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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 167 out of 10,493

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VAERS ID: 2009348 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial pain, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (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: Illness (no medical care required.); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Facial pain; Swelling face; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26390151) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PAIN (Facial pain) and SWELLING FACE (Swelling face) in a 49-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Illness (no medical care required.) and Suspected COVID-19 from 10-Aug-2021 to 17-Aug-2021. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced FACIAL PAIN (Facial pain) (seriousness criterion medically significant) and SWELLING FACE (Swelling face) (seriousness criterion medically significant). At the time of the report, FACIAL PAIN (Facial pain) and SWELLING FACE (Swelling face) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-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 reported that about 2 hours after receiving the vaccine started experiencing pain on the left side of jaw below left ear. This was severe enough that chewing food was difficult. About 4 hours after the vaccine, my wife reported that left cheek and jaw area was swollen. Took 2 ibuprofen and went to bed. This morning the pain and swelling is reduced but still present. No Concomitant medication information was reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This report is not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a 49-year-old, male patient with with no relevant medical history, who experienced the serious unexpected , according to the RA, events of Facial pain and Swelling face. The events occurred approximately the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The outcome of the events was recovering/ resolving. 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 a 49-year-old, male patient with with no relevant medical history, who experienced the serious unexpected , according to the RA, events of Facial pain and Swelling face. The events occurred approximately the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The outcome of the events was recovering/ resolving. 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.


VAERS ID: 2009352 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Pain in arm; Feeling hot and cold; Fever; Aches & pains in legs; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26390220) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Aches & pains in legs), HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) in a 22-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) had not resolved and PAIN IN EXTREMITY (Aches & pains in legs) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-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 concomitant medication were reported. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment medication were reported. Company comment: This is a regulatory case concerning a 22 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according regulatory authority, events of pyrexia, pain in extremity (reported as Pain in arm and Aches & pains in legs), headache and Feeling of body temperature change. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event pain in extremity (reported as Aches & pains in legs) was reported as recovered and the rest of the events as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 22 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according regulatory authority, events of pyrexia, pain in extremity (reported as Pain in arm and Aches & pains in legs), headache and Feeling of body temperature change. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event pain in extremity (reported as Aches & pains in legs) was reported as recovered and the rest of the events as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009357 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211220; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shivery; sleepy; High temperature; Shivering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26390434) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivery), SOMNOLENCE (sleepy), PYREXIA (High temperature) and CHILLS (Shivering) in a 26-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivery) (seriousness criterion medically significant) and SOMNOLENCE (sleepy) (seriousness criterion medically significant). On 24-Dec-2021, CHILLS (Shivering) had resolved. At the time of the report, CHILLS (shivery) and SOMNOLENCE (sleepy) was resolving and PYREXIA (High temperature) 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. No concomitant medications were reported. No treatment medication was provided. Patient''s last menstrual period date was at 22-DEC-2021. Patient felt really cold and shivery whilst patient''s partner was very very warm. Patient could not warm up feet or face/nose for a long time. The effects came on about 6 hours after the booster vaccination and then lasted all night and patient still had a very high temperature and felt very sleepy and headachey. Patient could not sleep for a few hours while patient was trying to get warm either. Company Comment - This case concerns a 26 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of chills, somnolence, pyrexia and chills. The events pyrexia and chills occurred on the same date after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the dose of mRNA-1273 vaccine. 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 case concerns a 26 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of chills, somnolence, pyrexia and chills. The events pyrexia and chills occurred on the same date after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the dose of mRNA-1273 vaccine. 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: 2009359 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shivers; Fever; Nausea; Swollen glands; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26390729) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), NAUSEA (Nausea) and LYMPHADENOPATHY (Swollen glands) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Previously administered products included for Oral contraceptive: Evra (Evra for Contraceptive patch); for Neurocardiogenic syncope: Bisoprolol (Bisoprolol 2.5 (Daily) - Neurocardiogenic syndrome). Past adverse reactions to the above products included No adverse event with Bisoprolol and Evra. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 24-Dec-2021, CHILLS (Shivers), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen glands) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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 last menstrual period date was mentioned as 20-Dec-2021. Patient received vaccine in the right arm. After 15 minutes patient had arm ache and two hours later patient had swollen arm pit and swollen glands around throat. Patient woke up at 4 in the morning with a fever also patient had the following symptoms like shivers, nausea, temperature and brain fog. Laboratory details was mentioned as patient took two lateral flow test and they were both negative. Treatment medication was mentioned as patient took ibuprofen and paracetamol to relieve symptoms and fever has gone, but pain in arm is still there and patient was tired. Patient has not had symptoms associated with COVID-19. Company comment: This is a regulatory authority case concerning a 25-year-old female patient with no relevant medical history, who experienced events of peripheral swelling, lymphadenopathy, pyrexia, chills and nausea (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). On 23-Dec-2021 the patient received third dose of mRNA-1273 vaccine, after 15 minutes patient had arm ache and two hours later patient had swollen arm pit and swollen glands around throat. Patient woke up at 4 in the morning with fever and also experienced shivers, nausea, temperature and brain fog. Treatment included ibuprofen and paracetamol. 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 25-year-old female patient with no relevant medical history, who experienced events of peripheral swelling, lymphadenopathy, pyrexia, chills and nausea (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). On 23-Dec-2021 the patient received third dose of mRNA-1273 vaccine, after 15 minutes patient had arm ache and two hours later patient had swollen arm pit and swollen glands around throat. Patient woke up at 4 in the morning with fever and also experienced shivers, nausea, temperature and brain fog. Treatment included ibuprofen and paracetamol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009368 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: fever; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26391244) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever) and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient reported fever, aching through whole body, dizziness when sitting up and occasional shooting pain through side of head. 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. Company comment: This is a regulatory authority case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected and serious event of dizziness and pyrexia. The event pyrexia occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered while event dizziness occurred the same day after vaccine was given. 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 patient of unknown age and gender with no medical history reported, who experienced the unexpected and serious event of dizziness and pyrexia. The event pyrexia occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered while event dizziness occurred the same day after vaccine was given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009384 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Fatigue, Feeling hot, Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Taste and smell disorders (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; COVID-19 VACCINE ASTRAZENECA
Current Illness: Back pain (Patient had Ongoing Musco-skeletal Back Pain for 2 years after osteopathic manipulations for shoulder injury.); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Shoulder injury
Allergies:
Diagnostic Lab Data: Test Date: 20211207; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: First felt hot; Tiredness; Muscle pain; Taste metallic; Pain legs; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26392145) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING HOT (First felt hot), FATIGUE (Tiredness), MYALGIA (Muscle pain), DYSGEUSIA (Taste metallic) and PAIN IN EXTREMITY (Pain legs) in a 40-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 Shoulder injury. Concurrent medical conditions included Suspected COVID-19 since 11-Oct-2021 and Back pain (Patient had Ongoing Musco-skeletal Back Pain for 2 years after osteopathic manipulations for shoulder injury.). Concomitant products included AMITRIPTYLINE from 10-Aug-2021 to an unknown date for Pain back, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain legs) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING HOT (First felt hot) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 23-Dec-2021, PAIN IN EXTREMITY (Pain legs) had resolved. At the time of the report, FEELING HOT (First felt hot), FATIGUE (Tiredness) and MYALGIA (Muscle pain) had not resolved and DYSGEUSIA (Taste metallic) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-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 is not currently breastfeeding. It was reported that patient first felt hot, then seriously disgusting metallic taste like chewing foil for around an hour. Then muscle pain, particularly in her thighs and severe tiredness. No treatment information was reported. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 40-year-old female patient with medical history of musculoskeletal back pain, who experienced the unexpected and serious events of feeling hot, myalgia, dysgeusia, pain in extremity and fatigue. The events dysgeusia and pain in extremity occurred the same day after a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. Medical history of musculoskeletal back pain remains as a 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 40-year-old female patient with medical history of musculoskeletal back pain, who experienced the unexpected and serious events of feeling hot, myalgia, dysgeusia, pain in extremity and fatigue. The events dysgeusia and pain in extremity occurred the same day after a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. Medical history of musculoskeletal back pain remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009387 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry mouth, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dry mouth; Fever; Headache; Muscle ache; Fever chills; This case was received via RA (Reference number: GB-MHRA-ADR 26392199) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever chills) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was provided by the reporter. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 09-Jul-2021 to an unknown date for Vaccination. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DRY MOUTH (Dry mouth) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 24-Dec-2021, PYREXIA (Fever chills) had resolved. At the time of the report, DRY MOUTH (Dry mouth) had not resolved and PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-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 had no symptoms associated with COVID-19. It was stated that headache started 5 hours after injection, followed by gradual all over muscle ache, after 7 hours fever/chills and fatigue, headache got worse effecting sleep with mild nausea. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This case concerns a male patient of unknown age with a history of tozinamerna COVID-19 vaccine who experienced the unexpected serious events of dry mouth, pyrexia, headache, and myalgia which occurred 1 day after vaccination with mRNA-1273 administered as a third dose. The use of concomitant medication tozinamerna COVID-19 vaccine 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 male patient of unknown age with a history of tozinamerna COVID-19 vaccine who experienced the unexpected serious events of dry mouth, pyrexia, headache, and myalgia which occurred 1 day after vaccination with mRNA-1273 administered as a third dose. The use of concomitant medication tozinamerna COVID-19 vaccine 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: 2009392 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANNABIS; QUETIAPINE; SERTRALINE; TESTOGEL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: General soreness; Dizzy; Dizzy spells; Tension; Ache; Feverish; Chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26392320) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TENSION (Tension), DIZZINESS (Dizzy), DIZZINESS (Dizzy spells), PAIN (General soreness), PAIN (Ache), PYREXIA (Feverish) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included SERTRALINE for Depression, TESTOSTERONE (TESTOGEL) from 01-Dec-2020 to an unknown date for Gender dysphoria, QUETIAPINE for Personality disorder, CANNABIS SATIVA (CANNABIS) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced TENSION (Tension) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant) and PAIN (General soreness) (seriousness criterion medically significant). On 24-Dec-2021, TENSION (Tension) and PYREXIA (Feverish) had resolved with sequelae, CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (Dizzy), DIZZINESS (Dizzy spells), PAIN (General soreness) and PAIN (Ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-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. Treatment information was not provided. Patient reported that symptoms began with sore arm a few hours after injection. Patient had cold sweats. Symptoms were impeded sleep and care duties until the next day. Symptoms began resolving around midday and no longer significantly impede activities. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 26-year-old female patient with concomitant use of Sertraline, Quetiapine and Cannabis, who experienced the serious unexpected events of Tension, Dizziness, Pain, Pyrexia and Chills. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The concomitant medications use could remain as confounders for the events of dizziness, tension and chills. 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 26-year-old female patient with concomitant use of Sertraline, Quetiapine and Cannabis, who experienced the serious unexpected events of Tension, Dizziness, Pain, Pyrexia and Chills. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The concomitant medications use could remain as confounders for the events of dizziness, tension and chills. 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: 2009393 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Skin irritation, Skin sensitisation
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: Negative COVID 19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: highly sensitive skin; Skin irritation; This case was received via RA (Reference number: GB-MHRA-ADR 26392309) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SKIN SENSITISATION (highly sensitive skin) and SKIN IRRITATION (Skin irritation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SKIN IRRITATION (Skin irritation) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN SENSITISATION (highly sensitive skin) (seriousness criterion medically significant). On 24-Dec-2021, SKIN IRRITATION (Skin irritation) was resolving. At the time of the report, SKIN SENSITISATION (highly sensitive skin) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID 19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient says they have highly sensitive skin, felt like skin was on fire. Painful to wear clothes or shower. Moving underneath blanket with contact on skin was extremely painful Concomitant medication was not provided, Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial; Sender''s Comments: This case concerns a patient of an unknown age and gender, with medical history not reported, who experienced the serious (medically significant) unexpected multiple event(s) of Skin sensitisation. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2009399 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Dyspnoea, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Diabetic; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)
Preexisting Conditions: Comments: Type 1 diabetic Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; Shortness of breath; Racing heart (tachycardia); Heartburn; Chest pain; This case was received via (Reference number: GB-MHRA-ADR 26392353) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), the first episode of CHEST PAIN (Chest pain), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Type 1 diabetic Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concurrent medical conditions included Diabetic and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 27-May-2021 to 18-Jun-2021 for an unknown indication. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant) and the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, DYSPEPSIA (Heartburn) had not resolved and last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-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. Treatment medication use was not provided by the reporter. Patient had type 1 diabetic,not had symptoms associated with COVID-19 , Patient was not pregnant and was not currently breastfeeding. patients Date of last administration of concomitant COVID-19 MRNA VACCINE BIONTECH was 18-JUN-2021. Company Comment: This case concerns a year-old male / female patient with a history of tozinameran COVID-19 vaccine, immunodeficiency, and diabetes mellitus who experienced the unexpected serious events of dyspepsia and chest pain which occurred 6 days after vaccination with mRNA-1273 administered as a third dose, and the unexpected serious events of chest pain, dyspnea, and tachycardia on an unknown date relative to vaccination. 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 year-old male / female patient with a history of tozinameran COVID-19 vaccine, immunodeficiency, and diabetes mellitus who experienced the unexpected serious events of dyspepsia and chest pain which occurred 6 days after vaccination with mRNA-1273 administered as a third dose, and the unexpected serious events of chest pain, dyspnea, and tachycardia on an unknown date relative to vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009400 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-23
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Platelet factor 4, SARS-CoV-2 test, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Platelet factor 4; Result Unstructured Data: Anti-PF4 antibodies were not identified; Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: platelet count <150 x 109/L; Thrombus; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26392846) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of THROMBOSIS (Thrombus) and THROMBOCYTOPENIA (platelet count <150 x 109/L) in a 46-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On an unknown date, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced THROMBOSIS (Thrombus) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced THROMBOCYTOPENIA (platelet count <150 x 109/L) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, THROMBOSIS (Thrombus) was resolving and THROMBOCYTOPENIA (platelet count <150 x 109/L) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. On an unknown date, Platelet factor 4: anti-pf4 antibodies were not identified Anti-PF4 antibodies were not identified. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient presented to surgical receiving with flank pain and abdominal pain. Radiological investigations showed multiple splenic infarcts with thrombus at the origin of the splenic artery. Commenced on treatment dose dalteparin. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient experienced multiple splenic infarcts with thrombus at the origin of the splenic artery following a recent Booster vaccine 1 week prior to start of symptoms. This was diagnosed with CT Abdomen and Pelvis on 23-Dec-2021. The lowest platelet count after vaccine (usual normal range 150-450) was 214 on 18-Dec-2021. This case was discussed with Haematologist. Company Comment: This case concerns a 46-year-old, male patient, with no medical history reported in this case, who experienced the serious unexpected events of Thrombosis and Thrombocytopenia. The event Thrombosis occurred after the administration of the 3rd dose of the mRNA-1273 vaccine of an unknown schedule and date of vaccination and the outcome at the time of the report was Recovering/Resolving. The event Thrombocytopenia occurred in an unknown date and the outcome at the time of the report was Unknown. 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 in this case, who experienced the serious unexpected events of Thrombosis and Thrombocytopenia. The event Thrombosis occurred after the administration of the 3rd dose of the mRNA-1273 vaccine of an unknown schedule and date of vaccination and the outcome at the time of the report was Recovering/Resolving. The event Thrombocytopenia occurred in an unknown date and the outcome at the time of the report was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009402 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: High temperature; Headache; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26392853) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), HEADACHE (Headache) and FATIGUE (Tiredness) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 MRNA VACCINE BIONTECH. Past adverse reactions to the above products included No adverse event with COVID-19 MRNA VACCINE BIONTECH. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature), HEADACHE (Headache) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. No concomitant medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient had Pfizer-BioNtech''s vaccine as the first and second dose. Company Comment - This case concerns a 37 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pyrexia, headache and fatigue. The events occurred on the same day after the third dose of mRNA-1273 vaccine and had not resolved at the time of the report. 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 case concerns a 37 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pyrexia, headache and fatigue. The events occurred on the same day after the third dose of mRNA-1273 vaccine and had not resolved at the time of the report. 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: 2009405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20214

