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From the 1/14/2022 release of VAERS data:

Found 1,031,637 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 538 out of 10,317

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VAERS ID: 1922172 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Immunisation, Interchange of vaccine products, Joint swelling, Musculoskeletal stiffness, Off label use, Oxygen saturation, Peripheral swelling, Throat tightness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Ehlers-Danlos syndrome (Autoimmune disorder.); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:144/100; Test Name: oxygen; Result Unstructured Data: Test Result:93
CDC Split Type: GBPFIZER INC202101629162

Write-up: Off label use; interchange of vaccine products; Booster; Swollen joints; thickness in my throat; stiffness in my neck and fingers; headache; my right foot starts swelling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111191357367790-UJVA6 (MHRA). Other Case identifiers: GB-MHRA-ADR 26227697 (MHRA). A 50 year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s last menstrual period was 19Nov2021. Relevant medical history included: "Allergy" (unspecified if ongoing); "Suspected COVID-19", start date: 09Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response; "Ehlers-Danlos" (unspecified if ongoing) notes: Autoimmune disorder. It was reported that the patient had previously been told to avoid the Pfizer vaccine, and after more research she was told, it was safe for her to take Pfizer vaccine. Patient was not pregnant, not currently breastfeeding and was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine nor had a COVID-19 test also not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, single, Lot number: Unknown, Primary Immunization series complete but manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, single, Lot number: Unknown, Primary Immunization series complete but manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; JOINT SWELLING (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Swollen joints"; THROAT TIGHTNESS (medically significant) with onset 19Nov2021, outcome "unknown", described as "thickness in my throat"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 19Nov2021, outcome "unknown", described as "stiffness in my neck and fingers"; HEADACHE (medically significant) with onset 19Nov2021, outcome "unknown", described as "headache"; PERIPHERAL SWELLING (medically significant) with onset 19Nov2021, outcome "unknown", described as "my right foot starts swelling". The clinical course was reported as follows: The patient reported feeling of thickness in throat immediately after the vaccination which progressed to stiffness in neck and fingers, plus headache, whilst still in the venue. Within a couple of minutes of leaving, the right foot starts swelling to the extent that it was difficult to keep slip-on shoe on. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 144/100; oxygen saturation: 93. No follow up attempts are possible. No further information is expected.


VAERS ID: 1922189 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Panic attack, Paraesthesia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629356

Write-up: fainting; pins and needles; Panic attack; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111191704147940-4PJGJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26228717 (MHRA). A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant), outcome "not recovered", described as "fainting"; PARAESTHESIA (non-serious), outcome "not recovered", described as "pins and needles"; PANIC ATTACK (non-serious) with onset 19Nov2021, outcome "unknown", described as "Panic attack". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that, as patient did not improve the ambulance was called and they attended quickly. As patient did not recover fully, the ambulance took her to hospital for further tests/observation. There was no indication of a heart attack and anaphylaxis. Patient did not take the advice when tried to instruct her in her breathing. Patient has not had symptoms associated with COVID-19, was not currently breastfeeding, not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. It was reported that this report was not related to possible inflammation of the heart (myocarditis or pericarditis), possible blood clots or low platelet counts. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK059G / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Inappropriate schedule of product administration, Rhinitis allergic, Rhinorrhoea, SARS-CoV-2 test, Seasonal allergy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Conjunctival disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma aggravated
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629326

Write-up: this did happen on the first vaccine but on the second day; stuffy and runny nose; hay-fever; Dose 1 of BNT162B2 taken on 23Sep2021 and dose 2 of BNT162B2 taken on 19Nov2021; Allergic rhinitis; 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-202111191717187640-QKPCL (MHRA). Other Case identifier(s): GB-MHRA-ADR 26228757 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK059G) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,), administration date: 23Sep2021, for COVID-19 immunisation. The patient has not had symptoms associated with COVID-19. The following information was reported: EPILEPSY (medically significant), outcome "recovering", described as "this did happen on the first vaccine but on the second day"; RHINITIS ALLERGIC (medically significant) with onset 19Nov2021, outcome "recovering", described as "Allergic rhinitis"; RHINORRHOEA (medically significant), outcome "unknown", described as "stuffy and runny nose"; SEASONAL ALLERGY (medically significant), outcome "unknown", described as "hay-fever"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Dose 1 of BNT162B2 taken on 23Sep2021 and dose 2 of BNT162B2 taken on 19Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) negative, notes: No - Negative COVID-19 test. Clinical Course: It was reported that when the vaccine was injected patient felt fine so was asked to wait in the waiting area for the 15 minutes, and within a couple of minutes her nose started to feel stuffy and runny like hay-fever. This happened for the entire 15 minutes so she asked a nurse if it was anything to worry about and nurse told her to stay another 15 minutes, after the 15 minutes had passed nurse checked her again and because there was no chest tightness or wheezing nurse told her that she was free to go but she need to get some antihistamines from the chemist and take those for the next couple of days because it looks like allergy rhinitis. This did happen on the first vaccine but on the second day, so she was surprised to see it happen within the 15 minutes on the second dose. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922209 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Heart rate, Immunisation, Interchange of vaccine products, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (I am diagnosed with atrial fibrillation and have had 3 catheter ablations.)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629252

