive for COVID-19/pyrexia/cough; Tested positive for COVID-19; cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 06Nov2021, at 12-years-old, (Lot number: PCB0002) as dose 1, single and administration date 27Nov2021, at 13-years-old, (Lot number: FJ8760) 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: COVID-19 (medically significant) with onset 29Dec2021, outcome "unknown", described as "Tested positive for COVID-19/pyrexia/cough"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Tested positive for COVID-19"; NASOPHARYNGITIS (non-serious) with onset 29Dec2021, outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030698 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-12-29
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: ovid 19 rapid antigen test nasal swab; Test Result: Positive
CDC Split Type: PHPFIZER INC202200002128

Write-up: Covid 19 rapid antigen test nasal swab done which yielded positive results; Covid 19 rapid antigen test nasal swab done which yielded positive results; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative and product quality group. A 38 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Sep2021 13:45 (Lot number: FF8871) at the age of 37 years as dose 2, single and administered in deltoid left, administration date 14Aug2021 16:16 (Lot number: FF8871) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Covid 19 rapid antigen test nasal swab done which yielded positive results". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. On December 29, 2021, chills, fever, headache and body malaise. Patient took Ibuprofen for headache and Paracetamol for fever. On December 30, 2021, fever, headache and body malaise. On December 31, 2021, head heaviness, body malaise and colds. Covid 19 rapid antigen test nasal swab done which yielded positive results. On January 2022, head heaviness, colds and body malaise. Investigation results received on 04Jan2022 included The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF8871. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.


VAERS ID: 2030797 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: Arthralgia, Erythema, Fatigue, Myalgia, Peripheral swelling, Restlessness, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
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: restlessness; Swollen arm; Aching joints; Redness; Muscle pain; Exhaustion; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26423298) 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 RESTLESSNESS (restlessness), ARTHRALGIA (Aching joints), ERYTHEMA (Redness), MYALGIA (Muscle pain), FATIGUE (Exhaustion) and PERIPHERAL SWELLING (Swollen arm) in a 39-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) for COVID-19. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced RESTLESSNESS (restlessness) (seriousness criterion medically significant). At the time of the report, RESTLESSNESS (restlessness) outcome was unknown and ARTHRALGIA (Aching joints), ERYTHEMA (Redness), MYALGIA (Muscle pain), FATIGUE (Exhaustion) and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-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. Patients last menstrual period date is reported as 28-DEC-2021. Treatment medication were not reported. Patient experienced severe exhaustion, fatigue, painful muscles and joints. Painful cramping that never normally occurs. Restlessness under the skin and sensitive to touch. Arm, below the booster site was really red, hot, swollen and hard. The injection site is bruised but no redness around it. Patient is not enrolled in clinical trial. Re-challenge was reported as unknown. Company comment: This RA case concerns a female patient of 39-years-old with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) on unknown dates before current vaccination), who experienced the unexpected serious events of Restlessness, Arthralgia, Erythema, Myalgia, Fatigue and Peripheral swelling. The events Arthralgia, Erythema, Myalgia and Fatigue occurred one day after the third dose of mRNA-1273 vaccine except Peripheral swelling which occurred 2 days later to vaccination. The restlessness occurred on unknown date after the third dose of vaccination and outcome was reported unknown. The outcome was reported not resolved for Arthralgia, Erythema, Myalgia, Fatigue and Peripheral Swelling. The benefit-risk relationship of the 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 RA case concerns a female patient of 39-years-old with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) on unknown dates before current vaccination), who experienced the unexpected serious events of Restlessness, Arthralgia, Erythema, Myalgia, Fatigue and Peripheral swelling. The events Arthralgia, Erythema, Myalgia and Fatigue occurred one day after the third dose of mRNA-1273 vaccine except Peripheral swelling which occurred one day later to vaccination. The restlessness occurred on unknown date after the third dose of vaccination and outcome was reported unknown. The outcome was reported not resolved for Arthralgia, Erythema, Myalgia, Fatigue and Peripheral Swelling. The benefit-risk relationship of the 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: 2030807 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
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: Hypoaesthesia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: vomiting; pyrexia; Numbness in leg; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424979) 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 VOMITING (vomiting), PYREXIA (pyrexia) and HYPOAESTHESIA (Numbness in leg) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. Concomitant products included DESOGESTREL for Heavy periods. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HYPOAESTHESIA (Numbness in leg) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion medically significant) and PYREXIA (pyrexia) (seriousness criterion medically significant). On 30-Dec-2021, HYPOAESTHESIA (Numbness in leg) had resolved. At the time of the report, VOMITING (vomiting) and PYREXIA (pyrexia) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug information was provided. Patient felt headaches, Pyrexia, Diarrhoea and vomiting. Dizziness no energy lasting 4 days and seemed help of 111 and urgent treatment clinic. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 27-year-old, female patient with no reported medical history, who experienced the unexpected serious events of hypoaesthesia, pyrexia and vomiting. The event hypoaesthesia occurred 1 day after the third dose of mRNA-1273 vaccine administration while pyrexia, vomiting, diarrhea, headache, dizziness and no energy occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event hypoaesthesia was resolved, the events vomiting and pyrexia were not resolved from the time of last observation while diarrhea, headache, dizziness and no energy the outcome were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 27-year-old, female patient with no reported medical history, who experienced the unexpected serious events of hypoaesthesia, pyrexia and vomiting. The event hypoaesthesia occurred 1 day after the third dose of mRNA-1273 vaccine administration while pyrexia, vomiting, diarrhea, headache, dizziness and no energy occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event hypoaesthesia was resolved, the events vomiting and pyrexia were not resolved from the time of last observation while diarrhea, headache, dizziness and no energy the outcome were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030809 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Dizziness, Dyspnoea, Fatigue, Headache, Insomnia, Nausea, Night sweats, Pain, Pain in extremity, Pelvic pain, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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; INFLUENZA VIRUS; BUSCOPAN; CODEINE PHOSPHATE; DUORESP SPIROMAX; SERTRALINE; PIRITEZE; SALBUTAMOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthmatic; Chronic pain (undiagnosed chronic pain despite investigation); Depression; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: chronic pain; pelvic pain; Pain worsened; Headache; Fatigue; Dizzy spells; Fever; Breathing difficult; Nausea; Itch; Painful arm; Night sweat; Insomnia; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425157) 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 DYSPNOEA (Breathing difficult), PAIN (chronic pain), PELVIC PAIN (pelvic pain), PAIN (Pain worsened), NAUSEA (Nausea), PRURITUS (Itch), PAIN IN EXTREMITY (Painful arm), NIGHT SWEATS (Night sweat), INSOMNIA (Insomnia), HEADACHE (Headache), FATIGUE (Fatigue), DIZZINESS (Dizzy spells) and PYREXIA (Fever) in a 39-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 23-Mar-2020. Concurrent medical conditions included Chronic pain (undiagnosed chronic pain despite investigation), Depression, Asthmatic and Anxiety. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE (DUORESP SPIROMAX) and SALBUTAMOL for Asthma, CODEINE PHOSPHATE for Chronic pain, SERTRALINE from January 2021 to an unknown date for Depression, INFLUENZA VACCINE (INFLUENZA VIRUS) from 31-Oct-2021 to an unknown date for Flu vaccination, CETIRIZINE HYDROCHLORIDE (PIRITEZE) for Hay fever, HYOSCINE BUTYLBROMIDE (BUSCOPAN) for Irritable bowel, PARACETAMOL for Pain relief, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DYSPNOEA (Breathing difficult) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), PRURITUS (Itch) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant), NIGHT SWEATS (Night sweat) (seriousness criteria disability and medically significant) and INSOMNIA (Insomnia) (seriousness criteria disability and medically significant). On 30-Dec-2021, the patient experienced PAIN (Pain worsened) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant), FATIGUE (Fatigue) (seriousness criteria disability and medically significant), DIZZINESS (Dizzy spells) (seriousness criteria disability and medically significant) and PYREXIA (Fever) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN (chronic pain) (seriousness criteria disability and medically significant) and PELVIC PAIN (pelvic pain) (seriousness criteria disability and medically significant). On 30-Dec-2021, NAUSEA (Nausea), DIZZINESS (Dizzy spells) and PYREXIA (Fever) had resolved. On 31-Dec-2021, DYSPNOEA (Breathing difficult), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. On 01-Jan-2022, PRURITUS (Itch) had resolved. At the time of the report, PAIN (chronic pain), PELVIC PAIN (pelvic pain), PAIN IN EXTREMITY (Painful arm), NIGHT SWEATS (Night sweat) and INSOMNIA (Insomnia) was resolving and PAIN (Pain worsened) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not pregnant and was not currently breastfeeding. Patient''s last menstrual period date was 01-Jan-2022. She did not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. It was reported that patient had itchy arm at vaccination site started almost immediately. Pain in the arm soon followed. The increase in usual chronic pain symptoms had been significant. The cause was undiagnosed but she struggled with chronic hip and pelvic pain. She was still struggling with this more since the jab and pain relief was ineffective. She struggled with night sweats and insomnia the first night after the jab and had a terrible night sleep. The next day the fatigue was the worse symptom. She slept during the day which was highly irregular for her. Treatment information was not provided. This is a regulatory case concerning a 39-year-old female patient with a medical history of suspected of having Covid-19, chronic pain, depression, asthma, and anxiety, who experienced the events of pain, pelvic pain, nausea, pruritus, dyspnoea, pain in extremity night sweats insomnia, headache, fatigue, dizziness and pyrexia. Concomitant products in this case are the Influenza vaccine and the Pfizer Biontech Covid-19 vaccine. Most of the events occurred on the same day or 1 day after the third dose of mRNA ? 1273 vaccine, only the events pelvic pain and pain was experienced on an unknown date. Events reportedly caused disability and at the time of report all the events have either resolved or were resolving except for pain which had not resolved. 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 39-year-old female patient with a medical history of suspected of having Covid-19, chronic pain, depression, asthma, and anxiety, who experienced the events of pain, pelvic pain, nausea, pruritus, dyspnoea, pain in extremity night sweats insomnia, headache, fatigue, dizziness and pyrexia. Concomitant products in this case are the Influenza vaccine and the Pfizer Biontech Covid-19 vaccine. Most of the events occurred on the same day or 1 day after the third dose of mRNA ? 1273 vaccine, only the events pelvic pain and pain was experienced on an unknown date. Events reportedly caused disability and at the time of report all the events have either resolved or were resolving except for pain which had not resolved. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2030867 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rashes (non-injection site); This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion hospitalization). At the time of the report, RASH (Skin rashes (non-injection site)) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Since Moderna second dose she had skin rash with itchiness from neck developed and extended to whole trunk front and back, all four limbs, face and in the same evening he developed urticaria (spreading from the neck to the whole body) and visited Hospital for treatment After administration of diphenhydramine injection, the symptoms are improved. 29-Dec-2021, developed rash and asthma, visited the emergency department of hospital for treatment. After improvement, the patient returned home. Due to symptoms relapsed on morning, the patient visited hospital again, with blood test of IgE [225.1 IU/mL] and thepatient breathed smoothly and effortlessly. The rash was not relieved and the patient received anti-allergic drugs and resolution of urticaria. After discussing with the dependents, the patient was hospitalized alone to continue treatment. After receiving the first dose of Moderna vaccine in November, reported only developed headache, which improved after a rest without medical treatment. The patient was assessed with smooth breathing and no general itching and was discharged from the hospital on 30-Dec-2021 the patient was admitted to the emergency department. On 30-Dec-2021, developed urticaria again and visited Hospital for treatment. At present, the symptoms have improved after treatment in the hospital and was expected to be discharged on 02-Jan-2022. The patient was informed with the matters related to VICP and accepted that. This is a regulatory authority case concerning a 23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Skin rash. The events occurred approximately 1 day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Skin rash. The events occurred approximately 1 day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2031097 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Hot flush, Myalgia, Pain in extremity, SARS-CoV-2 test, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; 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: Headache; Shivers; Hot flushes; Blurred vision; Painful arm; Generalized muscle aches; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425129) 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 MYALGIA (Generalized muscle aches), HEADACHE (Headache), CHILLS (Shivers), HOT FLUSH (Hot flushes), VISION BLURRED (Blurred vision) and PAIN IN EXTREMITY (Painful arm) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. 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 29-Dec-2021, the patient experienced MYALGIA (Generalized muscle aches) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), HOT FLUSH (Hot flushes) (seriousness criterion medically significant), VISION BLURRED (Blurred vision) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 30-Dec-2021, HEADACHE (Headache), CHILLS (Shivers) and VISION BLURRED (Blurred vision) had resolved. On 31-Dec-2021, MYALGIA (Generalized muscle aches) and HOT FLUSH (Hot flushes) had resolved. On 02-Jan-2022, PAIN IN EXTREMITY (Painful arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-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. Concomitant medication use information was not provided by reporter. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Treatment medication use information was not provided by reporter. Company comment: This is a regulatory authority case concerning a 43-year-old, male patient with no reported medical history, who experienced the unexpected serious events of generalized muscle aches, chills, hot flushes, blurred vision, painful arm and headache. The events generalized muscle aches, chills, hot flushes, blurred vision and painful arm occurred the same day with the third dose of mRNA-1273 vaccine administration while the event headache occurred 1 day after the third dose of mRNA-1273 vaccine administration with negative Covid-19 test result. No reported treatment information. The outcome of the events were resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 43-year-old, male patient with no reported medical history, who experienced the unexpected serious events of generalized muscle aches, chills, hot flushes, blurred vision, painful arm and headache. The events generalized muscle aches, chills, hot flushes, blurred vision and painful arm occurred the same day with the third dose of mRNA-1273 vaccine administration while the event headache occurred 1 day after the third dose of mRNA-1273 vaccine administration with negative Covid-19 test result. No reported treatment information. The outcome of the events were resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2032993 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, 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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000439

