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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 137 out of 10,493

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VAERS ID: 2033286 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Immunisation, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON (28)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000706

Write-up: Booster; Stomach pain/severe stomach cramps; Pyrexia/ About 8 hours after vaccine suffered severe stomach cramps and fever.; This is a spontaneous report received from a contactable reporter (consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312229053760-WCFFM. Other Case identifier: GB-MHRA-ADR 26423289. A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN3543) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Contraception" (unspecified if ongoing). Concomitant medications included: RIGEVIDON (28) taken for contraception, start date: 06Jun2018. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Covid-19 vaccine (Dose 2), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; ABDOMINAL PAIN UPPER (medically significant) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "Stomach pain/severe stomach cramps "; PYREXIA (medically significant) with onset 28Dec2021, outcome "unknown", described as "Pyrexia/ About 8 hours after vaccine suffered severe stomach cramps and fever". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (30Dec2021) no - negative covid-19 test. Clinical course: About 8 hours after vaccine suffered severe stomach cramps and fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033349 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Heart rate, Heart rate decreased, Immunisation, Influenza like illness, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:weak; Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000729

Write-up: Weak heart beat; Flu like symptoms; Pain in chest that travels down to the stomach; Chronic chest pain; 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-202201011300522730-VMQ5T. Other Case identifier: GB-MHRA-ADR 26424024. A male patient received BNT162B2 (COMIRNATY), administration date 28Dec2021 (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, SINGLE), for COVID-19 immunisation; BNT162B2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 28Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (hospitalization) with onset 31Dec2021, outcome "not recovered", described as "Chronic chest pain"; HEART RATE DECREASED (hospitalization), outcome "unknown", described as "Weak heart beat"; INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "Pain in chest that travels down to the stomach". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (31Dec2021) negative; heartbeat: (unspecified date) weak. Clinical course details: Patient reported pain in chest that travels down to the stomach, weak heartbeat and flu like symptoms. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033366 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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 INC202200000334

Write-up: Rash on face/this reaction seems much worse; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011440590120-EXAEK. A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FK9707) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-2, Lot number-Pn40041), administration date: 01May2021, for COVID-19 immunisation, reaction(s): "Rash on face"; Covid-19 vaccine (Dose-1 (Manufacturer unknown)), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; RASH (medically significant), outcome "unknown", described as "Rash on face/this reaction seems much worse". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of rash. Clinical course- Patient has not had symptoms associated with COVID-19. Had a previous reaction to Astra Zenica which lasted 2 months. This reaction seems much worse with the Pfizer which seems to had an immediate reaction. Medication using eczema cream. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patients report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-MHRA-ADR 26424126


VAERS ID: 2033373 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Inner ear inflammation, Lymph node pain, Palpitations, Pyrexia, SARS-CoV-2 test, Vision blurred
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), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; ISENTRESS [RALTEGRAVIR POTASSIUM]; TRUVADA
Current Illness: HIV positive (HIV-positive with symptoms or reduction in immune response)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Heart pounding; Inner ear inflammation; Lymph node pain; Blurring of vision; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26424144) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurring of vision), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), PALPITATIONS (Heart pounding), INNER EAR INFLAMMATION (Inner ear inflammation) and LYMPH NODE PAIN (Lymph node pain) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included HIV positive (HIV-positive with symptoms or reduction in immune response). Concomitant products included RALTEGRAVIR POTASSIUM (ISENTRESS [RALTEGRAVIR POTASSIUM]) and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for Antiviral treatment, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VISION BLURRED (Blurring of vision) (seriousness criteria hospitalization and medically significant), INNER EAR INFLAMMATION (Inner ear inflammation) (seriousness criteria hospitalization and medically significant) and LYMPH NODE PAIN (Lymph node pain) (seriousness criteria hospitalization and medically significant). On 29-Dec-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant), PYREXIA (Fever) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization and medically significant) and PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization and medically significant). On 28-Dec-2021, VISION BLURRED (Blurring of vision) had not resolved. At the time of the report, FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart palpitations) outcome was unknown and PALPITATIONS (Heart pounding), INNER EAR INFLAMMATION (Inner ear inflammation) and LYMPH NODE PAIN (Lymph node pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis): Yes. Relevant lab data : X-ray ECG. Patient has not tested positive for COVID-19 since having the vaccine, Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Company Comment: This is a case of interchange of vaccine products for this 31-year-old male subject, with a concurrent medical condition of being HIV positive, concomitant medication with Isentress and Truvada, and prior vaccination with COVID-19 VACCINE ASTRAZENECA (unknown dose number and date of administration), who experienced the serious (Seriousness criteria- Caused/prolonged hospitalization, Other medically important condition) unexpected events of Palpitations, Inner ear inflammation, Lymph node pain, Vision blurred, Fatigue, Chest pain, Pyrexia, and Dyspnoea. The event palpitations occurred 1 day after the third dose of mRNA-1273 vaccine, events inner ear inflammation, lymph node pain, and vision blurred occurred on the same day after vaccination, and all the other events occurred unknown number of days after. COVID-19 virus test was negative. Ecg and xray were done but results were not provided. There is also no available information regarding treatment medication. At the time of the report, blurred vision had not resolved, palpitations, inner ear inflammation, and lymph node pain were resolving, and all the other events had unknown outcomes. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s age & gender, concurrent medical condition of being HIV positive, concomitant medication with Isentress and Truvada, and prior vaccination with COVID-19 VACCINE ASTRAZENECA 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 31-year-old male subject, with a concurrent medical condition of being HIV positive, concomitant medication with Isentress and Truvada, and prior vaccination with COVID-19 VACCINE ASTRAZENECA (unknown dose number and date of administration), who experienced the serious (Seriousness criteria- Caused/prolonged hospitalization, Other medically important condition) unexpected events of Palpitations, Inner ear inflammation, Lymph node pain, Vision blurred, Fatigue, Chest pain, Pyrexia, and Dyspnoea. The event palpitations occurred 1 day after the third dose of mRNA-1273 vaccine, events inner ear inflammation, lymph node pain, and vision blurred occurred on the same day after vaccination, and all the other events occurred unknown number of days after. COVID-19 virus test was negative. Ecg and xray were done but results were not provided. There is also no available information regarding treatment medication. At the time of the report, blurred vision had not resolved, palpitations, inner ear inflammation, and lymph node pain were resolving, and all the other events had unknown outcomes. Rechallenge was not applicable as no additional dose is expected to be given. The patient''s age & gender, concurrent medical condition of being HIV positive, concomitant medication with Isentress and Truvada, and prior vaccination with COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033411 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pruritus, Vulvovaginal candidiasis, Vulvovaginal dryness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Sexual dysfunction (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 INC202200000444

Write-up: itchy; dry vagina; Thrush vaginal; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201012010177020-DCOEV. Other Case identifier(s): GB-MHRA-ADR 26424345. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (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 astrazeneca (Dose number unknown; Primary immunization), administration date: Jun2021, for COVID-19 immunization; Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PRURITUS (medically significant), outcome "not recovered", described as "itchy"; VULVOVAGINAL CANDIDIASIS (medically significant) with onset 01Jan2022, outcome "recovering", described as "Thrush vaginal"; VULVOVAGINAL DRYNESS (medically significant), outcome "unknown", described as "dry vagina". Therapeutic measures were taken as a result of pruritus, vulvovaginal candidiasis, vulvovaginal dryness. The patient had not symptoms associated with COVID-19 Not had a COVID-19 test. Patient not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Taken Canesten capsule and cream. Reaction: The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033424 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Tendonitis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (narrow), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; GEMFIBROZIL; LISINOPRIL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia universalis; Cholestasis; Hypertension; Seasonal allergy; Comments: Alopecia Universalis Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000865

Write-up: heel pain/Sudden extreme heel pain at the point where the achilles attaches to the heel bone; I was not capable of walking at all for 48 hours after onset; Achilles tendonitis; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201012116307070-YXXUM Regulatory Authority. Other Case identifier: GB-MHRA-ADR 26424599 Regulatory Authority. A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Cholestasis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Alopecia Universalis" (unspecified if ongoing). Concomitant medications included: FEXOFENADINE taken for seasonal allergy; GEMFIBROZIL taken for cholestasis; LISINOPRIL taken for hypertension; SERTRALINE taken for mood swings. Vaccination history included: Covid-19 vaccine moderna (Dose 1), administration date: 22Feb2021, for COVID-19 vaccination; Covid-19 vaccine moderna (Dose 2), administration date: 10Mar2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "heel pain/Sudden extreme heel pain at the point where the achilles attaches to the heel bone"; TENDONITIS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Achilles tendonitis"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "I was not capable of walking at all for 48 hours after onset". Therapeutic measures were taken as a result of gait disturbance that included icing and NSAIDs. Clinical course: Sudden extreme heel pain at the point where the Achilles attaches to the heel bone. Patient had mild cases before related to exercise when younger. Patient had not been involved in strenuous activities in 2021. Patient was not capable of walking at all for 48 hours after onset. With icing and NSAIDs patient can walk now but had not fully recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000337

Write-up: Off label use; Interchange of vaccine products; Booster; Pain in neck; Pain in shoulder; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201012144327550-KRHY5. Other Case identifier(s): GB-MHRA-ADR 26424412. A female patient received bnt162b2 (COMIRNATY) (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1, lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2, lot number: unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; NECK PAIN (medically significant), outcome "not recovered", described as "Pain in neck"; ARTHRALGIA (medically significant), outcome "not recovered", described as "Pain in shoulder". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical Course: Pain in neck and shoulder followed by swelling of lymph nodes in the neck and pain unresolved on day 5. Patient has not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Reaction. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033442 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary mass, Bone pain, Condition aggravated, Hypoaesthesia, Hypokinesia, Immunisation, Insomnia, Joint stiffness, Musculoskeletal chest pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Pain in jaw, Paraesthesia, Periarthritis, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Sleeplessness
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000320

Write-up: struggling to sleep at night; wake up in pain/pain all down left side/unable to sleep on left side at all; left arm feels numb; with some pins and needles effects; shoulder pain; lack of movement in shoulder; pain in left side of ribs; ankle pain; lump in left armpit; pain radiating into right collarbone; but now increased; Frozen shoulder; Hand pain; Neck pain; Jaw pain; Stiff joint/Knee Stiffness; Ankle stiffness; stifness into left lower side of jaw; Stiff neck; Knee pain; Stiff fingers/fingers feel like the want to turn in on themselves to be comfortable; Wrist pain; Pain in elbow; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201012248282870-I9LHQ. Other Case identifier(s): GB-MHRA-ADR 26424514. A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sleeplessness" (unspecified if ongoing); "Pain" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (disability) with onset 28Dec2021, outcome "unknown", described as "Booster"; INSOMNIA (disability), outcome "unknown", described as "struggling to sleep at night"; PAIN (disability), outcome "unknown", described as "wake up in pain/pain all down left side/unable to sleep on left side at all"; HYPOAESTHESIA (disability), outcome "unknown", described as "left arm feels numb"; PARAESTHESIA (disability), outcome "unknown", described as "with some pins and needles effects"; MUSCULOSKELETAL STIFFNESS (disability) with onset 28Dec2021, outcome "not recovered", described as "Stiff fingers/fingers feel like the want to turn in on themselves to be comfortable"; ARTHRALGIA (disability) with onset 28Dec2021, outcome "not recovered", described as "Wrist pain"; ARTHRALGIA (disability) with onset 28Dec2021, outcome "not recovered", described as "Pain in elbow"; ARTHRALGIA (disability), outcome "unknown", described as "shoulder pain"; HYPOKINESIA (disability), outcome "unknown", described as "lack of movement in shoulder"; MUSCULOSKELETAL CHEST PAIN (disability), outcome "unknown", described as "pain in left side of ribs"; ARTHRALGIA (disability) with onset 28Dec2021, outcome "not recovered", described as "Knee pain"; ARTHRALGIA (disability), outcome "unknown", described as "ankle pain"; NECK PAIN (disability) with onset 28Dec2021, outcome "not recovered", described as "Neck pain"; PAIN IN JAW (disability) with onset 28Dec2021, outcome "not recovered", described as "Jaw pain"; JOINT STIFFNESS (disability) with onset 28Dec2021, outcome "not recovered", described as "Stiff joint/Knee Stiffness"; JOINT STIFFNESS (disability) with onset 28Dec2021, outcome "not recovered", described as "Ankle stiffness"; JOINT STIFFNESS (disability) with onset 28Dec2021, outcome "not recovered", described as "stifness into left lower side of jaw"; MUSCULOSKELETAL STIFFNESS (disability) with onset 28Dec2021, outcome "not recovered", described as "Stiff neck"; AXILLARY MASS (disability), outcome "unknown", described as "lump in left armpit"; PERIARTHRITIS (disability) with onset 28Dec2021, outcome "not recovered", described as "Frozen shoulder"; PAIN IN EXTREMITY (disability) with onset 28Dec2021, outcome "not recovered", described as "Hand pain"; BONE PAIN (disability), outcome "unknown", described as "pain radiating into right collarbone"; CONDITION AGGRAVATED (disability), outcome "unknown", described as "but now increased". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient was in full clean health, with active lifestyle till booster, been resting now since booster and taking regular paracetamol to get through the day and night, struggling to sleep at night and wake up in pain, reduced to tears if the patient accidentally roll on to left side in sleep or bash when awake, hurts that much. Patient has not had symptoms associated with COVID-19. Patient last menstrual period date was 30Dec2021 same issue from 1st and 2nd dose, but now increased. pain all down left side, left arm feels numb with some pins and needles effects, fingers feel like the want to turn in on themselves to be comfortable, wrist pain, elbow pain, shoulder pain, lack of movement in shoulder, unable to hold a glass of water, feels too heavy. pain in left side of ribs, unable to sleep on left side at all. knee pain, ankle pain, they feel as if the patient have sprained them unable to put full weigh on left leg, some pain and stiffness in neck and into left lower side of jaw. lump in left armpit, unable to ware bra, or get the arm into a comfortable position, pain radiating into right collarbone. Unable to pic up the patients 13 month old, unable to lift arm above head, unable to get dressed or undressed with out assistance or very baggy clothes. Period so far ok. 1st dose period was very heavy and very long, 2nd dose not as bad in period department. The patient won''t be having another if offered in future because the patient feel they are trying to paralyse the patient down one side. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN1664 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhoids, Immunisation, Polyp, Rectal haemorrhage, SARS-CoV-2 test, Sigmoidoscopy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Sigmoidoscopy; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202200003479

Write-up: Haemorrhoids type symptoms; Polyp; Rectal bleeding; 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-202201021733523790-EPL75 (RA). Other Case identifier(s): GB-MHRA-ADR 26425098 (RA). A 31 year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN1664) as dose 3 (booster), single for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Relevant medical history included: "Suspected COVID-19", start date: 10Feb2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunisation; Bnt162b2 (Dose 2, Single), for COVID-19 immunisation, reaction(s): "Haemorrhoids", "Polyp". The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; RECTAL HAEMORRHAGE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Rectal bleeding"; HAEMORRHOIDS (non-serious), outcome "not recovered", described as "Haemorrhoids type symptoms"; POLYP (non-serious), outcome "unknown", described as "Polyp". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative; sigmoidoscopy: unknown results. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Clinical Course: Similar occurrence following a similar time frame after 2nd jab, haemorrhoids type symptoms, gastroenterologist was booked prior to recurrence for examination following discovery of polyp. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200022756 same patient/reporter/different dose/event (Dose 2)


VAERS ID: 2033616 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: chills; nausea; Stiff neck; Headache; Muscle pain; High temperature; This case was received via RA (Reference number: GB-MHRA-ADR 26429208) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (High temperature) and MUSCULOSKELETAL STIFFNESS (Stiff neck) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion disability). On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). On 30-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion disability). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion disability) and NAUSEA (nausea) (seriousness criterion disability). On 30-Dec-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (chills), NAUSEA (nausea) and HEADACHE (Headache) had not resolved and PYREXIA (High temperature) and MUSCULOSKELETAL STIFFNESS (Stiff neck) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient experienced High temperature, Chills, Joint and muscle pain, Tummy upset and nausea, Persistent headache with stiffness in back of neck for 7 days still ongoing. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This regulatory authority case concerns a 60-year-old female patient, with no relevant medical history reported, who experienced the serious (disability) unexpected events of CHILLS, NAUSEA, HEADACHE, MYALGIA, PYREXIA and MUSCULOSKELETAL STIFFNESS. The event of pyrexia occurred on the same day after receiving a third dose of mRNA-1273. The events of headache and myalgia occurred 1 day after vaccination, and the event of musculoskeletal stiffness occurred 2 days after vaccine administration. No onset date was provided for other reported events. No information about previous vaccination schedule was reported. No further clinical information (including permanent disability description) 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 60-year-old female patient, with no relevant medical history reported, who experienced the serious (disability) unexpected events of CHILLS, NAUSEA, HEADACHE, MYALGIA, PYREXIA and MUSCULOSKELETAL STIFFNESS. The event of pyrexia occurred on the same day after receiving a third dose of mRNA-1273. The events of headache and myalgia occurred 1 day after vaccination, and the event of musculoskeletal stiffness occurred 2 days after vaccine administration. No onset date was provided for other reported events. No information about previous vaccination schedule was reported. No further clinical information (including permanent disability description) 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: 2033618 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: welts; Itchy rash; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26429234) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (welts) and RASH PRURITIC (Itchy rash) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: PENICILLIN. Past adverse reactions to the above products included No adverse event with PENICILLIN. Concurrent medical conditions included Penicillin allergy. On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (welts) (seriousness criterion medically significant). At the time of the report, URTICARIA (welts) and RASH PRURITIC (Itchy rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient began with whole body itch. Progressed to specific raised itchy welts on body. Patient had not tested positive for COVID-19 since the vaccine.Patient was not enrolled in clinical trial. Treatment medication information that included antihistamines for the reaction. The report did not relate to possible inflammation of the heart myocarditis or pericarditis. Company Comment: This is a RA case concerning a 27-year-old male patient, with medical history of penicillin allergy, who experienced the unexpected and serious events of Urticaria and Rash pruritic. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event of Rash pruritic occurred 9 days after the third dose of mRNA-1273 vaccine. The event of Urticaria occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in RA. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a RA case concerning a 27-year-old male patient, with medical history of penicillin allergy, who experienced the unexpected and serious events of Urticaria and Rash pruritic. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event of Rash pruritic occurred 9 days after the third dose of mRNA-1273 vaccine. The event of Urticaria occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in RA. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache
SMQs:

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

Write-up: Throbbing headache; Exhaustion; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26430244) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Throbbing headache) and FATIGUE (Exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Throbbing headache) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). At the time of the report, HEADACHE (Throbbing headache) and FATIGUE (Exhaustion) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient felt like the worst hangover ever but without drinking any alcohol. Patient was not tested positive for COVID-19 since vaccination and not enrolled in clinical trials. No treatment information was reported. Company comment: This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected events of Headache and Fatigue on the same date after the third dose of mRNA-1273 vaccine (the previous doses were of another manufacturer). The patient reported that the symptoms seemed like the worst hangover ever but without drinking any alcohol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected events of Headache and Fatigue on the same date after the third dose of mRNA-1273 vaccine (the previous doses were of another manufacturer). The patient reported that the symptoms seemed like the worst hangover ever but without drinking any alcohol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.