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111191934055820-4WFYF (MHRA). Other Case identifier(s): GB-MHRA-ADR 26229537 (MHRA). A 76-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: I am diagnosed with atrial fibrillation and have had 3 catheter ablations. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 06Feb2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; HEART RATE (medically significant), outcome "recovering", described as "heart rate"; PALPITATIONS (medically significant) with onset 19Nov2021, outcome "recovering", on 19Nov2021 described as "Heart racing"; DIZZINESS (medically significant), outcome "recovering", described as "feel light headed"; DIZZINESS (medically significant), outcome "recovering", described as "dizzy"; ASTHENIA (medically significant), outcome "recovering", described as "felt wobbly". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Additional information: Patient has not had symptoms associated with COVID-19. patient was sitting after having had my Pfizer booster vaccine today, 19 November 2021. she had to wait for 15 minutes, sitting in a room with others. After about 7 minutes, she began to feel light headed and dizzy and heart raced. (she was diagnosed with atrial fibrillation and have had 3 catheter ablations). she have had no incidents of AFib since last ablation in the September before lockdown. To feel this again, was very frightening. A lady could see was in distress and called a medical helper and was taken to a side room, where they laid her on a couch and rested for about 20 minutes. she walked slowly home but felt wobbly. she rested at home and actually fell asleep on the sofa. She is a bit better now; heart rate was ok but felt nervous about it happening again. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1922243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Neck pain, Paraesthesia, SARS-CoV-2 test, Tinnitus
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVENING PRIMROSE OIL & CRANBERRY; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache recurrent; Mastalgia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629259

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Regulatory number: GB-RA-WEBCOVID-202111200748287730-V0ESM (RA). Other Case identifier(s): GB-RA-ADR 26231034 (RA). A 40 year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 19Nov2021 14:45 (Lot number: FH4751) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mastalgia" (unspecified if ongoing); "Headache recurrent" (unspecified if ongoing). Concomitant medication(s) included: EVENING PRIMROSE OIL & CRANBERRY taken for breast pain, start date: 01Jun2019; IBUPROFEN taken for headache, start date: 13Jan2021; PARACETAMOL taken for headache, start date: 13Jan2021. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation.LMP 06Nov2021.Patient has not had symptoms associated with COVID-19.Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.Within a minute of vaccine, pain occurred in left shoulder, tracked steadily up left hand side of neck and onto left ear. Ear felt like it was full of water and started ringing for approx. an hour. Was also light headed. When walking my legs felt strange like when you first walk after getting off a treadmill. Got pins and needles in left bicep approx. 1 hour later. Then around 6 hours later got shooting pains in left thigh and then pins and needles started in calf muscles, spreading down to both feet and then slowly up to thighs as well. Moving around and stretching did not help. Had jab at 2.45pm, pins and needles interfered with sleeping that night but more or less gone by the morning. The following information was reported: ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Shoulder pain"; NECK PAIN (medically significant) with onset 19Nov2021, outcome "recovering", described as "Neck pain"; TINNITUS (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Ear ringing"; PARAESTHESIA (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Pins and needles"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Light headedness"; HYPOAESTHESIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Numbness in toes". Adverse reaction did not occur as a result of an exposure during pregnancy. Reaction Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629299

Write-up: Allodynia; 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-202111200919499240-9BIIW. Other Case identifier(s): GB-MHRA-ADR 26231103. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) 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 number: 01, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose number: 02, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; ALLODYNIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Allodynia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Myocarditis, Off label use
SMQs:, Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629034

Write-up: Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY; COMIRNATY was administered as a third booster dose; Myocarditis; Swollen glands in underarm; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201244264050-MPTG8. Other Case identifier: GB-MHRA-ADR 26231370. A 61-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient had no symptoms associated with COVID-19. Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE;Lot number: Unknown; Route of administration: Unknown. MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE;Lot number: Unknown; Route of administration: Unknown.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY"; IMMUNISATION (medically significant), outcome "unknown", described as "COMIRNATY was administered as a third booster dose"; MYOCARDITIS (medically significant), outcome "not recovered", described as "Myocarditis"; LYMPHADENOPATHY (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Swollen glands in underarm". Clinical course: Patient was not enrolled in clinical trial. The patient not had a COVID-19 test. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1922273 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Body temperature, Fatigue, Headache, Nausea, SARS-CoV-2 test, Sinus pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown results; Comments: No - Negative COVID-19 test; Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629361