Write-up: Feels like holding something between my upper are and body that has been held too tight causing an ache; Swelling of upper arm; Aching inner arm/armpit area/breast area; 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-APPCOVID-20211231091232. Other Case identifier(s): GB-MHRA-ADR 26420287. A 39 year-old patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 39 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported.Patient is not enrolled in clinical trial. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swelling of upper arm"; PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Aching inner arm/armpit area/breast area"; PAIN (medically significant), outcome "unknown", described as "Feels like holding something between my upper are and body that has been held too tight causing an ache".Patient has not had symptoms associated with COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected


VAERS ID: 2032994 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Interchange of vaccine products, Malaise, Nausea, Off label use, SARS-CoV-2 test, Vaccination site pain, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Arthritis (broad), Medication errors (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: Comments: Patient has not had symptoms associated with 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 INC202200000837

Write-up: nausea; feeling sick; room spinning when lean to left; Tenderness of injection area; Throbbing all round shoulder; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-APPCOVID-20211231115751. Other Case identifier: GB-MHRA-ADR 26421407. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE ASTRAZENECA (Batch/lot number: Pv46673, Date of start of reaction/event:27Mar2021), administration date: 27Mar2021, for COVID-19 immunization, reaction: "Painful L arm". The following information was reported: OFF LABEL USE (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; NAUSEA (disability, medically significant), outcome "unknown", described as "nausea"; MALAISE (disability, medically significant), outcome "unknown", described as "feeling sick"; VERTIGO (disability, medically significant), outcome "unknown", described as "room spinning when lean to left"; VACCINATION SITE PAIN (disability, medically significant), outcome "unknown", described as "Tenderness of injection area"; ARTHRALGIA (disability, medically significant), outcome "unknown", described as "Throbbing all round shoulder". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Nausea and room spinning when lean to left. When she lays down room spins and feeling sick. Tenderness of injection area. Throbbing all round shoulder. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Diarrhoea, Insomnia, Malaise, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: ETHOSUXIMIDE; FLUCLOXACILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Infection
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.9; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8; Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000433

Write-up: Diarrhoea; Shivers; high temperature; feeling unwell; Vomiting; Fever; Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority, number: GB-MHRA-WEBCOVID-202112290749000220-DXSWE (MHRA). Other Case identifier(s): GB-MHRA-ADR 26406840 (MHRA). A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. 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. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Infection" (unspecified if ongoing). Concomitant medication(s) included: ETHOSUXIMIDE taken for epilepsy; FLUCLOXACILLIN taken for infection. Vaccination history included: Covid-19 vaccine ((MANUFACTURER UNKNOWN), Dose: 01), for COVID-19 immunisation. The following information was reported: VOMITING (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Vomiting"; PYREXIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fever"; INSOMNIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Insomnia"; DIARRHOEA (medically significant), outcome "unknown", described as "Diarrhoea"; CHILLS (medically significant), outcome "recovered" (2021), described as "Shivers"; PYREXIA (medically significant), outcome "not recovered", described as "high temperature"; MALAISE (medically significant), outcome "unknown", described as "feeling unwell". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 37.9; (unspecified date) 37.8; sars-cov-2 test: (20Sep2021) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of pyrexia, pyrexia. Got up after not sleeping feeling unwell and had diarrhoea. Checked temperature and was 37.9. FU received 30Dec2021: We reported side effects earlier. Patient vomited as well. Patient temp was still 37.8. Continuing with paracetamol. Patient was ok in herself. Shivers have stopped. Adverse reaction did not occur as a result of an exposure during pregnancy. Reaction: No, the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). 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: 2033097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Lymphadenopathy, Night sweats, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19; Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101885837

Write-up: Night sweat; Breathlessness; Swollen lymph nodes; Fatigue; This is a spontaneous report received from a contactable Consumer from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301140374750-B6L0I (RA). Other Case identifier(s): GB-MHRA-ADR 26415246 (RA). A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 06Jan2021, stop date: 16Jan2021. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fatigue"; NIGHT SWEATS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Night sweat"; DYSPNOEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Breathlessness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2021) yes - positive covid-19 test. The reporter did not consider the 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: 2033107 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Malaise, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885822

Write-up: Feeling sick; Vomited/throw up yellow bile; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301738150960-PWATJ. Other Case identifier(s): GB-MHRA-ADR 26417642. A 22 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose number unknown), administration date: 15Aug2021, for COVID-19 immunisation; Bnt162b2 (Dose number unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MALAISE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Feeling sick"; VOMITING (medically significant) with onset 30Dec2021, outcome "recovered" (Dec2021), described as "Vomited/throw up yellow bile ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course: About 24 hours after getting his COVID booster, he began feeling sick then another 6 hours later throw up yellow bile. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Lymph node pain, Lymphadenopathy, 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: Medical History/Concurrent Conditions: Irregular periods (My periods are not very regular is the only thing that I have, but I don''t have any meds.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885979

Write-up: fever; Lymph node pain; the lymph nodes in the armpit of the arm where I got the vaccine are very swollen; Booster; 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-202112302234163240-I6HOF (RA). Other Case identifier(s): GB-RA-ADR 26418556 (RA). A 34 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. Relevant medical history included: "My periods are not very regular" (unspecified if ongoing), notes: My periods are not very regular is the only thing that I have, but I don''t have any meds for it, I don''t know if it''s relevant. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Lymph node pain", "lymph nodes in the armpit of the arm where I got the vaccine are very swollen", "fever". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "recovering", described as "fever"; LYMPH NODE PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Lymph node pain"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "unknown", described as "the lymph nodes in the armpit of the arm where I got the vaccine are very swollen". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The next day (30Dec2021) after the vaccine the lymph nodes in the armpit of the arm where she got the vaccine were very swollen (easily visible, her partner was joking that she was growing a third boob). It was very painful and she was getting a fever. It happened with the second shot as well, but not with the first one. The patient was not taking any medication. The patient''s last menstrual period date was on 18Nov2021. Patient was not currently breastfeeding. Patient was not pregnant. Patient has not had symptoms associated with COVID-19. 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: 2033115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FKA706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Oropharyngeal pain, Pain, Peripheral swelling, SARS-CoV-2 test, Vaccination site bruising, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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 Date: 20211226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000486