Write-up: shivering; Vomiting; Headache; Fever; This case was received(Reference number: GB-MHRA-ADR 26393082) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of (shivering), PYREXIA (Fever),(Vomiting) and(Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering) was resolving and PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment medication reported. Violent shivering and fever started 12 hours after the injection. This persisted for 6/8 hours. Headache and vomiting began in the early hours of the morning Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant and Patient is not currently breastfeeding Company Comment - This regulatory authority case concerns a 45 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of chills, pyrexia, vomiting and headache. The events headache and pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine, the event vomiting occurred 1 day after the dose of mRNA-1273 vaccine and chills occurred on an unknown date. 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 45 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of chills, pyrexia, vomiting and headache. The events headache and pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine, the event vomiting occurred 1 day after the dose of mRNA-1273 vaccine and chills occurred on an unknown date. 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: 2009407 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-23
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life 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: Polycystic kidney (Adult polycystic kidney disease)
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: Echocardiogram; Result Unstructured Data: normal ventricular function. No pericardial effusi; Test Date: 20211224; Test Name: Troponin; Result Unstructured Data: raised, 4000
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest Pain; Perimyocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26393150) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Chest Pain) and MYOCARDITIS (Perimyocarditis) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s past medical history included Polycystic kidney (Adult polycystic kidney disease). On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest Pain) outcome was unknown and MYOCARDITIS (Perimyocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, Echocardiogram: normal (normal) normal ventricular function. No pericardial effusi. On 24-Dec-2021, Troponin: raised 4000 (High) raised, 4000. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. No treatment information was provided. Company Comment - This case concerns a 35 year old male patient with no relevant medical history, who experienced the serious (hospitalization) unexpected events of chest pain and the expected event of myocarditis. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Significant follow up received and included medical history and lab test information, action taken with the suspect product were updated, event myocarditis were removed.; Sender''s Comments: This case concerns a 35 year old male patient with no relevant medical history, who experienced the serious (hospitalization) unexpected event of chest pain and the expected event of myocarditis. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009409 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Fatigue, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; SAYANA PRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211217; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Nausea; Fatigue; Painful arm; Tummy ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26393397) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (Fatigue), PAIN IN EXTREMITY (Painful arm) and ABDOMINAL PAIN (Tummy ache) in a 30-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 11-Dec-2021. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 10-May-2021 to 15-Jul-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and MEDROXYPROGESTERONE ACETATE (SAYANA PRESS) from 01-Oct-2020 to an unknown date for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea) had resolved and FATIGUE (Fatigue), PAIN IN EXTREMITY (Painful arm) and ABDOMINAL PAIN (Tummy ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment drugs were reported. Company comment: This case concerns a 30-year-old female patient, with medical history of suspected Covid-19 prior the vaccination, who experienced the serious (medically significant according to Authority report), unexpected events pain in extremity, abdominal pain, nausea and fatigue after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had painful arm and abdominal pain on the same day after the vaccine, and then had nausea and fatigue one day after the vaccine. At the time of report, the events had not resolved. The patient received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), two doses, 7 and 5 months prior to the mRNA 1273 vaccine. The patient''s history of suspected Covid-19 12 days prior to the vaccination remain as confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old female patient, with medical history of suspected Covid-19 prior the vaccination, who experienced the serious (medically significant according to Authority report), unexpected events pain in extremity, abdominal pain, nausea and fatigue after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had painful arm and abdominal pain on the same day after the vaccine, and then had nausea and fatigue one day after the vaccine. At the time of report, the events had not resolved. The patient received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), two doses, 7 and 5 months prior to the mRNA 1273 vaccine. The patient''s history of suspected Covid-19 12 days prior to the vaccination remain as confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2009413 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26393529) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain) and PYREXIA (Fever) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The report related to the possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory authority case concerning a 34-year-old male patient with no relevant medical history, who experienced events of peripheral swelling, fatigue, chest pain and pyrexia (seriousness criterion medically significant assessed as per Regulatory Authority reporting). The event peripheral swelling occurred 1 day after the third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. 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 34-year-old male patient with no relevant medical history, who experienced events of peripheral swelling, fatigue, chest pain and pyrexia (seriousness criterion medically significant assessed as per Regulatory Authority reporting). The event peripheral swelling occurred 1 day after the third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Painful arm; Migraine; Sickness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26393862) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), MIGRAINE (Migraine) and ILLNESS (Sickness) in a female patient of an unknown age 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 29-Apr-2021 to an unknown date for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and ILLNESS (Sickness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved, MIGRAINE (Migraine) was resolving and ILLNESS (Sickness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No treatment medication was provided. Company comment: This case concerns a female patient of unknown age with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of pain in extremity, migraine and illness. The events occurred on the same day after the third dose of mRNA-1273. 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 female patient of unknown age with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of pain in extremity, migraine and illness. The events occurred on the same day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009429 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
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.MOD20214

Write-up: Nausea; Pain; Kidney pain; Headache; Reaction emotional; Fatigue; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26393892) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea), PAIN (Pain), RENAL PAIN (Kidney pain), HEADACHE (Headache) and EMOTIONAL DISORDER (Reaction emotional) in a 54-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), RENAL PAIN (Kidney pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and EMOTIONAL DISORDER (Reaction emotional) (seriousness criterion medically significant). On 24-Dec-2021, EMOTIONAL DISORDER (Reaction emotional) had resolved. At the time of the report, FATIGUE (Fatigue), NAUSEA (Nausea), PAIN (Pain) and RENAL PAIN (Kidney pain) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant product and treatment medication use was not provided by the reporter. Company comment: This regulatory case concerns a 54-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of FATIGUE, NAUSEA, PAIN, RENAL PAIN, HEADACHE and EMOTIONAL DISORDER. The event of fatigue occurred on the same day after receiving a dose of mRNA-1273 and all other reported events occurred 2 days after vaccination. Dose of mRNA-1273 is reported as a third dose; however, previous vaccination schedule included unspecified doses of AstraZeneca COVID 19 vaccine. The rechallenge is captured as unknown as per the regulatory authority assessment. No further clinical information for medical reviewing was provided.. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory case concerns a 54-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of FATIGUE, NAUSEA, PAIN, RENAL PAIN, HEADACHE and EMOTIONAL DISORDER. The event of fatigue occurred on the same day after receiving a dose of mRNA-1273 and all other reported events occurred 2 days after vaccination. Dose of mRNA-1273 is reported as a third dose; however, previous vaccination schedule included unspecified doses of AstraZeneca COVID 19 vaccine. The rechallenge is captured as unknown as per the regulatory authority assessment. No further clinical information for medical reviewing was provided.. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as provided by the Regulatory Authority.


VAERS ID: 2009439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dyspepsia, Fatigue, Headache, Lymphadenopathy, Myalgia, Neck pain, Renal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific dysfunction (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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.MOD20214

Write-up: Swollen glands; Kidney pain; Muscle pain; Neck pain; Fatigue; Appetite lost; Heartburn; Headache; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), LYMPHADENOPATHY (Swollen glands), RENAL PAIN (Kidney pain), MYALGIA (Muscle pain), NECK PAIN (Neck pain), FATIGUE (Fatigue), DECREASED APPETITE (Appetite lost) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), RENAL PAIN (Kidney pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). At the time of the report, DYSPEPSIA (Heartburn), LYMPHADENOPATHY (Swollen glands), RENAL PAIN (Kidney pain), MYALGIA (Muscle pain), NECK PAIN (Neck pain), FATIGUE (Fatigue) and DECREASED APPETITE (Appetite lost) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications provided by the reporter. Treatment medications was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The Patient had no possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a year-old male / female patient with no reported medical history who experienced the unexpected serious events of dyspepsia and headache which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of lymphadenopathy, renal pain, myalgia, neck pain, fatigue, and decreased appetite which occurred on an unknown date relative to vaccination. 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 year-old male / female patient with no reported medical history who experienced the unexpected serious events of dyspepsia and headache which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of lymphadenopathy, renal pain, myalgia, neck pain, fatigue, and decreased appetite which occurred on an unknown date relative to vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009451 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Rash; Fatigue; Fever; Cold; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26394487) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Fever), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and NASOPHARYNGITIS (Cold) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (Rash), PYREXIA (Fever), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug information provided. No treatment drug information provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment - This case concerns a 28 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of rash, pyrexia, nasopharyngitis and fatigue. The events occurred between the same day and 2 days after the third dose of mRNA-1273 vaccine. 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 case concerns a 28 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of rash, pyrexia, nasopharyngitis and fatigue. The events occurred between the same day and 2 days after the third dose of mRNA-1273 vaccine. 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: 2009454 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Immunisation, Myocarditis, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857617

Write-up: Booster; Myocarditis; racing heart; Fatigue/unusual tiredness; Chest pain; Fever; Racing heart (tachycardia); 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-202112251140389170-THDFJ. Other Case identifier(s): GB-MHRA-ADR 26394561. A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 23Dec2021, stop date: 25Dec2021. The patient''s 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 23Dec2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant) with onset 23Dec2021, outcome "recovering", described as "Myocarditis"; PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "racing heart"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Chest pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)". Diagnosis was not made by a medical professional. The symptoms did not lead to a hospital stay. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative, notes: No - Negative COVID-19 test. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Report was 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: 2009457 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shivering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26394639) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). On 24-Dec-2021, CHILLS (Shivering) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided. Patient felt rough at 3am started to shiver violently for over an hour tried to slow down breathing and concentrate to stop shivers but went on for nearly two hours then felt like all muscles had been over exerted for two days after, could eat and arm was swollen for 4 days after with red patch. 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 and not had a COVID-19 test. Company Comment - This regulatory case concerns a 57 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of chills. The event occurred 1 day after the third dose of mRNA-1273 vaccine. 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 case concerns a 57 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of chills. The event occurred 1 day after the third dose of mRNA-1273 vaccine. 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: 2009458 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Dyspepsia, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; SERTRALINE
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Upset stomach; Heartburn; Generalised muscle aches; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26394640) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), MYALGIA (Generalised muscle aches) and ABDOMINAL DISCOMFORT (Upset stomach) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, SERTRALINE for Depression. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion medically significant). On 24-Dec-2021, DYSPEPSIA (Heartburn) had resolved. At the time of the report, MYALGIA (Generalised muscle aches) was resolving and ABDOMINAL DISCOMFORT (Upset stomach) 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 medications were reported. Company Comment: This case concerns a 33 year-old male patient with a history of tozinameran COVID-19 vaccine who experienced the unexpected serious events of dyspepsia, myalgia and abdominal discomfort which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The use of concomitant medication tozinameran COVID-19 vaccine 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 tozinameran COVID-19 vaccine who experienced the unexpected serious events of dyspepsia, myalgia and abdominal discomfort which occurred 2 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The use of concomitant medication tozinameran COVID-19 vaccine 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: 2009466 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-12-23
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: ACICLOVIR; PARACETAMOL CODEINE; CAFFEINE; IBUPROFEN; NEXPLANON; SUMATRIPTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211215; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Joint pain; Fever; Muscle pain; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26394766) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 000014A and 3003608) for an unknown indication. Concomitant products included ETONOGESTREL (NEXPLANON) for Birth control, ACICLOVIR from 20-Nov-2021 to 25-Nov-2021 for Genital herpes, SUMATRIPTAN for Migraine, CODEINE PHOSPHATE, PARACETAMOL (PARACETAMOL CODEINE), CAFFEINE and IBUPROFEN for an unknown indication. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 24-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-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. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19. Patient was not enrolled in a clinical trial. Patient had only a sore arm with first vaccine. After second vaccine & booster, patient had extreme joint and muscle pain over full body. After the booster, patient was completely immobile for 6 hours due to pain especially in hips/lower back, struggled to move for 24 hours. It began to subside after 24 hours and just began to ache rather than pain (presume body response to vaccine). Treatment medications included painkillers Ibuprofen and Co-codamol. Company Comment: This is a regulatory case concerning a 36-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of arthralgia, pyrexia and myalgia. The events occurred on the same 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 36-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of arthralgia, pyrexia and myalgia. The events occurred on the same 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009468 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shivers; Swelling; Stomach cramps; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26394829) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), SWELLING (Swelling) and ABDOMINAL PAIN UPPER (Stomach cramps) in a 25-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 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant). At the time of the report, CHILLS (shivers) and SWELLING (Swelling) had not resolved and ABDOMINAL PAIN UPPER (Stomach cramps) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided. No treatment medications were reported. Patient was neither pregnant nor breastfeeding. Last menstrual period date- 26-Nov-2021. After the booster, patient arm hurt instantly, then had swelling in armpit, sort of like a water balloon. Patient also had the shivers, felt hot, cold and experienced stomach cramps. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 25-year-old female patient with no relevant medical history who experienced the unexpected events of Chills, Swelling and Abdominal pain upper. Swelling and Abdominal pain upper occurred 1 day after the third dose of mRNA-1273 vaccine while the event of Chills occurred after an unspecified number days post exposure to the vaccine. No causality assessment was provided by the reporter. 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 refers to a 25-year-old female patient with no relevant medical history who experienced the unexpected events of Chills, Swelling and Abdominal pain upper. Swelling and Abdominal pain upper occurred 1 day after the third dose of mRNA-1273 vaccine while the event of Chills occurred after an unspecified number days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009475 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vulval ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vulva ulceration; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26395000) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26395000) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VULVAL ULCERATION (Vulva ulceration) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced VULVAL ULCERATION (Vulva ulceration) (seriousness criterion medically significant). At the time of the report, VULVAL ULCERATION (Vulva ulceration) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.; Sender''s Comments: This is a regulatory case concerning an 18-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Vulval ulceration(seriousness criterion medically significant). The patient started to experience Vulval Ulceration 1 day after they received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009478 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Eructation, Headache, 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; AMITRIPTYLINE
Current Illness: Irritable bowel syndrome (Pt had IBS but this was not like an IBS flare)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Diarrhoea; Belching; Diarrhoea; Headache; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26395024) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERUCTATION (Belching), the first episode of DIARRHOEA (Diarrhoea), HEADACHE (Headache) and the second episode of DIARRHOEA (Diarrhoea) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. Concurrent medical conditions included Irritable bowel syndrome (Pt had IBS but this was not like an IBS flare). Concomitant products included AMITRIPTYLINE for Fibromyalgia, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 18-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ERUCTATION (Belching) (seriousness criterion medically significant), the first episode of DIARRHOEA (Diarrhoea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). At the time of the report, ERUCTATION (Belching), HEADACHE (Headache) and the last episode of DIARRHOEA (Diarrhoea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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. It was reported that, Pt didn''t felt unwell when the reaction first started, but as it continued she felt worse. As soon as Pt ate anything, ended up straight on the lavatory. Still had on going problem(4 days after the vaccine). Treatment information was not reported. Company Comment: This case concerns a 39 year-old female patient with a history of 2 doses of tozinameran COVID-19 vaccine and irritable bowel syndrome who experienced the unexpected serious events of eructation, diarrhea, and headache which occurred 3 days after vaccination with mRNA-1273 vaccine administered as a third dose. The medical history of irritable bowel syndrome and the use of concomitant medication tozinameran COVID-19 vaccine remain confounders 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 39 year-old female patient with a history of 2 doses of tozinameran COVID-19 vaccine and irritable bowel syndrome who experienced the unexpected serious events of eructation, diarrhea, and headache which occurred 3 days after vaccination with mRNA-1273 vaccine administered as a third dose. The medical history of irritable bowel syndrome and the use of concomitant medication tozinameran COVID-19 vaccine remain confounders 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: 2009512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Immunisation, Pericarditis, SARS-CoV-2 test, Tachycardia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECHO; Result Unstructured Data: Test Result:no RWMA; Comments: Bedside echo no RWMA; Test Name: Ecg; Result Unstructured Data: Test Result:changes; Comments: Ecg changes; Test Date: 20211226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: trop; Result Unstructured Data: Test Result:High trop 3000; Comments: High trop 3000
CDC Split Type: GBPFIZER INC202101870421