VAERS ID: 2033673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Rash; This case was received (Reference number: GB-MHRA-ADR 26434966) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) 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 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (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. No concomitant medications were reported. Patient has not had symptoms associated with COVID-19. No treatment details were 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 patient, with medical history (not reported), who experienced the serious unexpected event(s) of rash. The event(s) started occurring approximately within 11 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2033674 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Steroid therapy
Preexisting Conditions: Graves'' disease; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Flu; Vomiting; Headache; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26435076) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA, VOMITING, and HEADACHE 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 (Unsure when symptoms stopped) on 18-Sep-2021 and Graves'' disease. Concurrent medical conditions included Steroid therapy. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INFLUENZA (Flu) (seriousness criteria disability and medically significant), VOMITING (seriousness criteria disability and medically significant) and HEADACHE (seriousness criteria disability and medically significant). At the time of the report, INFLUENZA and VOMITING was resolving and HEADACHE 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. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. No possible inflammation of the heart (myocarditis or pericarditis) was reported. This case concerns a 46-year-old female patient with concurrent medical history of Graves'' disease, who experienced the serious unexpected events of Influenza, Vomiting and Headache. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of concurrent Graves'' disease remains a confounder. 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: 2033712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200026779

Write-up: Drug ineffective; SARS-CoV-2 infection; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201061655470020-991SD. Other Case identifier(s): GB-MHRA-ADR 26445441. A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 01Jan2022, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 01Jan2022, outcome "recovering", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) yes - positive covid-19 test.The patient''s last menstrual cycle date was 19Dec2021. The patient was not enrolled in a clinical trial. not breastfeeding at the time of this report No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200054925 Same patient/different dose/different events;GB-PFIZER INC-202200054955 Same patient/different dose/different events


VAERS ID: 2033908 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5929 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Muscle spasms, Vaccination site pain
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202200028354

Write-up: Tetanic spasm generalised; Chills; vaccination site pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician). A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Dec2021 13:30 (Lot number: FJ5929, Expiration Date: 30Apr2022) at the age of 61 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: Comirnaty (1st single dose, Lot number : EP9605, Expiration date: 30Jun2021, Administrated route: intramuscular, Administrated location: arm left), administration date: 31Mar2021, when the patient was 60 years old, for COVID-19 immunisation; Comirnaty (2nd single dose, Lot number : ET3674, Expiration date: 31Oct2021, Administrated route: intramuscular, Administrated location: arm left), administration date: 21Apr2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 28Dec2021 13:30, outcome "unknown", described as "Booster"; CHILLS (hospitalization) with onset 29Dec2021, outcome "recovered", described as "Chills"; VACCINATION SITE PAIN (hospitalization) with onset 29Dec2021, outcome "recovered", described as "vaccination site pain"; MUSCLE SPASMS (hospitalization) with onset 29Dec2021 07:00, outcome "recovered", described as "Tetanic spasm generalised". The patient was hospitalized for immunisation, chills, vaccination site pain, muscle spasms (start date: 29Dec2021, hospitalization duration: 2 day(s)). The events "chills", "vaccination site pain" and "tetanic spasm generalised" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of chills, vaccination site pain, muscle spasms. Clinical course: On 29Dec2021 (1 day after vaccination), the patient experienced chills, vaccination site pain and tetanic spasm generalized. The outcome of the events was recovered with treatment including Infusion. The course of the event was as follows: From dawn on 29Dec2021, there were chills and vaccination site pain. At about 7:00 on 29Dec2021, the patient experienced tetanic spasm generalized for 1 minute and the patient was transported to the hospital by emergency and hospitalized. The reporter classified the events as serious (hospitalization) and stated the events result in Emergency room/department or urgent care.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Booster, Chills, Vaccination site pain, Tetanic spasm generalised and the suspect drug BNT162b2 . 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: 2034037 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-12-28
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diplopia
SMQs:, Ocular motility 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus (witch was diet control)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20224

Write-up: Diplopia; This regulatory authority case was reported by an other health care professional and describes the occurrence of DIPLOPIA (Diplopia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Diabetes mellitus (witch was diet control). On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2021, the patient experienced DIPLOPIA (Diplopia) (seriousness criterion hospitalization). At the time of the report, DIPLOPIA (Diplopia) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had loss of vision after Moderna vaccine and went to o the outpatient department of Neurology of hospital on 12/27 then hospitalized on 12/28 for examination and treatment, got first vaccine on 07/02/2021 Patient had no history of adverse drug reactions and had GCS E4V5M6, SpO2 blood oxygen saturation 97.0%, BT body temperature 36.0 ? PR pulse 96.0 times/ minute, RR respiratory rate 18 breaths/ minute, SBP systolic blood pressure 93.0 mmHg, DBP diastolic blood pressure 63.0 mmHg, Pain screening 0 point assessment tool FLACC on 12/28/2021. Social History:Alcohol: Denied, Betel nuts: denied, Cigarette smoking: Denied. Company comment: This regulatory authority case concerns a 73-year-old male patient with no relevant medical history who experienced serious due to hospitalization, unexpected event of diplopia, that occurred approximately 2.5 months after the 2nd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 73-year-old male patient with no relevant medical history who experienced serious due to hospitalization, unexpected event of diplopia, that occurred approximately 2.5 months after the 2nd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2036763 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 840539006 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Epistaxis, Feeling cold, Haemorrhage, Malaise, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: Body temperature; Result Unstructured Data: had fever, still 38 C on the evening
CDC Split Type: FRMODERNATX, INC.MOD20224

Write-up: had fever, still 38C; hemorrhage, bleeding from the nose, it was coming out through her mouth; nosebleed for 20 minutes while standing up, bleeding from the nose; felt cold and frozen; did not feel well straight away; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (hemorrhage, bleeding from the nose, it was coming out through her mouth), EPISTAXIS (nosebleed for 20 minutes while standing up, bleeding from the nose), MALAISE (did not feel well straight away), FEELING COLD (felt cold and frozen) and PYREXIA (had fever, still 38C) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 840539006) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer (2 first dose of Pfizer and had no problems.). Past adverse reactions to the above products included No adverse event with Pfizer. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MALAISE (did not feel well straight away) (seriousness criterion hospitalization). On 31-Dec-2021, the patient experienced FEELING COLD (felt cold and frozen) (seriousness criterion hospitalization). On 31-Dec-2021 at 11:00 PM, the patient experienced EPISTAXIS (nosebleed for 20 minutes while standing up, bleeding from the nose) (seriousness criterion hospitalization). On 02-Jan-2022, the patient experienced HAEMORRHAGE (hemorrhage, bleeding from the nose, it was coming out through her mouth) (seriousness criteria hospitalization and medically significant). On 03-Jan-2022, the patient experienced PYREXIA (had fever, still 38C) (seriousness criterion hospitalization). The patient was treated with COLLAGEN (HEMOSTATIC) on 03-Jan-2022 for Adverse event, at an unspecified dose and frequency. On 31-Dec-2021, FEELING COLD (felt cold and frozen) had resolved. At the time of the report, HAEMORRHAGE (hemorrhage, bleeding from the nose, it was coming out through her mouth), EPISTAXIS (nosebleed for 20 minutes while standing up, bleeding from the nose) and MALAISE (did not feel well straight away) outcome was unknown and PYREXIA (had fever, still 38C) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Body temperature: 38 (High) had fever, still 38 C on the evening. Patient had no concomitant disease or treatment. No concomitant medication were reported. The patient received Booster Moderna on 28Dec2021 and did not feel well straight away. On 31-Dec-21 at 11PM the patient started to nosebleed for 20 minutes while standing up. She felt cold and frozen. On 01-Jan-22 at 2AM bled again and during the day she was not in good shape but it was ok. On 02-Jan-22 she had a hemorrhage, bleeding from the nose, it was coming out through her mouth. She called the emergency and doctor and went to the pharmacy where she received a coagulant. She went to sleep around 8PM. 03-Jan-22 4AM, she woke up and went to the emergencies as it did not stop bleeding. She had swallowed a lot of blood, 2 cups. They placed a temporary hemostatic plug. She had fever, still 38C on the 03-Jan-22 evening. Company Comment: This case concerns a 57-year-old female patient, with relevant medical history of COVID-19 vaccination with Pfizer, who experienced the unexpected serious events of Hemorrhage, Epistaxis, Malaise, Feeling cold and Pyrexia. The events started on the same day after the third dose of mRNA-1273 Vaccine. The patient allegedly had intermittent bouts of epistaxis which resulted in an ER consult for control of the bleeding. At the time of the report the outcome of the events was not resolved. The rechallenge is not applicable since no further dosing is expected. The patient''s medical history of COVID-19 vaccination with Pfizer remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old female patient, with relevant medical history of COVID-19 vaccination with Pfizer, who experienced the unexpected serious events of Hemorrhage, Epistaxis, Malaise, Feeling cold and Pyrexia. The events started on the same day after the third dose of mRNA-1273 Vaccine. The patient allegedly had intermittent bouts of epistaxis which resulted in an ER consult for control of the bleeding. At the time of the report the outcome of the events was not resolved. The rechallenge is not applicable since no further dosing is expected. The patient''s medical history of COVID-19 vaccination with Pfizer remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2036775 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis, Headache, Muscle tightness, Pain, Pain in extremity
SMQs:, Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), 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: CANDESARTAN; CINNARIZINE; AMITRIPTYLINE
Current Illness: Drug allergy (Allergic to Ibuprofen, which limits what pain relief to take); Environmental allergy (Airborne allergy to Aerosols); Photosensitivity (Increased sensitivity to light); Stress (Symptoms such as stress can trigger the increased symptoms of Bells palsy); Vertigo (Symptoms such as vertigo can trigger the increased symptoms of Bells palsy)
Preexisting Conditions: Medical History/Concurrent Conditions: Bell''s palsy (Bells palsy for 13 years, an unknown category as it is usually temporary.Symptoms such as increased sensitivity to light, airborne allergies to citrus, aerosols, can trigger the increased symptoms of Bells palsy); Fruit allergy (Allergic to Citrus.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.; Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.; Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.; Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.; This case was received (Reference number: GB-MHRA-ADR 26420903) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.), HEADACHE (Headache), PAIN IN EXTREMITY (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.), MUSCLE TIGHTNESS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) and PAIN (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. Previously administered products included for Drug use for unknown indication: IBUPROFEN. Past adverse reactions to the above products included Allergy with IBUPROFEN. Concurrent medical conditions included Bell''s palsy (Bells palsy for 13 years, an unknown category as it is usually temporary.Symptoms such as increased sensitivity to light, airborne allergies to citrus, aerosols, can trigger the increased symptoms of Bells palsy), Vertigo (Symptoms such as vertigo can trigger the increased symptoms of Bells palsy), Stress (Symptoms such as stress can trigger the increased symptoms of Bells palsy), Environmental allergy (Airborne allergy to Aerosols), Fruit allergy (Allergic to Citrus.), Photosensitivity (Increased sensitivity to light) and Drug allergy (Allergic to Ibuprofen, which limits what pain relief to take). Concomitant products included CANDESARTAN, CINNARIZINE and AMITRIPTYLINE for an unknown indication. On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 28-Dec-2021, the patient experienced FACIAL PARALYSIS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) (seriousness criterion disability), MUSCLE TIGHTNESS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) (seriousness criterion disability) and PAIN (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) (seriousness criterion disability). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion disability). At the time of the report, FACIAL PARALYSIS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.), MUSCLE TIGHTNESS (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) and PAIN (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) had not resolved, HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Increase in facialy palsy, tightened jaw pain, difficulty eating and swallowing.) had resolved. Patient reported increase in facial palsy, tightened jaw pain, difficulty eating and swallowing. The patient as a long-term sufferer of Bell''s palsy (13 years), two hours after having the Moderna vaccine, her jaw became tight causing difficulty in speech and painful. Her attempts to eat became difficult and resulted in having soup, lots of water and paracetamol. She was woken up by extreme pain in the arm the injection was given at 2 am, with clothes, moving the arm or laying on back increased the sharp pain. She continued to take paracetamol every 4 to 6 hours. Three days later her arm no longer had pain but woke up at 4 am with a headache and took paracetamol. There was no change to the tightness and difficulty speaking. But the pain was managed with paracetamol and can eat small amounts at a time, chewing on the left side only. Company comment: This is a regulatory case concerning a 43-year-old female patient with medical history of Bell''s palsy for 13 years, a number of symptoms such as increased sensitivity to light, airborne allergies to citrus and aerosols and vertigo, and stress, which can all trigger increased symptoms of Bell''s palsy, who experienced the serious unexpected, according CCDS, events of headache, pain in extremity, muscle tightness, pain and expected serious AESI event of facial paralysis. The events facial paralysis, pain in extremity, muscle tightness, pain occurred on the same day after the third dose of mRNA-1273 vaccine. The event headache occurred on an unknown date, after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of Bell''s palsy remains a confounder for facial paralysis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 43-year-old female patient with medical history of Bell''s palsy for 13 years, a number of symptoms such as increased sensitivity to light, airborne allergies to citrus and aerosols and vertigo, and stress, which can all trigger increased symptoms of Bell''s palsy, who experienced the serious unexpected, according CCDS, events of headache, pain in extremity, muscle tightness, pain and expected serious AESI event of facial paralysis. The events facial paralysis, pain in extremity, muscle tightness, pain occurred on the same day after the third dose of mRNA-1273 vaccine. The event headache occurred on an unknown date, after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of Bell''s palsy remains a confounder for facial paralysis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2036820 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000015A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Epileptiform attacks (NOS)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20224

Write-up: Blackout spell; This case was received via regulatory authority (Reference number: FR-AFSSAPS-TO20219958) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout spell) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 000015A) for COVID-19 vaccination. The patient''s past medical history included Epileptiform attacks (NOS). On 27-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blackout spell) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout spell) was resolving. No concomitant product was provided by the reporter. No treatment medication was provided. Date of Last Administration 27-DEC-2021.; Sender''s Comments: This case concerns a patient, with medical history (Epileptiform attacks (NOS).), who experienced the serious unexpected event(s) of, loss of consciousness. The event(s) started occurring approximately within 1 days(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2036894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: have no illness
Allergies:
Diagnostic Lab Data: Test Date: 20211026; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003839

Write-up: Pins and needles; Pain in foot; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201021552377660-JOCUE. Other Case identifier(s): GB-MHRA-ADR 26425022. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/Lot number: unknown), administration date: 21Apr2021, for COVID-19 Immunization; Covid-19 vaccine astrazeneca (Dose 2, Batch/Lot number: unknown), administration date: 01Jul2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Pins and needles"; PAIN IN EXTREMITY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Pain in foot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Oct2021) yes - positive covid-19 test. Clinical course: Patient last menstrual period date was 27Dec2021. Patient did not have symptoms associated with COVID-19. Patient was not breastfeeding. Patient was experiencing pain in her left foot when putting pressure on it, and pins and needles in the foot and up her left leg when resting. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Onset latency for the events was 04 days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036933 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Hyperhidrosis, Immunisation, Malaise, Myalgia, Nausea, Pain in extremity, Poor quality sleep, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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: DIHYDROCODEINE; DULOXETINE; LYRICA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003728