Write-up: Sinus pain; Eye strain; Exhaustion; Body temperature; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111201445360000-KP2FP. Other Case identifier(s): GB-MHRA-ADR 26231507. A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 24 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: NAUSEA (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Nausea"; SINUS PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Sinus pain"; ASTHENOPIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Eye strain"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Exhaustion"; BODY TEMPERATURE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Body temperature"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) unknown results, notes: No - Negative COVID-19 test; sars-cov-2 test: (20Nov2021) negative, notes: No - Negative COVID-19 test. Clinical Course: The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient not had symptoms associated with COVID-19 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Eyelid sensory disorder, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), Periorbital and eyelid disorders (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629270

Write-up: Numbness of eyelid; bells palsy/ Patient have bells palsy on left side of her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201820052340-BDYYR (RA). Other Case identifier(s): GB-MHRA-ADR 26231772 (RA). A 57-year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 15Nov2021. The following information was reported: BELL''S PALSY (medically significant) with onset 2021, outcome "not recovered", described as "bells palsy/ Patient have bells palsy on left side of her face"; EYELID SENSORY DISORDER (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Numbness of eyelid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) negative, notes: No - Negative COVID-19 test. The clinical course was as follows: Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relate to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19. The patient details of relevant investigations or tests conducted included: "Went to out of hours HCF". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coagulation time, Full blood count, Heavy menstrual bleeding, Immunisation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Non-smoker; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Clotting screen; Result Unstructured Data: Test Result:Not reported; Comments: No-Was the platelet count <150A-109/L; Test Date: 20211120; Test Name: FBC; Result Unstructured Data: Test Result:Not reported
CDC Split Type: GBPFIZER INC202101629513

Write-up: Menorrhagia/Very heavy PV loss - passing blood clots the size of her palm; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111201858588020-5EBFB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231934 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Polycystic ovaries" (unspecified if ongoing); "Non-tobacco user" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Heparin; Metformin, notes: started on Metformin within the last month to treat her PCOS. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Menorrhagia/Very heavy PV loss - passing blood clots the size of her palm". The patient underwent the following laboratory tests and procedures: coagulation time: (20Nov2021) not reported, notes: No-Was the platelet count <150A-109/L; full blood count: (20Nov2021) not reported. Clinical course: Very heavy PV loss - passing blood clots the size of her palm. Changing tampon eve-ry 20 mins since this morning. she has been started on Metformin within the last month to treat her PCOS. She reports she has not had bleeding this bad for years. 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. The report relate to possible blood clots or low platelet counts. The report did not relate to possible myocarditis or pericarditis. Patient had not confirmed or suspected autoimmune or inflammatory disease, including vasculitis and not had any previous reactions to medications, especially heparin or anticoagulants. It was unknown the D-dimer $g4000 or anti-PF4 antibodies identified. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211109; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629351

Write-up: Swollen lymph nodes; 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-202111202002285630-DURLC. Other Case identifier(s): GB-MHRA-ADR 26231874. A 51-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: PERINDOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1), administration date: 12Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: 19Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen lymph nodes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: No - Negative COVID-19 test. Clinical Course: Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922303 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling hot, Immunisation, Interchange of vaccine products, Malaise, Muscle fatigue, Myalgia, Off label use, SARS-CoV-2 test, Tension headache, Tremor, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; COVID-19 (Unsure when symptoms stopped. Previously very ill with Covid.); Depression; Diabetes (Diabetes diet controlled); OA hip (Severe pain in right hip); Obesity; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101629470

Write-up: Pain muscle; Feeling sick; Shaking; Tension headaches; Muscle fatigue; Tired all the time; Injection site warmth; Feeling of warmth; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111202147498840-CTQFS (RA). Other Case identifier(s): GB-MHRA-ADR 26231963 (RA). A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes diet controlled; "Obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Pain" (unspecified if ongoing); "COVID-19", start date: 09Feb2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. Previously very ill with Covid.; "OA hip" (unspecified if ongoing), notes: Severe pain in right hip. Concomitant medication(s) included: CODEIN taken for osteoarthritis, start date: 10Nov2021; INFLUENZA VIRUS taken for immunisation, administration date Nov2021; SERTRALINE taken for depression. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain muscle"; MALAISE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Feeling sick"; TREMOR (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Shaking"; TENSION HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Tension headaches"; MUSCLE FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle fatigue"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tired all the time"; VACCINATION SITE WARMTH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Injection site warmth"; FEELING HOT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Feeling of warmth". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Feb2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient was not breastfeeding. The patient had last menstruation on 27Oct2021. Onset latency for the events was one day. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Gait disturbance, Headache, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Myalgia, Off label use, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629045