Write-up: Chest Pain; Tachycardia; Pericarditis; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112271545193940-ULE2N (RA). Other Case identifier(s): GB-MHRA-ADR 26399153 (RA). A 34 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (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 (hospitalization) with onset 23Dec2021, outcome "unknown", described as "Booster"; PERICARDITIS (hospitalization) with onset 25Dec2021, outcome "not recovered", described as "Pericarditis"; CHEST PAIN (hospitalization), outcome "unknown", described as "Chest Pain"; TACHYCARDIA (hospitalization), outcome "unknown", described as "Tachycardia". The events "pericarditis", "chest pain" and "tachycardia" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (unspecified date) no rwma, notes: Bedside echo no RWMA; electrocardiogram: (unspecified date) changes, notes: Ecg changes; sars-cov-2 test: (26Dec2021) no - negative covid-19 test; troponin: (unspecified date) high trop 3000, notes: High trop 3000. Clinical course: The 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 Reaction. The report did not relate to possible blood clots or low platelet counts. The report was related to possible inflammation of the heart (myocarditis or pericarditis). For Myocarditis and pericarditis patient was admitted to hospital and seen by a cardiologist. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Contusion, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Rash, SARS-CoV-2 test, Skin swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), 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 (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: CITALOPRAM; FEXOFENADINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Depression (CITALOPRAM taken for depression)
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101870182

Write-up: hives; skin swelling; myocarditis; Bruising; SARS-CoV-2 infection; Skin rash; 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-202112271611402810-S6OH9 (RA). Other Case identifier(s): GB-MHRA-ADR 26399364 (RA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 25Dec2021 (ongoing); "depression" (unspecified if ongoing), notes: CITALOPRAM taken for depression. Concomitant medication(s) included: CITALOPRAM taken for depression, start date: 01Jan2020; FEXOFENADINE. Vaccination history included: Covid-19 vaccine astrazeneca (Dose: 1, Manufacturer Astrazeneca), administration date: 01Apr2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose: 2, Manufacturer Astrazeneca), administration date: 01Jun2021, for covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Dec2021, outcome "unknown", described as "Booster"; COVID-19 (medically significant) with onset 26Dec2021, outcome "recovering", described as "SARS-CoV-2 infection"; URTICARIA (medically significant), outcome "not recovered", described as "hives"; SKIN SWELLING (medically significant), outcome "not recovered", described as "skin swelling"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; RASH (medically significant) with onset 25Dec2021, outcome "recovering", described as "Skin rash"; CONTUSION (medically significant), outcome "unknown", described as "Bruising". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Severe skin swelling between thighs and bruising once the swelling subsided. Worsening of hives, the swelling was unlike the hives. Patient was not enrolled in clinical trial. Patient report did not relate to possible inflammation of the heart (myocarditis or pericarditis. The patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009681 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Musculoskeletal stiffness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: 2/3 hours after injection stiff arm; fever; Adverse reaction; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26394826) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (2/3 hours after injection stiff arm), PYREXIA (fever) and ADVERSE REACTION (Adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: PARACETAMOL. Past adverse reactions to the above products included No adverse event with PARACETAMOL. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ADVERSE REACTION (Adverse reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (2/3 hours after injection stiff arm) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). On 25-Dec-2021, ADVERSE REACTION (Adverse reaction) was resolving. At the time of the report, MUSCULOSKELETAL STIFFNESS (2/3 hours after injection stiff arm) and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-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 was not taking any drugs and have not had any symptoms of any illness prior to Moderna vaccination. Patient had taken paracetamol to help with adverse vaccination symptoms. Lab data include lateral flow test two hours before vaccination and that was negative. Patient had not had symptoms associated with COVID-19 After 2 or 3 hours of injection patient experienced stiff arm, shoulder, and neck. Approximately 12 hours after Moderna vaccine administered patient experienced pain in lower back and intense pain in kidneys accompanied by feelings of fever rolling through body. After another 24 hours began to diminish and after 50 hours from injection only the injection site remains sore. Only the Moderna booster injection has caused any form of adverse response. 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 patient of unknown age and gender with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected serious events of adverse reaction (unspecified), musculoskeletal stiffness (stiff arm, shoulder and neck) and pyrexia. The event adverse reaction (unspecified) occurred the same day with the third dose of mRNA-1273 vaccine administration and was accompanied by musculoskeletal stiffness (stiff arm, shoulder and neck), pyrexia, pain in lower back and intense pain in kidneys. No reported treatment medication. The outcome of the events musculoskeletal stiffness (stiff arm, shoulder and neck) and pyrexia was not resolved, the event adverse reaction (unspecified) was resolving from the time of last observation while pain in lower back and intense pain in kidneys 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 patient of unknown age and gender with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected serious events of adverse reaction (unspecified), musculoskeletal stiffness (stiff arm, shoulder and neck) and pyrexia. The event adverse reaction (unspecified) occurred the same day with the third dose of mRNA-1273 vaccine administration and was accompanied by musculoskeletal stiffness (stiff arm, shoulder and neck), pyrexia, pain in lower back and intense pain in kidneys. No reported treatment medication. The outcome of the events musculoskeletal stiffness (stiff arm, shoulder and neck) and pyrexia was not resolved, the event adverse reaction (unspecified) was resolving from the time of last observation while pain in lower back and intense pain in kidneys the outcome were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009912 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Chills, Feeling abnormal, Immunisation, Interchange of vaccine products, Loss of consciousness, Off label use, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive (she was hypertensive)
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: blood pressure; Result Unstructured Data: Test Result:22.4; Test Date: 20211223; Test Name: Fever; Result Unstructured Data: Test Result:38.5
CDC Split Type: ARPFIZER INC202101870140

Write-up: the 3rd dose of Pfizer vaccine.; The first two doses were Sputnik; the 3rd dose of Pfizer vaccine.; she Fainted; she had fainted and lost completely the notion; began to feel bad; vomiting; They took the blood pressure and was 22.4; fever; shaking chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EX-2021-126427224- -APN-DGA#ANMAT. A 84 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 84 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "hypertensive" (unspecified if ongoing), notes: she was hypertensive. The patient''s concomitant medications were not reported. Vaccination history included: Sputnik vaccine (Dose 1, First two doses were Sputnik and the sided effects were imperceptible (complete initial immunization).), for COVID-19 immunization, reaction(s): "Side effect"; Sputnik vaccine (Dose 2, First two doses were Sputnik and the sided effects were imperceptible (complete initial immunization).), for COVID-19 immunization, reaction(s): "Side effect". The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "the 3rd dose of Pfizer vaccine."; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "The first two doses were Sputnik"; SYNCOPE (medically significant) with onset 23Dec2021, outcome "unknown", described as "she Fainted"; LOSS OF CONSCIOUSNESS (medically significant) with onset 23Dec2021, outcome "unknown", described as "she had fainted and lost completely the notion"; FEELING ABNORMAL (non-serious) with onset 23Dec2021, outcome "unknown", described as "began to feel bad"; VOMITING (non-serious) with onset 23Dec2021, outcome "unknown", described as "vomiting"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 23Dec2021, outcome "recovering", described as "They took the blood pressure and was 22.4"; PYREXIA (non-serious) with onset 23Dec2021, outcome "recovering", described as "fever"; CHILLS (non-serious) with onset 23Dec2021, outcome "recovering", described as "shaking chills". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Dec2021) 22.4; body temperature: (23Dec2021) 38.5. Therapeutic measures were taken as a result of blood pressure abnormal. Clinical course was reported as on 23Dec2021, 12 hours after patient applied the vaccine, she began to feel bad to the point that she Fainted. If her daughter was not by her side, she would have beaten and fallen to the ground precipitously. Between her two daughters, sat her on the bed and whiting 5 or 7 minutes approximately she reacted, and started vomiting. They took the blood pressure and was 22.4 (as reported) which began to worry because did not now if it could trigger a CVA since she was hypertensive. She took a tablet for her pressure and the rest of the night. Patient had 38.5 fever, shaking chills and slowly began to felt better and the pressure did get low. As she was aware of the side effects that may provoke the vaccines, she got very worried that she had fainted and lost completely the notion. And obviously she had fear that the next vaccine could repeat the same situation. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2010910 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-12-23
   Days after vaccination:257
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Inflammation, Oxygen saturation, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VYVANSE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: O2 Saturation; Result Unstructured Data: O2 Saturations was 98
CDC Split Type: CAMODERNATX, INC.MOD20214

Write-up: Decrease inflammation caused by pericarditis; Decrease inflammation caused by pericarditis; Felt tired; Heaviness in my chest / felt as though an elephant was sitting on my chest; This spontaneous case was reported by a nurse and describes the occurrence of PERICARDITIS (Decrease inflammation caused by pericarditis) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 062H21A, 3002914 and 3001654) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced CHEST DISCOMFORT (Heaviness in my chest / felt as though an elephant was sitting on my chest). On an unknown date, the patient experienced PERICARDITIS (Decrease inflammation caused by pericarditis) (seriousness criterion medically significant), INFLAMMATION (Decrease inflammation caused by pericarditis) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Inflammation, at a dose of 1 dosage form. At the time of the report, PERICARDITIS (Decrease inflammation caused by pericarditis), CHEST DISCOMFORT (Heaviness in my chest / felt as though an elephant was sitting on my chest), INFLAMMATION (Decrease inflammation caused by pericarditis) and FATIGUE (Felt tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Oxygen saturation: 98 (normal) O2 Saturations was 98. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No medical history was provided. Company Comment: This is a spontaneous case concerning a 46-year-old, female patient with no medical history, who experienced the expected serious AESI event of Pericarditis and non-serious events like chest discomfort, Inflammation and Fatigue. The event pericarditis occurred on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the event is reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender''s Comments: This is a spontaneous case concerning a 46-year-old, female patient with no medical history, who experienced the expected serious AESI event of Pericarditis and non-serious events like chest discomfort, Inflammation and Fatigue. The event pericarditis occurred on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the event is reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2011287 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-AMOXICLAV; SANOFI PASTEUR MSD INFLUENZA
Current Illness:
Preexisting Conditions: Comments: Covid positive Nov 2020, still parosmia. No other health conditions Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20201109; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Result: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Diarrhea; Abdominal pain; Nausea; This case was received (Reference number: GB-MHRA-ADR 26382442) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Covid positive Nov 2020, still parosmia. No other health conditions Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concomitant products included AMOXYCILLIN, POTASSIUM CLAVULANATE (CO-AMOXICLAV) from 20-Dec-2021 to an unknown date for Cat bite, SANOFI PASTEUR MSD INFLUENZA from 05-Nov-2021 to an unknown date for Flu vaccination. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Result: Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Covid positive Nov 2020, still parosmia. No other health conditions Patient has not had symptoms associated with COVID-19 It was reported that patient reactions started 17 hours after vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you additional questions at the end of this report: No No treatment medication information. Company comment This case concerns a 36-year-old female patient, with medical history of use of Concomitant medication AMOXYCILLIN, POTASSIUM CLAVULANATE 2 days prior the administration of mRNA-1273 vaccine, who experienced the unexpected serious events of DIARRHOEA, ABDOMINAL PAIN and NAUSEA. The events occurred on the following day of the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of use of Concomitant medication AMOXYCILLIN, POTASSIUM CLAVULANATE 2 days prior the administration of mRNA-1273 vaccine, remains as a confounder. Patient had received PASTEUR MSD INFLUENZA for Flu vaccination approximately 1 month and 20 days prior mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient, with medical history of use of Concomitant medication AMOXYCILLIN, POTASSIUM CLAVULANATE 2 days prior the administration of mRNA-1273 vaccine, who experienced the unexpected serious events of DIARRHOEA, ABDOMINAL PAIN and NAUSEA. The events occurred on the following day of the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of use of Concomitant medication AMOXYCILLIN, POTASSIUM CLAVULANATE 2 days prior the administration of mRNA-1273 vaccine, remains as a confounder. Patient had received PASTEUR MSD INFLUENZA for Flu vaccination approximately 1 month and 20 days prior mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012042 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: insomnia; Muscle pain; Joint pain; Pain stomach; Chills; This case was received via RA (Reference number: GB-MHRA-ADR 26382285) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (Pain stomach) and CHILLS (Chills) in a 29-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 01-Jun-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (insomnia) (seriousness criterion medically significant). At the time of the report, INSOMNIA (insomnia), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (Pain stomach) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided. The patient was not pregnant and was not currently breastfeeding. Treatment information was not provided. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. It was reported that 12 hours after vaccine, the patient had severe muscle pain all over body, shooting pains through joints and stomach, urge to urinate and pain but could not go, insomnia, chills. Patient was not enrolled in clinical trial. Patient''s last menstrual period was on 01 Dec 2021. Company comment: This case concerns a 29-year-old female patient with no medical history provided who experienced serious unexpected events of Myalgia, Arthralgia, Abdominal pain upper, Chills and Insomnia. It was reported that, 12 hours after the third, booster dose of mRNA-1273, the patient experienced severe muscle pain all over the body, shooting pains through joints and stomach, urge to urinate and pain but could not go, insomnia and chills. At the time of the report, all the events were still ongoing and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 29-year-old female patient with no medical history provided who experienced serious unexpected events of Myalgia, Arthralgia, Abdominal pain upper, Chills and Insomnia. It was reported that, 12 hours after the third, booster dose of mRNA-1273, the patient experienced severe muscle pain all over the body, shooting pains through joints and stomach, urge to urinate and pain but could not go, insomnia and chills. At the time of the report, all the events were still ongoing and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2012143 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Disorientation, Dizziness, Fatigue, Nausea, Night sweats, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Nausea; Ringing in ears; Fatigue; Dizziness; Night sweats; Chills; Disorientation; This case was received via RA (Reference number: GB-MHRA-ADR 26383982) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), DIZZINESS (Dizziness), NIGHT SWEATS (Night sweats), DISORIENTATION (Disorientation) and TINNITUS (Ringing in ears) in a 54-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 05-Jun-2021 to an unknown date for an unknown indication. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), DISORIENTATION (Disorientation) (seriousness criterion medically significant) and TINNITUS (Ringing in ears) (seriousness criterion medically significant). On 23-Dec-2021, TINNITUS (Ringing in ears) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea), DIZZINESS (Dizziness), NIGHT SWEATS (Night sweats) and DISORIENTATION (Disorientation) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding.; Sender''s Comments: This regulatory authority case concerns a 54-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of NAUSEA, TINNITUS, FATIGUE, DIZZINESS, NIGHT SWEATS, CHILLS and DISORIENTATION. The events occurred 2 days after receiving a dose of mRNA-1273. Previous vaccination schedule included unspecified doses of Tozinameran. No further clinical information for medical reviewing was provided. 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: 2012176 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), 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: 20211030; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: after urinating; nauseated; headache; Fainting; This case was received(Reference number: GB-MHRA-ADR 26384535) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (after urinating), NAUSEA (nauseated), HEADACHE (headache) and SYNCOPE (Fainting) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 30-Oct-2021 to 10-Nov-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Jan-2021 to an unknown date for Vaccination. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (after urinating) (seriousness criterion medically significant), NAUSEA (nauseated) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, PAIN (after urinating), NAUSEA (nauseated) and HEADACHE (headache) was resolving and SYNCOPE (Fainting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-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. He felt fluish the night before, went to bed, woke up this morning and went to the toilet. After urinating, he felt extremely nauseated and leaned over a sink, thinking he was about to vomit. Instead he fainted. After this, he felt very nauseated again. After unlocking the door to let his brother and father in, he fainted again in the hallway (roughly 2 minutes after the first instance). Now in bed, feeling better but with a slight headache. 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 case concerns a 20 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain, nausea, headache and the expected event of syncope. The event syncope occurred 1 day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date, after the dose of mRNA-1273 vaccine. 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 case concerns a 20 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain, nausea, headache and the expected event of syncope. The event syncope occurred 1 day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date, after the dose of mRNA-1273 vaccine. 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: 2012179 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feverish; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26384561) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) in a 39-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion disability). At the time of the report, PYREXIA (Feverish) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. The patient woke up due to pain around injection site which was swollen, red and hot. Extremely nauseous and was sick. Started shivering uncontrollably, feverish, weak and struggled to walk, headache was extremely painful and felt scared. Went on for hours. No treatment information was provided by the reporter. Company comment: This is a regulatory case concerning a 39 year-old, female patient with no reported medical history, who experienced the serious (due to disability) unexpected, according CCDS, event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273 vaccine. Event seriousness assessed as per Regulatory Authority reporting. The outcome of the event was reported as recovering. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 39 year-old, female patient with no reported medical history, who experienced the serious (due to disability) unexpected, according medical team, event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273 vaccine. Event seriousness assessed as per Regulatory Authority reporting. The outcome of the event was reported as recovering. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012206 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: chills; stomach cramps; Diarrhea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26385136) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (Diarrhea) in a 45-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. Concomitant products included LANSOPRAZOLE for Hiatus hernia. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criterion medically significant). At the time of the report, CHILLS (chills) and ABDOMINAL PAIN UPPER (stomach cramps) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Temp was normal 37.5 under tongue. Patient has not had symptoms associated with COVID-19. Patient had chills stomach cramps and diarrhea. Patient got waves of painful peristaltic action even though there was nothing for me to pass. Patient had not tested positive for COVID-19 since having the vaccine. Study details: Company comment: This regulatory authority case concerns a 45-year-old male patient, with history of lansoprazole use due to hiatal hernia, who experienced the serious (medically significant) unexpected events of CHILLS, ABDOMINAL PAIN UPPER and DIARRHOEA. The event of diarrhoea occurred 1 day after receiving a third dose of mRNA-1273. No onset date was provided for other reported events. No information about previous vaccination schedule was provided. Patient''s history of hiatal hernia remains as a confounder. 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 45-year-old male patient, with history of lansoprazole use due to hiatal hernia, who experienced the serious (medically significant) unexpected events of CHILLS, ABDOMINAL PAIN UPPER and DIARRHOEA. The event of diarrhoea occurred 1 day after receiving a third dose of mRNA-1273. No onset date was provided for other reported events. No information about previous vaccination schedule was provided. Patient''s history of hiatal hernia remains as a confounder. 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: 2012233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dizziness, Headache, Heart rate increased, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Vestibular disorders (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Low back pain; Headache; Dizzy spells; Heart rate high; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26385324) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), HEART RATE INCREASED (Heart rate high), HEADACHE (Headache) and DIZZINESS (Dizzy spells) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced HEART RATE INCREASED (Heart rate high) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Low back pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Low back pain) was resolving and HEART RATE INCREASED (Heart rate high), HEADACHE (Headache) and DIZZINESS (Dizzy spells) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a male subject of unknown age, with no medical history reported, who experienced the unexpected and serious events of Back pain, Heart rate increased, Headache, and Dizziness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event of Heart rate increased occurred 1 day after the third dose of mRNA-1273 vaccine. The events of Back pain, Headache, and Dizziness occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a male subject of unknown age, with no medical history reported, who experienced the unexpected and serious events of Back pain, Heart rate increased, Headache, and Dizziness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event of Heart rate increased occurred 1 day after the third dose of mRNA-1273 vaccine. The events of Back pain, Headache, and Dizziness occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012242 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Feeling hot, Illness, Malaise, 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 Date: 20211220; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feeling sick; Feeling hot; Sickness; Dizziness; Coldness; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DIZZINESS (Dizziness), FEELING COLD (Coldness), MALAISE (Feeling sick) and FEELING HOT (Feeling hot) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and FEELING COLD (Coldness) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant) and FEELING HOT (Feeling hot) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness), DIZZINESS (Dizziness) and FEELING COLD (Coldness) had not resolved and MALAISE (Feeling sick) and FEELING HOT (Feeling hot) was resolving. 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. No concomitant medications were reported It was reported that about 26 hours after getting the booster jab, patient experienced feeling sick and dizziness started, feeling hot and cold, then being sick and had room spinning feelings, feeling very cold. Patient has not tested positive for COVID-19 since having the vaccine No treatment information was provided.; Sender''s Comments: This case concerns a 49-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Illness, Dizziness, Feeling Cold, Malaise, and Feeling Hot. The events occurred approximately 26 hours after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2012288 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; LEVOTHYROXINE SODIUM
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.MOD20214