Write-up: swelling to upper arm; sore throat; Swelling to upper arm, shoulder and armpit on injection side; Bruised upper arm around injection site; pain on collarbone/pain in arm pit; Lymph node pain; 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-202112310814359150-6OATK (RA). Other Case identifier(s): GB-MHRA-ADR 26420382 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FKA706) 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. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant), outcome "not recovered", described as "swelling to upper arm"; OROPHARYNGEAL PAIN (medically significant), outcome "not recovered", described as "sore throat"; LYMPH NODE PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Lymph node pain"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "Swelling to upper arm, shoulder and armpit on injection side"; VACCINATION SITE BRUISING (medically significant), outcome "unknown", described as "Bruised upper arm around injection site"; PAIN (medically significant), outcome "unknown", described as "pain on collarbone/pain in arm pit". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) no - negative covid-19 test. Clinical Course: It was reported that the report does not relates to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033121 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: COVID-19, Chest pain, Dyspnoea, Fatigue, Headache, Heart rate, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: Fatigue/unusual tiredness; Chest pain; Shortness of breath; SARS-CoV-2 infection; Heart rate; Chest pain; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26420094) 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 COVID-19 (SARS-CoV-2 infection), HEART RATE (Heart rate), the first episode of CHEST PAIN (Chest pain), HEADACHE (Headache), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) in a 39-year-old male 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 29-Dec-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant), HEART RATE (Heart rate) (seriousness criterion medically significant), the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) was resolving, HEART RATE (Heart rate) and HEADACHE (Headache) had not resolved and FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) outcome was unknown. 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 has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Related to possible inflammation of the heart (myocarditis or pericarditis) was reported. Treatment information was not provided. Company Comment: This case concerns a 39-year-old, male subject with unknown medical history, who experienced the serious (Seriousness criteria- Other medically important condition) unexpected events of COVID-19, Chest pain, Headache, Fatigue, and Dyspnoea. Events COVID-19, Chest pain, and Headache occurred the same day after the third dose of mRNA-1273 vaccine, while Fatigue and Dyspnoea occurred unknown number of days after. COVID-19 virus test, done on unknown date, was negative. At the time of the report, COVID-19 was resolving, chest pain and headache were not resolving, while fatigue and dyspnoea had unknown outcomes. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s age and gender, which are risk factors for possible myocarditis/pericarditis mentioned in the report, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 39-year-old, male subject with unknown medical history, who experienced the serious (Seriousness criteria- Other medically important condition) unexpected events of COVID-19, Chest pain, Headache, Fatigue, and Dyspnoea. Events COVID-19, Chest pain, and Headache occurred the same day after the third dose of mRNA-1273 vaccine, while Fatigue and Dyspnoea occurred unknown number of days after. COVID-19 virus test, done on unknown date, was negative. At the time of the report, COVID-19 was resolving, chest pain and headache were not resolving, while fatigue and dyspnoea had unknown outcomes. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s age and gender, which are risk factors for possible myocarditis/pericarditis mentioned in the report, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOPROPANOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20211101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000466

Write-up: Tenderness muscle; 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-202112310847233180-DEQSW. Other Case identifier(s): GB-MHRA-ADR 26420140 . A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: ISOPROPANOL taken for migraine, start date: 2019. Vaccination history included: Astrazeneca (1ST DOSE), administration date: 27Mar2021, for COVID-19 Immunisation; Astrazeneca (2ND DOSE), administration date: 18Jun2021, for COVID-19 Immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tenderness muscle". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient last menstrual period date was 15Dec2021. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient experienced tenderness under the left arm pit area. Patient had 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: 2033125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Heavy menstrual bleeding, Immunisation, Menstruation irregular, Peripheral swelling, SARS-CoV-2 test, Tenderness, Vaccination site erythema, Vaccination site mass
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), 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 INC202200000493

Write-up: For both my second vaccine and booster I have had an early period triggered within 24-36hours of having the vaccination/For the booster, my period is now almost a week and a half early; the vaccination arm has now got a large (2-3 inch) size swollen lump around point of entry and has continued to grow since the vaccination; the vaccination arm has now got a large (2-3 inch) size swollen lump around point of entry and has continued to grow since the vaccination; Tender to touch and red, not itchy; Tender to touch and red, not itchy; Menstruation increased; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112310857491770-HORHM. Other Case identifier(s): GB-MHRA-ADR 26420145. A 27 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''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jul2021, for COVID-19 immunisation; Bnt162b2 (Dose 2, outcome: unknown), administration date: Aug2021, for COVID-19 immunisation, reaction(s): "For both my second vaccine (Pfizer, Aug) and booster (Pfizer, Dec) I have had an early period triggered within 24-36hours of having the vaccination". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 31Dec2021, outcome "recovering", described as "Menstruation increased"; MENSTRUATION IRREGULAR (medically significant), outcome "unknown", described as "For both my second vaccine and booster I have had an early period triggered within 24-36hours of having the vaccination/For the booster, my period is now almost a week and a half early"; VACCINATION SITE MASS (medically significant), PERIPHERAL SWELLING (medically significant), outcome "unknown" and all described as "the vaccination arm has now got a large (2-3 inch) size swollen lump around point of entry and has continued to grow since the vaccination"; TENDERNESS (medically significant), VACCINATION SITE ERYTHEMA (medically significant), outcome "unknown" and all described as "Tender to touch and red, not itchy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) no - negative covid-19 test. Clinical Course: For both second vaccine (Pfizer, Aug) and booster (Pfizer, Dec). The patient had an early period triggered within 24-36hours of having the vaccination. For the booster, the patient period was then almost a week and a half early. The patient was normally very regular. Unlike previous vaccinations, the vaccination arm has now got a large (2-3 inch) size swollen lump around point of entry and has continued to grow since the vaccination. Tender to touch and red, not itchy. Patient has not had symptoms associated with COVID-19 Patient was not pregnant. Patient was not currently breastfeeding. Patient last menstrual period date was 07Dec2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report do 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: 2033130 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Hyperhidrosis, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000853

Write-up: Chest pain; off label use; Drug use in unapproved population; Sweating; 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-202112310906343880-CSHMP. Other Case identifier(s): GB-MHRA-ADR 26420237. A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Not known) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "COVID-19", start date: 08Feb2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Sweating"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chest pain"; OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Drug use in unapproved population". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Feb2021) yes - positive covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200024395 Baby case


VAERS ID: 2033132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Abdominal pain upper, Axillary pain, Immunisation, Migraine, Neck pain, Peripheral swelling, Pharyngeal swelling, Pyrexia, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000436

Write-up: Neck pain; Swollen arm; Armpit pain; Migraine; Stomach pain; Throat swelling; Rash; Fever; 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-202112310914309610-PIF4R. Other Case identifier(s): GB-MHRA-ADR 26420285. A 18 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''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. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Migraine"; ABDOMINAL PAIN UPPER (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Stomach pain"; PHARYNGEAL SWELLING (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Throat swelling"; RASH (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Rash"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever"; NECK PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Neck pain"; AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Armpit pain"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm". Clinical course: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient 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: 2033134 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Off label use, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Medical History/Concurrent Conditions: Blood pressure increased
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000697

Write-up: swelling/spread to the top part of the chest (on the injection side) along the clavicle bone; Swelling arm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory number: GB-RA-WEBCOVID-202112310928229370-VWTGD (RA). Other Case identifier: GB-RA-ADR 26420346 (RA). A 48-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN) and (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The patient had negative sars-cov-2 test on 28Dec2021. Then, received the booster dose of bnt162b2 (COMIRNATY) on 29Dec2021 as off label use and interchange of vaccine products. On 31Dec2021, the patient had swelling arm. It was stated that the swelling (as reported) has spread to the top part of the chest (on the injection side) along the clavicle bone on unknown date. Patient was not enrolled in clinical trial. The events were considered as serious (medically significant). Outcome of swelling arm and swelling (as reported) has spread to the top part of the chest (on the injection side) along the clavicle bone was not recovered. The patient does not relate the events 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: 2033149 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Headache, Immunisation, Interchange of vaccine products, Off label use, Palpitations, Photophobia, Pyrexia, Seizure, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202200000520

Write-up: Light sensitivity to eye; off label use; Interchange of vaccine products; Booster; Convulsions; Heart racing; High temperature; Shaking; Headache; 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-202112311038212450-5AMFS (RA). Other Case identifier(s): GB-RA-ADR 26420844 (RA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; SEIZURE (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Convulsions"; PALPITATIONS (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Heart racing"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "High temperature"; TREMOR (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Shaking"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache"; PHOTOPHOBIA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Light sensitivity to eye". The patient underwent the following laboratory tests and procedures: body temperature: high. The patient last menstrual period date 29Nov2021. The patient had not symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient is not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. Reaction: Does your report 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: 2033150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, 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: 20210125; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000522

Write-up: Swollen lymph nodes; Chills; 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-202112311044537940-5ZRM6. Other Case identifier(s): GB-MHRA-ADR 26420845. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FL1939) 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., Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (dose 2., Unknown manufacturer.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; CHILLS (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2021) positive, notes: Yes - Positive 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 was not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033164 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Diarrhoea, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Lymph node pain, Off label use, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEMOSTON; TRAMADOL HYDROCHLORIDE; VALIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Back pain; Hormone replacement therapy; Irritable bowel syndrome; Night terrors; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000580

Write-up: Headache; Lymph node pain; Back pain; Sweating; Diarrhea; Painful arm; Joint pain; off label use; Interchange of vaccine products; Booster; Fever; 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-202112311158270060-GQCKL (MHRA). Other Case identifier(s): GB-MHRA-ADR 26421440 (MHRA). A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) at the age of 54 years as dose 3(booster),single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Pain" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Hormone replacement therapy" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Night terrors" (unspecified if ongoing). Patient is not currently breastfeeding.Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Concomitant medication(s) included: FEMOSTON taken for hormone replacement therapy; TRAMADOL HYDROCHLORIDE taken for back pain; VALIUM taken for sleep terror. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), for Covid-19 vaccination; Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN ), for COVID-19 immunization. Patient is not enrolled in clinical trial The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Fever"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Joint pain"; LYMPH NODE PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Lymph node pain"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovered", described as "Painful arm"; BACK PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Back pain"; HYPERHIDROSIS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Sweating"; DIARRHOEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Diarrhea". Clinical course: First symptom, Diarrhoea, then fever, then severe headache and joint pain, sweating, finally lymph node soreness, still ongoing 2 days afterwards. Patient has not tested positive for COVID-19 since having the vaccine. Report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033172 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Arthralgia, Asthenia, Axillary pain, Back pain, Body temperature fluctuation, Dizziness, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Muscle disorder, Muscular weakness, Musculoskeletal chest pain, Myalgia, Off label use, Pain in extremity, Pain of skin, Painful respiration, Pyrexia, Renal pain, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: temperature fluctuating; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202200000704