Write-up: appetite has not fully returned; Headache; no energy to do anything; Tiredness; Muscle ache; Fever; Feeling unwell; Nausea; Drenching sweats; whole arm was feeling painful to move; restless sleep; Booster; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201022327164600-LCSAD (MHRA). Other Case identifier(s): GB-MHRA-ADR 26425432 (MHRA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing). Concomitant medication(s) included: DIHYDROCODEINE taken for pain, start date: 01Feb2018; DULOXETINE taken for pain, start date: 01Jan2019; LYRICA taken for pain, start date: 01Oct2017. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache"; VACCINATION SITE PAIN (medically significant) with onset 28Dec2021, outcome "recovering", described as "Injection site pain"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovered with sequelae", described as "Tiredness"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovered" (01Jan2022), described as "Muscle ache"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Fever"; MALAISE (medically significant) with onset 29Dec2021, outcome "recovered with sequelae", described as "Feeling unwell"; NAUSEA (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Nausea"; HYPERHIDROSIS (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Drenching sweats"; PAIN IN EXTREMITY (medically significant) with onset 28Dec2021, outcome "recovered", described as "whole arm was feeling painful to move"; POOR QUALITY SLEEP (medically significant) with onset 28Dec2021, outcome "recovered", described as "restless sleep"; ASTHENIA (medically significant) with onset 29Dec2021, outcome "recovered", described as "no energy to do anything"; DECREASED APPETITE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "appetite has not fully returned". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of headache, vaccination site pain, fatigue, myalgia, pyrexia, malaise, nausea, hyperhidrosis, pain in extremity, poor quality sleep, asthenia, decreased appetite as the patient took dihydrocodeine. Clinical course details: The patient had no immediate reaction after vaccine at mid afternoon. The injection site began to be achy after a few hours and by evening her whole arm was feeling painful to move and she felt generally unwell in herself. She fell asleep fine, but woke up at 1am with an extremely sore head, fever, covered in sweat and a very painful arm. She took some of her own dihydrocodeine which helped with the headache slightly. She had a very restless sleep with the headache causing the most issue, but feeling very ill too. This continued for most of the 2nd day, and she was forced to stay in bed as she had no energy to do anything, as well as the headache preventing her getting about. The worst symptoms slowly abated after 48 hours but has left her still tired and her appetite has not fully returned. She took extra dihydrocodeine but this didn''t help much with the pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2037015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200009345

Write-up: Head pain/ Back left side of head pain never goes ever behind left ear, going a straight line from back of head over head to the front of head; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201031637000870-OYT2U. Other Case identifier(s): GB-MHRA-ADR 26429451. A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Lot number: Ej6790) as dose 3 (booster), single for COVID-19 immunisation. Patient last menstrual period date was 16Dec2021. Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunisation; Bnt162b2 (Dose 2, single), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; HEADACHE (disability, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Head pain/ Back left side of head pain never goes ever behind left ear, going a straight line from back of head over head to the front of head". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: negative. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations or tests conducted was Painful. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037024 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache
SMQs:, Arthritis (broad)

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

Write-up: Headache; Aching joints; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26429858) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Aching joints) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Aching joints) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment information was not provided. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial The report did not relate to possible inflammation of the heart myocarditis or pericarditis. Company comment: This case concerns a 45-year-old, female patient with no relevant medical history, who experienced the unexpected events of fatigue, arthralgia and headache. The event of fatigue occurred on the same day while arthralgia and headache occurred 1 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 45-year-old, female patient with no relevant medical history, who experienced the unexpected events of fatigue, arthralgia and headache. The event of fatigue occurred on the same day while arthralgia and headache occurred 1 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: 2037059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Sexual dysfunction, Vertigo
SMQs:, Vestibular disorders (narrow), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (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: ATENOLOL; LAMOTRIGINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Epilepsy (Neurologist for Epilepsy.); Focal epilepsy; Head injury (Also fell and hit head in October with significant concussion (unrelated to epilepsy).); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009641

Write-up: Vertigo; Sexual dysfunction; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201032211485880-2WAUF. Other Case identifier: GB-MHRA-ADR 26430432. A 50-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FK9707) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Neurologist for Epilepsy.; "fell and hit head", start date: Oct2021 (unspecified if ongoing), notes: Also fell and hit head in October with significant concussion (unrelated to epilepsy).; "Suspected COVID-19", start date: 15Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Atrial fibrillation" (unspecified if ongoing); "Focal epilepsy" (unspecified if ongoing). Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included: ATENOLOL taken for atrial fibrillation, start date: 15Oct2017; LAMOTRIGINE taken for partial seizures, start date: 22Mar2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, (single)), administration date: 19Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (DOSE 2, (single)), administration date: 05Jun2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; VERTIGO (medically significant) with onset 29Dec2021, outcome "recovering", described as "Vertigo"; SEXUAL DYSFUNCTION (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Sexual dysfunction". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) yes - positive covid-19 test. Additional information: Severe vertigo occurred first thing in the morning after taking lamotrigine. Took about 3 hours each day to wear off. Worst day was the day after the vaccination. She could barely stand up. Getting better but still a problem. For sexual dysfunction, she had no orgasm when having sex. She had no problems before the vaccine. 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). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Myalgia, Myocarditis, Palpitations, Pericarditis, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200009367

Write-up: Fatigue/unusual tiredness; Chest pain; Heart palpitations; Racing heart (tachycardia); Myocarditis; Pericarditis; Muscle pain/stabbing muscle pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201040154388610-JOI7K (MHRA). Other Case identifier(s): GB-MHRA-ADR 26430572 (MHRA). A 44 year-old male patient 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. Patient had not had symptoms associated with COVID-19 and did not have a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (disability), outcome "unknown", described as "Myocarditis"; PERICARDITIS (disability), outcome "unknown", described as "Pericarditis"; MYALGIA (disability) with onset 28Dec2021, outcome "not recovered", described as "Muscle pain/stabbing muscle pains"; FATIGUE (disability), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (disability), outcome "unknown", described as "Chest pain"; PALPITATIONS (disability), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (disability), outcome "unknown", described as "Racing heart (tachycardia)". Report did relate to possible inflammation of the heart (myocarditis or pericarditis). Symptoms did not lead to a hospital stay. Diagnosis was not made by a medical professional. There were 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: 2037067 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, 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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211105; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Frontal headache; Fatigue; Aching joints; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26431381) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frontal headache), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 05-Nov-2021 to 11-Nov-2021. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 30-Dec-2021, ARTHRALGIA (Aching joints) had resolved. At the time of the report, HEADACHE (Frontal headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use was not provided by reporter. Patient last menstruation period date was 20-Dec-2021. Exactly 10 hours after dose patient woke up with a blinding headache, temperature, shivers and body aches all over. Patient also felt very nauseous, dizzy and stiff. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment medication use was not provided by reporter. Company comment: This case concerns a 42-year-old, female patient with medical history of suspected COVID 19 and positive SARS-CoV-2 test (approximately 1.5 months prior to events), who experienced the unexpected events of headache, fatigue and arthralgia. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, exactly 10 hours after dose patient woke up with a blinding headache, temperature, shivers and body aches all over. Patient also felt very nauseous, dizzy and stiff, as reported. 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 42-year-old, female patient with medical history of suspected COVID 19 and positive SARS-CoV-2 test (approximately 1.5 months prior to events), who experienced the unexpected events of headache, fatigue and arthralgia. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, exactly 10 hours after dose patient woke up with a blinding headache, temperature, shivers and body aches all over. Patient also felt very nauseous, dizzy and stiff, as reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037095 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Rash, Skin burning sensation, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rash; Burning skin; Skin warm; Headache; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 26432953) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Skin rash), SKIN BURNING SENSATION (Burning skin), PAIN IN EXTREMITY (Painful arm), SKIN WARM (Skin warm) and HEADACHE (Headache) in a 41-year-old female 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 Patient is not pregnant,Patient is not currently breastfeeding. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced RASH (Skin rash) (seriousness criterion medically significant), SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, RASH (Skin rash), SKIN BURNING SENSATION (Burning skin), PAIN IN EXTREMITY (Painful arm), SKIN WARM (Skin warm) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Patient had 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. No treatment medications were reported. Company comment This is a regulatory case concerning a 41-year-old female patient with no medical history reported, who experienced the serious unexpected, according RA, events of rash, skin burning sensation, pain in extremity, skin warm and headache. The event pain in extremity occurred the day after the third dose of mRNA-1273 vaccine. The events rash, skin burning sensation, skin warm and headache occurred approximately 5 days after the third dose of mRNA-1273 vaccine. At the time of the report, the events were resolving. 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 41-year-old female patient with no medical history reported, who experienced the serious unexpected, according RA, events of rash, skin burning sensation, pain in extremity, skin warm and headache. The event pain in extremity occurred the day after the third dose of mRNA-1273 vaccine. The events rash, skin burning sensation, skin warm and headache occurred approximately 5 days after the third dose of mRNA-1273 vaccine. At the time of the report, the events were resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037097 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Herpes zoster, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox (Patient had chickenpox as a child (4 years old).)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shingles; Armpit pain; Tiredness; Fever; Shivering; Shoulder pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26433644) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), AXILLARY PAIN (Armpit pain), FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Shivering) and ARTHRALGIA (Shoulder pain) in a 36-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 Chickenpox (Patient had chickenpox as a child (4 years old).). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). On 30-Dec-2021, PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 31-Dec-2021, FATIGUE (Tiredness) had resolved. On 02-Jan-2022, ARTHRALGIA (Shoulder pain) had resolved. At the time of the report, HERPES ZOSTER (Shingles) and AXILLARY PAIN (Armpit 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. No concomitant medications were provided. Treatment information was not provided. Within a half a day after receiving the vaccine, patient arm around the prick started hurting. After about 24 h after receiving the vaccine, she suddenly felt tired, experienced shivering and higher temperature. About 2 days after receiving the vaccine, she found a very mild rush on her right hip which, after light scratching, hurt a lot for about a minute and remained very sensitive for about 2 days (even touching by clothing that area hurt). Whilst the other symptoms recovered, the area with the rush was still sensitive a hurt when pressed or scratched. 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. Patient was not currently breastfeeding. Company comment: This regulatory authority case concerns a 36-year-old female patient, with no relevant medical history reported, who experienced the serious (seriousness criterion medically significant) unexpected events of herpes zoster, fatigue, pyrexia, chills, arthralgia and axillary pain after the third dose of mRNA-1273. The events started the next day after vaccination. Events fatigue, pyrexia, chills and arthralgia were recovered and events herpes zoster and axillary pain were recovering at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 36-year-old female patient, with no relevant medical history reported, who experienced the serious (seriousness criterion medically significant) unexpected events of herpes zoster, fatigue, pyrexia, chills, arthralgia and axillary pain after the third dose of mRNA-1273. The events started the next day after vaccination. Events fatigue, pyrexia, chills and arthralgia were recovered and events herpes zoster and axillary pain were recovering at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 2037100 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: high temperature; Headache; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26433218) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (high temperature), HEADACHE (Headache) and PYREXIA (Fever) 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 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (high temperature) (seriousness criterion medically significant). On 04-Jan-2022, HEADACHE (Headache) was resolving. At the time of the report, PYREXIA (high temperature) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided. Patient has not had symptoms associated with COVID-19. Severe headache since the next morning, the temperature went up and up. Continuous headache lasts a week disappeared after the last two rounds of high temperature. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Lab data included blood test (low level of infection), head CT scan. No bleeding or blood clot found. Company comment: This regulatory authority case concerns a33 -year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of HEADACHE and PYREXIA. The events occurred 1 day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was disclosed. Patient states that relevant tests performed included unspecified blood tests and a brain computerized tomography, and that no bleeding or blood clot were found. 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 a33 -year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of HEADACHE and PYREXIA. The events occurred 1 day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was disclosed. Patient states that relevant tests performed included unspecified blood tests and a brain computerized tomography, and that no bleeding or blood clot were found. 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: 2037119 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Illness, Injection site pain, Nausea, SARS-CoV-2 test, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; PARACETAMOL; SUDAFED EXPECTORANT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201216; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes-Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: sickness; groggy; Nausea; Appetite lost; Pain injection site; Tiredness; Headache; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26434530) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (sickness), SOMNOLENCE (groggy), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Tiredness), DECREASED APPETITE (Appetite lost) and INJECTION SITE PAIN (Pain injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 16-Dec-2020 to 26-Dec-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, PARACETAMOL from 25-Nov-2021 to 07-Dec-2021 and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED EXPECTORANT) from 15-Dec-2021 to 20-Dec-2021 for Cough. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (sickness) (seriousness criterion medically significant) and SOMNOLENCE (groggy) (seriousness criterion medically significant). On 01-Jan-2022, DECREASED APPETITE (Appetite lost) had resolved. On 02-Jan-2022, HEADACHE (Headache) had resolved. On 03-Jan-2022, NAUSEA (Nausea) had resolved. On 04-Jan-2022, FATIGUE (Tiredness) and INJECTION SITE PAIN (Pain injection site) was resolving. At the time of the report, ILLNESS (sickness) and SOMNOLENCE (groggy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-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. The patient had pain at injection site on day one. On day two, she had headache, nausea, loss of appetite. She slept most of day and was unable to work. Day three was same as day two. Day four, headache pain increased, and she also had nausea and was unable to work. Day five, severe headache at back of head that would not shift with PARACETAMOL. Day six, she had nausea. She was groggy and very tired on that day. Day seven, she had slight sickness but recovered and was able to work. Patient had 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). Negative lat flows throughout Dec 2021 including day if booster. Neg lat flow 04 Jan 2021. No treatment medications were reported. Company Comment: This case concerns a 44 year-old female patient with a history of suspected COVID-19 and 2 doses of AstraZeneca COVID-19 vaccine who experienced the unexpected events of headache, nausea, fatigue, decreased appetite, and injection site pain which occurred 1 to 2 days after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of illness and somnolence which occurred on an unknown date relative to vaccination. The history of suspected COVID-19 and 2 doses of AstraZeneca 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 44 year-old female patient with a history of suspected COVID-19 and 2 doses of AstraZeneca COVID-19 vaccine who experienced the unexpected events of headache, nausea, fatigue, decreased appetite, and injection site pain which occurred 1 to 2 days after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of illness and somnolence which occurred on an unknown date relative to vaccination. The history of suspected COVID-19 and 2 doses of AstraZeneca 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: 2037152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Adverse reaction, Fatigue, Feeling abnormal, Headache, Nasopharyngitis, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015787

Write-up: achy legs; freezing cold; Adverse reaction; headache; upset tummy; brain fog; fatigue; 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-202201042106458270-OVDLS (RA). Other Case identifier(s): GB-MHRA-ADR 26435981 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: Fg3712) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1, MANUFRACTUER UNKNOWN), for Covid-19 immunisation. The following information was reported: ADVERSE REACTION (medically significant) with onset 28Dec2021, outcome "recovering", described as "Adverse reaction"; HEADACHE (medically significant), outcome "unknown", described as "headache"; PAIN (medically significant), outcome "unknown", described as "achy legs"; NASOPHARYNGITIS (medically significant), outcome "unknown", described as "freezing cold"; ABDOMINAL PAIN (medically significant), outcome "unknown", described as "upset tummy"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "brain fog"; FATIGUE (medically significant), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) no - negative covid-19 test. Awful headache, achy legs, back, temperature, freezing cold, upset tummy, brain fog extreme fatigue for 5 days and took pcr on day 5. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037370 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: LOSS OF CONCIOUSNESS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (LOSS OF CONCIOUSNESS) in a 13-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Dec-2021 at 10:25 AM, the patient experienced LOSS OF CONSCIOUSNESS (LOSS OF CONCIOUSNESS) (seriousness criterion medically significant). On 28-Dec-2021 at 10:30 AM, LOSS OF CONSCIOUSNESS (LOSS OF CONCIOUSNESS) had resolved. Not Provided The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Patient experienced Non Fatal drowning. Duration of the event was 5minute. Concomitant product usage were not provided. Treatment details were not provided. Company Comment - This regulatory authority case concerns a 13 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of loss of consciousness. The event occurred on the same day after a dose of mRNA-1273 vaccine, and resolved five minutes later. The rechallenge was not applicable. Additional details of clinical presentation, and clinical course were not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 13 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of loss of consciousness. The event occurred on the same day after a dose of mRNA-1273 vaccine, and resolved five minutes later. The rechallenge was not applicable. Additional details of clinical presentation, and clinical course were not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2038697 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Nausea. Cramp shaking hallucinations joint pain. Exhaustion myalgia headache; Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 26440976) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Nausea. Cramp shaking hallucinations joint pain. Exhaustion myalgia headache) and NAUSEA (Nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. Concomitant products included SERTRALINE HYDROCHLORIDE for Ill-defined disorder. On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 28-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Nausea. Cramp shaking hallucinations joint pain. Exhaustion myalgia headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 29-Dec-2021, NAUSEA (Nausea) had resolved. On 04-Jan-2022, ADVERSE DRUG REACTION (Nausea. Cramp shaking hallucinations joint pain. Exhaustion myalgia headache) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. The treatment information was not provided. The patient was taking Moderna for Covid booster. Patient experienced nausea, cramp shaking hallucinations joint pain,exhaustion myalgia headache post vaccination This is a regulatory case concerning a 37-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of adverse drug reaction and nausea. The events occurred on the same day after the unknown dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The events were assessed as serious by the Regulatory Authority. The rechallenge was reported as unknown. 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 female patient with no reported medical history, who experienced the serious per reported severity unexpected events of adverse drug reaction and nausea. The events occurred on the same day after the unknown dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The events were assessed as serious by the Regulatory Authority. The rechallenge was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2038700 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Cold sweat, Disturbance in attention, Dry eye, Eye pain, Fatigue, Headache, Neck pain, Palpitations, Pruritus, SARS-CoV-2 test, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; EVOREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dry eye; Pain eye; Hazy vision; Headache; Exhaustion; Joint ache; Heart racing; Clammy; Itching; Poor concentration; Neck pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26428259) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Exhaustion), ARTHRALGIA (Joint ache), PALPITATIONS (Heart racing), COLD SWEAT (Clammy), PRURITUS (Itching), DRY EYE (Dry eye), EYE PAIN (Pain eye), VISION BLURRED (Hazy vision), DISTURBANCE IN ATTENTION (Poor concentration) and NECK PAIN (Neck pain) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT000029A MODEMA) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from an unknown date to 21-Sep-2021 for COVID-19 vaccination, ESTRADIOL (EVOREL) from May 2017 to an unknown date for HRT. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DISTURBANCE IN ATTENTION (Poor concentration) (seriousness criterion medically significant) and NECK PAIN (Neck pain) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), COLD SWEAT (Clammy) (seriousness criterion medically significant) and PRURITUS (Itching) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced DRY EYE (Dry eye) (seriousness criterion medically significant), EYE PAIN (Pain eye) (seriousness criterion medically significant) and VISION BLURRED (Hazy vision) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Exhaustion), PALPITATIONS (Heart racing), COLD SWEAT (Clammy), PRURITUS (Itching), DRY EYE (Dry eye), EYE PAIN (Pain eye), VISION BLURRED (Hazy vision), DISTURBANCE IN ATTENTION (Poor concentration) and NECK PAIN (Neck pain) had not resolved and ARTHRALGIA (Joint ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, 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 drug information was not provided. The reaction happened 16 hours after injection. Patient had the same reaction to her first Astra zenica and it lasted 9 days. Patient felt heart racing, exhaustion and swollen hands and feet was the start then the complete exhaustion. Sleeping all day all night and just lifting a mug tires her out. Patient had a heavy sensation over her eyes and vision was blurry. The headache was separate to that. A tingly itchy sensation. In her head and in limbs cones and goes. Swelling in hands and feet gone but achy joints still there. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This is a regulatory case concerning a 48-year-old female patient with no medical history reported, who experienced the unexpected events of headache, fatigue, arthralgia, palpitations, cold sweat, pruritus, dry eye, eye pain, vision blurred, disturbance in attention and neck pain. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events all occurred between the same day until the 4th day after the third dose of mRNA ? 1273 vaccine. Events were reported as medically significant and at the time of report only arthalgia was resolving.The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 48-year-old female patient with no medical history reported, who experienced the unexpected events of headache, fatigue, arthralgia, palpitations, cold sweat, pruritus, dry eye, eye pain, vision blurred, disturbance in attention and neck pain. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events all occurred between the same day until the 4th day after the third dose of mRNA ? 1273 vaccine. Events were reported as medically significant and at the time of report only arthalgia was resolving.The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2039023 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 216035 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Syncope; This case was received via Regulatory Agency (Reference number: LV-SAM-2021127492) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 216035) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2021 at 6:02 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 28-Dec-2021 at 6:10 PM, after starting mRNA-1273 (Spikevax), the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company comment: This Regulatory Authority case is concerning a male patient of 41-years-old with no medical history, experienced the unexpected serious event of Syncope (medically significant) which occurred 8 mins after the second dose of mRNA-1273 vaccine. There is no medical assessment or treatment has been informed and event outcome was reported resolved. 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 medically significant event.; Sender''s Comments: This Regulatory Authority case is concerning a male patient of 41-years-old with no medical history, experienced the unexpected serious event of Syncope (medically significant) which occurred 8 mins after the second dose of mRNA-1273 vaccine. There is no medical assessment or treatment has been informed and event outcome was reported resolved. 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 medically significant event.