Write-up: Presyncope; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26386400) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRESYNCOPE (Presyncope) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) for an unknown indication. Concomitant products included LEVOTHYROXINE SODIUM for Hypothyroidism, COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PRESYNCOPE (Presyncope) (seriousness criterion medically significant). At the time of the report, PRESYNCOPE (Presyncope) 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. Treatment information was not provided by the reporter. Unsure if patient 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 case refers to a 46-year-old female patient with no relevant medical history who experienced the unexpected event of Presyncope 1 day after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 46-year-old female patient with no relevant medical history who experienced the unexpected event of Presyncope 1 day after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2012292 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Headache, Pelvic pain, Pyrexia, Renal pain, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; DESOGESTREL; METHYLPHENIDATE
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.MOD20214

Write-up: Armpit pain; Feverish; Kidney pain; Painful joints; Headache; Pelvic pain female; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26386424) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), PYREXIA (Feverish), RENAL PAIN (Kidney pain), ARTHRALGIA (Painful joints), HEADACHE (Headache) and PELVIC PAIN (Pelvic pain female) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concomitant products included METHYLPHENIDATE for ADHD, DESOGESTREL for Endometriosis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 23-Apr-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), RENAL PAIN (Kidney pain) (seriousness criterion medically significant), ARTHRALGIA (Painful joints) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PELVIC PAIN (Pelvic pain female) (seriousness criterion medically significant). At the time of the report, AXILLARY PAIN (Armpit pain), PYREXIA (Feverish), RENAL PAIN (Kidney pain), ARTHRALGIA (Painful joints), HEADACHE (Headache) and PELVIC PAIN (Pelvic pain female) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided by the reporter. Patient reported, after vaccine at 9pm yesterday, had joint pain and feels Ng feverish around 11am today. Kidney and pelvic pain around 1pm, kidneys feel uncomfortable, like a kidney infection. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, and was not currently breastfeeding. Treatment medication was not provided by the reporter. COMPANY COMMENT: This is a regulatory case concerning a 40-year-old female patient with no clinical history who experienced the unexpected events of AXILLARY PAIN, PYREXIA, RENAL PAIN, ARTHRALGIA, HEADACHE and PELVIC PAIN The events occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 40-year-old female patient with no clinical history who experienced the unexpected events of AXILLARY PAIN, PYREXIA, RENAL PAIN, ARTHRALGIA, HEADACHE and PELVIC PAIN The events occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority


VAERS ID: 2012304 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (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; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Numbness; Tingling; Joint pain; Chest pain; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 26386569) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Painful arm) and CHEST PAIN (Chest pain) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 20-Dec-2021 to an unknown date for Bronchitis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 20-Jun-2021 to an unknown date for Vaccination. On 23-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion disability). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion disability), PARAESTHESIA (Tingling) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and CHEST PAIN (Chest pain) (seriousness criterion disability). At the time of the report, HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Painful arm) had not resolved and CHEST PAIN (Chest pain) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient experienced tingling, numbness and joint pain in left arm only. The patient took 2 paracetamol tablet with water because of her symptoms. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant was not currently breastfeeding. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 36-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two prior doses of COVID-19 MRNA VACCINE BIONTECH) and recent vaccination with INFLUENZA VIRUS (3 days before current vaccination), who experienced the unexpected serious events of Hypoaesthesia, Paraesthesia, Arthralgia, Pain in extremity and Chest pain. Pain in extremity occurred approximately on the same day after the third dose of mRNA-1273 vaccine, the other events occurred at an unknown date. It is reported that it could be related to possible inflammation of the heart (myocarditis or pericarditis), however no medical confirmation nor additional studies were available. The patient was treated with paracetamol. Interchange of vaccine products and recent vaccination with INFLUENZA VIRUS remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to disability.; Sender''s Comments: This case concerns a 36-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two prior doses of COVID-19 MRNA VACCINE BIONTECH) and recent vaccination with INFLUENZA VIRUS (3 days before current vaccination), who experienced the unexpected serious events of Hypoaesthesia, Paraesthesia, Arthralgia, Pain in extremity and Chest pain. Pain in extremity occurred approximately on the same day after the third dose of mRNA-1273 vaccine, the other events occurred at an unknown date. It is reported that it could be related to possible inflammation of the heart (myocarditis or pericarditis), however no medical confirmation nor additional studies were available. The patient was treated with paracetamol. Interchange of vaccine products and recent vaccination with INFLUENZA VIRUS remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to disability.


VAERS ID: 2012311 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-23
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Deep vein thrombosis, Immunisation, Interchange of vaccine products, Off label use, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Test Name: blood test; Result Unstructured Data: Test Result:Unknown result; Test Name: Uss scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101856909

Write-up: DVT of calf; Patient received third (booster) dose which is different brand to primary vaccines; Patient received third (booster) dose which is different brand to primary vaccines; patient received third (booster) dose of bnt162b2; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112231709330740-OEECR (RA). Other Case identifier(s): GB-MHRA-ADR 26386563 (RA). A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. 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), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 2021, outcome "unknown" and all described as "Patient received third (booster) dose which is different brand to primary vaccines"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "patient received third (booster) dose of bnt162b2"; DEEP VEIN THROMBOSIS (medically significant) with onset 23Dec2021, outcome "not recovered", described as "DVT of calf". Patient was diagnosed DVT 23Dec2021. The patient underwent the following laboratory tests and procedures: blood test: unknown result; ultrasound scan: unknown results. Patient did not test positive for COVID-19 since having the vaccine. Clinical course: The report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012315 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Dizziness, Dyspnoea, Immunisation, Nausea, Photopsia, SARS-CoV-2 test, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), 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: CERAZETTE [DESOGESTREL]; ETORICOXIB; EVACAL D3; LANSOPRAZOLE; ZAPAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bone pain; Contraception; Pain; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis); Sickness
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101856932

Write-up: Booster; Blurred vision; Flashing lights; Dizzy spells; Breathlessness; Mental confusion; Nausea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112231722548340-CNAXI. Other Case identifier: GB-MHRA-ADR 26386642. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: rheumatoid arthritis (taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis); contraception; pain; bone pain; sickness. Patient is not enrolled in clinical trial. Concomitant medications included: desogestrel (CERAZETTE) taken for contraception; etoricoxib taken for pain; calcium carbonate, colecalciferol (EVACAL D3) taken for bone pain; lansoprazole taken for sickness; codeine phosphate, paracetamol (ZAPAIN) taken for pain; and other regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis. Vaccination history included: bnt162b2 (dose 1, lot number unknown), administration date: 17Jun2021, for COVID-19 immunization; bnt162b2 (dose 2, lot number unknown), administration date: 23Jul2021, for COVID-19 immunization. On 23Dec2021, the patient experienced blurred vision, flashing lights, dizzy spells, breathlessness, mental confusion, nausea, it was 2 hours from vaccine started the above symptoms. The report was serious for being medically significant. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (22Dec2021) no - negative COVID-19 test. Patient has not been tested positive for COVID-19 since having the vaccine. The outcome of blurred vision was resolved on 23Dec2021, flashing lights was resolved in Dec2021, the outcome of dizzy spells, breathlessness, mental confusion, nausea was not resolved. The report is 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: 2012339 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101856935

Write-up: Abdominal pain; 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-202112231823198060-W9993 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26387134 (regulatory authority). A male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Lot number: FN3543) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 29Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Abdominal pain". Patient didn''t 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: 2012345 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20214

Write-up: Painful arm; Joint ache; Tiredness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26387309) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), ARTHRALGIA (Joint ache) and FATIGUE (Tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), ARTHRALGIA (Joint ache) and FATIGUE (Tiredness) 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. She was not currently breastfeeding. No Concomitant medication details were provided. No Treatment medication details were provided. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company Comment - This case concerns a 36 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, arthralgia and fatigue. The events occurred 1 day after the third dose of mRNA-1273 vaccine. 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 case concerns a 36 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, arthralgia and fatigue. The events occurred 1 day after the third dose of mRNA-1273 vaccine. 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: 2012381 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sensitive skin
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: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Hypersensitive skin; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26388018) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Hypersensitive skin) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (Hypersensitive skin) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided. Patient had no symptoms associated with COVID-19. Patient was neither pregnant nor breastfeeding. It was stated that about 9 hours after vaccine administered, patient skin started to hurt, similarly to second vaccine, skin hurts all over and seem to hurt in different places over time, also hurts when touched by clothes etc. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 24 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according, event of Sensitive skin. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 24 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according , event of Sensitive skin. Event was assessed as serious by the Regulatory Authority. The event occurred the same day after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012393 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sweating fever
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Aches & pains in legs; Fever chills; Headache; Sweating fever; Confusion; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26388169) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches & pains in legs), PYREXIA (Fever chills), HEADACHE (Headache), SWEATING FEVER (Sweating fever) and CONFUSIONAL STATE (Confusion) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), SWEATING FEVER (Sweating fever) (seriousness criterion medically significant) and CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Aches & pains in legs), PYREXIA (Fever chills), HEADACHE (Headache), SWEATING FEVER (Sweating fever) and CONFUSIONAL STATE (Confusion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient has 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 35-year-old male patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PAIN IN EXTREMITY, PYREXIA, HEADACHE, SWEATING FEVER and CONFUSIONAL STATE. The events occurred 1 day after receiving a third dose of mRNA-1273. Previous vaccination schedule was not reported. No further clinical information was available 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 35-year-old male patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PAIN IN EXTREMITY, PYREXIA, HEADACHE, SWEATING FEVER and CONFUSIONAL STATE. The events occurred 1 day after receiving a third dose of mRNA-1273. Previous vaccination schedule was not reported. No further clinical information was available 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: 2012396 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy, SARS-CoV-2 test, Sensitive skin
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211204; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: skin sensitivity; severe pounding headache; Lethargy; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26388216) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin sensitivity), HEADACHE (severe pounding headache) and LETHARGY (Lethargy) in a 21-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant). On an unknown date, the patient experienced SENSITIVE SKIN (skin sensitivity) (seriousness criterion medically significant) and HEADACHE (severe pounding headache) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (skin sensitivity) and HEADACHE (severe pounding headache) had not resolved and LETHARGY (Lethargy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment drug information was not provided. Patient last menstrual period date was 3-DEC-2021. Patient had extreme lethargy. Unable to get up to do anything, multiple naps throughout the day (uncharacteristically). Patient had severe joint stiffness and pain felt like all body was bruised all over to the point where she could not even bend enough to properly get dressed. Patient had severe pounding headache and Skin sensitivity (feels like light sunburn). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 21 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according , events of Sensitive skin, headache and lethargy. Events were assessed as serious by the Regulatory Authority. The event lethargy occurred approximately 1 day after the third dose of mRNA-1273 vaccine and the events of Sensitive skin, headache on an unknown date. The outcome of the event lethargy was reported as recovering and the events Sensitive skin, headache as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 21 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according , events of Sensitive skin, headache and lethargy. Events were assessed as serious by the Regulatory Authority. The event lethargy occurred approximately 1 day after the third dose of mRNA-1273 vaccine and the events of Sensitive skin, headache on an unknown date. The outcome of the event lethargy was reported as recovering and the events Sensitive skin, headache as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012398 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857088