Write-up: Armpit pain; Joint pain; Sore back; Weakness muscle; Pain kidney; muscle issues; muscle pain; dizzy; sore ribs/ chest when taking deep breaths; very weak; temperature fluctuating; lymph nodes in armpit swollen; jab site bright red blotch; sore arm; headache; sore ribs/ chest when taking deep breaths; jab site hot to touch and hard; jab site hot to touch and hard; Off label use; Interchange of vaccine products; Booster; High temperature; Skin pain; This is a spontaneous report received from a contactable reporter (Consumer ) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112311236244040-0OM3R. Other Case identifier: GB-MHRA-ADR 26421500. A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 09:30 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), 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 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "High temperature"; PAIN OF SKIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Skin pain"; AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Armpit pain"; ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Joint pain"; BACK PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Sore back"; MUSCULAR WEAKNESS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Weakness muscle"; RENAL PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Pain kidney"; MUSCLE DISORDER (medically significant) with onset 29Dec2021, outcome "unknown", described as "muscle issues"; MYALGIA (medically significant) with onset 29Dec2021, outcome "unknown", described as "muscle pain"; DIZZINESS (medically significant) with onset 29Dec2021, outcome "unknown", described as "dizzy"; MUSCULOSKELETAL CHEST PAIN (medically significant), PAINFUL RESPIRATION (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "sore ribs/ chest when taking deep breaths"; ASTHENIA (medically significant) with onset 29Dec2021, outcome "unknown", described as "very weak"; BODY TEMPERATURE FLUCTUATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "temperature fluctuating"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "unknown", described as "lymph nodes in armpit swollen"; VACCINATION SITE ERYTHEMA (medically significant) with onset 29Dec2021, outcome "unknown", described as "jab site bright red blotch"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "unknown", described as "sore arm"; HEADACHE (medically significant) with onset 29Dec2021, outcome "unknown", described as "headache "; VACCINATION SITE WARMTH (medically significant), VACCINATION SITE INDURATION (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "jab site hot to touch and hard". The patient underwent the following laboratory tests and procedures: body temperature fluctuation: (29Dec2021) unknown results. Therapeutic measures were taken as a result of pyrexia, pain in extremity, headache. Additional information: Patient last menstrual period date: 04Dec2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant, is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033182 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Chest discomfort, Chills, Eye swelling, Facial pain, Immunisation, Interchange of vaccine products, Lip swelling, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000703

Write-up: Tight chest; Swollen lips; Swollen eyes; Cheek swelling/Swelling face; Pain in face; Off-label use; Interchange of vaccine products; Booster; Chills; Fever; Muscle ache; 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-202112311309240980-KVPWY. Other Case identifier(s): GB-MHRA-ADR 26421790. A 43-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 43 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 astrazeneca (DOSE NUMBER UNKNOWN; PRIMARY SERIES), administration date: 21Apr2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN, PRIMARY SERIES), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Chills"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Fever"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Muscle ache"; CHEST DISCOMFORT (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Tight chest"; LIP SWELLING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen lips"; EYE SWELLING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen eyes"; SWELLING FACE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Cheek swelling/Swelling face"; FACIAL PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Pain in face". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) no - negative covid-19 test. Therapeutic measures were taken as a result of chills, pyrexia, myalgia, chest discomfort, lip swelling, eye swelling, swelling face, facial pain: paracetamol was administrated to relieve symptoms and antihistamine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Reaction. The 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: 2033185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Breast swelling, Dyspnoea, Fatigue, Hypoaesthesia, Immunisation, Myocarditis, Palpitations, Paraesthesia, Pericarditis, SARS-CoV-2 test, Swelling, Vaccination site urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000824

Write-up: Fatigue/unusual tiredness; Heart palpitations; possible inflammation of the heart (myocarditis or pericarditis); possible inflammation of the heart (myocarditis or pericarditis); Booster; Injection site hives; Neck swelling; Breast swelling; Pins and needles; Numbness in hand; Shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311324534780-BN144 (RA). Other Case identifier: GB-RA-ADR 26421734 (RA). A female patient received BNT162B2 (COMIRNATY), administration date 29Dec2021 (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. The following information was reported: Booster with onset 29Dec2021 and outcome of unknown; Injection site hives, neck swelling, breast swelling, pins and needles, numbness in hand, and shortness of breath, all with onset 29Dec2021 and outcome of not recovered; Fatigue/unusual tiredness and heart palpitations, both with outcome of unknown. This report was also noted to related to possible inflammation of the heart (myocarditis or pericarditis), outcome "unknown". The events were reported as serious per other medically important condition. The symptoms did not lead to a hospital stay and a diagnosis was not made by a medical professional. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033190 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 increased, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Oropharyngeal pain, SARS-CoV-2 test, Sinus headache
SMQs:, Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211218; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000392

Write-up: Swollen glands; Headache sinus; Temperature elevation; Sore throat; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311350577130-WENOE (RA). Other Case identifier(s): GB-RA-ADR 26421856 (RA). A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen glands"; SINUS HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache sinus"; BODY TEMPERATURE INCREASED (medically significant) with onset 29Dec2021, outcome "recovering", described as "Temperature elevation"; OROPHARYNGEAL PAIN (medically significant) with onset 29Dec2021, outcome "recovering", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2021) negative, notes: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033195 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK0 706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Immunisation, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (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), 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: DASATINIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic myeloid leukaemia (I have well controlled chronic myeloid leukaemia); Clinical trial participant (Study details: Co-vax CML); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000322

Write-up: off label use; Interchange of vaccine products; Booster; Vomiting; Muscle pain; Diarrhea; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112311409386050-2TFN1 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26421951 (MHRA). A 53-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK0 706) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic myeloid leukaemia" (unspecified if ongoing), notes: I have well controlled chronic myeloid leukaemia; "Clinical trial participant" (unspecified if ongoing), notes: Study details: Co-vax CML; "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Concomitant medication(s) included: DASATINIB taken for chronic myeloid leukaemia, start date: 07Jan2020. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 22Feb2021, for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 15Apr2021, for Covid-19 immunisation; Comirnaty (Dose number unknown), administration date: 23Sep2021, for Covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Vomiting"; MYALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Muscle pain"; DIARRHOEA (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Diarrhea"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fatigue". 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. The report of the consumer 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: 2033199 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
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: Chills, Headache, Myalgia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Neuralgia (neauralgia to left side of head)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Blurry vision; Headache; Shivering; Muscle ache; This case was received (Reference number: GB-MHRA-ADR 26422211) 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 VISION BLURRED (Blurry vision), HEADACHE (Headache), CHILLS (Shivering) and MYALGIA (Muscle ache) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014a) for an unknown indication. The patient''s past medical history included Neuralgia (neauralgia to left side of head). Previously administered products included for Product used for unknown indication: PREGABALIN and Co-codamol. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-Apr-2021 to an unknown date 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 29-Dec-2021, the patient experienced VISION BLURRED (Blurry vision) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurry vision) and HEADACHE (Headache) had not resolved and CHILLS (Shivering) and MYALGIA (Muscle ache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient had to stay in bed for 2 days. She got up on 3rd day, her vision was getting better but was not right. Headache was getting better slowly. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment medication details were provided. Company Comment : This RA case concerns a 53 year old female with relevant medical history of neuralgia , immunodeficiency state , vaccinated initially with Covid 19 vaccine Astra Zeneca ( 1 dose reported) , who experienced, Serious ( Medically significant ) , unexpected events of vision blurred, headache, chills and myalgia. These events occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The history of neuralgia and the immunodeficiency state of this patient may be considered as a confounder. for this case. 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 53 year old female with relevant medical history of neuralgia , immunodeficiency state , vaccinated initially with Covid 19 vaccine Astra Zeneca ( 1 dose reported) , who experienced, Serious ( Medically significant ) , unexpected events of vision blurred, headache, chills and myalgia. These events occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The history of neuralgia and the immunodeficiency state of this patient may be considered as a confounder. for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2033208 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Feeling of body temperature change, Hyperhidrosis, Immunisation, Insomnia, Interchange of vaccine products, Nausea, Off label use, Oropharyngeal pain, Pain in extremity, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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 INC202200000575

Write-up: Shivers overnight including cold and then too hot; Shivers overnight including cold and then too hot; Sore throat started 2nd day; Sweating; Nausea; Painful arm (injection site); Insomnia 1st and 2nd night; Off label use; Interchange of vaccine products; Booster; Painful 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-202112311510412370-POLFZ. Other Case identifier(s): GB-MHRA-ADR 26422248. A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Naproxen, notes: regularly take mefanemic acid and naproxen (not the same time); Mefanemic acid, notes: regularly take mefanemic acid and naproxen (not the same time). Vaccination history included: Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovering", described as "Painful arm"; HYPERHIDROSIS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Sweating"; INSOMNIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Insomnia 1st and 2nd night"; OROPHARYNGEAL PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sore throat started 2nd day"; NAUSEA (medically significant) with onset 29Dec2021 15:00, outcome "recovering", described as "Nausea"; VACCINATION SITE PAIN (medically significant) with onset 29Dec2021, outcome "recovering", described as "Painful arm (injection site)"; CHILLS (medically significant), FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "unknown" and all described as "Shivers overnight including cold and then too hot". Therapeutic measures were taken as a result of pain in extremity, hyperhidrosis, insomnia, oropharyngeal pain, nausea, vaccination site pain, chills, feeling of body temperature change. Clinical course- Patient had not symptoms associated with COVID-19 and 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. Last menstrual period date: 05Dec2021. Patient had nausea from the evening after the injection (at 3pm) worse the following morning. Shivers overnight including cold and then too hot, resulting in sweating. Painful arm (injection site) started the same evening but was worse the following day, significantly improved on day 3 but still uncomfortable. Insomnia first and second night, Sore throat started second day. Treated with paracetamol. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033217 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Hypoaesthesia, Inappropriate schedule of product administration, Myocarditis, Palpitations, Pericarditis, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:less than 2; Comments: normal
CDC Split Type: GBPFIZER INC202200000660