VAERS ID: 2039086 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Headache, Limb discomfort, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2; AMITRIPTYLINE; DABIGATRAN
Current Illness: Chronic fatigue syndrome (CFS for 24+ years. Nowmild, but vaccine effects exacerbated symptoms again to moderate/severe. Unable to leave the house really. After 9 days slowly starting to improve.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue; Muscle ache; Joint ache; Nausea; Poor concentration; Headache; Tiredness; Arm discomfort; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26438645) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), NAUSEA (Nausea), DISTURBANCE IN ATTENTION (Poor concentration), HEADACHE (Headache), FATIGUE (Tiredness) and LIMB DISCOMFORT (Arm discomfort) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Chronic fatigue syndrome (CFS for 24+ years. Nowmild, but vaccine effects exacerbated symptoms again to moderate/severe. Unable to leave the house really. After 9 days slowly starting to improve.). Concomitant products included AMITRIPTYLINE from 27-Oct-2021 to an unknown date for Pain relief, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 27-Feb-2021 to an unknown date, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 27-Feb-2021 to an unknown date and DABIGATRAN from 08-Dec-2016 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion disability), ARTHRALGIA (Joint ache) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), DISTURBANCE IN ATTENTION (Poor concentration) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), FATIGUE (Tiredness) (seriousness criterion disability) and LIMB DISCOMFORT (Arm discomfort) (seriousness criterion disability). On 29-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability). At the time of the report, FATIGUE (Fatigue) had not resolved, MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), DISTURBANCE IN ATTENTION (Poor concentration), HEADACHE (Headache) and FATIGUE (Tiredness) was resolving and NAUSEA (Nausea) and LIMB DISCOMFORT (Arm discomfort) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient did not had symptoms associated with COVID-19. Patient was not currently breastfeeding. It was reported that the patient had exacerbation of existing CFS symptoms. Since the patient had received the vaccine, she had not tested positive for COVID-19. No treatment information was provided. Company Comment: This regulatory case concerns a 45-year-old, female patient with relevant medical history of Chronic Fatigue Syndrome (CFS), Dabigatran intake and history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines, who experienced the unexpected, serious events of fatigue (LLT: fatigue), myalgia, arthralgia, nausea, disturbance in attention, headache, fatigue (LLT: tiredness) and limb discomfort. The events myalgia, arthralgia, nausea, disturbance in attention, headache, fatigue (LLT: tiredness) and limb discomfort occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The event fatigue (LLT: fatigue) occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events nausea and limb discomfort had resolved at the time of the report. The events myalgia, arthralgia, disturbance in attention, headache and fatigue (LLT: tiredness) were resolving, while the event fatigue (LLT: fatigue) had not resolved at the time of the report. The medical history of CFS, which may cause the common symptoms of fatigue, disturbance in attention, headache, myalgia and arthralgia; Dabigatran intake, which may cause the common side effect of nausea; and history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 45-year-old, female patient with relevant medical history of Chronic Fatigue Syndrome (CFS), Dabigatran intake and history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines, who experienced the unexpected, serious events of fatigue (LLT: fatigue), myalgia, arthralgia, nausea, disturbance in attention, headache, fatigue (LLT: tiredness) and limb discomfort. The events myalgia, arthralgia, nausea, disturbance in attention, headache, fatigue (LLT: tiredness) and limb discomfort occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The event fatigue (LLT: fatigue) occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events nausea and limb discomfort had resolved at the time of the report. The events myalgia, arthralgia, disturbance in attention, headache and fatigue (LLT: tiredness) were resolving, while the event fatigue (LLT: fatigue) had not resolved at the time of the report. The medical history of CFS, which may cause the common symptoms of fatigue, disturbance in attention, headache, myalgia and arthralgia; Dabigatran intake, which may cause the common side effect of nausea; and history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2040529 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-12-28
   Days after vaccination:208
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: positive; Test Date: 20211230; Test Name: COVID-19 PCR test; Result Unstructured Data: positive
CDC Split Type: COJNJFOC20211266899

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 38 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, (Dose number in series was 1) administered 1 in total on 03-JUN-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient started experiencing symptoms like cough, body pain, general discomfort, and chills which is a confirmed clinical vaccination failure, and confirmed covid-19 infection (Dose number in series was 1). Laboratory data included: COVID-19 virus test (NR: not provided) positive (rapid test) on 28-DEC-2021, COVID-19 PCR test (polymerase chain reaction) on 30-DEC-2021 and result came on 02-JAN-2022 as positive. Treatment medications included: caffeine/paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed. This report was associated with product quality complaint: 90000209566. This case was reassessed as serious based on additional information received from patient on 10-JAN-2022. The following information was updated and incorporated into the case narrative: patient date of birth, patient age, age at the time of vaccination, events changed from covid-19 test positive to confirmed covid-19 infection and new event added confirmed clinical vaccination failure, event onset date changed, lab data (PCR test), treatment drug, suspect vaccine batch number, date of vaccination, vaccine facility details and void result added.; Sender''s Comments: V3: This version was reassessed as serious based on additional information received from patient on 10-JAN-2022. The following information was updated and incorporated into the case narrative: patient date of birth, patient age, age at the time of vaccination, events changed from covid-19 test positive to confirmed covid-19 infection and new event added confirmed clinical vaccination failure, event onset date changed, lab data (PCR test), treatment drug, suspect vaccine batch number, date of vaccination, vaccine facility details and PQC void result added. 20211266899-COVID-19 VACCINE - confirmed clinical vaccination failure. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 2041025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-27
Onset:2021-12-28
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1003A / 3 LA / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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: 20211228; Test Name: sars cov2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202200011366

Write-up: dry cough grade 1; runny nose grade 1; fatigue grade 1; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer) from a sales representative. A female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Oct2021 (Lot number: 1F1003A) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (manufacture unknown), (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "tested positive for COVID"; COUGH (medically significant), outcome "recovered" (03Jan2022), described as "dry cough grade 1"; RHINORRHOEA (medically significant), outcome "not recovered", described as "runny nose grade 1"; FATIGUE (medically significant), outcome "recovered" (03Jan2022), described as "fatigue grade 1". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature fluctuation, Body temperature increased, Feeling cold, Headache, Hyperhidrosis, Immunisation, Myalgia, SARS-CoV-2 test, Seizure, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), 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 Name: temperature was still all over the place; Result Unstructured Data: Test Result:still all over the place; Test Date: 20201001; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009602

Write-up: sweating; feeling cold; shaking; Convulsions; Muscle ache; headaches; temperature was still all over the place; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201031334004650-TTHIC (MHRA). Other Case identifier(s): GB-MHRA-ADR 26428061 (MHRA). A 20 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient 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: Bnt162b2 (DOSE 1, SINGLE, Batch/lot no: unknown), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Batch/lot no: unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; HYPERHIDROSIS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "sweating"; FEELING COLD (medically significant) with onset 29Dec2021, outcome "not recovered", described as "feeling cold"; TREMOR (medically significant) with onset 29Dec2021, outcome "not recovered", described as "shaking"; SEIZURE (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Convulsions"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Muscle ache"; HEADACHE (medically significant) with onset 29Dec2021, outcome "unknown", described as "headaches"; BODY TEMPERATURE FLUCTUATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "temperature was still all over the place". The patient underwent the following laboratory tests and procedures: body temperature increased: (unspecified date) still all over the place; sars-cov-2 test: (01Oct2020) yes - positive covid-19 test. Additional information: the patient woke up fitting over night continued for about half an hour and then once the convulsion had stopped, continued shaking sweating whilst feeling cold throughout the night and into the next day- temperature was still all over the place the following evening but the shaking stopped; also had headaches throughout this period. Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041211 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Diarrhoea, Disease recurrence, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Nausea, Off label use, Pain in extremity, Palpitations, Pericarditis, Pruritus, Pyrexia, Rash papular, Rash pruritic, SARS-CoV-2 test, Skin warm, Sleep disorder due to a general medical condition, Sweating fever, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Suspected COVID-19 (Long COVID sufferer)
Preexisting Conditions: Medical History/Concurrent Conditions: Disease recurrence; Rash papular; Raynauds (for over 20 years)
Allergies:
Diagnostic Lab Data: Test Date: 20211025; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200015454

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Heart palpitations; Racing heart (tachycardia); Itchy rash; Itching; Possible inflammation of the heart (myocarditis or pericarditis); Possible inflammation of the heart (myocarditis or pericarditis); Diarrhoea; Raised rash/Red, raised, itchy rash; Rash is back in original spot but much more aggravated than previously; Sweating fever; Nausea; Skin warm/also very hot to touch; Armpit pain; Off label use; Interchange of vaccine products; Booster; Painful arm/sore arm; Sore arm from day before causing sleep issues anyway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201041907158580-LX65A. Other Case identifier(s): GB-MHRA-ADR 26435798. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN5254) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Primary Raynauds" (unspecified if ongoing), notes: for over 20 years; "Suspected COVID-19", start date: 12Mar2020 (ongoing), notes: Long COVID sufferer; "Red, raised, itchy rash/this rash occurred also when I caught COVID in March 2020", start date: Mar2020 (not ongoing); "Rash recurred in a slightly different part of the body", start date: Oct2021 (not ongoing). Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. 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 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 28Dec2021, outcome "recovering", described as "Painful arm/sore arm"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (medically significant) with onset 28Dec2021, outcome "recovering", described as "Sore arm from day before causing sleep issues anyway"; RASH PAPULAR (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Raised rash/Red, raised, itchy rash"; DISEASE RECURRENCE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Rash is back in original spot but much more aggravated than previously"; SWEATING FEVER (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Sweating fever"; NAUSEA (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Nausea"; SKIN WARM (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Skin warm/also very hot to touch"; AXILLARY PAIN (medically significant) with onset 29Dec2021, outcome "recovering", described as "Armpit pain"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Diarrhoea"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; RASH PRURITIC (medically significant), outcome "not recovered", described as "Itchy rash"; PRURITUS (medically significant), outcome "not recovered", described as "Itching"; MYOCARDITIS (medically significant), PERICARDITIS (medically significant), outcome "unknown" and all described as "Possible inflammation of the heart (myocarditis or pericarditis)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Oct2021) yes - positive COVID-19 test. Therapeutic measures were taken as a result of rash papular, disease recurrence, rash pruritic, pruritus which included hydrocortisone cream and germolene. Clinical course: Patient woke around 3 the morning after jab with severe sweating fever, sore arm from day before causing sleep issues anyway. Nausea. Red, raised, itchy rash along stomach which was also very hot to touch. It needs to be noted that this rash occurred also when she caught COVID in Mar2020 - it lessened over that year and was clear by the end of the year. The rash recurred in a slightly different part of the body when a second variant of COVID was caught end Oct2021. It had settled down before having booster and rash was back in original spot but much more aggravated than previously. Patient had used hydrocortisone cream and germolene which helps reduce itching. She was wearing cotton next to the skin also helped to not aggravate it. The report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041261 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Ear pain, Headache, Influenza, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney stones (Recently had kidney stones with kidney stent); Pneumonia (developed into pneumonia but was fully recovered by December 2021)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Irritant cough; Earache; Flu symptoms; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26441128) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), EAR PAIN (Earache), COUGH (Irritant cough) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Kidney stones (Recently had kidney stones with kidney stent) and Pneumonia (developed into pneumonia but was fully recovered by December 2021). Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced COUGH (Irritant cough) (seriousness criterion medically significant). On 31-Dec-2021, HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA (Flu symptoms), EAR PAIN (Earache) and COUGH (Irritant cough) 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. Patient was taking unspecified statin for hyper cholesterol from genetics. Patient has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. Patient had heavy flu symptoms, headache, ears popping and right ear still unable to pop. Heavy chesty cough. Patient is not enrolled in clinical trial. No concomitant and treatment drug provide by reporter. Company Comment: This regulatory case concerns a 34-year-old, male patient with no relevant medical history reported, who experienced the unexpected, serious events of influenza, ear pain, cough and headache. The events occurred beginning on the same day and up to 3 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event headache had resolved at the time of the report. The events influenza, ear pain and cough 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 34-year-old, male patient with no relevant medical history reported, who experienced the unexpected, serious events of influenza, ear pain, cough and headache. The events occurred beginning on the same day and up to 3 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event headache had resolved at the time of the report. The events influenza, ear pain and cough 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: 2041266 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Immunisation, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2; Test Date: 20211108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200019469

Write-up: Primary immunisation: BNT162b2; Booster: COMIRNATY; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201052232364510-NKQAR. Other Case identifier(s): GB-MHRA-ADR 26441472. A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 08Nov2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 13Aug2021, for COVID-19 immunisation, reaction(s): "Drug ineffective"; Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 17Jun2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; PYREXIA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Fever". The events "primary immunisation: bnt162b2; booster: comirnaty" and "fever" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (28Dec2021) 39.2; sars-cov-2 test: (08Nov2021) yes - positive covid-19 test. Therapeutic measures were taken as a result of pyrexia. Clinical course: Phoned 111 as GP closed and told to take rehydration sachets and keep taking paracetamol and ibuprofen. Phoned 111 again that night as temperature had reached 39.2 and again told to keep taking ibuprofen and paracetamol and stay hydrated. Phoned doctors once open and had been advised to have blood tests taken but no other symptoms mean very little to go on. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200067866 same patient/drug/different dose/ event


VAERS ID: 2041280 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-12
Onset:2021-12-28
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: exhaustion; cold symptoms; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26442411) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), NASOPHARYNGITIS (cold symptoms) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 12-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (exhaustion) (seriousness criterion medically significant) and NASOPHARYNGITIS (cold symptoms) (seriousness criterion medically significant). At the time of the report, FATIGUE (exhaustion) and NASOPHARYNGITIS (cold symptoms) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported. Patient has not had symptoms associated with COVID-19 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 Patient got vaccinated on 12th. Side effects of nausea, shivers, being freezing cold, weak, swollen gland under arm, aching started on 13th. Skin all over body felt like it had been scalded by 14th. Over the next 2 weeks extreme exhaustion, constantly falling asleep, mild cold Symptoms until 28th, then severe headache which is ongoing. Patient took Medical help sought from A&E on 1st Jan 2022 and called back to the hospital on 2nd Jan and consultant examination where was diagnosed with reaction to moderna booster vaccination. Headache on left side, behind ear, from base of skull to above top of the ear. Medication used to try to relieve is paracetamol, ibuprofen, cocodamol were all unsuccessful. Headache was worse lying down and was not eased by a hot water bottle being held against my head. No treatment medications were reported. Company comment: This regulatory case concerns a 48-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, FATIGUE and NASOPHARYNGITIS. The event HEADACHE occurred sixteen days after the third dose of the mRNA-1273 vaccine. The events FATIGUE and NASOPHARYNGITIS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 was performed with a negative result on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 48-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, FATIGUE and NASOPHARYNGITIS. The event HEADACHE occurred sixteen days after the third dose of the mRNA-1273 vaccine. The events FATIGUE and NASOPHARYNGITIS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 was performed with a negative result on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2041361 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Disorientation, Headache, Hyperhidrosis, Nausea, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