Write-up: Palsy Bells; 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-202112232136195430-YOBP8 (RA). Other Case identifier(s): GB-MHRA-ADR 26388221 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) 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: BELL''S PALSY (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Palsy Bells". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative 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: 2012408 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-23
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Dizziness, Headache, Myalgia, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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; DIHYDROCODEINE; INFLUENZA VIRUS; SERTRALINE
Current Illness: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Stomach cramps; Dizziness; Headache; Shoulder pain; Muscle pain; Sensitive skin; Diarrhea; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26388374) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Shoulder pain), MYALGIA (Muscle pain), SENSITIVE SKIN (Sensitive skin), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps) and DIZZINESS (Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)) and Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). Concomitant products included SERTRALINE for Anxiety, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, DIHYDROCODEINE for Pain, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and INFLUENZA VACCINE (INFLUENZA VIRUS) for Vaccination. In 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), ARTHRALGIA (Shoulder pain) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), SENSITIVE SKIN (Sensitive skin) (seriousness criterion disability) and DIARRHOEA (Diarrhea) (seriousness criterion disability). On 23-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion disability) and DIZZINESS (Dizziness) (seriousness criterion disability). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Shoulder pain), MYALGIA (Muscle pain), SENSITIVE SKIN (Sensitive skin), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps) and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Report not relate to possible inflammation of the heart (myocarditis or pericarditis). Company comment This is a regulatory case concerning a 32-year-old female patient with medical history of Inflammatory bowel disease and Rheumatoid arthritis, who experienced the serious unexpected, according CCDS, events of HEADACHE, ARTHRALGIA, MYALGIA, SENSITIVE SKIN, DIARRHOEA, ABDOMINAL PAIN UPPER and DIZZINESS. The events ARTHRALGIA, MYALGIA, SENSITIVE SKIN, DIARRHOEA occurred on an unknown date the same year after the third dose of mRNA-1273 vaccine. The events ABDOMINAL PAIN UPPER and DIZZINESS occurred on 23-Dec-2021 (vaccination date is unknown). The rechallenge is unknown according to SD. The medical history of Inflammatory bowel disease and Rheumatoid arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 32-year-old female patient with medical history of Inflammatory bowel disease and Rheumatoid arthritis, who experienced the serious unexpected, according CCDS, events of HEADACHE, ARTHRALGIA, MYALGIA, SENSITIVE SKIN, DIARRHOEA, ABDOMINAL PAIN UPPER and DIZZINESS. The events ARTHRALGIA, MYALGIA, SENSITIVE SKIN, DIARRHOEA occurred on an unknown date the same year after the third dose of mRNA-1273 vaccine. The events ABDOMINAL PAIN UPPER and DIZZINESS occurred on 23-Dec-2021 (vaccination date is unknown). The rechallenge is unknown according to SD. The medical history of Inflammatory bowel disease and Rheumatoid arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2012412 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Migraine, Myalgia, Pain in extremity, Peripheral coldness, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: painful arm; migraine; cold feet; shivering; chills; high temperature; muscle pain; Fainting; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26388389) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), MIGRAINE (migraine), PERIPHERAL COLDNESS (cold feet), CHILLS (shivering), CHILLS (chills), PYREXIA (high temperature), MYALGIA (muscle pain) and SYNCOPE (Fainting) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) (seriousness criterion disability), MIGRAINE (migraine) (seriousness criterion disability), PERIPHERAL COLDNESS (cold feet) (seriousness criterion disability), CHILLS (shivering) (seriousness criterion disability), CHILLS (chills) (seriousness criterion disability), PYREXIA (high temperature) (seriousness criterion disability) and MYALGIA (muscle pain) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (painful arm), MIGRAINE (migraine), PERIPHERAL COLDNESS (cold feet), CHILLS (shivering), CHILLS (chills), PYREXIA (high temperature), MYALGIA (muscle pain) and SYNCOPE (Fainting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information not provided. About 12 hours later shivering, freezing cold feet and chills over body. Not able to sleep. Painful arm. High temperature 39 and after waking up the next morning at about 17 hours after the vaccination she nearly fainted 3 times after she stood up. The following day extreme migraine where paracetamol didn''t take the pain. High temperature of 39 when taking paracetamol. Muscle pain and weakness. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment - This case concerns a 40 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, migraine, peripheral coldness, chills, chills, pyrexia, myalgia and the expected event of syncope. The event syncope occurred 1 day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as t here 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 case concerns a 40 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, migraine, peripheral coldness, chills, chills, pyrexia, myalgia and the expected event of syncope. The event syncope occurred 1 day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as t here are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012433 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Maternal exposure during breast feeding, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shivers; high temperature; Maternal exposure during breast feeding; Body temperature; Joint ache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26388761) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), PYREXIA (high temperature), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), BODY TEMPERATURE (Body temperature) and ARTHRALGIA (Joint ache) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant), PYREXIA (high temperature) (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, CHILLS (shivers) and PYREXIA (high temperature) had not resolved, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and BODY TEMPERATURE (Body temperature) and ARTHRALGIA (Joint ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had a paracetamol and naproxen, which helped to treat the adverse events. Onset about 21 hours after the booster was given. Concomitant product use was not provided by the reporter. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This regulatory authority case of maternal exposure during breastfeeding concerns a 37-year-old female patient, who experienced the serious (medically significant) unexpected events of CHILLS, PYREXIA and ARTRHALGIA. The event of chills occurred 1 day after receiving a booster dose of mRNA-1273. No onset date was provided for other reported events; however, source document states that events started within 21 hours of vaccination. No information about previous vaccination schedule was provided. The rechallenge is captured as unknown as per the regulatory authority assessment. No further clinical information for medical reviewing was provided. 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 of maternal exposure during breastfeeding concerns a 37-year-old female patient, who experienced the serious (medically significant) unexpected events of CHILLS, PYREXIA and ARTRHALGIA. The event of chills occurred 1 day after receiving a booster dose of mRNA-1273. No onset date was provided for other reported events; however, source document states that events started within 21 hours of vaccination. No information about previous vaccination schedule was provided. The rechallenge is captured as unknown as per the regulatory authority assessment. No further clinical information for medical reviewing was provided. 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: 2012450 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Maternal exposure during breast feeding, Menstrual disorder, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Maternal exposure during breast feeding; Menstrual cycle abnormal; Menstrual flooding; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26388869) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle abnormal), HEAVY MENSTRUAL BLEEDING (Menstrual flooding) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle abnormal) and HEAVY MENSTRUAL BLEEDING (Menstrual flooding) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-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 has not had symptoms associated with COVID-19 Patient is not pregnant . After the booster vaccine patient had early Menstruation onset, by approximately 1.5 weeks.Typically regular and predictable cycles. Patient had Increased menstrual flow and flooding. Patient has not tested positive for COVID-19 since having the vaccine and is not enrolled in clinical trial The report does not relate to possible inflammation of the heart. No Concomitant medication were reported. No Treatment information was reported. This is a regulatory case concerning a 37-year-old breast feeding female patient with no relevant medical history, who experienced the serious per reported severity unexpected events of maternal exposure during breast feeding, menstrual disorder and heavy menstrual bleeding. The events of menstrual disorder and heavy menstrual bleeding occurred on the next days after the third dose of mRNA-1273 vaccine administration and the event of maternal exposure during breast feeding occurred on unknown date. The company causality for the event of maternal exposure during breast feeding was not applicable and remaining 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 37-year-old breast feeding female patient with no relevant medical history, who experienced the serious per reported severity unexpected events of maternal exposure during breast feeding, menstrual disorder and heavy menstrual bleeding. The events of menstrual disorder and heavy menstrual bleeding occurred on the next days after the third dose of mRNA-1273 vaccine administration and the event of maternal exposure during breast feeding occurred on unknown date. The company causality for the event of maternal exposure during breast feeding was not applicable and remaining 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: 2012457 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; COVID-19 VACCINE ASTRAZENECA; FOLIC ACID; JARDIANCE; LEVEMIR; METFORMIN; NOVORAPID; A TO Z
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
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.MOD20214

Write-up: Lymph node pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26388920) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was provided by the reporter. Concomitant products included INSULIN DETEMIR (LEVEMIR), METFORMIN and INSULIN ASPART (NOVORAPID) for Diabetes, EMPAGLIFLOZIN (JARDIANCE) for Diabetic, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN) for Diabetic neuropathy, FOLIC ACID for Premedication, COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) for Vaccination, A TO Z for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). At the time of the report, LYMPH NODE PAIN (Lymph node pain) 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 experienced large painful lump in armpit which is the same arm where vaccine was administered. She also had deep throbbing pain, causing pons and needles in fingers and pain in elbow. No treatment medication was provided. 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 event of lymph node pain. The event occurred 2 days after the third dose of mRNA-1273 vaccine administration. The event was 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 patient was given a dose of AstraZeneca COVID-19 vaccine on unknown date. 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 event of lymph node pain. The event occurred 2 days after the third dose of mRNA-1273 vaccine administration. The event was 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 patient was given a dose of AstraZeneca COVID-19 vaccine on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012470 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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), 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: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: really swollen under left armpit; Swelling arm; This case was received (Reference number: GB-RA-ADR 26388967) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and SWELLING (really swollen under left armpit) 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 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (really swollen under left armpit) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm) had not resolved and SWELLING (really swollen under left armpit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment medication information was not provided by the reporter. It was reported that it was really swollen under left armpit, very painful and uncomfortable. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 25-year-old female patient with no known medical history who experienced the unexpected events of Peripheral swelling and Swelling. Peripheral swelling occurred approximately 1 day after the third dose of mRNA-1273 vaccine while the event of Swelling occurred after an unspecified number days post exposure to the vaccine. No causality assessment was provided by the reporter. 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 refers to a 25-year-old female patient with no known medical history who experienced the unexpected events of Peripheral swelling and Swelling. Peripheral swelling occurred approximately 1 day after the third dose of mRNA-1273 vaccine while the event of Swelling occurred after an unspecified number days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2012475 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101856961

Write-up: Off label use; interchange of vaccine products; Booster; Fever; Sickness; Sleep loss; Ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112240500277120-WPPSH (RA). Other Case identifier: GB-MHRA-ADR 26389038 (RA). A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, patient is not currently breastfeeding. Patient is not enrolled in clinical trial. 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. On 23Dec2021, the patient experienced fever, sickness, sleep loss, ache. The events fever, sickness, sleep loss, ache were serious for being medically significant. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of fever, sickness, sleep loss, ache was not resolved. The report is 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: 2012495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oral herpes
SMQs:, Oropharyngeal infections (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Cold sores; This case was received (Reference number: GB-RA-ADR 26389671) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ORAL HERPES (Cold sores) (seriousness criterion medically significant). At the time of the report, ORAL HERPES (Cold sores) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No Treatment medication was provided. Severe painful large cold sore breakout near right eye. Applying cold sore cream. As the vaccine caused other symptoms such as tiredness unable to carry on day to day activities. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of oral herpes. The event occurred 1 day after a dose of mRNA-1273 vaccine and had not resolved at the time of the report. Clinical manifestation was a painful, large cold sore breakout near right eye. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report..; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of oral herpes. The event occurred 1 day after a dose of mRNA-1273 vaccine and had not resolved at the time of the report. Clinical manifestation was a painful, large cold sore breakout near right eye. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-23
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Immunisation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101857113

Write-up: Booster; Chills; Muscle pain; Exhaustion; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112240719461760-DFOGI (RA). Other Case identifier(s): GB-RA-ADR 26389691 (RA). A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (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 2; MANUFACTUERER UNKNOWN), administration date: 08May2021, for Covid-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), administration date: 23Mar2021, for COVID-19 vaccination. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 23Dec2021, outcome "recovering", described as "Chills"; MYALGIA (medically significant) with onset 23Dec2021, outcome "recovering", described as "Muscle pain"; FATIGUE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Exhaustion"; HYPERHIDROSIS (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Sweating". Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report dose 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: 2012501 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211221; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: High temperature; Migraine; Shivering; Tenderness; Sleeplessness; Painful arm; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26389968) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), MIGRAINE (Migraine), CHILLS (Shivering), TENDERNESS (Tenderness), INSOMNIA (Sleeplessness) and PAIN IN EXTREMITY (Painful arm) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), TENDERNESS (Tenderness) (seriousness criterion medically significant), INSOMNIA (Sleeplessness) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 24-Dec-2021, CHILLS (Shivering) had resolved. At the time of the report, PYREXIA (High temperature), TENDERNESS (Tenderness) and INSOMNIA (Sleeplessness) was resolving and MIGRAINE (Migraine) and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-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 has not had symptoms associated with COVID-19. No relevant concomitant medications were reported. Vaccine was administered on 22Dec2021 at 02:25 pm. By 04:00 am of 23Dec2021, patient had flu symptoms and headache which became a migraine. Patient has 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 regulatory case concerns a 54-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious events of pyrexia, migraine, chills, tenderness, insomnia and pain in extremity. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event chills had resolved at the time of the report. The events pyrexia, tenderness and insomnia were resolving, while the events migraine and pain in extremity had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 54-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious events of pyrexia, migraine, chills, tenderness, insomnia and pain in extremity. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event chills had resolved at the time of the report. The events pyrexia, tenderness and insomnia were resolving, while the events migraine and pain in extremity had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012507 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Muscle ache; Headache; Shivers; Pins and needles; Ear pain; Muscle weakness; This case was received via RA (Reference number: GB-MHRA-ADR 26390478) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Shivers), PARAESTHESIA (Pins and needles), EAR PAIN (Ear pain) and MUSCULAR WEAKNESS (Muscle weakness) in a 33-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), EAR PAIN (Ear pain) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache), CHILLS (Shivers), PARAESTHESIA (Pins and needles) and MUSCULAR WEAKNESS (Muscle weakness) had not resolved, HEADACHE (Headache) was resolving and EAR PAIN (Ear pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant medical history reported. No relevant concomitant medication information provided. No relevant treatment medication information provided Patient had vaccination at 9.30am. Patient was fine until 8pm at night. Patient experienced whole body shivering, restless muscles, left arm (jabbed arm) feels like it has been pulled off and reattached. Patient could not lift left arm up, pins and needles in fingers and feeling of weakness in arm. Patient experienced lower back pain, shoulder pain, ear pain (left side), all joints were hurting. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 33-year-old, female patient with no reported medical history, who experienced the unexpected serious events of myalgia, headache, chills, paraesthesia, ear pain and muscular weakness. The events myalgia, headache, chills, paraesthesia, ear pain and muscular weakness occurred the same day with the third dose of mRNA-1273 vaccine administration accompanied by restless muscles, low back pain, shoulder pain and joints pain. No reported treatment medication. The outcome of the events myalgia, chills, paraesthesia and muscular weakness was not resolved, headache was resolving while the event ear pain the outcome was recovered from the time of last observation, restless muscles, low back pain, shoulder pain and joints pain outcome was 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 33-year-old, female patient with no reported medical history, who experienced the unexpected serious events of myalgia, headache, chills, paraesthesia, ear pain and muscular weakness. The events myalgia, headache, chills, paraesthesia, ear pain and muscular weakness occurred the same day with the third dose of mRNA-1273 vaccine administration accompanied by restless muscles, low back pain, shoulder pain and joints pain. No reported treatment medication. The outcome of the events myalgia, chills, paraesthesia and muscular weakness was not resolved, headache was resolving while the event ear pain the outcome was recovered from the time of last observation, restless muscles, low back pain, shoulder pain and joints pain outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012509 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26390458) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) was resolving. 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 medications were reported. No Treatment information was reported.; Sender''s Comments: This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the expected serious event of Anaphylactic Reaction. The event occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2012512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysarthria, Feeling abnormal, Hypoaesthesia, Immunisation, Migraine with aura, Ocular discomfort, Pyrexia, SARS-CoV-2 test, Seizure, Unresponsive to stimuli, Vision blurred
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (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: Hypoaesthesia; Migraine with aura (Occasionally suffer with migraine with aura); Speech slurred (blurred speech and lack of sensitivity on my left side of my body which I experienced...)
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:temperature got up to nearly 40C (39.6C recorded); Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857726

Write-up: scary moment occurred when my eyes started to glitch and close and open uncontrollably for 20-30 seconds; body temperature/temperature got up to nearly 40C (39.6C recorded).; migraine with aura; lack of sensitivity on my left side of my body which I experienced just once in the past as of my migraine; A scary moment occurred when my eyes started to glitch and close and open uncontrollably for 20-30 seconds; Feeling abnormal; blurred speech; I became unresponsive to any external input for a few seconds; Fever; Fit (non-epileptic); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-RA-WEBCOVID-202112241101130790-FVTIC (RA). Other Case identifier(s): GB-RA-ADR 26391719 (RA). A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "migraine with aura" (unspecified if ongoing), notes: Occasionally suffer with migraine with aura; "blurred speech" (unspecified if ongoing), notes: blurred speech and lack of sensitivity on my left side of my body which I experienced just once in the past as of my migraine; "lack of sensitivity on my left side of my body" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s 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 23Dec2021, outcome "unknown", described as "Booster"; SEIZURE (medically significant) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "Fit (non-epileptic)"; VISION BLURRED (medically significant), outcome "unknown", described as "scary moment occurred when my eyes started to glitch and close and open uncontrollably for 20-30 seconds"; BODY TEMPERATURE (medically significant), outcome "unknown", described as "body temperature/temperature got up to nearly 40C (39.6C recorded)."; MIGRAINE WITH AURA (medically significant), outcome "unknown", described as "migraine with aura"; PYREXIA (medically significant) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "Fever"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "lack of sensitivity on my left side of my body which I experienced just once in the past as of my migraine"; OCULAR DISCOMFORT (medically significant), outcome "unknown", described as "A scary moment occurred when my eyes started to glitch and close and open uncontrollably for 20-30 seconds"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "Feeling abnormal "; DYSARTHRIA (medically significant), outcome "unknown", described as "blurred speech"; UNRESPONSIVE TO STIMULI (medically significant), outcome "unknown", described as "I became unresponsive to any external input for a few seconds". Fever was unusually high, temperature got up to nearly 40C (39.6C recorded). He couldn''t manage to make it lower by taking one paracetamol tablet. I eventually got to normal body temperature after 4hrs. He rarely suffer with migraine with aura, but this time the migraine was very severe. He experienced blurred speech and lack of sensitivity on my left side of my body which he experienced just once in the past as of my migraine. A scary moment occurred when my eyes started to glitch and close and open uncontrollably for 20-30 seconds, he became unresponsive to any external input for a few seconds. He have never experienced this symptom ever before, it looked and felt like he was about to have a fit and was scary. He have ever since recovered so he haven''t seek medical attention yet. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) temperature got up to nearly 40c (39.6c recorded); sars-cov-2 test: (24Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of body temperature, pyrexia. Report not related to possible inflammation of the heart (myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012514 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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 Date: 20210801; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Joint ache; Nausea; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26391971) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (Joint ache) 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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (Joint ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. It was reported that, patient did not had symptoms associated with COVID-19 nor did tested positive for COVID-19 after taking the vaccine. Patient was not enrolled in clinical trial. Company Comment : This RA case concerns a 23 year old female with no medical history reported, who experienced Serious ( Medically significant ), unexpected event of nausea which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . One day after vaccination with the 3rd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) , she experienced Serious ( Medically significant ) , unexpected events of headache and arthralgia. 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 23 year old female with no medical history reported, who experienced Serious ( Medically significant ), unexpected event of nausea which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . One day after vaccination with the 3rd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) , she experienced Serious ( Medically significant ) , unexpected events of headache and arthralgia. 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: 2012515 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Migraine, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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.MOD20214