Write-up: Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; numbness LEFT arm; myocarditis; pericarditis; inappropriate schedule of vaccine administered; Acute chest pain/Chest pain; This is a spontaneous report received from a contactable Consumer from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112311610416030-DZUFA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26422895 (MHRA). A 46 year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) at the age of 46 years as dose 2, 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: COMIRNATY (Dose 1), administration date: 15Sep2021, for COVID-19 immunisation. The following information was reported: CHEST PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Acute chest pain/Chest pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "numbness LEFT arm"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "inappropriate schedule of vaccine administered". The report was considered to be related to possible inflammation of the heart (myocarditis or pericarditis), of which the diagnosis was made by an Emergency Room Doctor (Cardiologist). The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; chest x-ray: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (28Dec2021) negative; troponin (0-16): (unspecified date) less than 2, notes: normal. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033219 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Disorientation, Dizziness, Fatigue, Headache, Immunisation, Nausea, Photosensitivity reaction, SARS-CoV-2 test, Taste disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000584

Write-up: extreme nausea; dizziness; photo sensitivity; Booster; Spatial disorientation; headache; Unusual taste in mouth; fatigue/ heavy fatigue; 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-202112311633398240-IAKDG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26422932 (MHRA). A 44 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 44 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 (DOSE1, SINGLE, Start date of event: unknown, Outcome of event :recovered), administration date: May2021, for COVID-19 immunisation, reaction(s): "feeling of unsteadiness", "heavy fatigue", "sore arm", "Unusual taste in mouth"; Bnt162b2 (DOSE 2, SINGLE, Start date of event: unknown, Outcome of event :recovered), for COVID-19 immunisation, reaction(s): "spatial disorientation", "heavy fatigue", "sore arm". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; DISORIENTATION (medically significant) with onset 29Dec2021, outcome "recovering", described as "Spatial disorientation"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "headache"; TASTE DISORDER (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Unusual taste in mouth"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "fatigue/ heavy fatigue"; NAUSEA (medically significant), outcome "not recovered", described as "extreme nausea"; DIZZINESS (medically significant), outcome "not recovered", described as "dizziness"; PHOTOSENSITIVITY REACTION (medically significant), outcome "not recovered", described as "photo sensitivity". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: 3rd booster Pfizer Covid 19 vaccine - Unusual taste in mouth, spatial disorientation, headache and fatigue immediately after. Then feeling better until following day. Onset of extreme nausea, dizziness, spatial disorientation, photo sensitivity and heavy fatigue. Side effects less severe but still present 48 hours after injection. The report not related to possible inflammation of the heart (myocarditis or pericarditis). 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200016923 Same patient,product,different dose/event (Dose 1);GB-PFIZER INC-202200016924 Same patient,product,different dose/event (Dose 2)


VAERS ID: 2033221 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9707 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Heart rate, Loss of consciousness, Oxygen saturation, SARS-CoV-2 test, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:ok; Test Name: ECG; Result Unstructured Data: Test Result:ok; Test Name: Pulse; Result Unstructured Data: Test Result:83; Test Name: oxygen level; Result Unstructured Data: Test Result:ok; Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000487

Write-up: convulsions; Unconsciousness; 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-202112311651092040-TWGNB. Other Case identifier(s): GB-MHRA-ADR 26422803. A 16 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 13Oct2021 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Period pains" (unspecified if ongoing). Concomitant medication(s) included: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL] taken for dysmenorrhoea, start date: 01May2021. The following information was reported: SEIZURE (hospitalization, medically significant), outcome "recovering", described as "convulsions"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Unconsciousness". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) ok; electrocardiogram: (unspecified date) ok; heart rate: (unspecified date) 83; oxygen saturation: (unspecified date) ok; sars-cov-2 test: (13Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient was not currently breastfeeding. Patient''s last menstrual period date was 26Nov2021. 6 hours after the injection the patient fainted at the dinner table for almost a minute. According to patients parent''s the patient had convulsions for 4-6 seconds; it took her a good 10 minutes to properly come around. Patient''s father called an ambulance and she was taken to hospital for obs, released at 1AM. The following day her father called the GP and they were now being referred to a neurologist to be safe, but she was pretty certain it was the vaccine that caused the adverse reaction. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). 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: 2033234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Hypersensitivity, Immunisation, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (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 started )
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000443

Write-up: rash; Allergic reaction; 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-202112311825323090-N3XBA (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26423050 (regulatory authority). A 35 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. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, . The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; RASH (medically significant), outcome "not recovered", described as "rash"; HYPERSENSITIVITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Allergic reaction". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2021) yes - positive covid-19 test. Clinical course: Had a small rash within hours of having booster. Now (31st) the rash had tripled in size. Patient had 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: 2033239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 discomfort, Dizziness, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000555

Write-up: Headache; Dizziness; Pain; Tight chest; Nausea; 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-202112311909481190-BP62G. Other Case identifier(s): GB-MHRA-ADR 26423108. A 52 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (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 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Dizziness"; PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Pain"; CHEST DISCOMFORT (medically significant) with onset 30Dec2021, outcome "recovering", described as "Tight chest"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient''s last menstrual period was on 01Dec2021. Reporter had picked a scab the day before the jab and normal bleeding but after vaccine very watery and runny blood like it had been radically thinned. The patient did not know how if this impact on my blood clotting factor long term or not. Patient had not tested positive for COVID-19 since having the vaccine. Clinical trial participant. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033250 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Dizziness, Immunisation, Musculoskeletal stiffness, SARS-CoV-2 test, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000602

Write-up: tinnitus; stiff arm; Tinnitus, unspecified/After 3rd jab loud, high pitched, electronic like ringing in one ear; dizziness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112312023542310-B7GKT (RA). Other Case identifier(s): GB-RA-ADR 26423203 (RA). A 19-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''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation, reaction(s): "After first jab extremely stiff arm the next day"; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; TINNITUS (medically significant), outcome "recovering", described as "tinnitus"; DIZZINESS (medically significant) with onset 31Dec2021, outcome "recovering", described as "dizziness"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "recovering", described as "stiff arm"; TINNITUS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Tinnitus, unspecified/After 3rd jab loud, high pitched, electronic like ringing in one ear". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that after first jab, patient had an extremely stiff arm the next day. After 3rd jab loud, high pitched, electronic like ringing in one ear and dizziness 2 days after getting vaccinated. The medical history was reported as nothing of relevance. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, not currently breastfeeding. Patient has 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 relevant investigations or tests conducted. 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-202200018275 same patient and different dose/event


VAERS ID: 2033256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Arthralgia, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Arthritis (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 INC202200000764

Write-up: Pain joint/Joints in elbows wrists thumbs in both hands really painful; 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-202112312133024250-W3LU3 (RA). Other Case identifier(s): GB-RA-ADR 26423245 (RA). A 35 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''s relevant medical history and 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 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pain joint/Joints in elbows wrists thumbs in both hands really painful". Clinical course: Patient last menstrual period date: 24Dec2021. Patient is not pregnant, Patient is not currently breastfeeding. Joints in elbows wrists thumbs in both hands really painful. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033302 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Fatigue, Headache, Immunisation, Lethargy, Pain in extremity
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Medical History/Concurrent Conditions: Asthma (controlled); Comments: Asthma, controlled Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000578

Write-up: Headache; Lethargy; Aches & pains in legs; became very tired and slept for 13 hours; Pain in arm; 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-202201010120404080-9BYEZ (RA). Other Case identifier(s): GB-MHRA-ADR 26423370 (RA). A 29-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: controlled. Patient has not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: unknown), for COVID-19 Immunization; Bnt162b2 (Dose 2, Batch/lot number: unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovered", described as "Headache"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovered", described as "Pain in arm"; LETHARGY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Lethargy"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovered", described as "Aches & pains in legs"; FATIGUE (medically significant) with onset 29Dec2021, outcome "unknown", described as "became very tired and slept for 13 hours". Clinical course: Patient had 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: 2033305 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Chills, Fatigue, Headache, Hunger, Hyperhidrosis, Immunisation, Insomnia, Interchange of vaccine products, Lymphadenopathy, Menstrual disorder, Nausea, Off label use, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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; Chronic fatigue syndrome; Heart murmur
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000711

Write-up: fever; sweating; shivering; tiredness; Swollen lymph nodes; Menstrual cycle abnormal; Throat pain; Nausea; Fever chills; Pain; Insomnia; Off label use; Interchange of vaccine products; Booster; Headache; Fatigue; Hunger; 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-202201010207240220-8KCD1 (RA). Other Case identifier(s): GB-MHRA-ADR 26423396 (RA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9712) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "Cardiac murmur" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Patient''s last menstrual period date was on 17Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, and not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Past drug history included: Montelukast; Propranolol for Anxiety. 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 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache". It was reported that extreme headache which started at the back and then was like a migraine; HUNGER (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Hunger". Hunger - feel ravenous. FATIGUE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fatigue"; INSOMNIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Insomnia". Fatigue/insomnia-extreme tiredness yet now struggling to sleep; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Nausea". It was reported that patient experienced nausea first thing in morning day after; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever chills"; PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pain". Pain-particularly worst on the side patient was jabbed shoulder blade, collar bone and arm as well as general aches and pains over her body; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes". Swollen lymph nodes-very painful unable to wear bra; MENSTRUAL DISORDER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Menstrual cycle abnormal". Menstrual cycle-has come very early; OROPHARYNGEAL PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Throat pain". Throat pain - sore throat; PYREXIA (medically significant), outcome "recovering", described as "fever"; HYPERHIDROSIS (medically significant), outcome "recovering", described as "sweating"; CHILLS (medically significant), outcome "recovering", described as "shivering"; all reported as fever/chills - one minute sweating, the next shivering, still suffering. FATIGUE (medically significant), outcome "recovering", described as "tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Sep2021) positive, notes: Yes - Positive COVID-19 test. 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: 2033307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Back pain, Chills, Fatigue, Headache, Immunisation, Peripheral swelling, Pyrexia, Skin warm, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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)

Life Threatening? No
Birth Defect? No
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 INC202200000659

Write-up: Vomiting; Fatigue; Fever; Shivers; Backache; Skin warm; Headache; BOOSTER; Armpit pain; Swollen arm; This is a spontaneous report received from a contactable Consumer from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201010236538330-4AFV1 (RA). Other Case identifier(s): GB-MHRA-ADR 26423401 (RA). A female patient received BNT162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was unsure if patient had had symptoms associated with COVID-19. The patient had not had a COVID-19 test. 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 29Dec2021, outcome "unknown", described as "BOOSTER"; AXILLARY PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Armpit pain"; PERIPHERAL SWELLING (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen arm"; VOMITING (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Vomiting"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Headache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fatigue"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Fever"; CHILLS (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Shivers"; BACK PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Backache"; SKIN WARM (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Skin warm". 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: 2033316 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Fatigue, Headache, Immunisation, Insomnia, Interchange of vaccine products, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism congenital
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000714