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

Write-up: Nausea; Fever; Swollen arm; Armpit pain; Sweating; Disorientation; Joint ache; Headache; This case was received (Reference number: GB-MHRA-ADR 26445952) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), PERIPHERAL SWELLING (Swollen arm), AXILLARY PAIN (Armpit pain), HYPERHIDROSIS (Sweating), DISORIENTATION (Disorientation) and ARTHRALGIA (Joint ache) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), DISORIENTATION (Disorientation) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), PERIPHERAL SWELLING (Swollen arm), AXILLARY PAIN (Armpit pain), HYPERHIDROSIS (Sweating), DISORIENTATION (Disorientation) and ARTHRALGIA (Joint ache) 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 took treatment at 7.15 pm on the 28-DEC-2021 and by 5am had all of the above symptoms for over 24 hours. Patient has not had symptoms associated with COVID-19, Patient is not enrolled in clinical trial. Concomitant medication information was not provided by the reporter. Re-challenge was reported as unknown. Company comment: This regulatory case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the serious unexpected events of HEADACHE, NAUSEA, PYREXIA, PERIPHERAL SWELLING, AXILLARY PAIN, HYPERHIDROSIS, DISORIENTATION and ARTHRALGIA. The event HEADACHE occurred on the same day of the third dose of the mRNA-1273 vaccine. The events NAUSEA, PYREXIA, PERIPHERAL SWELLING, AXILLARY PAIN, HYPERHIDROSIS, DISORIENTATION and ARTHRALGIA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 was performed with a negative result on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the serious unexpected events of HEADACHE, NAUSEA, PYREXIA, PERIPHERAL SWELLING, AXILLARY PAIN, HYPERHIDROSIS, DISORIENTATION and ARTHRALGIA. The event HEADACHE occurred on the same day of the third dose of the mRNA-1273 vaccine. The events NAUSEA, PYREXIA, PERIPHERAL SWELLING, AXILLARY PAIN, HYPERHIDROSIS, DISORIENTATION and ARTHRALGIA occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 was performed with a negative result on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2041403 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Dyspnoea, Fatigue, 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), Other ischaemic heart disease (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); heart pain; Chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 26448423) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart pain), the first episode of CHEST PAIN (Chest pain), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 26-Dec-2020 to 01-Jan-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-Apr-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ANGINA PECTORIS (heart pain) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (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, ANGINA PECTORIS (heart pain) had not resolved and FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-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. Treatment information included patient was Self medicated with co-codamol. It was reported that report related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment : This regulatory case concerns a 40-year-old female patient with no medical history, who experienced the unexpected serious events of chest pain, Angina Pectoris, Fatigue, Chest Pain, Dyspnoea, Palpitations and Tachycardia after the third dose of mRNA-1273 Vaccine for an unknown indication. The patient experienced the first episode of the chest pain a day after and Angina Pectoris, Fatigue, second episode of Chest Pain, Dyspnoea, Palpitations and Tachycardia unknown days after receiving the vaccine. It was reported that report related to possible inflammation of the heart (myocarditis or pericarditis). The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. The case was assessed as Serious as per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 40-year-old female patient with no medical history, who experienced the unexpected serious events of chest pain, Angina Pectoris, Fatigue, Chest Pain, Dyspnoea, Palpitations and Tachycardia after the third dose of mRNA-1273 Vaccine for an unknown indication. The patient experienced the first episode of the chest pain a day after and Angina Pectoris, Fatigue, second episode of Chest Pain, Dyspnoea, Palpitations and Tachycardia unknown days after receiving the vaccine. It was reported that report related to possible inflammation of the heart (myocarditis or pericarditis). The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. The case was assessed as Serious as per Regulatory Authority?s report.


VAERS ID: 2041422 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Lymphadenopathy, Palpitations, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; LANSOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heart fluttering; Swollen arm; Swollen lymph nodes; Heart racing; This case was received via the RA (Reference number: GB-MHRA-ADR 26452354) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart racing), PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen lymph nodes) in a 44-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 18-Mar-2021 to an unknown date, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), INFLUENZA VACCINE (INFLUENZA VIRUS) from 22-Nov-2021 to an unknown date and LANSOPRAZOLE from 2018 to an unknown date for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved, PALPITATIONS (Heart racing) was resolving and PERIPHERAL SWELLING (Swollen arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient has not had symptoms associated with COVID-19 Patient under arm and breast swelled up and Lumps occurred in arm pit to and took 5 days before swelling reduced. Could not move arm properly. This case concerns a 44-year-old female patient with no medical history, who experienced the unexpected serious events of Palpitations, Peripheral Swelling, Lymphadenopathy and adverse event of special interest, Cardiac Flutter, all events were medically significant as reported by the regulatory authority. The event of Palpitations occurred 2 days after receiving the third dose of mRNA-1273 Vaccine, while the events of Cardiac Flutter, Peripheral Swelling, and Lymphadenopathy occurred 3 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the events Cardiac Flutter and Lymphadenopathy has not resolved while Palpitations was resolving and Peripheral Swelling had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient with no medical history, who experienced the unexpected serious events of Palpitations, Peripheral Swelling, Lymphadenopathy and adverse event of special interest, Cardiac Flutter, all events were medically significant as reported by the regulatory authority. The event of Palpitations occurred 2 days after receiving the third dose of mRNA-1273 Vaccine, while the events of Cardiac Flutter, Peripheral Swelling, and Lymphadenopathy occurred 3 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the events Cardiac Flutter and Lymphadenopathy has not resolved while Palpitations was resolving and Peripheral Swelling had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2041446 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

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

Write-up: Breath shortness; Cough; Fatigue; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26463766) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (Breath shortness), COUGH (Cough) and FATIGUE (Fatigue) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced DYSPNOEA (Breath shortness) (seriousness criteria disability and medically significant), COUGH (Cough) (seriousness criteria disability and medically significant) and FATIGUE (Fatigue) (seriousness criteria disability and medically significant). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (Breath shortness), COUGH (Cough) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient did not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine.; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious (Medically Significant) unexpected event(s) of dizziness, dyspnoea, cough and fatigue. The event(s) started occurring approximately 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2041682 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hemianaesthesia, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200022532

Write-up: Numbness on the left side of the face; blurred vision in the eye; Numbness on the left side of the face, blurred vision in the eye.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: IT-MINISAL02-826604 (MINISAL02). A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: 1F1016A) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HEMIANAESTHESIA (medically significant) with onset 28Dec2021 15:00, outcome "not recovered", described as "Numbness on the left side of the face"; VISION BLURRED (non-serious) with onset 28Dec2021 15:00, outcome "not recovered", described as "blurred vision in the eye"; HEADACHE (non-serious) with onset 28Dec2021 15:00, outcome "not recovered", described as "Numbness on the left side of the face, blurred vision in the eye.". Reporter Comment: Today 29Dec2021 the numbness remains in the middle of my face, my eyesight seems to have improved but a constant headache has been added. - No flu vaccination - Reaction time: 15:00 - Posted by VigiCovid19-schedule No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Today 29Dec2021 the numbness remains in the middle of my face, my eyesight seems to have improved but a constant headache has been added. - No flu vaccination - Reaction time: 15:00 - Posted by VigiCovid19-schedule


VAERS ID: 2041768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Food aversion, Hypersomnia, Lethargy, Lymphadenopathy, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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? 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
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Food aversion; Sleep excessive; Lethargy; Nausea; Glands swollen; Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of FOOD AVERSION (Food aversion), HYPERSOMNIA (Sleep excessive), LETHARGY (Lethargy), NAUSEA (Nausea), LYMPHADENOPATHY (Glands swollen) and PAIN IN EXTREMITY (Pain in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion disability). On 29-Dec-2021, the patient experienced FOOD AVERSION (Food aversion) (seriousness criterion disability), HYPERSOMNIA (Sleep excessive) (seriousness criterion disability), LETHARGY (Lethargy) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability) and LYMPHADENOPATHY (Glands swollen) (seriousness criterion disability). At the time of the report, FOOD AVERSION (Food aversion), HYPERSOMNIA (Sleep excessive), LETHARGY (Lethargy), NAUSEA (Nausea), LYMPHADENOPATHY (Glands swollen) and PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Medical History information was reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Treatment medication was not provided by the reporter. This is a regulatory authority case concerning a female patient of unknown age, with no relevant medical history, who experienced the unexpected serious events of Food aversion, Hypersomnia, Lethargy, Nausea, Lymphadenopathy, Pain in extremity. 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 events were reported as not resolved. 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 female patient of unknown age, with no relevant medical history, who experienced the unexpected serious events of Food aversion, Hypersomnia, Lethargy, Nausea, Lymphadenopathy, Pain in extremity. 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 events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2044526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202200049822

Write-up: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 691515 (TGA). A 21 year-old male patient received bnt162b2 (COMIRNATY), intramuscular (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: BELL''S PALSY (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Bell''s palsy".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2044534 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204421A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Inappropriate schedule of product administration, Malaise, Off label use, Oxygen saturation, Oxygen saturation decreased, Pulmonary pain
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad), Medication errors (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Oxygen saturation; Result Unstructured Data: Low (60%-70%)
CDC Split Type: BRJNJFOC20220116497

Write-up: LOW OXYGEN SATURATION (60-70%); RIGHT-SIDE OF LUNGS HURT; DIFFICULTY IN BREATHING; DIZZINESS; NOT FEELING WELL; CONSTANT HEADACHE; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 50 year old female of unspecified ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on 25-JUN-2021 at left arm for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2. S, patient had a lump on the injection site that stayed for 4 months (dose number in series 1). The patient recovered from lump on the injection site (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204421A, expiry: Unknown) dose was not reported (dose number in series 2), 01 in total administered on 28-DEC-2021 at left arm for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered. No concomitant medications were reported. On 30-DEC-2021, following vaccination with covid-19 vaccine ad26. cov2. S2, the patient had low oxygen saturation (60-70%), right-side of lungs hurt when she used to breathe, difficulty in breathing, dizziness, not feeling well and constant headache (dose number in series 2). Laboratory data included: Oxygen saturation (NR: not provided) Low (60%-70%). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constant headache on 01-JAN-2022, and the outcome of difficulty in breathing, dizziness, right-side of lungs hurt, not feeling well, off label use, inappropriate schedule of vaccine administered and low oxygen saturation (60-70%) was unknown (dose number in series 2). This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220116399.; Sender''s Comments: V0: 20220116497-covid-19 vaccine ad26.cov2.s-and low oxygen saturation (60-70%). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 2044575 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID; Result Unstructured Data: Test Result:positive; Comments: Patient was symptomatic on 28Dec2021- tested + for COVID same day with an at home test and then tested + with a PCR test in the community
CDC Split Type: CAPFIZER INC202200013347

Write-up: Booster; flaring; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (061945). A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 28Dec2021, outcome "recovering" and all described as "tested positive for COVID"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flaring". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Patient was symptomatic on 28Dec2021- tested + for COVID same day with an at home test and then tested + with a PCR test in the community. At the time of report, she felt better and was symptom free. She had all 3 vaccines and her COVID quarantine should now be 5 days. The patient wanted to know if she can be infused on 06Jan2022 as was her current infusion appointment because she was flaring. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information in the case, the causal association between the events immunization, drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.


VAERS ID: 2044853 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM3092 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye contusion, Eye swelling, Headache, Hypersensitivity, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: no previous medical issues
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200015600

Write-up: Initially had a really bad headache; Allergic reaction; Could barely open eyes, also bruised; Inappropriate schedule of vaccine administered; Eyes swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201041132380990-6ZFB0 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26432949 (MHRA). A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FM3092) at the age of 17 years as dose 2, single for COVID-19 immunisation. Patient has not 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. The patient had no relevant medical history (no previous medical issues). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), administration date: 20Aug2021, for COVID-19 immunization. The following information was reported: EYE SWELLING (medically significant) with onset 28Dec2021, outcome "recovered" (30Dec2021), described as "Eyes swollen"; HEADACHE (medically significant), outcome "not recovered", described as "Initially had a really bad headache"; HYPERSENSITIVITY (medically significant), outcome "not recovered", described as "Allergic reaction"; EYE CONTUSION (medically significant), outcome "unknown", described as "Could barely open eyes, also bruised"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (28Dec2021) negative. Clinical course: Patient initially had a really bad headache, following morning eyes swollen like an allergic reaction. Could barely open them, also bruised. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2044995 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A/V1574 / 3 - / OT

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

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

Write-up: unwell; Fever; Headache; General body pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26449083) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (unwell), PYREXIA (Fever), HEADACHE (Headache) and PAIN (General body pain) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A/V1574) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criteria hospitalization, disability and medically significant), HEADACHE (Headache) (seriousness criteria hospitalization, disability and medically significant) and PAIN (General body pain) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, MALAISE (unwell) was resolving and PYREXIA (Fever), HEADACHE (Headache) and PAIN (General body pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. unwell within minutes of getting moderna jjab, body aches, fever, chills, fatigue and severe headache. Symptoms ongoing for 10 days without pause, advised to go to A+E ? CVST ? cause of symptoms. No concomitant medication was reported No treatment information was provided Company Comment: This case concerns a 36-year-old male patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Malaise, Pyrexia, Headache and Pain. The event Malaise occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The events of Pyrexia, Headache and Pain occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old male patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Malaise, Pyrexia, Headache and Pain. The event Malaise occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The events of Pyrexia, Headache and Pain occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045070 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, 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 Date: 20220105; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Headache; This case was received (Reference number: GB-MHRA-ADR 26452492) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 47-year-old male patient 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 28-Dec-2021, the patient experienced HEADACHE (Headache) (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), DYSPNOEA (Shortness of breath) (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, HEADACHE (Headache) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided by reporter. Week after booster vaccine, patient began to get migraine type headache that does not go with paracetamol, heart palpitations and sharp pains in chest and back. Patient had diarrhoea 3 weeks later. 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 by reporter. The report was related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory case concerns a 47-year-old, male patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of headache, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The patient developed headache approximately 10 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that the headache did not improve with paracetamol. Evolved with heart palpitations, sharp pains in chest and back, as well as diarrhoea 3 weeks later. It was not reported if the previous two doses of his COVID-19 vaccination schedule were mRNA-1273 vaccines as well. It was reported in narrative that the case was related to possible inflammation of the heart, however, no further information about this was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 47-year-old, male patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of headache, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The patient developed headache approximately 10 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that the headache did not improve with paracetamol. Evolved with heart palpitations, sharp pains in chest and back, as well as diarrhoea 3 weeks later. It was not reported if the previous two doses of his COVID-19 vaccination schedule were mRNA-1273 vaccines as well. It was reported in narrative that the case was related to possible inflammation of the heart, however, no further information about this was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.


VAERS ID: 2045090 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Myocarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Exercise regular (cardio routines for 25-30 minutes a day.); Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Angina attack (Patient history: Start: N/A Stop: N/A Angina Continuing? Unknown.); Angina attack (Father had angina.); Atrial fibrillation (Father had atrial fibrillation); Atrial fibrillation; Blood pressure high (Father had high blood pressure)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Myocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26452806) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. The patient''s past medical history included Atrial fibrillation and Angina attack (Patient history: Start: N/A Stop: N/A Angina Continuing? Unknown.). Family history included Atrial fibrillation (Father had atrial fibrillation), Blood pressure high (Father had high blood pressure) and Angina attack (Father had angina.). Concurrent medical conditions included Non-smoker and Exercise regular (cardio routines for 25-30 minutes a day.). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 13-Jul-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). On 29-Dec-2021, MYOCARDITIS (Myocarditis) had resolved. At the time of the report, FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: 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 previous history of chest pain. Patient was non-drinker. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. 28-Dec-21, Tuesday - intense chest pain episode calming down after a couple of minutes, but still mild pain for the rest of the day. 29-Dec-21, Wednesday - woke up with chest pain at 6am with pain radiating down shoulders and tops of both arms. Pain subsided, but mild for rest of morning. Got worse about 12.30pm with radiating pain into neck and back of throat. Went to hospital with ambulance at 2pm. A&E blood test showed triponin levels of 28.5, other blood results normal, EEG trace showed minor trace shape issues, blood pressure was fine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient report relate to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations included Heart echo - heart activity normal, cardiac CT scan on 7-Jan-22, all clear.~ Patient symptoms lead to a hospital stay for 9 days. Diagnosis made by a medical professional. Cardio consultant said that if CT scan clear then only possible cause would be myocarditis from a reaction to the booster. Medication prescribed for the treatment of symptoms included Clopidogrel, aspirin, bisoprol, atorvastatin. Imaging carried out such as, Chest x-ray, echocardiogram and cardiac CT. Blood tests conducted. The peak troponin value "31". Troponin reference range: "28.5 first blood test, 31 second blood test ". Company comment: This case concerns a 49-year-old female patient with past medical history of Atrial fibrillation and Angina attack, who experienced the unexpected serious events of Fatigue, Chest Pain, Dyspnea, and adverse event of special interest, Myocarditis, the events led to the hospitalization of the patient as reported by the regulatory authority. The events occurred 11 days after receiving the third dose of mRNA-1273 Vaccine.; Sender''s Comments: This case concerns a 49-year-old female patient with past medical history of Atrial fibrillation and Angina attack, who experienced the unexpected serious events of Fatigue, Chest Pain, Dyspnea, and adverse event of special interest, Myocarditis, the events led to the hospitalization of the patient as reported by the regulatory authority. The events occurred 11 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. SARS-CoV-2 test yielded negative results, no other clinical or treatment details were given. It was reported that the outcome of Myocarditis has resolved, while the rest of the event outcome was unknown. The past medical history of Atrial fibrillation and Angina attack remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2045107 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fever chills; Headache; Numbness of fingers; Generalised aching; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), HEADACHE (Headache), HYPOAESTHESIA (Numbness of fingers) and PAIN (Generalised aching) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness of fingers) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). On 28-Dec-2021, HYPOAESTHESIA (Numbness of fingers) had resolved. On 29-Dec-2021, PYREXIA (Fever chills) and PAIN (Generalised aching) had resolved. On 31-Dec-2021, 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. Treatment information was not reported This is a regulatory authority case concerning a 28-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pyrexia, Headache, Hypoaesthesia, Pain. 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 events were reported as resolved. 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 28-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pyrexia, Headache, Hypoaesthesia, Pain. 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 events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2045174 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), COVID-19 (broad)