Write-up: Migrainous headache; Fever chills; Fatigue extreme; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26391985) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migrainous headache), PYREXIA (Fever chills), FATIGUE (Fatigue extreme) and NAUSEA (Nausea) in a 50-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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MIGRAINE (Migrainous headache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), FATIGUE (Fatigue extreme) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migrainous headache), PYREXIA (Fever chills), FATIGUE (Fatigue extreme) 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. Concomitant medications were not reported. No treatment information was provided by the reporter. Patient had the same side effects with the second dose of Moderna but didn''t report these. Both occurred after about 10 hours, quite sudden and very intense. Patient has not tested positive for COVID-19 since had the vaccine. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Company Comment: This regulatory case concerns a 50-year-old, female patient with no medical history reported, who experienced the unexpected, serious events of migraine, pyrexia, fatigue and nausea. The events occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events were resolving at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 50-year-old, female patient with no medical history reported, who experienced the unexpected, serious events of migraine, pyrexia, fatigue and nausea. The events occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events were resolving at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012520 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chest discomfort, Dizziness postural, Fatigue, Headache, Muscle spasms, Myalgia, Paraesthesia oral, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLONIDINE HYDROCHLORIDE; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Cramps; Tingling lips; Headache; Dizzy on standing; Tight chest; Runny nose; Spasm muscle; Muscle ache; Tiredness; Stomach ache; This case was received (Reference number: GB-RA-ADR 26392170) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), PARAESTHESIA ORAL (Tingling lips), HEADACHE (Headache), DIZZINESS POSTURAL (Dizzy on standing), CHEST DISCOMFORT (Tight chest), RHINORRHOEA (Runny nose), MUSCLE SPASMS (Spasm muscle), MYALGIA (Muscle ache), FATIGUE (Tiredness) and ABDOMINAL PAIN UPPER (Stomach ache) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 24-Mar-2021 to an unknown date for COVID-19 vaccination, CLONIDINE HYDROCHLORIDE from 11-Dec-2021 to an unknown date for Night sweat. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced MUSCLE SPASMS (Cramps) (seriousness criterion medically significant), PARAESTHESIA ORAL (Tingling lips) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant), MUSCLE SPASMS (Spasm muscle) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Cramps), HEADACHE (Headache), MYALGIA (Muscle ache) and FATIGUE (Tiredness) was resolving, PARAESTHESIA ORAL (Tingling lips), DIZZINESS POSTURAL (Dizzy on standing), CHEST DISCOMFORT (Tight chest), MUSCLE SPASMS (Spasm muscle) and ABDOMINAL PAIN UPPER (Stomach ache) had resolved and RHINORRHOEA (Runny nose) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding. Treatment medications was not reported. No medical history was reported. Vaccine was given 3:15 pm on 23rd. Patient went to bed feeling tired around 8pm. Woke up around 11 pm with symptoms listed. Slept on and off all night. Symptoms started easing around 9 am on 24 th. 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 is a regulatory authority case concerning a 52-year-old, female patient with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious events of cramps, tingling lips, headache, dizziness on standing, tight chest, rhinorrhea, muscle spasms, myalgia, fatigue and stomach ache. The events cramps, tingling lips, headache, dizziness on standing, tight chest, rhinorrhea, muscle spasms, myalgia, fatigue and stomach ache occurred the same day with the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events cramps, headache, myalgia and fatigue was resolving, the events tingling lips, dizziness on standing, tight chest, muscle spasm and stomach ache was resolved while the event rhinorrhea the outcome was not 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 52-year-old, female patient with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious events of cramps, tingling lips, headache, dizziness on standing, tight chest, rhinorrhea, muscle spasms, myalgia, fatigue and stomach ache. The events cramps, tingling lips, headache, dizziness on standing, tight chest, rhinorrhea, muscle spasms, myalgia, fatigue and stomach ache occurred the same day with the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events cramps, headache, myalgia and fatigue was resolving, the events tingling lips, dizziness on standing, tight chest, muscle spasm and stomach ache was resolved while the event rhinorrhea the outcome was not resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012523 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Oropharyngeal pain, Suspected COVID-19, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101857478

Write-up: off label use; interchange of vaccine products; Booster; Suspected COVID-19; Chills; Headache; Blurred vision; Tiredness; Anxiety reaction; Aching joints; Lymph nodes enlarged; Sore throat; 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-202112241246010760-RIUTY (RA). Other Case identifier(s): GB-MHRA-ADR 26392172 (RA). A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FK9706) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Patient not had a covid 19 test. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Dec2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Suspected COVID-19"; CHILLS (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Chills"; HEADACHE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Headache"; VISION BLURRED (medically significant) with onset 23Dec2021, outcome "recovered with sequelae" (2021), described as "Blurred vision"; FATIGUE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Tiredness"; ANXIETY (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Anxiety reaction"; ARTHRALGIA (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Aching joints"; LYMPHADENOPATHY (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Lymph nodes enlarged"; OROPHARYNGEAL PAIN (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Sore throat". Clinical course: 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. Report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012540 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Motor dysfunction, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211221; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857856

Write-up: tingling; Near complete loss of left arm motor skill; Booster; Numbness of limbs; 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-202112242318558500-AZYVI (RA). Other Case identifier(s): GB-MHRA-ADR 26393981 (RA). A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FN3543) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: 26Nov2021. 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 23Dec2021, outcome "unknown", described as "Booster"; HYPOAESTHESIA (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Numbness of limbs"; PARAESTHESIA (medically significant), outcome "unknown", described as "tingling"; MOTOR DYSFUNCTION (medically significant), outcome "unknown", described as "Near complete loss of left arm motor skill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) no - negative covid-19 test. Additional information: Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Near complete loss of left arm motor skill, numbness, tingling etc. Patient has not tested positive for COVID-19 since having the vaccine. Case reported as serious by health authority (other medically important condition). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012549 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Paraesthesia, Pruritus, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; Itchy skin; Fever; Nausea; Shivers; Pins and needles; This case was received (Reference number: GB-RA-ADR 26394844) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), PRURITUS (Itchy skin), PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Shivers) and PARAESTHESIA (Pins and needles) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and PARAESTHESIA (Pins and needles) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). On 24-Dec-2021, PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Shivers) and PARAESTHESIA (Pins and needles) had resolved. At the time of the report, HEADACHE (headache) and PRURITUS (Itchy skin) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-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 medications were reported. No treatment medications were reported. Patient felt fever, shivers, pins and needles in hands, headache, no appetite, nausea, itchy arm around vaccine site. Dosage text :Dose 3b 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 , Patient is not currently breastfeeding Company Comment: This RA case concers a 24 year old female patient with no medical history reported, who experienced Serious ( medically significant ) , unexpected events of fever, nausea , chills and paresthesia which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) . The day after the vaccination with the 3rd dose , she experienced Serious ( Medically significant ) , unexpected event of pruritus while on an unknown date after vaccination with the 3rd dose , she experienced Serious ( medically significant ) , unexpected event of 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 concers a 24 year old female patient with no medical history reported, who experienced Serious ( medically significant ) , unexpected events of fever, nausea , chills and paresthesia which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) . The day after the vaccination with the 3rd dose , she experienced Serious ( Medically significant ) , unexpected event of pruritus while on an unknown date after vaccination with the 3rd dose , she experienced Serious ( medically significant ) , unexpected event of 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: 2012554 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Allergic skin reaction (Mild Skin allergy)
Preexisting Conditions: Medical History/Concurrent Conditions: Stomach pain (Mild)
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Chest pain; Fatigue/unusual tiredness; Fever; Stomachache; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHEST PAIN (Chest pain), FATIGUE (Fatigue/unusual tiredness), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomachache) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Stomach pain (Mild). Concurrent medical conditions included Allergic skin reaction (Mild Skin allergy). On 22-Dec-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved, CHEST PAIN (Chest pain), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) outcome was unknown and ABDOMINAL PAIN UPPER (Stomachache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. After vaccination patient were experienced with Mild Stomachache and mild headache. Fast beating while walking slowly for around 15 minute. Patient was allergic to Mild Skin allergy, mild stomach allergy and mild to severe nose allergy. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment Medication use information was not provided by reporter. This is a regulatory authority case concerning a 37-year-old, male patient with medical history of stomach pain , who experienced the unexpected serious events of Headache, Chest Pain, Fatigue, Pyrexia, Abdominal pain upper. 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 event upper abdominal pain was resolving. The medical history of stomach pain remains a confounder. 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 37-year-old, male patient with medical history of stomach pain , who experienced the unexpected serious events of Headache, Chest Pain, Fatigue, Pyrexia, Abdominal pain upper. 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 event upper abdominal pain was resolving. The medical history of stomach pain remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2012557 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Heart rate increased, Injection site mass, Nausea, Neck pain, Pain, Paraesthesia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; tingling; Nausea; Heart rate increased; Injection site lump; Swelling; Neck pain; Shoulder pain; Redness; Pain; Fatigue; Tenderness; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), PARAESTHESIA (tingling), INJECTION SITE MASS (Injection site lump), SWELLING (Swelling), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain), ERYTHEMA (Redness), PAIN (Pain), FATIGUE (Fatigue), TENDERNESS (Tenderness), NAUSEA (Nausea) and HEART RATE INCREASED (Heart rate increased) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and TENDERNESS (Tenderness) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and HEART RATE INCREASED (Heart rate increased) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and PARAESTHESIA (tingling) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), PARAESTHESIA (tingling), INJECTION SITE MASS (Injection site lump), SWELLING (Swelling), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain), ERYTHEMA (Redness), PAIN (Pain), FATIGUE (Fatigue) and TENDERNESS (Tenderness) had not resolved and NAUSEA (Nausea) and HEART RATE INCREASED (Heart rate increased) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Patient had been taking paracetamol (due to dental issues as well). Patient was fine for about an hour after the vaccine. Then the headache began just like the two previous she had. Then later that night the redness and swelling were more visible. Next day the patient woke up shivering and feeling like it was flu. Later into the second evening patient felt her heart very fast and different to normal for and pain was noticed in the neck and the shoulder (same side as vaccine) which yet had to subside. On the day after the swelling on the upper arm became a hard lump, very red, itchy, achy, sore, and burning. There was tingling sensations around the site of injection only and at very random intervals. Patient did not test positive for COVID-19 since having the vaccine. Patient was not breastfeeding. Patient was not enrolled in clinical trial. This is a regulatory authority case concerning a 26-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Paraesthesia, Injection site mass, Swelling, neck pain, Arthralgia, Erythema, Pain, Fatigue, Tenderness, Nausea, Heart rate increased. The events occurred approximately on the same day after the third 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 26-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Paraesthesia, Injection site mass, Swelling, neck pain, Arthralgia, Erythema, Pain, Fatigue, Tenderness, Nausea, Heart rate increased. The events occurred approximately on the same day after the third 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: 2012559 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Pyrexia; Shivering; Muscle ache; Headache; This case was received (Reference number: GB-RA-ADR 26395117) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia), CHILLS (Shivering), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Dec-2021, PYREXIA (Pyrexia), CHILLS (Shivering), MYALGIA (Muscle ache) and HEADACHE (Headache) 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 unable to leave the house due to severe illness, effects started 7 hours post vaccine and resolved within around 36 hours. Concomitant product was not provided by the reporter. Treatment information was not provided. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 24-year-old, female patient with no reported medical history, who experienced the unexpected serious events of pyrexia, chills, myalgia and headache. The events pyrexia, chills, myalgia and headache occurred the same day after the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events was 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 24-year-old, female patient with no reported medical history, who experienced the unexpected serious events of pyrexia, chills, myalgia and headache. The events pyrexia, chills, myalgia and headache occurred the same day after the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events was resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-11
Onset:2021-12-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test
SMQs:, 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 ; Result Unstructured Data: No-Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shoulder pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26395452) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Shoulder 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. The patient had a painful ache that came and went away in the opposite shoulder to the one in which the patient had the jab. It was unsure if the patient had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This report was not related to possible inflammation of the heart(myocarditis or pericarditis). No concomitant medications were reported. No treatment medications were reported. Company comment: This is a regulatory authority case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected and serious event of arthralgia. The event occurred 12 days after a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected and serious event of arthralgia. The event occurred 12 days after a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012565 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dermatitis, Fatigue, Headache, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: chills; generally unwell; Skin inflammation; Fatigue; Headache; Muscle ache; Feverish; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26395453) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (generally unwell), DERMATITIS (Skin inflammation), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Feverish) in a 46-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 27-Mar-2020 to 02-Apr-2020. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced DERMATITIS (Skin inflammation) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant) and MALAISE (generally unwell) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), MALAISE (generally unwell), DERMATITIS (Skin inflammation) and FATIGUE (Fatigue) had not resolved and HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Feverish) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No issues on day of vaccination. Felt generally unwell on day 2, but by 8pm had to go to bed, woke through the night with chills and fever, aches and pains. Day 3 continued with day 2 side effects with added lack of energy/fatigue and pain under arm in same side as injection site. This has continued into day 4 & 5, with added symptom of hot inflamed area around injection site. Patient has not tested positive for COVID-19 since having the vaccine. No concomitant medication was provided. No Treatment medication was provided.; Sender''s Comments: This case concerns a 46-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Chills, Malaise, Dermatitis, Fatigue, Headache, Myalgia, and Pyrexia. The events of headache, myalgia, and pyrexia occurred approximately 1 day after the third dose of mRNA-1273 (Moderna Covid-19 vaccine); fatigue 2 days after third dose; dermatitis 3 days after third dose; while chills and malaise occurred at an unspecified interval after third dose. The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 Vaccine) is not affected by this report.


VAERS ID: 2012572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Nasal congestion
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
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.MOD20214

Write-up: Nasal stuffiness; Cough; This case was received (Reference number: GB-RA-ADR 26395648) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough) and NASAL CONGESTION (Nasal stuffiness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced NASAL CONGESTION (Nasal stuffiness) (seriousness criterion medically significant). At the time of the report, COUGH (Cough) and NASAL CONGESTION (Nasal stuffiness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. After the vaccination, patient experienced cough, aside from fever, chills and dizziness. Later the cough developed and became chesty and wet. Then that was followed by nasal congestion. Patient had not tested positive for COVID-19 since having the vaccine. No treatment information was provided. Company Comment This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious unexpected events of Cough and Nasal congestion. The event of Cough occurred one day after the third dose of mRNA-1273 vaccine while the event of Nasal congestion occurred 2 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as Medically significant and retained for consistency with the RA report.; Sender''s Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious unexpected events of Cough and Nasal congestion. The event of Cough occurred one day after the third dose of mRNA-1273 vaccine while the event of Nasal congestion occurred 2 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as Medically significant and retained for consistency with the RA report.