Write-up: Insomnia NOS; Fatigue; Headache; Generalised muscle aches; 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 Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201010906002280-5HLK5 (RA). Other Case identifier(s): GB-MHRA-ADR 26423764 (RA). A 55 year-old patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism congenital" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for congenital hypothyroidism. 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. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; INSOMNIA (disability, medically significant), outcome "not recovered", described as "Insomnia NOS"; FATIGUE (disability, medically significant), outcome "not recovered", described as "Fatigue"; HEADACHE (disability, medically significant), outcome "not recovered", described as "Headache"; MYALGIA (disability, medically significant), outcome "not recovered", described as "Generalised muscle aches". 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033319 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Hypersensitivity, Immunisation, Interchange of vaccine products, Off label use, Peripheral swelling, Pyrexia, Rash, Rash macular, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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? 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 INC202200000325

Write-up: fever; rash; swelling to hands and arms/Rapid spread and anger of the rash/blotches/swellings; swelling to hands and arms/Rapid spread and anger of the rash/blotches/swellings; Systemic allergic reaction; 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-202201010952278830-54PV3. Other Case identifier(s): GB-MHRA-ADR 26423822. A 32-year-old patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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 X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown) ), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HYPERSENSITIVITY (hospitalization, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Systemic allergic reaction"; PYREXIA (hospitalization, medically significant), outcome "not recovered", described as "fever"; RASH (hospitalization, medically significant), outcome "not recovered", described as "rash"; RASH MACULAR (hospitalization, medically significant), PERIPHERAL SWELLING (hospitalization, medically significant), outcome "not recovered" and all described as "swelling to hands and arms/Rapid spread and anger of the rash/blotches/swellings". The events "rash", "swelling to hands and arms/rapid spread and anger of the rash/blotches/swellings" and "swelling to hands and arms/rapid spread and anger of the rash/blotches/swellings" 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. Therapeutic measures were taken as a result of hypersensitivity, rash, rash macular, peripheral swelling. Clinical course: One taken. No improvement. Rash rapidly growing and swelling to hands and arms. Attended a and e. Given stat dose of 40mg steroids. And a prescription for 5 days 30 mg prednisolone if needed. No better from steroids. Rapid spread and anger of the rash/blotches/swellings. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction. The investigations or tests conducted, reported as Seen by GP and A and E. taken fexofenadine and prednisolone.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: 2033331 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Atonic seizures, Headache, Immunisation, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (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: LACOSAMIDE; PROPRANOLOL; QUININE SULPHATE; TOPIRAMATE; ZEBINIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epileptic seizure; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Muscle spasms; Tremor
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000499

Write-up: Drop seizures; Nausea; Headache; 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-202201011137427390-OTMRD. A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "Tremor" (unspecified if ongoing); "Muscle spasms" (unspecified if ongoing). Concomitant medication(s) included: LACOSAMIDE taken for epilepsy, start date: 2016; PROPRANOLOL taken for tremor, start date: 2016; QUININE SULPHATE taken for muscle spasms, start date: 2015; TOPIRAMATE taken for epilepsy, start date: 1997; ZEBINIX taken for epilepsy, start date: 20Aug2020. Vaccination history included: Covid-19 vaccine (DOSE-1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose-2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ATONIC SEIZURES (medically significant) with onset 30Dec2021, outcome "recovering", described as "Drop seizures"; NAUSEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Nausea"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative. Clinical course-The headache was constantly there all the time, but patient can tolerate it, unfortunately patient cannot take paracetamol. The nausea was a sign of a drop seizure coming, these have dramatically increased since having her booster jab. This returns agains for about an hour after the seizure has taken place. Given a choice patient would opt for a different vaccine next time. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient was currently awaiting brain surgery. Her anti-epileptic medication weakened her immune system. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-MHRA-ADR 26423977


VAERS ID: 2033337 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 INC202200000497

Write-up: lethargy; aching joints; Head ache; general weakness; Tired out; 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-202201011216388190-ZZN8X. Other Case identifier(s): GB-MHRA-ADR 26423978. A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) at the age of 59 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 astrazeneca (DOSE 2), administration date: 26May2021, for Covid-19 immunization; Covid-19 vaccine astrazeneca (DOSE 1), administration date: 20Mar2021, for COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LETHARGY (medically significant), outcome "not recovered", described as "lethargy"; ARTHRALGIA (medically significant), outcome "not recovered", described as "aching joints"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Tired out"; HEADACHE (medically significant), outcome "unknown", described as "Head ache"; ASTHENIA (medically significant), outcome "unknown", described as "general weakness". 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 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. No further information is expected.


VAERS ID: 2033340 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 INC202200000540

Write-up: Booster; Off label use; Interchange of vaccine products; Headache; Tired out; Lethargy; 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-202201011228187610-KNAJF. Other Case identifier(s): GB-MHRA-ADR 26423981. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) 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: 21Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (dose 2), administration date: 14Jun2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Tired out"; LETHARGY (medically significant) with onset 29Dec2021, outcome "recovering", described as "Lethargy". 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 had 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. No further information is expected.


VAERS ID: 2033343 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Decreased appetite, Dysgeusia, Fatigue, Glossodynia, Immunisation, Influenza, Interchange of vaccine products, Myocarditis, Neck pain, Off label use, Pain, Pericarditis, SARS-CoV-2 test, Swelling, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000733

Write-up: Fatigue/unusual tiredness/tired; possible inflammation of the heart (myocarditis); possible inflammation of the heart (pericarditis); no appetite; injection site swollen; injection site was tender; injection site bruised; Taste metallic; Sore tongue; body aches down to her hips; body aches from her neck down; blood was seen in the syringe; body ache; Off label use; Interchange of vaccine products; Booster; flu; Swelling; Back ache; This is a spontaneous report received from a contactable reporter (consumer) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011248357160-DTFHL. Other Case identifier: GB-MHRA-ADR 26424020. A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: fk9706) at the age of 59 years as dose 3, (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medications included: INFLUENZA VIRUS taken for immunisation, administration date 01Dec2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN ), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN ). The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; INFLUENZA (medically significant) with onset 29Dec2021, outcome "recovering", described as "flu"; SWELLING (medically significant) with onset 29Dec2021, outcome "recovering", described as "Swelling"; BACK PAIN (medically significant) with onset 29Dec2021, outcome "recovering", described as "Back ache"; GLOSSODYNIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Sore tongue"; DYSGEUSIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Taste metallic"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness/tired"; MYOCARDITIS (medically significant), outcome "unknown", described as "possible inflammation of the heart (myocarditis)"; PERICARDITIS (medically significant), outcome "unknown", described as "possible inflammation of the heart (pericarditis)"; PAIN (medically significant) with onset 29Dec2021, outcome "unknown", described as "body ache"; DECREASED APPETITE (medically significant), outcome "unknown", described as "no appetite"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "injection site swollen"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "injection site was tender"; ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "unknown", described as "body aches down to her hips"; NECK PAIN (medically significant) with onset 29Dec2021, outcome "unknown", described as "body aches from her neck down"; VACCINATION SITE HAEMORRHAGE (medically significant) with onset 29Dec2021, outcome "unknown", described as "blood was seen in the syringe"; VACCINATION SITE BRUISING (medically significant), outcome "unknown", described as "injection site bruised". The patient underwent the following laboratory tests and procedures COVID-19 virus test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were not taken as a result of myocarditis, pericarditis. Clinical course: Patient asked for her booster to be aspirated before injecting and blood was seen in the syringe. The clinician started to inject the vaccine, she said to stop and try another place which he did although a small amount of the vaccine was injected into her blood vessel. The second attempt did not show blood on aspiration so she said to continue with the vaccination. Within 3 hours she started to feel flu like body aches from her neck down to her lower back/hips. She also felt very tired and had no appetite. The injection site was swollen and tender. The initial injection site bruised significantly where she had bled. This report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. No treatment given. No imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT), no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033360 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pain in jaw, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000773

Write-up: Period pains; jaw pain; Off label use; Interchange of vaccine products; booster; Muscle 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-202201011355355180-FKJQD. Other Case identifier(s): GB-MHRA-ADR 26424075. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS, administration date Nov2021. 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 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Muscle pain"; DYSMENORRHOEA (medically significant), outcome "not recovered", described as "Period pains"; PAIN IN JAW (medically significant), outcome "unknown", described as "jaw pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) no - negative covid-19 test. Clinical course: Patient had extreme muscle pain everywhere, including jaw, extreme period pain (have not had period approximately 5 years) back too. 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: 2033371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Blister, Hypersensitivity, Immunisation, Rash, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000348

Write-up: hives; blisters; rash; Allergy; 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-202201011520249140-CCM8W. Other Case identifier(s): GB-MHRA-ADR 26424131. A 61 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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 (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; URTICARIA (disability, medically significant), outcome "recovering", described as "hives"; HYPERSENSITIVITY (disability, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Allergy"; BLISTER (disability, medically significant), outcome "unknown", described as "blisters"; RASH (disability, medically significant), outcome "unknown", described as "rash". Therapeutic measures were taken as a result of urticaria, hypersensitivity, blister, rash. Clinical course: Unsure if patient has 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. Patient report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient was given antihistamine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033377 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Headache, Heart rate irregular, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; 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: stomach pain; joint ache; nausea; muscle ache; headache; Heartbeats irregular; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26424181) 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 HEART RATE IRREGULAR (Heartbeats irregular), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (joint ache), NAUSEA (nausea), MYALGIA (muscle ache) and HEADACHE (headache) in a 55-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) (COVID-19 VACCINE ASTRAZENECA) from 07-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 29-Dec-2021, the patient experienced HEART RATE IRREGULAR (Heartbeats irregular) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion medically significant), ARTHRALGIA (joint ache) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant), MYALGIA (muscle ache) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 30-Dec-2021, HEART RATE IRREGULAR (Heartbeats irregular) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (joint ache), NAUSEA (nausea), MYALGIA (muscle ache) and HEADACHE (headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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. Patient reported that after receiving Moderna vaccine at 3:30pm On 29-Dec-2021 She experienced irregular heartbeat, nausea, stomach pain, headache and muscle ache, joint ache & felt very tired, pain at the injection site and felt very cold but was hot to touch. Patient was fit and doing exercise every day, had no underlying health conditions. Patient took paracetamol every 4 hours and rested until symptoms stopped in late afternoon of 30-Dec-2021. 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 55 year old female with no medical history reported, vaccinated with COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) as primary series, who experienced serious ( Medically significant ) , unexpected, AESI event of heart rate irregular which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , On an unknown date after vaccination with the 3rd dose , she experienced , Serious ( medically significant ) , unexpected events of abdominal pain upper, arthralgia , myalgia , nausea and headache. 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 55 year old female with no medical history reported, vaccinated with COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) as primary series, who experienced serious ( Medically significant ) , unexpected, AESI event of heart rate irregular which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , On an unknown date after vaccination with the 3rd dose , she experienced , Serious ( medically significant ) , unexpected events of abdominal pain upper, arthralgia , myalgia , nausea and headache. 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: 2033379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Headache, Immunisation, Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000841