Write-up: Generalised muscle aches; Fatigue; Headache dull; Fingers stiffness; Pain in arm; Gait instability; 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. Regulatory number: GB-MHRA-WEBCOVID-202111210605477950-1BOY0. Other Case identifier(s): GB-MHRA-ADR 26232133. A 61 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS taken for influenza, administration date 03Sep2021. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. The patient not had a COVID-19 test and was not enrolled in the clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY."; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Generalised muscle aches"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache dull"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fingers stiffness"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain in arm"; GAIT DISTURBANCE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Gait instability". 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.


VAERS ID: 1922320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
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, SARS-CoV-2 test, Vaccination site rash, Vaccination site swelling
SMQs:, Hypersensitivity (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637759

Write-up: Swollen arm/Swollen at sight of injection with red rash; Swollen at sight of injection with red rash; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111212242349700-IMFIM (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232973 (MHRA). A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 19Nov2021 (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 1), administration date: 10Jan2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 09Apr2021, for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 .Patient is not pregnant. Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen arm/Swollen at sight of injection with red rash"; VACCINATION SITE RASH (medically significant) with onset 20Nov2021, outcome "unknown", described as "Swollen at sight of injection with red rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The patient did not relate the events to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922325 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Fatigue, Migraine, Pain in extremity, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654195

Write-up: Migraine headache; Fatigue; Dry mouth; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111231303168610-ONGD. Other Case identifier(s): GB-MHRA-ADR 26238548. A 21-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 21 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, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MIGRAINE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Migraine headache"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "recovering", described as "Pain in arm"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; DRY MOUTH (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Dry mouth". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient was not breastfeeding at the time of this report. The last menstrual date of the patient was reported as 15Nov2021. The patient had no symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: This case was received via RA (Reference number: GB-RA-ADR 26244180) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 21-Nov-2021, MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. No treatment information was reported. Patient had no symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a male patient with no reported relevant medical history, who experienced the unexpected serious events of myalgia, nausea, and headache. The events are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. 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 regulatory authority case concerns a male patient with no reported relevant medical history, who experienced the unexpected serious events of myalgia, nausea, and headache. The events are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1922360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FHU751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Headache, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Off label use, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: ESTRADIOL; UTROGESTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (''ONS COVID-19 Infection Survey''); Menopause
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661867

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Regulatory number: GB-RA-WEBCOVID-202111250654453600-8FTCH (RA). Other Case identifier(s): GB-RA-ADR 26248029 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 19Nov2021 (Lot number: FHU751) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing); notes: ''ONS COVID-19 Infection Survey''; "Menopause" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause, start date: Nov2018; UTROGESTAN taken for menopause, start date: Nov2018. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Vaccination history included: COVID-19 vaccine (DOSE 1, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; COVID-19 vaccine (DOSE 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 2021, outcome "unknown", described as "stiffness in armpit"; HEADACHE (medically significant) with onset 2021, outcome "recovered" (2021), described as "headache"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Joint pain"; AXILLARY PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain in armpit". The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2021) no - negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922404 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Malaise, Migraine, Nausea, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201002; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101642443

Write-up: Feeling unwell; Nausea; Inappropriate schedule of vaccine administered; Chronic migraine; Itchy skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. A 23-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 05Oct2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Past drug history included: Ibuprofen; Paracetamol; Aspirin. Vaccination history included: Comirnaty (Dose 1, lot number: FF8222), administration date: 17Sep2021, for COVID-19 Immunisation, reaction(s): "Swollen lymph nodes", "Feeling unwell", "Diarrhea", "Chronic migraine", "Pain in arm". The following information was reported: MIGRAINE (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Chronic migraine"; PRURITUS (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Itchy skin"; MALAISE (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Feeling unwell"; NAUSEA (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nausea"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Oct2020) yes - positive covid-19 test. Clinical Course: Patient was not pregnant. Patient was not currently breastfeeding. The last menstrual period date was reported as 15Sep2020. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101629077 Same patient and product, different event/dose.


VAERS ID: 1922711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-11-19
   Days after vaccination:297
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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:
CDC Split Type: PLPFIZER INC202101623483

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. An adult female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), administration date 26Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Jan2021 (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: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 19Nov2021, outcome "unknown", described as "COVID-19". The patient reported falling ill with COVID-19 despite being vaccinated with COMIRNATY. Symptoms of illness: chills, loss of smell and taste. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.