VAERS ID: 2012589 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, SARS-CoV-2 test, Skin swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 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; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shivering; nausea; Skin swelling of; This case was received via RA (Reference number: GB-MHRA-ADR 26395857) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering), NAUSEA (nausea) and SKIN SWELLING (Skin swelling of) in a 61-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 started Unsure when symptoms stopped). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced SKIN SWELLING (Skin swelling of) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering) and NAUSEA (nausea) had not resolved and SKIN SWELLING (Skin swelling of) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment drugs were reported Injection site arm painfull swelling and redness under arm pit . Nausea and shivering . Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Reaction ~Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No"; Sender''s Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Chills, Nausea, and Skin Swelling. The events of swelling of arm occurred approximately 1 day after third dose of mRNA-1273 (Moderna covid-19 vaccine); while chills and nausea occurred on an unspecified interval after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2012594 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20214

Write-up: Diarrhoea; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26396043) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and Patient is not currently breastfeeding. It was reported that patient developed stomach cramping and diarrhea throughout day and nights since 1 day post booster. Slight nausea and on and off headaches and joint aching. Does not seem to be getting better. No treatment information was reported. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial.; Sender''s Comments: This case concerns a 33-year-old female patient, with medical history not reported, who experienced the serious unexpected event(s) of Diarrhoea, and headache. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2012597 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-29
Onset:2021-12-23
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201214; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Menstrual flooding; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26396118) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26396118) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flooding) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant). On 26-Dec-2021, HEAVY MENSTRUAL BLEEDING (Menstrual flooding) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date: 23-DEC-2021 No concomitant medications were reported. Patient not had symptoms associated with COVID-19. No treatment medications were reported. Patient was not enrolled in clinical trial.; Sender''s Comments: This is a regulatory case concerning a 40-year-old female patient with no medical history reported, who experienced the serious unexpected event of Heavy menstrual bleeding(seriousness criterion medically significant). This event occurred approximately one month after the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2012602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate irregular, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: irregular heart beat; Heart palpitations; Irregular pulse; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26396167) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26396167) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat), HEART RATE IRREGULAR (Irregular pulse) and PALPITATIONS (Heart palpitations) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced HEART RATE IRREGULAR (Irregular pulse) (seriousness criterion medically significant). On an unknown date, the patient experienced HEART RATE IRREGULAR (irregular heart beat) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations) (seriousness criterion medically significant). At the time of the report, HEART RATE IRREGULAR (irregular heart beat) and HEART RATE IRREGULAR (Irregular pulse) had not resolved and PALPITATIONS (Heart palpitations) 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. No concomitant medication information was provided. Patient experienced irregular heart beat, enlarged armpit lymph nodes. Attended A and E, released with no treatment. No treatment medication was provided.; Sender''s Comments: This is a regulatory case concerning a male patient of an unknown age with no medical history reported, who experienced the serious unexpected events of Heart rate irregular (twice) and Palpitations(seriousness criterion medically significant). The first episode of Heart rate irregular occurred 5 days after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine), with the second episode of heart rate irregular and Palpitations occurring on an unknown date. The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2012636 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-12-23
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry skin, Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Skin red; Rash; Skin dry; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26389727) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin red), RASH (Rash) and DRY SKIN (Skin dry) in a 28-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 11-Jun-2021 to 27-Aug-2021 for COVID-19. On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ERYTHEMA (Skin red) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant) and DRY SKIN (Skin dry) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (Skin red), RASH (Rash) and DRY SKIN (Skin dry) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No Medical History information was reported. Company comment: This case concerns a 28-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of erythema, rash and dry skin. The events occurred approximately 3 months after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report. 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.; Sender''s Comments: This case concerns a 28-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of erythema, rash and dry skin. The events occurred approximately 3 months after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2012637 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen lymph nodes; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26389972) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. This is in addition to other side effects that were previously reported via yellow card. Company Comment: This case concerns a 41-year-old female subject, with no relevant medical condition, who experienced the serious (seriousness criterion= Other medically important condition) unexpected event of Lymphadenopathy. The event Lymphadenopathy occurred 2 days after the third dose of mRNA 1273 vaccine. No information regarding treatment medication given was available. At the time of the report, lymphadenopathy had not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 41-year-old female subject, with no relevant medical condition, who experienced the serious (seriousness criterion= Other medically important condition) unexpected event of Lymphadenopathy. The event Lymphadenopathy occurred 2 days after the third dose of mRNA 1273 vaccine. No information regarding treatment medication given was available. At the time of the report, lymphadenopathy had not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.


VAERS ID: 2012641 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dehydration, Headache, Lymphadenopathy, Myalgia, Nausea, Night sweats, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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; LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen lymph nodes; Shivers; Night sweat; Fever; Nauseous; Headache; Muscle pain; Dehydration; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26395375) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), NIGHT SWEATS (Night sweat), PYREXIA (Fever), LYMPHADENOPATHY (Swollen lymph nodes), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nauseous), HEADACHE (Headache), MYALGIA (Muscle pain) and DEHYDRATION (Dehydration) in a 25-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 vaccination, ETHINYLESTRADIOL, LEVONORGESTREL (LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]) for The pill. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and DEHYDRATION (Dehydration) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivers), NIGHT SWEATS (Night sweat), PYREXIA (Fever), HEADACHE (Headache) and DEHYDRATION (Dehydration) had resolved and LYMPHADENOPATHY (Swollen lymph nodes), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nauseous) and MYALGIA (Muscle pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Patient did not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not breastfeeding . Patient not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial. Company Comment: This is a case of Interchange of vaccine products for this 25-year-old female subject, with a medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH (18-JUN-2021 dose 1= 6 months 5 days prior to mRNA 1273 vaccination; 20-AUG-2021 dose 2 = 4 months 3 days prior to mRNA 1273 vaccination) and concomitant medication with Levest (ETHINYLESTRADIOL, LEVONORGESTREL), who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Chills, Night sweats, Pyrexia, Lymphadenopathy, Peripheral swelling (swollen arm), Nausea, Headache, Myalgia, and Dehydration. The event Peripheral swelling occurred on the same day after the third dose of mRNA 1273 vaccine, event Lymphadenopathy occurred 2 days after, and all the other events occurred 1 day after. COVID-19 virus test was negative. No information regarding treatment medication taken was available. At the time of the report, events Chills, Night sweats, Pyrexia, Headache, and Dehydration were resolved, while all the other events were resolving. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH and concomitant medication with Levest, which can cause headache and nausea, remain as confounders. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.; Sender''s Comments: This is a case of Interchange of vaccine products for this 25-year-old female subject, with a medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH (18-JUN-2021 dose 1= 6 months 5 days prior to mRNA 1273 vaccination; 20-AUG-2021 dose 2 = 4 months 3 days prior to mRNA 1273 vaccination) and concomitant medication with Levest (ETHINYLESTRADIOL, LEVONORGESTREL), who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Chills, Night sweats, Pyrexia, Lymphadenopathy, Peripheral swelling (swollen arm), Nausea, Headache, Myalgia, and Dehydration. The event Peripheral swelling occurred on the same day after the third dose of mRNA 1273 vaccine, event Lymphadenopathy occurred 2 days after, and all the other events occurred 1 day after. COVID-19 virus test was negative. No information regarding treatment medication taken was available. At the time of the report, events Chills, Night sweats, Pyrexia, Headache, and Dehydration were resolved, while all the other events were resolving. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s medical history of vaccination with COVID-19 MRNA VACCINE BIONTECH and concomitant medication with Levest, which can cause headache and nausea, remain as confounders. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.


VAERS ID: 2012647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0000014 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Ear pain, Lymphadenopathy, Pharyngeal swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: back ache; ear ache; fever; swollen throat; Fever chills; Swollen glands; This case was received (Reference number: GB-MHRA-ADR 26396149) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (back ache), EAR PAIN (ear ache), PYREXIA (fever), PYREXIA (Fever chills), PHARYNGEAL SWELLING (swollen throat) and LYMPHADENOPATHY (Swollen glands) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 0000014) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion disability). On 25-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion disability). On an unknown date, the patient experienced BACK PAIN (back ache) (seriousness criterion disability), EAR PAIN (ear ache) (seriousness criterion disability), PYREXIA (fever) (seriousness criterion disability) and PHARYNGEAL SWELLING (swollen throat) (seriousness criterion disability). At the time of the report, BACK PAIN (back ache), EAR PAIN (ear ache), PYREXIA (fever), PYREXIA (Fever chills), PHARYNGEAL SWELLING (swollen throat) and LYMPHADENOPATHY (Swollen glands) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Patient did not had symptoms associated with COVID-19. Patient had swollen throat, ear ache, high fever, swollen glands in groin, back ache and hip pain Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) events of back pain, ear pain, and pharyngeal swelling. The events occurred the next day after the booster dose of mRNA-1273. The patient tested negative for COVID-19 four days after vaccine administration. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) events of back pain, ear pain, and pharyngeal swelling. The events occurred the next day after the booster dose of mRNA-1273. The patient tested negative for COVID-19 four days after vaccine administration. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2012712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-12-23
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2022-01-07
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 Date: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 20211212; Test Name: COVID-19 virus test; Test Result: Negative; Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: upon arrival in the Temporary Specimen Collection Centre (TSCC)
CDC Split Type: HKPFIZER INC202200010498

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007578. This is a spontaneous report received from a non-contactable HCP. The regulatory authority report number is not applicable. As of 0:00 am, 25-Dec-2021, DH announced that nineteen additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 19 patients that confirmed COVID-19 after Comirnaty vaccination. A 33-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 29-Apr-2021 and 21-May-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 12-Dec-2021, the patient tested negative on the same day. On 23-Dec-2021, the patient''s specimen collected upon arrival in the Temporary Specimen Collection Centre (TSCC) tested positive with Ct value less than 30. The patient developed symptoms on the same day. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Dec-2021, 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. The adverse event'' confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the 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 26-Dec-2021 and 28-Dec-2021. This case was split from AER 2021FOS007494 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Drug: COMIRNATY COVID-19, Vaccination failure Per Primary reporter: Possible Per Company (BioNTech SE): Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101874688 same reporter/product, different event/patient


VAERS ID: 2012713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-12-23
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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 Date: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result: carried the Variant of Concern Omicron; Comments: COVID-19 with mutant strains of N501Y and T478K; Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200010503

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007579. A 33-year-old female patient received bnt162b2, administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 23Apr2021 (Batch/Lot number: unknown) 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: COVID-19 (medically significant) with onset 23Dec2021, outcome unknown, described as CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; VACCINATION FAILURE (medically significant) with onset 23Dec2021, outcome unknown, described as CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON. The patient underwent the following laboratory tests and procedures: gene sequencing: (Dec2021) carried the variant of concern omicron, notes: COVID-19 with mutant strains of N501Y and T478K; sars-cov-2 test: (Dec2021) positive. Clinical course. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 25Dec2021, DH announced that nineteen additional confirmed cases of COVID-19 after BNT162B2 vaccination. This report was split for 1 of 19 patients that confirmed COVID-19 after BNT162B2 vaccination. The patient received BNT162B2. On 23Dec2021, the patient arrived via flight. The patient developed symptoms on the same day. In Dec2021, the patient tested positive. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Dec2021, the whole genome sequencing analysis conducted confirmed that the patient carried the Variant of Concern Omicron. Initial report was received on 26Dec2021 and 28Dec2021. This case was split from AER 2021FOS007494 due to same reporter/product, different event/patient. BNT162B2 is under agreement with BioNTech: Causality Assessment: Drug: BNT162B2, Events: Vaccination failure, COVID-19. Per Reporter = Possible, Per Company = Possible 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) : HK-PFIZER INC-202101874688 same reporter/suspect drug and different patients


VAERS ID: 2013245 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, 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.MOD20214

Write-up: Painful periods; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26384565) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Painful periods) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Painful periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. First period following booster was extremely painful and unbearably heavy. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 19-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of dysmenorrhoea. The event occurred 7 days after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of dysmenorrhoea. The event occurred 7 days after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2013301 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK7441 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Conjunctival hyperaemia, Cough, Dyspnoea, Erythema, Feeling abnormal, Heart rate, Immunisation, Oropharyngeal discomfort, Oxygen saturation, Pyrexia, Respiratory rate, Rhinorrhoea, Sneezing, Somnolence, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: BP; Result Unstructured Data: Test Result:140/91 mmHg; Comments: 15:06; Test Date: 20211223; Test Name: BP; Result Unstructured Data: Test Result:128/88 mmHg; Comments: 15:29; Test Date: 20211223; Test Name: BP; Result Unstructured Data: Test Result:123/76 mmHg; Comments: 15:59; Test Date: 20211223; Test Name: BP; Result Unstructured Data: Test Result:128/88 mmHg; Comments: 16:09; Test Date: 20211223; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before the vaccination; Test Date: 20211223; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: 15:06; Test Date: 20211223; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: 15:29; Test Date: 20211223; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: 20:00; Test Date: 20211224; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: 03:00; Test Date: 20211224; Test Name: Body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Comments: 14:00; Test Date: 20211223; Test Name: P; Result Unstructured Data: Test Result:76; Comments: times/minute 15:06; Test Date: 20211223; Test Name: P; Result Unstructured Data: Test Result:79; Comments: times/minute 15:29; Test Date: 20211223; Test Name: P; Result Unstructured Data: Test Result:80; Comments: times/minute 15:59; Test Date: 20211223; Test Name: P; Result Unstructured Data: Test Result:78; Comments: times/minute 16:09; Test Date: 20211223; Test Name: SPO2; Test Result: 99 %; Comments: 15:06; Test Date: 20211223; Test Name: SPO2; Test Result: 97 %; Comments: 15:29; Test Date: 20211223; Test Name: SPO2; Test Result: 97 %; Comments: 15:59; Test Date: 20211223; Test Name: SPO2; Test Result: 98 %; Comments: 16:09; Test Date: 20211223; Test Name: RR; Result Unstructured Data: Test Result:22; Comments: times/minute at 15:06; Test Date: 20211223; Test Name: RR; Result Unstructured Data: Test Result:20; Comments: times/minute at 15:29; Test Date: 20211223; Test Name: RR; Result Unstructured Data: Test Result:13; Comments: times/minute at 15:59
CDC Split Type: JPPFIZER INC202101864043

Write-up: sneezing; pyrexia at 39.4 degrees Centigrade; sleepiness; coughing; Oral feeling strange; nasal discharge; closed sensation of Nasopharyngeal/Throat obstruction; The feeling of dyspnea was extremely mild; redness around the eyes; pharynx discomfort/Pharynx strange sensation of; conjunctival hyperaemia; Anaphylaxis; Booster; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21132930. The patient was a 57-year-old female adult (At the age of 57-year-old) Body temperature before vaccination was 36.4 degrees centigrade. There was a point to be considered that the patient had pharynx discomfort, conjunctival hyperaemia, etc after SARS-CoV-2 vaccination(dose number unknown). On 23Dec2021 at 14:00 (the day of vaccination), the patient received the third single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FK7441, Expiration date 30Apr2022) via an unspecified route of administration for COVID-19 immunization. On 23Dec2021 at 14:30 (30 minutes after vaccination), the patient experienced events. On 25Dec2021(2 days after vaccination), the outcome of the events was recovered. Clinical course of the event was reported as follows: The patient experienced pharynx discomfort, conjunctival hyperaemia after the vaccination, received SOLU-CORTEF 100mg, POLARAMINE 1ml vein injection. On 23Dec2021 at 20:00, the patient was pyrexia at 39.4 degrees Centigrade and took CALONAL 2 tablets. On 24Dec2021 at 03:00, the patient was pyrexia at 39.2 degrees Centigrade and took CALONAL 2 tablets. On 24Dec2021 at 14:00, the patient was pyrexia at 39.3 degrees Centigrade and took CALONAL 2 tablets. Below, from the medical record. At 15:06, the emergency outpatient patient went to the treatment room with the physician. Chief complaint)Oral feeling strange, pharynx strange feeling of (feeling like biting sand), nasal discharge. There was a closed sensation of Nasopharyngeal. Compare to lying position, the patient prefer to sitting position, and urged the patient to lie down several times, but the patient hoped a sitting position. Consultation of the physician. P:76 times/minute, SPO2:99%, BT 36.5 degrees Centigrade, BP 140/91mmHg. The feeling of dyspnoea was extremely mild. There was redness around the eyes. Instruction) securing blood vessels, SOLU-CORTEF 100mg intravenous drip infusion started. At 15:16, as a result of the medical examination, the patient complained with did not want to use Polaramine 1A because the patient drive a car. During the examination, the amount of nasal discharge increased and coughing appeared, so the physician gave the instruction again and the patient agreed to use polaramine. Physician suggested the patient not to drive, let the family pick up or take other measures. 15:29, continued follow-up with a sitting position witch the patient hoped. Nasal discharge disappeared and pharynx strange feeling of improved. P:79 times/minute, SPO2:97%, BP 128/88mmHg, RR:22 times/minute, BT 37.0 degrees Centigrade. 15:38, The patient experienced sleepiness and lie down. 15:59, BP 123/76mmHg, SPO2:97%, P:80 times/minute, RR:20 times/minute. S)The symptoms disappeared. There was a fluffy feeling. 16:09, P:78 times/minute, SPO2:98%, BP 128/88mmHg, RR:13 times/minute. Reported to physician. The patient was instructed to take today''s internal medicine after returning home. Contacted with the ward chief. There was a reply that it was okay to wait in the treatment room for a while and follow up. The patient wanted to leave the treatment room and had a direct telephone conversation with the ward chief. When I left the room, I proceeded to use a wheelchair, but I was refused, so I accompanied him to the checkout. When the patient left the room, she refused the suggestion of using a wheelchair, so the reporter accompanied the patient to checkout by walking. S) It became relaxed. The eyes could see clearly. o) Redness around the eyes was reduced. No dizziness. The reporting physician commented as follows: Ministry of Health and Welfare, issued on 20Mar2021, "How to describe a post-vaccine vaccine adverse reaction suspicion report regarding a vaccine related to a new coronavirus infection" In line with the "Brighton Classification" (attachment 1): ?level? Mandatory criteria: sudden onset, rapid progression of signs and symptoms, symptoms of two or more multi-organs Level 3: Skin, Mucosal symptoms: minor symptoms, painful red eyes. Respiratory symptoms: Minor symptoms "throat obstruction", "sneezing, nasal discharge" No image, no blood sampling test This report met the criteria of Anaphylaxis. The reporting physician classified the event as serious(Medically significant), and assessed that the events were related to BNT162B2. There was no other possible cause of the event such as any other diseases. ; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101884459 same patient/drug, different dose/events