Write-up: Glands swollen; Headache; Muscle pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201011618166950-JKQM2. Other Case identifier(s): GB-MHRA-ADR 26424182. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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, lot unknown, single), for COVID-19 immunization; Bnt162b2 (Dose 2, lot unknown, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Glands swollen"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Orchitis, Pain
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: SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Suspected COVID-19 (Unsure when symptoms started and when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000300

Write-up: Orchitis; 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-202201011707173310-GGAFN. Other Case identifier(s): GB-MHRA-ADR 26424219. A 28 year-old male patient received BNT162B2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started and when symptoms stopped; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SALBUTAMOL taken for asthma. 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 29Dec2021, described as "Booster"; ORCHITIS (medically significant) with onset 01Jan2022, outcome "recovering", described as "Orchitis"; PAIN (medically significant) with onset 01Jan2022, outcome "recovering", described as "Ache". It was reported that, ever since had Covid previously, the patient required a salbutamol inhailer. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033389 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Back pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Muscle spasms, Off label use, Pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (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; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000370

Write-up: pain; my underarm started swelling; had a bruise like pain; the pain started travelling to the back of my underarm/back area; Back muscle spasms; Booster; off-label use; Interchange of vaccine products; 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-202201011725594590-ZBZK6. Other Case identifier(s): GB-MHRA-ADR 2642423. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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 moderna (DOSE 1), administration date: 2021, for COVID-19 Immunisation; Covid-19 vaccine moderna (DOSE 2), administration date: 2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN (medically significant), outcome "recovering", described as "pain"; MUSCLE SPASMS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Back muscle spasms"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "my underarm started swelling"; AXILLARY PAIN (medically significant), outcome "unknown", described as "had a bruise like pain"; BACK PAIN (medically significant), outcome "unknown", described as "the pain started travelling to the back of my underarm/back area". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical information: Patient had both their two vaccinations earlier in the years of 2021. Patient was offered the moderna vaccine and had the common side effects. Since getting their booster jab (Pfizer), Patient had the usual side effects. 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: 2033478 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Chills, Fatigue, Immunisation, Influenza like illness, Lethargy, Musculoskeletal stiffness, Myalgia, Nausea, Night sweats, Oedema, Rash pruritic, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE; OCTASA; METHYLPHENIDATE HYDROCHLORIDE; PARACETAMOL; CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD, combined type; Anxiety; Chest infection; Colitis; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Pain; Ulcerative colitis (Currently in remission with Ulcerative colitis and it is generally mild when active)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003528

Write-up: Flu like symptoms; Lethargy/general feeling of lethargy; Edema; Chills; Night sweat; Booster; Pain at injection site began a few hours after vaccine; Muscle ache; Stiff muscle in arm and leg on side of body where vaccine was done; Nausea; Fatigue; Itchy rash/Itchy bumps on skin; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021150362800-D6MDT (RA). Other Case identifier(s): GB-MHRA-ADR 26424856 (RA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing), notes: Currently in remission with Ulcerative colitis and it is generally mild when active; "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); "Chest infection" (unspecified if ongoing); "ADHD, combined type" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE taken for anxiety, start date: 01Jun2017; OCTASA taken for colitis, start date: 01Oct2018; METHYLPHENIDATE HYDROCHLORIDE taken for attention deficit hyperactivity disorder, start date: 01Apr2019; PARACETAMOL taken for pain, start date: 01Nov2021; CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM] taken for lower respiratory tract infection, start date: 21Dec2021, stop date: 27Dec2021. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation.Unsure if patient 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. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (medically significant) with onset 29Dec2021, outcome "unknown", described as "Pain at injection site began a few hours after vaccine"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Muscle ache"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 29Dec2021, outcome "recovered", described as "Stiff muscle in arm and leg on side of body where vaccine was done"; NAUSEA (medically significant) with onset 29Dec2021, outcome "recovered", described as "Nausea"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fatigue"; RASH PRURITIC (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Itchy rash/Itchy bumps on skin"; OEDEMA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Edema"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chills"; NIGHT SWEATS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Night sweat"; INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "Flu like symptoms"; LETHARGY (medically significant), outcome "recovered", described as "Lethargy/general feeling of lethargy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course: It was reported that the patient had pain at injection site began a few hours after vaccine. Stiff muscle in arm and leg on side of body where vaccine was done within minutes of having vaccine but soon resolved itself. Flu like symptoms for a few days and general feeling of lethargy. Small itchy bumps on skin. 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: 2033479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FM3092 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Influenza, Interchange of vaccine products, Lymphadenopathy, Malaise, Off label use, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELLESTE DUET
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003558

Write-up: Felt generally unwell for approx 4 days; Swollen lymph nodes came on later and are uncomfortable; Pain/ My arm was extremely painful (couldn''t bear it to be touched); Flu symptoms; 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 Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021151291550-FT1IZ (RA). Other Case identifier(s): GB-MHRA-ADR 26424854 (RA). A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FM3092) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: ELLESTE DUET, start date: 01Sep2020. 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. Patient had no symptoms associated with COVID-19 had not undergone a COVID-19 test. Patient was not currently breastfeeding and had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Pain/ My arm was extremely painful (couldn''t bear it to be touched)"; INFLUENZA (medically significant) with onset 30Dec2021, outcome "recovered" (02Jan2022), described as "Flu symptoms"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes came on later and are uncomfortable"; MALAISE (medically significant), outcome "not recovered", described as "Felt generally unwell for approx 4 days". 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: 2033482 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Dyspnoea, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, Rash, Rash pruritic, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; OMEPRAZOLE [OMEPRAZOLE SODIUM]; BISOPROLOL; BUTRANS; CETIRIZINE; DOCUSATE; OXYBUTYNIN; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Antacid therapy; Bladder disorder; Blood pressure abnormal; Constipation; COVID-19 (Tested positive on 27Nov2021); High cholesterol; Pain; Sensation of blood flow
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003465

Write-up: Suspected COVID-19; Headache; Tiredness; Rash; Lethargy; I started getting a rash which is extremely itchy; Off label use; Interchange of vaccine products; Booster; Dizziness; Breath shortness/Short of breath; 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-202201021204302920-IPYZU (RA). Other Case identifier(s): GB-MHRA-ADR 26424876 (RA). A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 27Nov2021 (unspecified if ongoing), notes: Tested positive on 27Nov2021; "High cholesterol" (unspecified if ongoing); "Bladder disorder" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Antacid therapy" (unspecified if ongoing); "Sensation of blood flow" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for sensation of blood flow; OMEPRAZOLE [OMEPRAZOLE SODIUM] taken for antacid therapy; BISOPROLOL taken for blood pressure abnormal; BUTRANS taken for pain; CETIRIZINE taken for hypersensitivity; DOCUSATE taken for constipation; OXYBUTYNIN taken for bladder disorder; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: COVID-19 vaccine astrazeneca (Dose number unknown), administration date: Mar2021, for COVID-19 Immunisation; COVID-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Dizziness"; DYSPNOEA (medically significant) with onset 29Dec2021, outcome "recovered", described as "Breath shortness/Short of breath"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Tiredness"; RASH (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Rash"; LETHARGY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Lethargy"; RASH PRURITIC (medically significant) with onset 30Dec2021, outcome "unknown", described as "I started getting a rash which is extremely itchy"; SUSPECTED COVID-19 (medically significant), outcome "not recovered", described as "Suspected COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) yes - positive COVID-19 test. Therapeutic measures (cream and antihistamines) were taken as a result of rash, rash pruritic. Clinical course: It was reported that after vaccine she was dizzy and short of breath for that day and further 2 days. Next day along with headache, tiredness she started getting a rash which was extremely itchy. She was putting on cream and taking antihistamines. The tiredness had also continued. No investigations or tests were conducted. 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: 2033492 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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, Pain in extremity, 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), 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: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003610

Write-up: Swollen sore lymph nodes under armpit; Large red bump on arm, still sore; booster; Swollen arm; 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-202201021355373460-SBHCR. Other Case identifier(s): GB-MHRA-ADR 26424919. A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 31 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 1), for Covid-19 immunisation; Bnt162b2 (DOSE 2), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen arm"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "Swollen sore lymph nodes under armpit"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Large red bump on arm, still sore". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Large red bump on arm, still sore and remains after 72 hours. Swollen sore lymph nodes under armpit. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report is 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: 2033497 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear discomfort, Ear pain, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003536

Write-up: Ear pressure/fullness sensation; Tinnitus/sudden onset of severe tinnitus/Ear ringing in both ears; Ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202201021416026960-2G80G. Other Case identifier(s): GB-MHRA-ADR 26424939. A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FK9706) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19, not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: TINNITUS (hospitalization, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Tinnitus/sudden onset of severe tinnitus/Ear ringing in both ears"; EAR PAIN (hospitalization, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Ear pain"; EAR DISCOMFORT (hospitalization, medically significant), outcome "unknown", described as "Ear pressure/fullness sensation". Clinical course: Tinnitus/ear ringing continues at steady level with no relief across the day/night. No record of tinnitus prior to the vaccine. The report of the patient 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: 2033505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Diarrhoea, Immunisation, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003552