VAERS ID: 1922801 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Drowsiness; Dyspnea, chest tightness and pain, dizziness; Dyspnea, chest tightness and pain, dizziness; Dyspnea, chest tightness and pain, dizziness; Dyspnea, chest tightness and pain, dizziness; This regulatory authority case was reported by an other health care professional and describes the occurrence of SOMNOLENCE, DYSPNOEA, CHEST DISCOMFORT, CHEST PAIN, and DIZZINESS in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced SOMNOLENCE (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced DYSPNOEA (seriousness criterion medically significant), CHEST DISCOMFORT (seriousness criterion medically significant), CHEST PAIN (seriousness criterion medically significant), and DIZZINESS (seriousness criterion medically significant). At the time of the report, SOMNOLENCE, DYSPNOEA, CHEST DISCOMFORT, CHEST PAIN, and DIZZINESS was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had a history of hypertension, a family history of myocardial infarction. On 13-Aug-2021, he received the first dose of Moderna, followed by influenza vaccination. After the second dose of Moderna on 15-Nov-2021, he went to the outpatient department of the hospital due to chest tightness and breathlessness on 19-Nov-2021. After diagnosis and treatment and echocardiography, he was found to have pericardial effusion. He was prescribed the anti-inflammatory agent CONICINE and CATAFLAM oral medications. At present, the symptoms of chest tightness and wheezing still persist. He was resting at home, and he was expected to return to the clinic one week later. No Concomitant medications were reported. This case concerns a 53 year old female with relevant medical history of hypertension, who experienced, Serious (medically Significant), unexpected events of somnolence, dyspnea, chest discomfort, and dizziness which occurred 5 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). This patient consulted at an OPD clinic where 2D echo was performed revealing pericardial effusion hence given anti-inflammatory agents. Patient was not admitted and managed as outpatient and events were reported as resolving. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given and also the events are still resolving based on the report. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1922810 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-25
Onset:2021-11-19
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

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

Write-up: Vensous thrombosis; This regulatory authority case was reported by an other health care professional and describes the occurrence of VENOUS THROMBOSIS (Vensous thrombosis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced VENOUS THROMBOSIS (Vensous thrombosis) (seriousness criterion hospitalization). At the time of the report, VENOUS THROMBOSIS (Vensous thrombosis) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. 11/19/2021 The patient had a history of hypertension.On 11/7, he received the second dose of MODERNA at Hospital. In the afternoon on 11/6, he had speaking and reading difficulties. He went to the emergency department of our hospital for treatment.Emergency vital signs: Blood pressure: 224/114; HR: 93 beats/min; Body temperature: 36.7 ?; RR: 20 breaths/min; Con''s:E4V5M6; Blood oxygen concentration: 100%, 11/7, he was found to have brain MRI found right tempooccipital lobe lesion with focal ICH and Right transverse vensous thrombosis, so he was hospitalized. During the hospitalization, he was given Clexane treatment and blood pressure control. As the disease stabled, he switched to warfarin to maintain INR and oral blood pressure drugs to control blood pressure. He was discharged from the outpatient clinic on 11/19 for followup. Reported because the association between adverse events and the vaccines could not be ruled out. Company Comment: This case concerns a 58-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected event of Venous thrombosis. The event occurred approximately 25 days after the administration of the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the event was Recovering/Resolving. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected event of Venous thrombosis. The event occurred approximately 25 days after the administration of the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the event was Recovering/Resolving. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1922811 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fatigue; fever; Nausea; Skin rash (non-injection site); Diarrhea; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), PYREXIA (fever), NAUSEA (Nausea), RASH (Skin rash (non-injection site)) and DIARRHOEA (Diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNk) for COVID-19 vaccination. No Medical History information was reported. On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), RASH (Skin rash (non-injection site)) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhea) (seriousness criterion hospitalization). At the time of the report, FATIGUE (Fatigue), PYREXIA (fever), NAUSEA (Nausea), RASH (Skin rash (non-injection site)) and DIARRHOEA (Diarrhea) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After receiving the second dose on 11/16/2021 the patient developed chills on the same day and started to develop a rash all over the next day.After going to the Hospital for medical treatment, he returned home and started nausea, diarrhea and rashes and itching all over the body this morning, so he came to our emergency department, was admitted to the hospital for steroid treatment, and was discharged from the hospital on 11/19. Company comment: This case concerns a 55-year-old female patient with no medical history, who experienced the serious unexpected events of Fatigue, Pyrexia, Nausea, Diarrhoea and Rash. The events occurred 6 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 55-year-old female patient with no medical history, who experienced the serious unexpected events of Fatigue, Pyrexia, Nausea, Diarrhoea and Rash. The events occurred 6 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1922813 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-11-19
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Leukaemia, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