VAERS ID: 2013318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Immunisation, Myocarditis, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: Blood test; Result Unstructured Data: Test Result: Troponin I positive; Comments: after vaccination; Test Date: 20211226; Test Name: Chest X-ray; Result Unstructured Data: Test Result: No abnormality; Comments: after vaccination; Test Date: 20211226; Test Name: Echocardiography; Result Unstructured Data: Test Result: No abnormality; Comments: after vaccination; Test Date: 20211226; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: No abnormality; Comments: after vaccination.
CDC Split Type: JPPFIZER INC202101868472

Write-up: Myocarditis; Chest pain; Palpitations; Dyspnoea; Booster; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 25-year-old female adult. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient was not pregnant at the time of vaccination. On 19Mar2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number Unknown (not available/provided to reporter at the time of report completion), Expiration date Unknown) via intramuscular for COVID-19 immunization. On 09Apr2021, the patient previously received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number Unknown (not available/provided to reporter at the time of report completion), Expiration date Unknown) via intramuscular in the left arm for COVID-19 immunization. On 23Dec2021 at 17:00 (the day of vaccination), the patient received the third single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number Unknown (not available/provided to reporter at the time of report completion), Expiration date Unknown) intramuscular in the left arm as dose 3 (booster), single for COVID-19 immunization. On 26Dec2021 at 02:00 (2 days and 9 hours after the vaccination), the patient experienced myocarditis, chest pain, palpitations, and dyspnoea. The clinical course was reported as follows on 26Dec2021 at 02:00, the patient experienced myocarditis, chest pain, palpitations, dyspnoea. The patient went to nearby hospital for treatment, the result of Electrocardiogram, Chest X-ray, Echocardiogram was no abnormality. The result of Blood test was Troponin I positive. The symptoms disappeared and went recovering by resting. The reporter stated the events resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2021 without treatment. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Myocarditis, Booster, and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.


VAERS ID: 2013562 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neck pain, SARS-CoV-2 test
SMQs:, 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 ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Neck pain; This case was received via RA (Reference number: GB-MHRA-ADR 26383627) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) in a 49-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication was reported by patient. Patient reported that he had Severe neck pain and sleepless night. Company comment: This case concerns a 49-year-old male patient, with no reported medical history, who experienced the serious, unexpected event of neck pain 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Patient experienced severe neck pain and sleepless night. At the time of report event had not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old male patient, with no reported medical history, who experienced the serious, unexpected event of neck pain 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Patient experienced severe neck pain and sleepless night. At the time of report event had not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2013568 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Red rash; Swelling of injection site; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26389051) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling of injection site) and RASH ERYTHEMATOUS (Red rash) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced INJECTION SITE SWELLING (Swelling of injection site) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). At the time of the report, INJECTION SITE SWELLING (Swelling of injection site) and RASH ERYTHEMATOUS (Red rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Patient has not had symptoms associated with COVID-19. It was reported that patient took the modern vaccine on Wednesday and had symptoms of Swelling/tenderness of the underarm glands on the same side as the injection site, Pain or swelling at the injection site Rash, redness, or hives at the injection site patient want to know if it''s normal. Patient is not enrolled in clinical trial Treatment medications was not reported Compant comment:This RA case concerns a female patient of 31 years with no medical history, who experienced the unexpected serious events of Injection site swelling and Rash erythematous (Medically significant). The event Injection site swelling occurred one day and Rash erythematous occurred on unknown date after the third dose of mRNA-1273 vaccine. The outcome of Injection site swelling and Rash erythematous was reported not resolved. 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 31 years with no medical history, who experienced the unexpected serious events of Injection site swelling and Rash erythematous (Medically significant). The event Injection site swelling occurred one day and Rash erythematous occurred on unknown date after the third dose of mRNA-1273 vaccine. The outcome of Injection site swelling and Rash erythematous was reported not resolved. 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: 2015506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-12-23
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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: 20211224; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: DEPFIZER INC202200016977

Write-up: COVID-19; Vaccination Failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 112536 (RA reference number), 112547 (RA reference number). A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 16Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05May2021 (Batch/Lot number: unknown) 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: COVID-19 (medically significant) with onset 23Dec2021, outcome "not recovered", described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Vaccination Failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2015727 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, General physical health deterioration, Herpes zoster disseminated
SMQs:, Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Diagnosed in Mexico); Rash zosteriform
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101865784

Write-up: generalized zona without fever but deterioration of the general condition; generalized zona without fever but deterioration of the general condition; very advanced intercostal zona; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent. A male patient received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "posterior zosteric vesicles", start date: 20Dec2021 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: The patient''s concomitant medications were not reported. The following information was reported: HERPES ZOSTER DISSEMINATED (medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) all with onset 25Dec2021, outcome "unknown" and all described as "generalized zona without fever but deterioration of the general condition"; CONDITION AGGRAVATED (medically significant) with onset 23Dec2021, outcome "unknown", described as "very advanced intercostal zona". Therapeutic measures were taken as a result of condition aggravated local antisepsis and prescription for pain. The physician asked if aciclovir should be prescribed due to generalized zona without fever but deterioration of the general condition. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report, a possible causal relationship between the events Herpes zoster disseminated, Condition aggravated and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2015737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Fibromyalgia, Immunisation, Local reaction, Pain, SARS-CoV-2 test, Sinus tachycardia
SMQs:, Supraventricular tachyarrhythmias (narrow), Dehydration (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: Back pain
Preexisting Conditions: Medical History/Concurrent Conditions: De Quervain''s tenosynovitis; Fibromyalgia; Irritable bowel syndrome; Sinus tachycardia; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101857621

Write-up: Local reaction; Pain; Tiredness; Booster; sinus tachycardia; fibromyalgia; 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-APPCOVID-202112242159533640-CBQWN. Other Case identifier(s): GB-MHRA-ADR 26393909. A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Vitamin D deficiency" (unspecified if ongoing); "Sinus tachycardia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Back pain" (ongoing); "IBS" (unspecified if ongoing); "de quervains" (unspecified if ongoing). Patient was not pregnant; Patient was not currently breast feeding. Patient''s concomitant medications were not reported. Past drug history included: Vitamin d. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (disability) with onset 23Dec2021, outcome "unknown", described as "Booster"; LOCAL REACTION (disability) with onset 24Dec2021, outcome "not recovered", described as "Local reaction"; PAIN (disability) with onset 24Dec2021, outcome "not recovered", described as "Pain"; FATIGUE (disability) with onset 24Dec2021, outcome "not recovered", described as "Tiredness"; SINUS TACHYCARDIA (disability) with onset 2021, outcome "unknown", described as "sinus tachycardia"; FIBROMYALGIA (disability) with onset 2021, outcome "unknown", described as "fibromyalgia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative. Clinical Course: It was reported that after each vaccine patient have felt progressively worse, patient suffered with fibromyalgia, sinus tachycardia along with other issues which come on and off. This lasts between 4-6 months. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2015738 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Condition aggravated, Fatigue, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
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: 20211224; Test Name: Body temperature test; Result Unstructured Data: Test Result:37.8 and 38.1; Comments: low fever of between 37.8 and 38.1
CDC Split Type: GBPFIZER INC202101857596

Write-up: feeling unwell; Very painful arm at vaccine site; fever; Armpit pain; armpit pain worse; fatigue; 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. Regulatory number: GB-MHRA-APPCOVID-202112250601108340-8BUBR. Other Case identifier(s): GB-MHRA-ADR 26394263. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. 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 23Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 24Dec2021, outcome "recovering", described as "fever"; MALAISE (medically significant), outcome "recovering", described as "feeling unwell"; FATIGUE (medically significant) with onset 23Dec2021, outcome "recovering", described as "fatigue"; AXILLARY PAIN (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Armpit pain"; CONDITION AGGRAVATED (medically significant) with onset 23Dec2021, outcome "unknown", described as "armpit pain worse"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Very painful arm at vaccine site". The patient underwent the following laboratory tests and procedures: body temperature: (24Dec2021) 37.8 and 38.1, notes: low fever of between 37.8 and 38.1. Clinical course: Fatigue on evening of vaccine. Next day a low fever of between 37.8 and 38.1. Very painful arm at vaccine site. Generally feeling unwell. Late evening pain in armpit on side of vaccine. Second day after vaccine, armpit pain worse. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2015827 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chromaturia, Fatigue, Nausea, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Asthma; Crohn''s (20 major ops)
Preexisting Conditions: Medical History/Concurrent Conditions: Ileostomy; Oophorectomy (Two ovaries removed); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211030; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: high temperature; nausea; Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); Urine discolouration; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26385782) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (high temperature), NAUSEA (nausea), CHROMATURIA (Urine discolouration), FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 62-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 28-Oct-2021 to 30-Oct-2021, Oophorectomy (Two ovaries removed) and Ileostomy. Concurrent medical conditions included Asthma and Crohn''s (20 major ops). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Apr-2021 to an unknown date for COVID-19 vaccination, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Apr-2021 to an unknown date for Vaccination. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced CHROMATURIA (Urine discolouration) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (high temperature) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, PYREXIA (high temperature), NAUSEA (nausea) and CHROMATURIA (Urine discolouration) had not resolved and FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had tachycardia, high temperature, nausea, aches and pains Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No treatment information was provided. Company comment: This is a regulatory authority case concerning a 62-year-old female patient with concurrent medical conditions of Crohn''s disease and permanent Ileostomy, who experienced events of pyrexia, nausea, chromaturia, fatigue, palpitations and tachycardia (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The event chromaturia occurred 1 day after the third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. Clinical course and treatment details were not provided. Concurrent medical conditions remain confounders. 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 62-year-old female patient with concurrent medical conditions of Crohn''s disease and permanent Ileostomy, who experienced events of pyrexia, nausea, chromaturia, fatigue, palpitations and tachycardia (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The event chromaturia occurred 1 day after the third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. Clinical course and treatment details were not provided. Concurrent medical conditions remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2015860 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; INDERAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic migraine; Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: vaginal bleeding; Menstrual cramp; Menstrual irregularity; Menstrual flow excessive; This case was received (Reference number: GB-MHRA-ADR 26389229) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding), DYSMENORRHOEA (Menstrual cramp), MENSTRUATION IRREGULAR (Menstrual irregularity) and HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Chronic migraine and Clinical trial participant. Previously administered products included for Product used for unknown indication: MIRENA (A 4 year old mirena coil IUD) since an unknown date and PROPRANOLOL (Propanolol 160mg daily) since an unknown date. Past adverse reactions to the above products included No adverse event with MIRENA and PROPRANOLOL. Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for Chronic migraine, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DYSMENORRHOEA (Menstrual cramp) (seriousness criterion medically significant), MENSTRUATION IRREGULAR (Menstrual irregularity) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) (seriousness criterion medically significant). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding), DYSMENORRHOEA (Menstrual cramp), MENSTRUATION IRREGULAR (Menstrual irregularity) and HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. she did not had a period in 3 years due to having an IUD coil fitted. he day after my moderna booster I had intense cramping. Two days after (Today) she had intense cramping and vaginal bleeding. Patient has not tested positive for COVID-19 since having the vaccine. Clinical trial participant. No treatment drug has been provided. Company Comment: This regulatory case concerns a 21-year-old, female patient using Mirena (levonorgestrel IUD), with an Interchange of vaccine products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), who experienced the unexpected serious events of Vaginal haemorrhage, Dysmenorrhoea, Menstruation irregular and Heavy menstrual bleeding. The event Vaginal haemorrhage occurred on an unknown date and events Dysmenorrhoea, Menstruation irregular and Heavy menstrual bleeding occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. patients use of Mirena (levonorgestrel IUD) remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This regulatory case concerns a 21-year-old, female patient using Mirena (levonorgestrel IUD), with an Interchange of vaccine products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), who experienced the unexpected serious events of Vaginal haemorrhage, Dysmenorrhoea, Menstruation irregular and Heavy menstrual bleeding. The event Vaginal haemorrhage occurred on an unknown date and events Dysmenorrhoea, Menstruation irregular and Heavy menstrual bleeding occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. patients use of Mirena (levonorgestrel IUD) remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2015892 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation, 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857888

Write-up: Dizziness; 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-202112240948170490-3L4AL (RA). Other Case identifier(s): GB-MHRA-ADR 26390443 (RA). A 41 year-old patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: Fk9707) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. No other medical problems. Patient has not had symptoms associated with COVID-19. 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 23Dec2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant), outcome "not recovered", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report doesn''t relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015903 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Immunisation, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857441

Write-up: difficulty breathing/Shortness of breath; Fatigue/unusual tiredness; Chest pain; Racing heart (tachycardia); Chest ache; Heart racing; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112241029114250-BOFKN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26390601 (MHRA). A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 28 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 2, single), administration date: 20Aug2021, for COVID-19 immunisation; Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 23Dec2021, outcome "unknown", described as "booster"; DYSPNOEA (medically significant), outcome "unknown", described as "difficulty breathing/Shortness of breath"; CHEST PAIN (medically significant) with onset 23Dec2021, outcome "recovering", described as "Chest ache"; PALPITATIONS (medically significant) with onset 23Dec2021, outcome "recovering", described as "Heart racing"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)". 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. It was reported that are both primary doses and booster, felt significant discomfort around chest, with heart seeming to have to work harder and slight difficulty breathing. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was not relate to possible inflammation of the heart (myocarditis or pericarditis). patient did not hospitalize and diagnosis was not made by a medical professional. No chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT) and no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2015905 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate, Immunisation, Myalgia, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:120bpm; Comments: Heart rate was 120bpm at rest
CDC Split Type: GBPFIZER INC202101857823

Write-up: Chest pain; Shortness of breath; Fatigue/unusual tiredness; Heart rate/Racing heart (tachycardia); Muscle pain; Fever; Booster; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112241035146050-MP7JH. Other Case identifier(s): GB-MHRA-ADR 26390709. A 44-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Dec2021 (Lot number: FN3543) 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 (1ST DOSE), for COVID-19 Immunisation; Bnt162b2 (2ND DOSE), for COVID-19 Immunisation. Patient''s last menstrual period date was on 22Dec2021. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 23Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; TACHYCARDIA (medically significant) with onset 23Dec2021, outcome "recovering", described as "Heart rate/Racing heart (tachycardia)"; MYALGIA (medically significant) with onset 23Dec2021, outcome "recovering", described as "Muscle pain"; PYREXIA (medically significant) with onset 23Dec2021, outcome "recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: heart rate: 120bpm, notes: Heart rate was 120bpm at rest. Therapeutic measures were taken as a result of myalgia, pyrexia. Additional information: Patient took paracetamol for ache and fever. Heart rate was 120bpm at rest. Usual rate at rest was 78 bpm. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were not related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to hospitalization. The events were not diagnosed by a medical professional. No follow-up attempts are possible. No further information is expected.


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