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

Write-up: chest pain; tightend throat; Chest pain with radiation to left arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26454149) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), THROAT TIGHTNESS (tightend throat) and CHEST PAIN (Chest pain with radiation to left arm) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced CHEST PAIN (Chest pain with radiation to left arm) (seriousness criterion disability). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion disability) and THROAT TIGHTNESS (tightend throat) (seriousness criterion disability). On 28-Dec-2021, CHEST PAIN (Chest pain with radiation to left arm) had not resolved. At the time of the report, CHEST PAIN (chest pain) and THROAT TIGHTNESS (tightend throat) 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. The concomitant medication was not reported. The treatment medication was not reported. Patient had suffered from lots of different problems and patient suffered chest pain shooting type pain in left side of chest and also suffered a tightend throat also. Company comment: This is a regulatory case concerning a 27 year-old, female patient with no reported medical history, who experienced the serious (due to disability) unexpected, events of Chest pain (reported as Chest pain with radiation to left arm and chest pain) and Throat tightness. Events were assessed as serious by the Regulatory Authority. The event chest pain (reported as Chest pain with radiation to left arm) occurred the same day after the third dose of mRNA-1273 vaccine and the events Chest pain (reported as chest pain) and Throat tightness on an unknown date. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the 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 27 year-old, female patient with no reported medical history, who experienced the serious (due to disability) unexpected, events of Chest pain (reported as Chest pain with radiation to left arm and chest pain) and Throat tightness. Events were assessed as serious by the Regulatory Authority. The event chest pain (reported as Chest pain with radiation to left arm) occurred the same day after the third dose of mRNA-1273 vaccine and the events Chest pain (reported as chest pain) and Throat tightness on an unknown date. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045193 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, COVID-19, Drug ineffective, Dyspnoea, Electrocardiogram, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Myocarditis, Off label use, Pain, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:All fine; Test Name: Blood test; Result Unstructured Data: Test Result:All fine; Test Name: ECG; Result Unstructured Data: Test Result:All fine; Test Date: 20220109; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: SARS-Cov-2- test; Result Unstructured Data: Test Result:All fine
CDC Split Type: GBPFIZER INC202200047048

Write-up: On Friday I had a heart palpitation which scared me so I called 111 and was sent to a&e; Myocarditis; Fever; Shortness of breath; Racing heart (tachycardia); Yes - Positive COVID-19 test; Yes - Positive COVID-19 test; Heart pounding; The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday.; The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday/unusual tiredness; The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday; I started to feel sick and getting a headache an hour after having the Pfizer booster; I started to feel sick and getting a headache an hour after having the Pfizer booster; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201102007492840-DSIYA. Other Case identifier(s): GB-MHRA-ADR 26458736. A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 25May2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), administration date: 28Mar2021, for COVID-19 immunisation; Covid 19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN, Lot Number: Unknown; Route of administration: Unspecified; Primary Immunisation series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Dose number 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Yes - Positive COVID-19 test"; PALPITATIONS (medically significant), outcome "unknown", described as "On Friday I had a heart palpitation which scared me so I called 111 and was sent to a&e"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "recovered", described as "Heart pounding"; HEADACHE (medically significant) with onset 28Dec2021, outcome "recovering", PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (03Jan2022) and all described as "The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday."; FATIGUE (medically significant) with onset 29Dec2021, outcome "unknown", described as "The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday/unusual tiredness"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; MALAISE (non-serious) with onset 28Dec2021, outcome "unknown", described as "I started to feel sick and getting a headache an hour after having the Pfizer booster"; PAIN (non-serious) with onset 29Dec2021, outcome "unknown", described as "The next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the Monday". The events "on friday i had a heart palpitation which scared me so i called 111 and was sent to a&e", "myocarditis" were evaluated at the physician office visit and emergency room visit. The events "heart pounding", "i started to feel sick and getting a headache an hour after having the pfizer booster", "the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the monday.", "the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the monday/unusual tiredness", "fever", "shortness of breath", "racing heart (tachycardia)", "i started to feel sick and getting a headache an hour after having the pfizer booster" and "the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain untill the monday" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) all fine; blood test: (unspecified date) all fine; electrocardiogram: (unspecified date) all fine; sars-cov-2 test: (09Jan2022) yes - positive covid-19 test; (unspecified date) all fine. Clinical Course: The patient did not take any medications. The patient was not pregnant and currently not breastfeeding. The last menstrual period date was reported as 22Dec2021. On an unknown date the patient experienced palpitation/on Friday she had a heart palpitation which scared her so she called 111 and was sent to a&e, myocarditis/myocarditis, fever/fever, dyspnoea/ shortness of breath and tachycardia/racing heart (tachycardia). On 28Dec2021, 1 hour after vaccination, the patient experienced headache/ she started to feel sick and getting a headache an hour after having the Pfizer booster, feeling sick/ she started to feel sick and getting a headache an hour after having the Pfizer booster. On 29Dec2021, 1 day after vaccination, the patient experienced fever/the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain until the Monday, fatigue/the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain until the Monday/unusual tiredness, general body pain/the next day the headaches became extreme and lasted everyday with a fever and extreme fatigue and body pain until the Monday. On 30Dec2021, 2 days after vaccination the patient experienced palpitation/heart pounding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Fibromyalgia, Headache, Immunisation, Interchange of vaccine products, Loss of personal independence in daily activities, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Dementia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia (been manageable for a couple of years. Not on medication at this time); Vertigo (Suffer from vertigo, not on medication at this time)
Allergies:
Diagnostic Lab Data: Test Date: 20220105; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200064306

Write-up: Constant headaches; Aching limbs; Joint pain; Severe fatigue; Affecting daily life; Fibromyalgia worsened; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY.; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY.; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201121008302960-UVFRT. Other Case identifier(s): GB-MHRA-ADR 26465375. A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Suffer from vertigo, not on medication at this time; "Fibromyalgia" (unspecified if ongoing), notes: been manageable for a couple of years. Not on medication at this time. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability), IMMUNISATION (disability) all with onset 28Dec2021, outcome "unknown" and all described as "Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY."; FIBROMYALGIA (disability) with onset 01Jan2022, outcome "not recovered", described as "Fibromyalgia worsened"; HEADACHE (disability), outcome "unknown", described as "Constant headaches", PAIN IN EXTREMITY (disability), outcome "unknown", described as "Aching limbs, ARTHRALGIA (disability), outcome "unknown", described as "Joint pain" and FATIGUE (disability), outcome "unknown", described as "Severe fatigue" that LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "unknown", described as "Affecting daily life" so the patient had to go to bed. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) no - negative covid-19 test. The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045344 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-04
Onset:2021-12-28
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Diplopia, SARS-CoV-2 test, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness: Arrhythmia; Epilepsy (been diagnosed epileptic and been given anti epilepsy medication); Epileptic seizure; Seizures (Can no longer drive now due to seizures)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Seizures; Double vision; Confusion; This case was received via Regulatory Authority, RA (Reference number: GB-MHRA-ADR 26453979) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (Seizures), DIPLOPIA (Double vision) and CONFUSIONAL STATE (Confusion) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 13-Jan-2021. Previously administered products included for Arrhythmia: BISOPROLOL (Take Bisoprolol 2.5mg daily for arrhythmias.) since an unknown date. Past adverse reactions to the above products included No adverse reaction with BISOPROLOL. Concurrent medical conditions included Arrhythmia, Epileptic seizure, Seizures (Can no longer drive now due to seizures) and Epilepsy (been diagnosed epileptic and been given anti epilepsy medication). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 26-Feb-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 11-May-2021 to an unknown date for an unknown indication. On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant), DIPLOPIA (Double vision) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization). At the time of the report, SEIZURE (Seizures) had resolved with sequelae, DIPLOPIA (Double vision) had not resolved and CONFUSIONAL STATE (Confusion) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medication was provided.Patient Three seizures on morning of 28/12/21.Patient Reported bad headache and problems with right eye and vision to husband before.Patient Struggled to talk, function for approx 5 days after.Patient Have blurred and double vision in right eye.Patient Spoke to optician who has said he needs to refered to the eye hospital as it''s not a prescription issue.Patient has not tested positive for COVID-19 since having the vaccinePatient is not enrolled in clinical trialPatient had Mri with white marking on frontal lobes, eye test and photos of back of eye by optician. "Patient Takes Bisoprolol 2.5mg daily for arrhythmias.Patient Can no longer drive now due to seizures, been diagnosed epileptic and been given anti epilepsy medication. Patient spoke to a neurologist until mid April. Patient was concerned that the seizures were caused by a reaction to a change in vaccination given Company Comment:This regulatory authority case concerns a 43-year-old female patient with a Concurrent medical conditions Arrhythmia, Epileptic seizure, Seizures and Epilepsy with an Interchange of vaccine products two doses of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) 6 months and 23 days before current vaccination, who experienced the unexpected serious AESI event of Seizure and unexpected serious events of Diplopia and Confusional state. The events occurred 24 days after the third dose of mRNA- 1273 vaccine. Patient was tested covid-19 positive 43 days after the third dose, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Patients concurrent medical condition 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 and hospitalization.; Sender''s Comments: This regulatory authority case concerns a 43-year-old female patient with a Concurrent medical conditions Arrhythmia, Epileptic seizure, Seizures and Epilepsy with an Interchange of vaccine products two doses of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) 6 months and 23 days before current vaccination, who experienced the unexpected serious AESI event of Seizure and unexpected serious events of Diplopia and Confusional state. The events occurred 24 days after the third dose of mRNA- 1273 vaccine. Patient was tested covid-19 positive 43 days after the third dose, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Patients concurrent medical condition 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 and hospitalization.


VAERS ID: 2045355 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-12-28
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Polymerase chain reaction, 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: 20220103; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: IEPFIZER INC202200024813

Write-up: Vaccination failure; Mild breakthrough infection; received dose 3 on 28Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group and a sales representative. A 20 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jun2021 (Lot number: FD5613) as dose 1, single and administration date 30Jul2021 (Lot number: FE9174) as dose 2, single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 30Dec2021, outcome "recovering", described as "Mild breakthrough infection"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "received dose 3 on 28Dec2021". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045392 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-12-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: 20211228; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202200022730

Write-up: Booster; PRIVACY. Positive molecular swab in vaccinated.; Vaccination Failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: IT-MINISAL02-826333 (MINISAL02). A 92 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 18Nov2021 (Formulation: solution for injection, Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single, intramuscular, administered in arm left, administration date 05May2021 (Formulation: solution for injection, Lot number: EX7389, Expiration Date: 31Aug2021) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 14Apr2021 (Formulation: solution for injection, Lot number: EW2246, Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SARS-COV-2 TEST POSITIVE (medically significant) with onset 28Dec2021, outcome "recovering", described as "PRIVACY. Positive molecular swab in vaccinated."; VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Vaccination Failure"; COVID-19 (medically significant) with onset 28Dec2021, outcome "unknown", described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. Clinical course: Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be associated lot(s) of the reported lot EW2246, lot EX7389, lot FF2382. A complaint sample was not returned and no related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable and The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Follow-up attempts are completed. No further information is expected.


VAERS ID: 2045730 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-12-28
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Femoral neck fracture, Humerus fracture, Neck deformity
SMQs:, Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202200020434

Write-up: FX FEMORAL NECK LEFT; FX HUMERAL NECK LEFT; Neck deformity; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129885. A 64 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 29Oct2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single , Lot number: UNKNOWN), administration date: 04Oct2021, when the patient was 64 years old, for Covid-19 immunisation. The following information was reported: NECK DEFORMITY (medically significant) with onset 28Dec2021 09:15, outcome "recovered" (28Dec2021 09:20), described as "Neck deformity" (as reported); FEMORAL NECK FRACTURE (medically significant), outcome "unknown", described as "FX FEMORAL NECK LEFT"; HUMERUS FRACTURE (medically significant), outcome "unknown", described as "FX HUMERAL NECK LEFT". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045732 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple injuries, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202200020462

Write-up: Vehicular accident; multiple injuries; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129886. A 16-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Dec2021 (Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, intramuscular), administration date: 01Dec2021, for COVID-19 immunization. The following information was reported: ROAD TRAFFIC ACCIDENT (medically significant) with onset 28Dec2021 09:25, outcome "recovered" (28Dec2021 09:30), described as "Vehicular accident"; MULTIPLE INJURIES (medically significant) with onset 28Dec2021 09:25, outcome "recovered" (28Dec2021 09:30), described as "multiple injuries". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045735 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL5324 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hypothermia, Vaccination site pain
SMQs:, Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PHPFIZER INC202200020477

Write-up: HYPOTHERMIA; Vaccination site pain; Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129890. A 16 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 27Dec2021 (Lot number: FL5324) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPOTHERMIA (medically significant) with onset 28Dec2021 07:00, outcome "recovering", described as "HYPOTHERMIA"; VACCINATION SITE PAIN (non-serious) with onset 28Dec2021 07:00, outcome "recovering", described as "Vaccination site pain"; CHILLS (non-serious) with onset 28Dec2021 07:00, outcome "recovering", described as "Chills". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2049076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Limb discomfort, Lymph node pain, Off label use, Pain in extremity
SMQs:, 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:
CDC Split Type: GBPFIZER INC202200019278

Write-up: Very painful armpit/glands; Sore arm; Heavy arm; Lymph node pain; DOSE 1/2, MANUFACTURER UNKNOWN; DOSE 1/2, MANUFACTURER UNKNOWN; 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-202201051340454280-SHRJR (RA). Other Case identifier(s): GB-MHRA-ADR 26439043 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "DOSE 1/2, MANUFACTURER UNKNOWN"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "booster"; LYMPH NODE PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Lymph node pain"; AXILLARY PAIN (medically significant), outcome "not recovered", described as "Very painful armpit/glands"; PAIN IN EXTREMITY (medically significant), outcome "recovered", described as "Sore arm"; LIMB DISCOMFORT (medically significant), outcome "recovered", described as "Heavy arm". Clinical course: Very painful armpit/glands and extremely sore heavy arm for 7 days. 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: 2049084 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200019102

Write-up: Bruising; Constant head pain worse when laying down/headache; 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-202201051419158610-BGFKS (RA). Other Case identifier(s): GB-MHRA-ADR 26439338 (RA). A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN; Lot Number: unknown; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: CONTUSION (disability), outcome "not recovered", described as "Bruising"; HEADACHE (disability) with onset 28Dec2021, outcome "not recovered", described as "Constant head pain worse when laying down/headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of contusion, headache. Clinical course constant head pain worse when laying down. Bruising appeared on forehead and around eyes. This was still an issue. Patient had been to urgent treatment. 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: 2049233 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Dizziness, Fatigue, Influenza like illness, Nausea, Paraesthesia, Pruritus, SARS-CoV-2 test, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Chest burning; Coughing; Tiredness; Itchy skin; Flu-like aching; Tingling skin; Dizzy spells; Nausea; Throat irritation; Itchy throat; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26453946) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), COUGH (Coughing), CHEST PAIN (Chest burning), FATIGUE (Tiredness), PRURITUS (Itchy skin), THROAT IRRITATION (Throat irritation), INFLUENZA LIKE ILLNESS (Flu-like aching), PARAESTHESIA (Tingling skin), DIZZINESS (Dizzy spells) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced THROAT IRRITATION (Itchy throat) (seriousness criterion medically significant), THROAT IRRITATION (Throat irritation) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), PRURITUS (Itchy skin) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and PARAESTHESIA (Tingling skin) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant). On 04-Jan-2022, the patient experienced CHEST PAIN (Chest burning) (seriousness criterion medically significant). On 06-Jan-2022, NAUSEA (Nausea) had resolved. At the time of the report, THROAT IRRITATION (Itchy throat), COUGH (Coughing), CHEST PAIN (Chest burning), FATIGUE (Tiredness), PRURITUS (Itchy skin), THROAT IRRITATION (Throat irritation), INFLUENZA LIKE ILLNESS (Flu-like aching), PARAESTHESIA (Tingling skin) and DIZZINESS (Dizzy spells) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient have no health conditions. Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient is not currently breastfeeding. No treatment medications were provided. Patient reported that she had never felt so unwell in all life and now very concerned about the safety of this vaccine. Suffering every day with no sign of getting better yet. Had an adverse reaction. 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 39-year-old female patient with no medical history reported, who experienced unexpected serious events of Throat irritation (two occurrences), Chest pain, Cough, Fatigue, Pruritus, Influenza like illness, Paraesthesia, Dizziness and Nausea. The events started developing on the same date after the third dose of mRNA-1273 vaccine and the outcome of majority of events was not recovered. It was reported that the previous dose was of another manufacture, which suggests Interchange of vaccine products. The COVID test was negative. 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 medical history reported, who experienced unexpected serious events of Throat irritation (two occurrences), Chest pain, Cough, Fatigue, Pruritus, Influenza like illness, Paraesthesia, Dizziness and Nausea. The events started developing on the same date after the third dose of mRNA-1273 vaccine and the outcome of majority of events was not recovered. It was reported that the previous dose was of another manufacture, which suggests Interchange of vaccine products. The COVID test was negative. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Depressed mood, Dysmenorrhoea, Heavy menstrual bleeding, Hyperhidrosis, Immunisation, Liver function test, Nausea, Pain, Palpitations, Polymerase chain reaction, Premenstrual pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LFT; Result Unstructured Data: Test Result:unknown result; Test Name: PCR; Result Unstructured Data: Test Result:unknown result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200064097