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

Write-up: Leukemia; Sepsis; Fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of LEUKAEMIA (Leukemia), SEPSIS (Sepsis) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LEUKAEMIA (Leukemia) (seriousness criteria hospitalization and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant) and PYREXIA (Fever) (seriousness criterion hospitalization). At the time of the report, LEUKAEMIA (Leukemia), SEPSIS (Sepsis) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. Company comment : This is a regulatory authority case concerning a 71-year-old female patient with no relevant medical history reported, who experienced serious, unexpected events of Leukemia, Sepsis and Pyrexia. The events occurred 1 month 23 days after a dose of mRNA-1273 vaccine. Clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 71-year-old female patient with no relevant medical history reported, who experienced serious, unexpected events of Leukemia, Sepsis and Pyrexia. The events occurred 1 month 23 days after a dose of mRNA-1273 vaccine. Clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1923656 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 51078911 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Influenza like illness, Interchange of vaccine products, Muscle atrophy, Nausea, Vaccine positive rechallenge, Weight decreased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Same reaction to first Astra Zenica covid vaccination
Other Medications: Tafluprost eye drops
Current Illness: Cold
Preexisting Conditions: Primary open angle glaucoma
Allergies: Fish allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Weight loss, muscle wastage, severe flu like symptoms, nausea, diarrhea


VAERS ID: 1924203 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN SDCC8 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20201110; Test Name: COVID-19; Result Unstructured Data: Positive
CDC Split Type: ROJNJFOC20211208931

Write-up: NUMBNESS FROM SHOULDER TO ELBOW; PAIN IN ARM; This spontaneous report received from a consumer via a Regulatory Authority [RO-NMA-2021-SPCOV15096] concerned a 35 year old female of unspecified race and ethnic origin. The patient''s weight was 69 kilograms, and height was 169 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: SDCC8 expiry: UNKNOWN) 1 dosage forms, dose number in series 1, 1 total administered on 19-NOV-2021 for an unspecified indication. No concomitant medications were reported. On 10-NOV-2020, Laboratory data included: COVID-19 (NR: not provided) Positive. On 19-NOV-2021, the patient experienced numbness from shoulder to elbow and pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness from shoulder to elbow, and pain in arm. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1925951 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ABZ5320 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy (Vaccines, some drugs); Food allergy; Renal function disorder; Viral hepatitis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHJNJFOC20211202467

Write-up: SPINE PAIN; BELLY ACHE; ARMPIT LYMPHADENOPATHY; FEVER; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, CH-SM-2021-28778] concerned a 59 year old male. The patient''s weight was 68.7 kilograms, and height was 166 centimeters. The patient''s concurrent conditions included: viral hepatitis, food allergy, allergy, and renal function disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: ABZ5320 expiry: UNKNOWN) dose was not reported, 1 total, dose number in series was 1,administered on 18-NOV-2021 for an unspecified indication. No concomitant medications were reported. On 19-NOV-2021, the patient experienced spine pain, belly ache, armpit lymphadenopathy, fever and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spine pain, armpit lymphadenopathy, fever, nausea, and belly ache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211202467-covid-19 vaccine ad26.cov2.s- spine pain and belly ache. 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). 20211202467-covid-19 vaccine ad26.cov2.s-fever, nausea and armpit lymphadenopathy. This event(s) is labeled per the regulatory authority and is therefore considered potentially related.


VAERS ID: 1926132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Bone pain, Chills, Electrocardiogram, Hypertension, Immunisation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Blood high pressure; Result Unstructured Data: Test Result:High; Test Date: 20211122; Test Name: ECG; Result Unstructured Data: Test Result:everything back to normal
CDC Split Type: DEPFIZER INC202101651101

Write-up: Bone pain; high blood pressure; massive cardiac arrhythmia; chills; fever; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 101306 (Biontech). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 17:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, lot unknown), administration date: 26Apr2021, for Covid-19 immunisation, reaction(s): "tiredness", "arm pain"; Comirnaty (2nd dose, lot unknown), for Covid-19 immunisation, reaction(s): "tiredness", "arm pain". The following information was reported: ARRHYTHMIA with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "massive cardiac arrhythmia"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "chills"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "fever"; BONE PAIN (non-serious), outcome "recovered", described as "Bone pain"; HYPERTENSION (non-serious) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "high blood pressure"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (21Nov2021) high; electrocardiogram: (22Nov2021) everything back to normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926548 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: Ipsos Mori Covid NHS swab trail); Suspected COVID-19 (Unsure when symptoms started, unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Temperature; Result Unstructured Data: Test Result:High; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629325