Write-up: Diarrhoea; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021518178770-9Z433. Other Case identifier(s): GB-MHRA-ADR 26424992. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", (not ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: unknown), for COVID-19 Immunization; Bnt162b2 (Dose 2, Batch/lot number: unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test, notes: No-Negative COVID-19 test. Therapeutic measures were taken as a result of diarrhoea. The clinical course reported as patient had to go first thing in the morning a few times, then a couple thereafter. On day 3 started taking Imodium but problem was still persisting, on day 4 also had been drinking diaoralite. Patient had not tested positive for COVID-19 since having the vaccine. Patent 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: 2033524 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Blood test, Chest X-ray, Electrocardiogram, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain, SARS-CoV-2 test, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: blood test; Result Unstructured Data: Test Result:Unknown result; Test Name: chest x Ray; Result Unstructured Data: Test Result:Unknown result; Test Date: 20220105; Test Name: Ecg; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC202200003668

Write-up: clots; Headaches; Pain; 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 the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021842496190-HUUOX. Other Case identifier(s): GB-MHRA-ADR 26425147. A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 45 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; THROMBOSIS (medically significant), outcome "recovering", described as "clots"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; HEADACHE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Headaches"; PAIN (medically significant) with onset 30Dec2021, outcome "unknown", described as "Pain". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result; chest x-ray: (unspecified date) unknown result; electrocardiogram: (05Jan2022) unknown result; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test; ultrasound scan: (unspecified date) unknown result. Therapeutic measures were taken as a result of thrombosis, lymphadenopathy, headache, pain. Clinical course: Patient last menstrual period date: 1-JAN-2022. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Swollen lymph nodes in neck which started on evening of vaccine, same side as vaccine arm, next day they were bigger and very painful, since then the pain and swelling as moved down towards my shoulder blade which is very puffy and swollen and very painful, can not even sleep properly on my neck. Headaches have also started. Went to hospital they checked for clots which thankfully was clear, have to go back for an ultrasound on the neck on Wednesday 5th jan, have been told to keep up painkillers! Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient 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: 2033525 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dysphonia, SARS-CoV-2 test, Somnolence, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood
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: Drowsiness; Voice lowered; Dizziness; Blurred vision; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425170) 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 VISION BLURRED (Blurred vision), SOMNOLENCE (Drowsiness), DYSPHONIA (Voice lowered) and DIZZINESS (Dizziness) in a 60-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. The patient''s past medical history included Clot blood. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced SOMNOLENCE (Drowsiness) (seriousness criterion medically significant) and DYSPHONIA (Voice lowered) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurred vision) and SOMNOLENCE (Drowsiness) was resolving, DYSPHONIA (Voice lowered) had resolved and DIZZINESS (Dizziness) had resolved with sequelae. 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. Patient had a previous blood clot reaction with the first Astra Zeneca dose. No concomitant and treatment information was provided. It was reported that after the booster patient did not experience any discomfort or pain. Following week patient started to feel tired and thought was due to work and life stress. His drowsiness was similar to a diabetic fit imagine, low blood pressure and could not talk clearly. Patient had some kind of fit like small naps when sitting at accident and emergency, department not sure if due to the situation or the effort made to reach the hospital. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Report not related to possible inflammation of the heart (myocarditis or pericarditis) Company comment: This regulatory authority case concerns a 60-year-old male patient with previous administration of COVID-19 Vaccine AstraZeneca and blood clot due to the vaccine, who experienced serious unexpected event of vision blurred, somnolence, dysphonia and dizziness, that occurred approximately 6 days 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 60-year-old male patient with previous administration of COVID-19 Vaccine AstraZeneca and blood clot due to the vaccine, who experienced serious unexpected event of vision blurred, somnolence, dysphonia and dizziness, that occurred approximately 6 days 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: 2033551 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Diarrhoea, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pyrexia, SARS-CoV-2 test, Vomiting
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), 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: TAMOXIFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer female; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003518

Write-up: Diarrhea recurrent; Off label use; Interchange of vaccine products; Booster; Unwell; Vomiting; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority and Healthcare products Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201022306376060-IANGP. Other Case identifier(s): GB-MHRA-ADR 26425389. A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 07Jul2021, stop date: 13Jul2021; "Breast cancer female" (unspecified if ongoing). Patient was not currently breastfeeding. She had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication(s) included: TAMOXIFEN taken for breast cancer female, start date: 05Jun2017. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1), administration date: 12Mar2021, for COVID-19 Immunization; COVID-19 vaccine astrazeneca (DOSE 2), administration date: 16May2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MALAISE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Unwell"; VOMITING (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Vomiting"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Fever"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Diarrhea recurrent". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test on an unspecified date and result showed yes - positive COVID-19 test. Reportedly, the patient began to feel unwell during the night after the vaccine. This began with vomiting and a fever and then diarrhoea too. According to the patient this was the worst D and V that she had ever experienced. The vomiting stopped after about eight hours but the diarrhoea was still going on, albeit now improving. She was in bed for three days. The fever lasted forty eight hours. 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: 2033590 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (Diagnosed endometriosis and on Combined Pill since then.)
Allergies:
Diagnostic Lab Data: Test Date: 20211227; 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; Fever; Shivers; Joint pain; Vomited; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26427422) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PYREXIA (Fever), CHILLS (Shivers), ARTHRALGIA (Joint pain) and VOMITING (Vomited) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. The patient''s past medical history included Endometriosis (Diagnosed endometriosis and on Combined Pill since then.) in 2017. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant), PYREXIA (Fever) (seriousness criteria hospitalization and medically significant), CHILLS (Shivers) (seriousness criteria hospitalization and medically significant), ARTHRALGIA (Joint pain) (seriousness criteria hospitalization and medically significant) and VOMITING (Vomited) (seriousness criteria hospitalization and medically significant). On 30-Dec-2021, CHEST PAIN (Chest pain), PYREXIA (Fever), CHILLS (Shivers) and VOMITING (Vomited) had resolved. At the time of the report, ARTHRALGIA (Joint pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-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. Patient has not had symptoms associated with COVID-19. 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. Company comment: This Regulatory Authority case concerns a 26-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of chest pain, pyrexia, chills, arthralgia and vomiting. The patient developed arthralgia on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with headache 6 hours after vaccination, for what she took paracetamol. She could not sleep as her chest felt pressured and developed chills along with body pain. Complicated with nausea and vomited a couple of times. Paramedics derived her to the hospital where she had blood tests, ECG tests and Xrays, however results were not reported. She was discharged in the afternoon the day after vaccination. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. 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 26-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of chest pain, pyrexia, chills, arthralgia and vomiting. The patient developed arthralgia on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with headache 6 hours after vaccination, for what she took paracetamol. She could not sleep as her chest felt pressured and developed chills along with body pain. Complicated with nausea and vomited a couple of times. Paramedics derived her to the hospital where she had blood tests, ECG tests and Xrays, however results were not reported. She was discharged in the afternoon the day after vaccination. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033592 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

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

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

Write-up: Neck swelling; Earache; This case was received via RA (Reference number: GB-MHRA-ADR 26427467) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling) and EAR PAIN (Earache) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 08-Apr-2021 to an unknown date for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced SWELLING (Neck swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (Neck swelling) and EAR PAIN (Earache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were reported Company comment: This is a regulatory authority case concerning a 52-year-old female patient with no relevant medical history, who experienced unexpected events of swelling and ear pain (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 52-year-old female patient with no relevant medical history, who experienced unexpected events of swelling and ear pain (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033598 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Migraine headache; Fatigue; Nausea; This case was received via regulatory authority on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 31-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 29-Dec-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine headache) and NAUSEA (Nausea) had not resolved and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient last menstrual period date was 27-Dec-2021. Concomitant product use was not provided by the reporter. 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 31-year-old female patient with no medical history provided, who experienced serious unexpected events of Migraine, Nausea and Fatigue. The events occurred during the same day when the patient had received the mRNA-1273 vaccine (as third dose, booster). At the time of this report, the events of Nausea and Migraine had not resolved, while the event of Fatigue was resolving. No additional details regarding the clinical course of the events were provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 31-year-old female patient with no medical history provided, who experienced serious unexpected events of Migraine, Nausea and Fatigue. The events occurred during the same day when the patient had received the mRNA-1273 vaccine (as third dose, booster). At the time of this report, the events of Nausea and Migraine had not resolved, while the event of Fatigue was resolving. No additional details regarding the clinical course of the events were provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2033600 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Palpitations
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

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

Write-up: Palpitations; Nausea; Headache; This case was received via RA. (Reference number: GB-MHRA-ADR 26427935) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Palpitations), HEADACHE (Headache) and NAUSEA (Nausea) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient did not have symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since she had received the vaccine. No treatment information was provided. Company comment: This case concerns a 50-year-old, female patient with no medical history reported, who experienced the unexpected events of headache, palpitations and nausea. The event of headache occurred on the same day after the third dose of mRNA-1273, while palpitations and nausea occurred one day later. 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 50-year-old, female patient with no medical history reported, who experienced the unexpected events of headache, palpitations and nausea. The event of headache occurred on the same day after the third dose of mRNA-1273, while palpitations and nausea occurred one day later. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2033620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia repair (I had hernia surgery on the 23rd November)
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: Swelling arm; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26429252) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Hernia repair (I had hernia surgery on the 23rd November). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 25-Jan-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 02-Apr-2021 to an unknown date 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 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and HEADACHE (Headache) 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 treatment information was provided Patient had a large lump which was hot to touch, which causing pain, where she had the vaccine. Patient constant headache. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Re-challenge was reported as unknown. Company comment: This is a regulatory case concerning unknown age, female patient, with no relevant medical history reported, with an Interchange of vaccine products (two doses were with PFIZER BIONTECH COVID-19 VACCINE, 8 months before current vaccination), who experienced the serious unexpected, according RA, events of Peripheral swelling and headache. The event headache occurred approximately the same day after the third dose of mRNA-1273 vaccine. The event peripheral swelling occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning unknown age, female patient, with no relevant medical history reported, with an Interchange of vaccine products (two doses were with PFIZER BIONTECH COVID-19 VACCINE, 8 months before current vaccination), who experienced the serious unexpected, according RA, events of Peripheral swelling and headache. The event headache occurred approximately the same day after the third dose of mRNA-1273 vaccine. The event peripheral swelling occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


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