Write-up: Premenstrual pain; Booster; Sweating; Patient was on the floor unable to do anything due to the pain; Heart palpitations; Extremely bad menstrual cramps; It caused to feel very nauseous; Lead on the much heavier than usual periods; Also felt extremely low in energy; low in mood; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the regulatory agency. The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Vaccination history included: BNT162B2 (Dose 2, Batch/lot number: FF3319), administration date: 19Aug2021, for COVID-19 Immunisation, reactions: "extremely bad menstrual cramps", "lead on the much heavier than usual periods", "felt extremely low in energy", "low in mood"; Bnt162b2 (Dose 2, Batch/lot number: FF3319), administration date: 19Aug2021, for COVID-19 immunisation, reactions: "heart palpitations", "sweating", "it caused me to feel very nauseous", "Patient was on the floor unable to do anything due to the pain"; Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; HYPERHIDROSIS (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Sweating"; PAIN (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Patient was on the floor unable to do anything due to the pain"; PALPITATIONS (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Heart palpitations"; DYSMENORRHOEA (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Extremely bad menstrual cramps"; NAUSEA (disability, medically significant) with onset 2021, outcome "unknown", described as "It caused to feel very nauseous"; HEAVY MENSTRUAL BLEEDING (disability, medically significant) with onset 2021, outcome "unknown", described as "Lead on the much heavier than usual periods"; ASTHENIA (disability, medically significant) with onset 2021, outcome "unknown", described as "Also felt extremely low in energy"; DEPRESSED MOOD (disability, medically significant) with onset 2021, outcome "unknown", described as "low in mood"; PREMENSTRUAL PAIN (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "Premenstrual pain". The patient underwent the following laboratory tests and procedures: liver function test (LFT): unknown result; polymerase chain reaction: unknown result; COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Clinical course: A few days after both vaccines, patient had extremely bad menstrual cramps (the worst she had in her life) with heart palpitations, sweating and it caused her to feel very nauseous. She was on the floor unable to do anything due to the pain. This lasted an hour both times within days of having the jabs, and lead on the much heavier than usual periods. She was convinced it was linked to the vaccines as she noticed how unusual it was after her second jab, and then when it occurred exactly the same following her booster. In between doses, her cycles returned to normal. She had also felt extremely low in energy and mood following both vaccines for 2 weeks after. Which then returns to normal. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. She had been self testing with LFT''s and also been PCR tested once a week for work and had not as far as she known contracted Covid during the time of vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200026856 Same patient/different dose/different events


VAERS ID: 2049509 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, SARS-CoV-2 test
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (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 MODERNA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220111; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No- Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Loss of memory ability; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26461392) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of AMNESIA (Loss of memory ability) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced AMNESIA (Loss of memory ability) (seriousness criterion medically significant). At the time of the report, AMNESIA (Loss of memory ability) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. It was reported that it''s more of a loss of ability to notice, focus on technical tasks or remember detailed pieces of information. Patient didn''t even notice, conducted normal payroll procedures for December month end. Running checks with senior, numerous and blatantly obvious mistakes were spotted. In the past couple of weeks patient also experienced multiple occasions when patient had forgotten appointments and could not recall the name of tv shows had watched only a few weeks ago. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment:This case concerns a 32-year-old female patient, with medical history of Interchange of vaccine products with ELASOMERAN (COVID-19 VACCINE MODERNA), who experienced the unexpected serious event of Amnesia (medically significant) which occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The patient''s medical history of vaccination with, ELASOMERAN (COVID-19 VACCINE MODERNA) remain as a confounder for the occurrence of the event. 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 case concerns a 32-year-old female patient, with medical history of Interchange of vaccine products with ELASOMERAN (COVID-19 VACCINE MODERNA), who experienced the unexpected serious event of Amnesia (medically significant) which occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The patient''s medical history of vaccination with, ELASOMERAN (COVID-19 VACCINE MODERNA) remain as a confounder for the occurrence of the event. 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: 2049513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; METHYLDOPA
Current Illness: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 Test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Acute migraine; Fatigue extreme; This case was received via RA (Reference number: GB-MHRA-ADR 26464739) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue extreme) and MIGRAINE (Acute migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concurrent medical conditions included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Jan-2021 to an unknown date and METHYLDOPA from 10-Jul-2021 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced MIGRAINE (Acute migraine) (seriousness criterion medically significant). On 01-Jan-2022, MIGRAINE (Acute migraine) had resolved. On 03-Jan-2022, FATIGUE (Fatigue extreme) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 Test. 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 is not enrolled in clinical trial. Company Comment: This case refers to a female patient of unspecified age with no relevant medical history who experienced the unexpected event of Fatigue on the same day after receiving the third dose of mRNA-1273 vaccine while the event of Migraine occurred 2 days after receiving 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 female patient of unspecified age with no relevant medical history who experienced the unexpected event of Fatigue on the same day after receiving the third dose of mRNA-1273 vaccine while the event of Migraine occurred 2 days after receiving 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: 2049799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, 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: 20220105; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: SEPFIZER INC202200052168

Write-up: tested positive for covid-19; Got sick with covid infection; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 26May2021 (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: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "not recovered", described as "booster"; VACCINATION FAILURE (medically significant) with onset 05Jan2022, outcome "not recovered", described as "tested positive for covid-19"; COVID-19 (medically significant) with onset 05Jan2022, outcome "not recovered", described as "Got sick with covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2049808 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event following immunisation, Dizziness, Nausea, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Arm pain at injection site; dizziness; Nausea; Vomiting; AEFI; This case was received via Regulatory Authority (Reference number: MOD-2022-263) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm pain at injection site), DIZZINESS (dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and ADVERSE EVENT FOLLOWING IMMUNISATION (AEFI) in a 45-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 049F21A) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at injection site) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and ADVERSE EVENT FOLLOWING IMMUNISATION (AEFI) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (Arm pain at injection site), DIZZINESS (dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and ADVERSE EVENT FOLLOWING IMMUNISATION (AEFI) was resolving. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment medication details were provided by reporter. Serial number was reported as RAM001212. This case concerns a 45-year-old female patient with no medical history, who experienced the unexpected serious events of Vaccination Site Pain, Dizziness, Nausea, Vomiting, and Adverse Event Following Immunization, the events were reported as medically significant by the regulatory authority. The events occurred in 2 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 45-year-old female patient with no medical history, who experienced the unexpected serious events of Vaccination Site Pain, Dizziness, Nausea, Vomiting, and Adverse Event Following Immunization, the events were reported as medically significant by the regulatory authority. The events occurred in 2 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2051779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension, Injection site erythema, Myalgia, Puncture site pain, Spinal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: Blood pressure measurement; Result Unstructured Data: Up to 200 mmHg of systolic pressure
CDC Split Type: CZJNJFOC20220135283

Write-up: Puncture site pain; Pain muscle; Injection site redness; Pain in cervical spine; Blood pressure high; This spontaneous report received from a consumer via a Regulatory Authority (regulatory authority, CZ-CZSUKL-21014374) concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total, administered on 28-DEC-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-DEC-2021, the patient experienced puncture site pain, pain muscle, injection site redness, pain in cervical spine, and blood pressure high. Laboratory data included: Blood pressure measurement (NR: not provided) Up to 200 mmHg of systolic pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in cervical spine, and blood pressure high, and had not recovered from puncture site pain, pain muscle, and injection site redness. This report was serious (Other Medically Important Condition).


VAERS ID: 2052186 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Muscle soreness; Nausea; Fever; Headache; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26408116) on 14-Jan-2022 and was forwarded to Moderna on 14-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MYALGIA (Muscle soreness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle soreness), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient did not had symptoms associated with COVID-19. Not had a COVID-19 test. Company Comment: This is a regulatory case concerning a 31-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of myalgia, nausea, pyrexia and headache. The events occurred on the same day after the third dose of mRNA-1273 vaccine administration and were not recovered at the time of this report. The events were assessed as related to the product administration. The rechallenge was 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 31-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of myalgia, nausea, pyrexia and headache. The events occurred on the same day after the third dose of mRNA-1273 vaccine administration and were not recovered at the time of this report. The events were assessed as related to the product administration. The rechallenge was 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: 2052299 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-08
Onset:2021-12-28
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Influenza, Influenza like illness, Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: Yes - Positive COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: flu like symptoms; myocarditis; Influenza; SARS-CoV-2 infection; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412852) on 14-Jan-2022 and was forwarded to Moderna on 14-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection), INFLUENZA LIKE ILLNESS (flu like symptoms), MYOCARDITIS (myocarditis) and INFLUENZA (Influenza) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 28-Dec-2021. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion disability). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion disability), MYOCARDITIS (myocarditis) (seriousness criterion disability) and INFLUENZA (Influenza) (seriousness criterion disability). At the time of the report, COVID-19 (SARS-CoV-2 infection), INFLUENZA LIKE ILLNESS (flu like symptoms) and MYOCARDITIS (myocarditis) had not resolved and INFLUENZA (Influenza) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided by the reporter. Company Comment: This is a regulatory case concerning a male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of COVID-19 pneumonia, serious expected AESI event of myocarditis and serious unexpected events of influenza like illness and influenza. The event of COVID-19 pneumonia occurred 21 days after the third dose of mRNA-1273 vaccine administration and the remaining events occurred on unknown dates. Causality for the event of COVID-19 was not applicable to the product administration and related for the remaining events. The events were assessed as serious per disability criterion by the Regulatory Authority. The rechallenge was 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 male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of COVID-19 pneumonia, serious expected AESI event of myocarditis and serious unexpected events of influenza like illness and influenza. The event of COVID-19 pneumonia occurred 21 days after the third dose of mRNA-1273 vaccine administration and the remaining events occurred on unknown dates. Causality for the event of COVID-19 was not applicable to the product administration and related for the remaining events. The events were assessed as serious per disability criterion by the Regulatory Authority. The rechallenge was 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: 2052333 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate, Heart rate increased, Immunisation, Liver function test, 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: Heart rate; Result Unstructured Data: Test Result:raised by 40-50 percent; Test Date: 20211229; Test Name: Heart rate; Result Unstructured Data: Test Result:High; Test Name: Liver Function Tests; Test Result: Negative ; Test Date: 20220104; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019212

Write-up: Chest pain; Shortness of breath; Racing heart (tachycardia); Fatigue/unusual tiredness; Heart pounding/Heart palpitations; Heart rate high; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201050928090250-6MZ0M (RA). Other Case identifier(s): GB-MHRA-ADR 26437855 (RA). A 24-year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FK9706) 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 enrolled in clinical trial. 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 28Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; HEART RATE INCREASED (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Heart rate high"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Heart pounding/Heart palpitations"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness". The patient underwent the following laboratory tests and procedures: heart rate: (29Dec2021) high; (unspecified date) raised by 40-50 percent; liver function test: (unspecified date) negative; COVID-19 virus testst: (04Jan2022) No - Negative COVID-19 test. Patient''s resting heart rate had raised by 40-50 percent and not lowered for over a week by the time of this report. The patient understood that was common for a few days after any vaccination, however it had persisted. Heart beat could be felt quite strongly throughout his chest and neck even when relaxed, and the expansion/contraction was easily visible in chest. Patient had restricted exercise slightly as he had short of breath more easily than normal. No apparent changes to diet/lifestyle/stress that could have caused this. It was reported that this report was related to possible inflammation of the heart (myocarditis or pericarditis), the symptoms did not lead to a hospital stay, a diagnosis was not made by a medical professional, there were no any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Patient''s daily LFTs (liver function tests) had all been negative, and no symptoms of any other infection that could cause similar symptoms. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052377 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Malaise
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: GBPFIZER INC202200026625

Write-up: Feeling very unwell; Swollen glands/ Swollen glands in armpits and groin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 45-year-old female patient received the second dose of BNT162b2 (COMIRNATY; batch number: unknown) via an unspecified route of administration on 28Dec2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and not had a COVID test. The patient was not enrolled in clinical trial. Previously, the patient received the first dose of COVID-19 vaccine (manufacturer unknown; lot number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 28Dec2021, the patient experienced swollen glands/ swollen glands in armpits and groin; reported as serious for being medically significant. On an unknown date, the patient experienced feeling very unwell. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event feeling very unwell was unknown while that of the event swollen glands/ swollen glands in armpits and groin was not recovered at the time of this report. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.


VAERS ID: 2052386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Muscle strain, Myocarditis, Palpitations, Pericarditis, Pulmonary embolism, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: electerocardiogarm; Result Unstructured Data: Test Result:Normal; Test Date: 20211220; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200026691

Write-up: racing heart; Racing heart (tachycardia); possible inflammation of the heart (myocarditis or pericarditis; possible inflammation of the heart (myocarditis or pericarditis; Fatigue/unusual tiredness; pulmonary embolism; Chest pain; Shortness of breath/heaviness breathing; pulled muscle in chest; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201061033321950-M60R6 (MHRA). Other Case identifier: GB-MHRA-ADR 26443102 (MHRA). A 22-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing) but had not suffered for 6 years from it and "Recurring psoriasis on hands " (unspecified if ongoing). The patient''s concomitant medications were not reported. The patient did not have symptoms associated with COVID-19. The patient was not pregnant and was not currently breast feeding. The patient was not enrolled in clinical trial. The patient did not receive any medication within two weeks of vaccination. On an unknown date, the patient experienced racing heart, fatigue/unusual tiredness, and heart (tachycardia). Then on 28Dec2021, the patient had chest pain on the left side, difficulty and heaviness breathing. The patient was sent to hospital GP initially diagnosed me with pulmonary embolism. No sign when tests were taken as blood tests, ECG, and chest X-Ray came back normal, so hospital doctor suggested pulled chest muscle. Prescribed ibuprofen with possible pulled muscle in chest. The symptoms did not lead to a hospital stay. Blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were not taken. On 20Dec2021, the patient had negative COVID-19 virus test. This report was related to possible inflammation of the heart (myocarditis or pericarditis). The clinical outcome of the events racing heart, pulmonary embolism and chest pain was not recovered while that of fatigue/unusual tiredness, shortness of breath, racing heart (tachycardia), myocarditis, pericarditis and pulled chest muscle was unknown at the time of this report. Events were reported as serious for being medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 2052514 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet factor 4 antibody test, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Fibrin D dimer, Immunisation, Interchange of vaccine products, Off label use, Platelet count, Pulmonary embolism, Thrombocytopenia, Troponin, Troponin increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Anti-PF4 antibody test; Result Unstructured Data: Test Result:UNK; Test Name: CT pulmonary angiogram test; Result Unstructured Data: Test Result:large saddle embolus; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Abnormal; Test Date: 20220107; Test Name: Fibrin D dimer test; Result Unstructured Data: Test Result:D-dimer was $g4000;D-dimer 6000; Test Date: 20220107; Test Name: Platelet count test; Result Unstructured Data: Test Result:200 (UNSPECIFIED); Comments: last platelet count before vaccine; Test Date: 20220107; Test Name: Platelet count test; Result Unstructured Data: Test Result:138 (UNSPECIFIED); Comments: lowest platelet count after vaccine; Test Name: Troponin; Result Unstructured Data: Test Result:Raised
CDC Split Type: GBPFIZER INC202200026601

Write-up: Shortness of breath; Thrombocytopenia (Platelet count <150 -109/L)/low platelet count; Raised troponin; Pulmonary embolism/blood clots/large saddle embolus; Primary immunisation: MODERNA and COVID-19 VACCINE ; Booster: COMIRNATY; Primary immunisation: MODERNA and COVID-19 VACCINE ; Booster: COMIRNATY; Primary immunisation: MODERNA and COVID-19 VACCINE ; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201070149015490-KC2JI. Other Case identifier(s): GB-MHRA-ADR 26446436. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-smoker" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWNLot number- UNKNOWN Route of Administration: Unspecified), for COVID-19 immunisation; Covid-19 vaccine moderna (DOSE NUMBER UNKNOWN, SINGLELot number- UNKNOWN Route of Administration: Unspecified), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), IMMUNISATION (hospitalization, medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Primary immunisation: MODERNA and COVID-19 VACCINE ; Booster: COMIRNATY"; DYSPNOEA (hospitalization), outcome "recovered", described as "Shortness of breath"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pulmonary embolism/blood clots/large saddle embolus"; THROMBOCYTOPENIA (hospitalization, medically significant), outcome "unknown", described as "Thrombocytopenia (Platelet count <150 -109/L)/low platelet count"; TROPONIN INCREASED (hospitalization), outcome "unknown", described as "Raised troponin". The events "shortness of breath", "pulmonary embolism/blood clots/large saddle embolus", "thrombocytopenia (platelet count <150 -109/l)/low platelet count" and "raised troponin" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: anti-platelet factor 4 antibody test: (unspecified date) unk; computerised tomogram thorax: (unspecified date) large saddle embolus; electrocardiogram: (unspecified date) abnormal; fibrin d dimer: (07Jan2022) d-dimer was $g4000;d-dimer 6000; platelet count (150-450): (07Jan2022) 200 (unspecified): last platelet count before vaccine; (07Jan2022) 138 (unspecified), notes: lowest platelet count after vaccine; troponin: (unspecified date) raised. Clinical course: The patient experienced shortness of breath 2 days post booster. Attended general practitioner 5 days later - ECG abnormalities and raised troponin. Sent to Accident and Emergency. The patient had not tested positive for COVID-19 since having the vaccine. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The report does not relate to possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052552 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Fatigue, Heart rate, Heart rate abnormal, Illness, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Medication errors (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; MORPHINE; NAPROXEN; OMEPRAZOL; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Gastrostomy; Hypertension arterial; Pain; Poor sleep; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200028123