Write-up: High temperature; Nausea; Tiredness; Headache; Pain in arm; 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 (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111201415023470-BBEYN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231474 (MHRA). A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH3220) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, unsure when symptoms stopped; "Clinical trial participant" (unspecified if ongoing), notes: Study details: Ipsos Mori Covid NHS swab trail. The patient''s concomitant medications were not reported. Past drug history included: Lansoprazole; Vitamin b12. Vaccination history included: Covid-19 vaccine astrazeneca, for Covid-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "High temperature"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Pain in arm"; NAUSEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tiredness"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) high; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926549 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Myocarditis, Nausea, Off label use, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatty liver; Irritable bowel syndrome (IBS)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629291

Write-up: myocarditis; Nausea; Vomiting; Off label use; Interchange of vaccine products; Booster; Drowsiness; Pain in joint involving upper arm; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111201423317400-SFMBO (RA). Other Case identifier: GB-MHRA-ADR 26231471 (RA). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hepatic steatosis" (unspecified if ongoing); "Irritable bowel syndrome " (unspecified if ongoing). Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (1st dose and 2nd dose, Primary immunization series completed but manufacturer unknown ) for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; NAUSEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nausea"; SOMNOLENCE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Drowsiness"; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Pain in joint involving upper arm"; VOMITING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Vomiting". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Breast pain, Chills, Diarrhoea, Feeling abnormal, Feeling of body temperature change, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637664

Write-up: loose bowels; headache; feeling awful; arm aches; feeling cold and hot; ache joints; shivery; I ache all over; arm hurts; Breast pain; underarm hurts; 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 regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111210815374390-K5EU4 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232203 (MHRA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (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 1), administration date: 23Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant), outcome "not recovered", described as "loose bowels"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; BREAST PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Breast pain"; AXILLARY PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "underarm hurts"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "feeling awful"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "arm aches"; FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "unknown", described as "feeling cold and hot"; ARTHRALGIA (medically significant), outcome "unknown", described as "ache joints"; CHILLS (medically significant), outcome "unknown", described as "shivery"; PAIN (medically significant), outcome "unknown", described as "I ache all over"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "arm hurts". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: I have been feeling awful since yesterday afternoon, arm aches from booster but underarm hurts and breast on that side had pain across ache all over, feeling cold and hot and shivery. Headache, ache joints, loose bowels. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926558 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637861

Write-up: Retention urinary; Fever; Constipation; Inappetence; Muscle pain; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from the Regulatory Authority (RA). Regulatory number: -MHRA-WEBCOVID-202111210849317180-4B4RF (RA). Other Case identifier(s): -MHRA-ADR 26232237 (MHRA). A 59 year-old patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunisation series complete but unknown manufacturer) for COVID-19 immunisation, Covid-19 vaccine (DOSE 2, SINGLE, Primary immunisation series complete but unknown manufacturer) for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off-label use", INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products", IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster", URINARY RETENTION (medically significant) with onset 20Nov2021, outcome "recovering", described as "Retention urinary", PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fever", MYALGIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Muscle pain", CONSTIPATION (medically significant) with onset 20Nov2021, outcome "recovering", described as "Constipation", DECREASED APPETITE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Inappetence". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical Information: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report 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: 1926563 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Discomfort, Fatigue, Feeling cold, Hypersomnia, Illness, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Nausea, Off label use, Pain, Pain in extremity, Tremor, Vomiting projectile
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637745

Write-up: Shaking; Sickness; Nausea; Stomachache; Ache; Tiredness; Off label Use; Interchange of vaccine products; Booster; discomfort; nauseous; feeling unwell; my arm was very very sore; projectile vomited a numerous occasions (5/6); felt extremely cold; the pain in my left arm; slept for 11/12 hours unbroken; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111210920412270-OEPHL (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232279 (MHRA). A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FL1939) 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: Covid-19 vaccine (First dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Second dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DISCOMFORT (medically significant) with onset 2021, outcome "recovering", described as "discomfort"; NAUSEA (medically significant) with onset 2021, outcome "recovering", described as "nauseous"; MALAISE (medically significant) with onset 2021, outcome "recovering", described as "feeling unwell"; TREMOR (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Shaking"; ILLNESS (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Sickness"; NAUSEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nausea"; PAIN (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Ache"; FATIGUE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Tiredness"; ABDOMINAL PAIN UPPER (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Stomachache"; MYALGIA (medically significant) with onset 2021, outcome "unknown", described as "my arm was very very sore "; VOMITING PROJECTILE (medically significant) with onset 2021, outcome "unknown", described as "projectile vomited a numerous occasions (5/6)"; FEELING COLD (medically significant) with onset 2021, outcome "unknown", described as "felt extremely cold"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "the pain in my left arm"; HYPERSOMNIA (medically significant) with onset 2021, outcome "unknown", described as "slept for 11/12 hours unbroken". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101637788