Write-up: racing heart/Heart palpitations; diarrhea; sickness; Fatigue/unusual tiredness; Chest pain; Fever; Racing heart (tachycardia); myocarditis; pericarditis; Diarrhoea recurrent; Off Label use; Interchange of vaccine products; Booster; Heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201070934506150-BHSWW. Other Case identifier(s): GB-MHRA-ADR 26447872. A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN5254) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 09Jan2021, stop date: 10Feb2021; "Poor sleep" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Gastrostomy" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE taken for poor quality sleep, start date: 04Jul2021; MORPHINE taken for pain, start date: 21Nov2019; NAPROXEN taken for arthritis, start date: 05Apr2017; OMEPRAZOL taken for gastrostomy, start date: 05Apr2017; RAMIPRIL taken for hypertension, start date: 06Mar2018. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 28Dec2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PALPITATIONS (disability, medically significant), outcome "unknown", described as "racing heart/Heart palpitations"; DIARRHOEA (disability, medically significant), outcome "unknown", described as "diarrhea"; ILLNESS (disability, medically significant), outcome "unknown", described as "sickness"; HEART RATE ABNORMAL (disability, medically significant) with onset 28Dec2021, outcome "recovered" (30Dec2021), described as "Heart rate"; DIARRHOEA (disability, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Diarrhoea recurrent"; FATIGUE (disability, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (disability, medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (disability, medically significant), outcome "unknown", described as "Fever"; TACHYCARDIA (disability, medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; MYOCARDITIS (disability, medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (disability, medically significant), outcome "unknown", described as "pericarditis". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) unknown results; sars-cov-2 test: (11Jan2021) yes - positive covid-19 test. Clinical details: Patient heart was racing for about 12 hrs after the booster then he had diarrhoea and sickness for 10 days so far. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report did relate to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. A diagnosis was not made by a medical professional. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200028000

Write-up: Booster; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201080618379870-2IHF0 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26452117 (regulatory authority). A female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Pain in arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient had not had symptoms associated with COVID-19. Patient had been experiencing pain in her arm for 10 days since she received by booster. She hadn''t had any treatment. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Reporter did not consider report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
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, Heart rate increased, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, Peripheral swelling, SARS-CoV-2 test, Swelling, Tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (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:
Allergies:
Diagnostic Lab Data: Test Name: resting heart rate; Result Unstructured Data: Test Result:Fast; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202200028253

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Myocarditis; pericarditis; swollen arm pit; swollen arm; fast resting heart rate; Heart racing; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201082055140180-SQQT6. Other Case identifier(s): GB-MHRA-ADR 26452992. A male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant), outcome "not recovered", described as "swollen arm"; HEART RATE INCREASED (medically significant), outcome "not recovered", described as "fast resting heart rate"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Heart racing"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; SWELLING (medically significant), outcome "unknown", described as "swollen arm pit". The patient underwent the following laboratory tests and procedures: heart rate: fast; sars-cov-2 test: no - negative. The clinical course was reported as follows: Fast resting heart rate, chest pains and tiredness lasting approximately 24 hours and swollen arm pit. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporter considered that this report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay, no diagnosis made by a medical professional; no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052858 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM3092 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Menstruation delayed, Off label use, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Endometriosis; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20211022; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200028243

Write-up: DOSE 1 and DOSE 2 COVID-19 VACCINE ASTRAZENECA/DOSE 3 Comirnaty; DOSE 1 and DOSE 2 COVID-19 VACCINE ASTRAZENECA/DOSE 3 Comirnaty; Booster; Delayed period; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201082126394820-1U1K9. Other Case identifier: GB-MHRA-ADR 26453004. A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FM3092) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Suspected COVID-19", start date: 23Mar2021 (ongoing); "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); "Crohn''s disease" (unspecified if ongoing). Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 23Mar2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 08Jun2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability) all with onset 28Dec2021, outcome "unknown" and all described as "DOSE 1 and DOSE 2 COVID-19 VACCINE ASTRAZENECA/DOSE 3 Comirnaty"; IMMUNISATION (disability) with onset 28Dec2021, outcome "unknown", described as "Booster"; MENSTRUATION DELAYED (disability) with onset 28Dec2021, outcome "not recovered", described as "Delayed period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) positive, notes: Yes - Positive COVID-19 test. Patient last menstrual period date was 18Nov2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052984 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 6336325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Flatulence, Headache, Hypertonic bladder, Lymph node pain, Palpitations, Rash, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic (Asthmatic take seretide 125 daily, asthma was controlled.); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally).)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: heart race; Overactive bladder; Gas in stomach; Rash; Swelling; Lymph node pain; Breathlessness; Headache; Fatigue; Palpitations; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26463016) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (heart race), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), DYSPNOEA (Breathlessness), FLATULENCE (Gas in stomach), RASH (Rash), HYPERTONIC BLADDER (Overactive bladder), HEADACHE (Headache), FATIGUE (Fatigue) and PALPITATIONS (Palpitations) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 6336325) for an unknown indication. Concurrent medical conditions included Asthmatic (Asthmatic take seretide 125 daily, asthma was controlled.) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally).). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) for Asthma. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant), DYSPNOEA (Breathlessness) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced FLATULENCE (Gas in stomach) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HYPERTONIC BLADDER (Overactive bladder) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (heart race) (seriousness criterion medically significant). On 02-Jan-2022, SWELLING (Swelling) had resolved. On 05-Jan-2022, RASH (Rash) and FATIGUE (Fatigue) had resolved. At the time of the report, PALPITATIONS (heart race) outcome was unknown, LYMPH NODE PAIN (Lymph node pain), DYSPNOEA (Breathlessness), FLATULENCE (Gas in stomach) and HYPERTONIC BLADDER (Overactive bladder) had not resolved and HEADACHE (Headache) and PALPITATIONS (Palpitations) 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. Relevant medical history and concurrent conditions included that the patient was asthmatic and took seretide 125 daily, asthma was controlled and not on off breathless before booster. Patient has not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. The patient felt heart race and breathless and exhausted within 10 minutes straight after vaccine, had been getting breathless on off since booster and lymph node swelling and pain across body. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient was given steroids for breathlessness. Company comment: This is a regulatory case concerning a 44-year-old female patient with medical history of asthma and steroid therapy, who experienced the unexpected serious events of Palpitations (two occurrences), Swelling, Lymph node pain, Dyspnoea, Flatulence, Rash, Hypertonic bladder, Headache and Fatigue. The events started developing on the same day after the third dose of mRNA-1273 vaccine. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event selection, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 44-year-old female patient with medical history of asthma and steroid therapy, who experienced the unexpected serious events of Palpitations (two occurrences), Swelling, Lymph node pain, Dyspnoea, Flatulence, Rash, Hypertonic bladder, Headache and Fatigue. The events started developing on the same day after the third dose of mRNA-1273 vaccine. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event selection, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.


VAERS ID: 2052986 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Flagellate dermatitis; This case was received via RA (Reference number: GB-MHRA-ADR 26463132) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FLAGELLATE DERMATITIS (Flagellate dermatitis) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FLAGELLATE DERMATITIS (Flagellate dermatitis) (seriousness criterion medically significant). At the time of the report, FLAGELLATE DERMATITIS (Flagellate dermatitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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 relevant concomitant medications were reported Patient has not had symptoms associated with COVID-19 Patient experienced rash which looks like bear claw marks. Appears mostly on the torso and top of legs, also at times on hands and arms. Rash appears then subsides within 30 minutes in one area. Then another rash will appear at another location Patient also experienced Throat swelled up inside made swallowing painful, but breathing fine. It occurred twice for about 20 minutes each time Patient was not enrolled in clinical trial It was reported that report not related to possible inflammation of the heart (myocarditis or pericarditis) Patient was visited to doctor and prescribed with anti histamines Company Comment : This regulatory case concerns a 44-year old female patient with no medical history reported, who experienced the unexpected serious event of Flagellate dermatitis with seriousness criterion of medically significant, 8 days after receiving the third dose of mRNA-1273 Vaccine. Patient experienced rash which looks like bear claw marks. Appears mostly on the torso and top of legs, also at times on hands and arms. Rash appears then subsides within 30 minutes in one area. Then another rash will appear at another location. Patient also experienced Throat swelled up inside made swallowing painful, but breathing was fine. It occurred twice for about 20 minutes each time. The patient was treated with anti histaminics. 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.; Sender''s Comments: This regulatory case concerns a 44-year old female patient with no medical history reported, who experienced the unexpected serious event of Flagellate dermatitis with seriousness criterion of medically significant, 8 days after receiving the third dose of mRNA-1273 Vaccine. Patient experienced rash which looks like bear claw marks. Appears mostly on the torso and top of legs, also at times on hands and arms. Rash appears then subsides within 30 minutes in one area. Then another rash will appear at another location. Patient also experienced Throat swelled up inside made swallowing painful, but breathing was fine. It occurred twice for about 20 minutes each time. The patient was treated with anti histaminics. 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.


VAERS ID: 2053099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-12-28
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia, COVID-19, Drug ineffective, Menstruation irregular, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Fertility disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200079504

Write-up: Hair loss; Menstruation irregular; Positive COVID-19 test; Positive COVID-19 test; 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-202201160838338310-MQR9S. Other Case identifier(s): GB-MHRA-ADR 26479510. A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Jun2021 (Lot number: FA1027) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Positive COVID-19 test"; ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "Menstruation irregular". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) yes - positive covid-19 test. The patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2053155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-12-28
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 ; Test Name: LFT; Test Result: Negative ; Comments: Regular covid tests; Test Name: PCR; Test Result: Negative ; Comments: Regular covid tests
CDC Split Type: GBPFIZER INC202200043759

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable reporter (Consumer). This is the second of two reports. The first report is a report from the regulatory authority GB-MHRA-WEBCOVID-202201062034254480-RJKCN. The reporter is the patient. A 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Dec2021, outcome "recovered" (04Jan2022) and all described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative; LFT: negative, notes: Regular covid tests; PCR: negative, notes: Regular covid tests. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200026995 Same patient/drug and different event/dose


VAERS ID: 2053169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200052170

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). This is the second of two reports. The first report is a report received from the MHRA GB-MHRA-WEBCOVID-202201072142045260-NBLCD. A female patient received bnt162b2 (COMIRNATY), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single and (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 28Dec2021, outcome "recovering", described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "recovering", described as "Drug ineffective". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200028144 same drug/patient, different event/dose


VAERS ID: 2053355 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-07
Onset:2021-12-28
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram head, Fibrin D dimer, Fibrin D dimer increased, Hemiparesis, Ischaemic stroke, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRIATEC-8; PANTORC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: Brain CT; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20211228; Test Name: Fragment D dimer; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20211228; Test Name: Low platelets; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: ITMODERNATX, INC.MOD20224

Write-up: hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke; This case was received via Agency Regulatory Authority(Reference number: IT-MINISAL02-826387) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), ISCHAEMIC STROKE (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), THROMBOCYTOPENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), the first episode of ASTHENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), the second episode of ASTHENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) and FIBRIN D DIMER INCREASED (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concomitant products included CAFFEINE CITRATE, CODEINE PHOSPHATE, PARACETAMOL (TRIATEC-8) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTORC) for an unknown indication. On 07-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 28-Dec-2021, the patient experienced HEMIPARESIS (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization), ISCHAEMIC STROKE (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization), THROMBOCYTOPENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization), the first episode of ASTHENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization), the second episode of ASTHENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization) and FIBRIN D DIMER INCREASED (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) (seriousness criterion hospitalization). At the time of the report, HEMIPARESIS (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), ISCHAEMIC STROKE (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), THROMBOCYTOPENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke), the last episode of ASTHENIA (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) and FIBRIN D DIMER INCREASED (hemisphenia left hemiparesis left hemiparesis platelet openia fragment D-dimer strength deficiency increased ischaemic stroke) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Computerised tomogram head: inconclusive (Inconclusive) Inconclusive. On 28-Dec-2021, Fibrin D dimer: inconclusive (Inconclusive) Inconclusive. On 28-Dec-2021, Platelet count decreased: inconclusive (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Spikevax) (Unknown Route) was unknown. For mRNA-1273 (Spikevax) (Unknown Route), the reporter did not provide any causality assessments. Treatment medication were not reported. The lot number of the vaccine was reported to be unknown. Company comment: This is a regulatory case concerning a 69-year-old, male patient with no medical history reported, who experienced the serious unexpected, according Agency, AESIs of Ischaemic stroke and Thrombocytopenia and, the serious unexpected, according Agency, events of Hemiparesis, Asthenia and Fibrin D dimer increased. The events Hemiparesis, Asthenia and Fibrin D dimer increased could be in association with event ischaemic stroke. The events occurred approximately 21 days after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since no information on other doses is available. 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 hospitalization.; Sender''s Comments: This is a regulatory case concerning a 69-year-old, male patient with no medical history reported, who experienced the serious unexpected, according Agency, AESIs of Ischaemic stroke and Thrombocytopenia and, the serious unexpected, according Agency, events of Hemiparesis, Asthenia and Fibrin D dimer increased. The events Hemiparesis, Asthenia and Fibrin D dimer increased could be in association with event ischaemic stroke. The events occurred approximately 21 days after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since no information on other doses is available. 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 hospitalization.


VAERS ID: 2053383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK6304 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Headache, Immunisation, Lymph node pain, Lymphadenopathy, Nausea, Pyrexia, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200030745

Write-up: Shakiness; Pain chest; Fever; Swollen lymph nodes; Lymph node pain; Generalised joint pains; Headache; Nausea; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Medicines Agency (EMA) EudraVigilance-WEB. Regulatory number: IT-MINISAL02-826908 (MINISAL02). A 38 year-old female patient received bnt162b2 (COMIRNATY), intramuscular (Lot number: FK6304) as dose 3 (booster), 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; TREMOR (medically significant) with onset 28Dec2021, outcome "unknown", described as "Shakiness"; CHEST PAIN (medically significant) with onset 28Dec2021, outcome "unknown", described as "Pain chest"; PYREXIA (medically significant) with onset 28Dec2021, outcome "unknown", described as "Fever"; LYMPHADENOPATHY (medically significant) with onset 28Dec2021, outcome "unknown", described as "Swollen lymph nodes"; LYMPH NODE PAIN (medically significant) with onset 28Dec2021, outcome "unknown", described as "Lymph node pain"; ARTHRALGIA (medically significant) with onset 28Dec2021, outcome "unknown", described as "Generalised joint pains"; HEADACHE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Headache"; NAUSEA (medically significant) with onset 28Dec2021, outcome "unknown", described as "Nausea". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2053476 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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)

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

Write-up: Sore throat; Fever; Cough; Myalgia; This case was received via RA. (Reference number: PH-PHFDA-300130527) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of COUGH (Cough), MYALGIA (Myalgia), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Dec-2021, the patient experienced COUGH (Cough) (seriousness criterion hospitalization) and MYALGIA (Myalgia) (seriousness criterion hospitalization). On 29-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). At the time of the report, COUGH (Cough), MYALGIA (Myalgia), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment medication were not provided. On 28-DEC-2021, the patient had experienced non-productive cough and myalgia. On 29-DEC-2021, patient had experienced Sore throat, fever 38.5 degrees Celsius, whitish phlegm.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Cough, Myalgia, Oropharyngeal Pain, and Pyrexia. The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable, as the event happened after a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2053625 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021F21A / 4 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fainting; This case was received via RA (Reference number: MOD-2022-270) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in a 53-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 021F21A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received fourth dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) had resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case concerns a 53-year-old male patient with no medical history, who experienced the unexpected serious event of Syncope, the event was reported as medically significant by the regulatory authority. The events occurred in 1 day after receiving the fourth dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old male patient with no medical history, who experienced the unexpected serious event of Syncope, the event was reported as medically significant by the regulatory authority. The events occurred in 1 day after receiving the fourth dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1998665 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 068H21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: xanax, dichcline, simvastatin, aspirin, acetaminophen
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling and Redness at injected site/ left deltoid. Occurred at night on 12/7/27/21.


VAERS ID: 1981363 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Chills, Fatigue, Muscle spasms, Myalgia, Neck pain, Pain, Pain in extremity, Pyrexia, Tendonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Celexa
Current Illness:
Preexisting Conditions:
Allergies: Codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Long-term symptoms: Random sharp shooting pains down left arm and sometimes legs. Pain in forearm when flexing arm or making fist (feels like tendinitis). Short-term symptoms: Chills, fever, body aches, sore muscles in neck and fatigue. Also I had a lumbar fusion in my L5 S1 about 4 years ago. After the vaccine, I noticed I have worse lower back pain muscle spasms. Did not report to my doctor yet. I wasn''t sure if it was a coincidence after the first vaccine. But today I got the second dose. I have the same symptoms. So it must be related. Doctor''s office was closed today.


VAERS ID: 1981370 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Missouri  
Vaccinated:1921-07-07
Onset:2021-12-27
   Days after vaccination:36698
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA D06D21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure fluctuation
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Regular BP meds.
Current Illness: none
Preexisting Conditions: Hypertension BP problems
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: BP under control for 40 years with meds totally out of control since the second "jab"... Dailly range from 190/105 to 95/50 within q 12 hour period.. PB is starting to be under control after 5 months since the last Moderna jab. Not there yet. The Devil himself will be organizing snowball fights before I take another Covid shot.


VAERS ID: 1981586 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2010-12-27
Onset:2021-12-27
   Days after vaccination:4018
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall, Head injury, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Vestibular 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: teanut allergie
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient fell , landed on head, got dizziness, lighheadness, trembling , 911 was already here for sister, they check on her, took her to hospital


VAERS ID: 1981593 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: tea nut allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient got her 1st shot, few minutes later, she felt throwing up, stomach issues, sweating , dizziness, called 911 , they came checked her bp, and virtals, looked all good, did not take her to hospital


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