Write-up: Headache; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; Patient received third dose of COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111210935596710-WK7C8. Other Case identifier: GB-MHRA-ADR 26232287. A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) as dose 3 (booster), 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 and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization 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 19Nov2021, outcome "unknown" and all described as "The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received third dose of COMIRNATY"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) negative. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, Pain in extremity, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637731

Write-up: Injection site pain; Chills; Arm still hurt; Nausea; Feeling unwell; Weakness generalized; Tiredness; 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 regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211031360060-LXRUZ (RA). Other Case identifier(s): GB-MHRA-ADR 26232348 (RA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: INFLUENZA VIRUS, administration date 11Sep2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, Primary Immunization series complete but unknown manufacturer), administration date: 20Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2, Primary Immunization series complete but unknown manufacturer), administration date: 08May2021. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Injection site pain"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Chills"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "recovering", described as "Arm still hurt"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Nausea"; MALAISE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Feeling unwell"; ASTHENIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Weakness generalized"; FATIGUE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Tiredness". Clinical course: Injection site pain was first then nausea as the day progressed the other symptoms also kicked in and became worse. Next morning arm still hurt but nowhere near as bad, other symptoms still there but not so severe. Patient had not tested positive for COVID-19 since having the vaccine. It was unsure if patient was enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926598 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate, Heart rate irregular, Illness, Inappropriate schedule of product administration, Pain in extremity, Palpitations, Pyrexia, 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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Pulse; Result Unstructured Data: Test Result:irregular
CDC Split Type: GBPFIZER INC202101646290

Write-up: Fatigue/unusual tiredness; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Pulse irregular; Sickness; Headache; Pain in arm; Dose 1 Jul2021/Dose 2 19Nov2021; 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-202111211233508210-ZQ3Q8. Other Case identifier(s): GB-MHRA-ADR 26232437. A 27-year-old male patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number unknown), administration date: Jul2021, for COVID-19 IMMUNISATION. Nothing to date that would effect heart rhythm! Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Pain in arm"; HEART RATE IRREGULAR (medically significant) with onset 21Nov2021, outcome "recovering", described as "Pulse irregular"; ILLNESS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Sickness"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; 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)"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION with onset 19Nov2021, outcome "unknown", described as " Dose 1 Jul2021/Dose 2 19Nov2021". Additional information is as follows: Fatigue/unusual tiredness, fever, headache, pain in arm, heart palpitations, pulse irregular, shortness of breath, sickness and tachycardia. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report related to possible inflammation of the heart (myocarditis or pericarditis). If continuing until Monday 22nd the patient will seek medical advice. Additional questions: The symptoms does not lead to a hospital stay. No diagnosis made by a medical professional. No imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerized tomography (CT). No any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No other recent or ongoing illness haven''t already mentioned. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926601 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Immunisation, Interchange of vaccine products, Migraine, Musculoskeletal stiffness, Off label use, Pyrexia, SARS-CoV-2 test, Somnolence, Vaccination site erythema
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: COVID vaccine trial, completed last week.); Vaccination
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637928

Write-up: Migraine; feverish; exhausted; slept for one day; my arm had a large red patch near the Covid-19 vaccine injection site; felt very stiff; armpit was also painful; Fever; 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-202111211247551490-IBPKS (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232454 (MHRA). A 57 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK5475) at the age of 57 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: COVID vaccine trial, completed last week.; "Vaccination" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) taken for immunisation, administration date 19Nov2021. Vaccination history included: Covid-19 vaccine (Dose-1), administration date: 15Oct2020, for Vaccination; Covid-19 vaccine (Dose-2), administration date: 05Nov2020, for Vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant), outcome "recovering", described as "Migraine"; PYREXIA (medically significant), outcome "recovering", described as "feverish"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fever"; FATIGUE (medically significant), outcome "unknown", described as "exhausted"; SOMNOLENCE (medically significant), outcome "unknown", described as "slept for one day"; Vaccination site erythma (medically significant), outcome "unknown", described as "my arm had a large red patch near the Covid-19 vaccine injection site"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "felt very stiff"; AXILLARY PAIN (medically significant), outcome "unknown", described as "armpit was also painful". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) no - negative covid-19 test. Clinical course: Felt feverish and exhausted and slept for one day. The following day, my arm had a large red patch near the Covid-19 vaccine injection site, felt very stiff, and my armpit was also painful. Patient has not tested positive for COVID-19 since having the vaccine. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No" No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926617 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Headache, Immunisation, Interchange of vaccine products, Muscular weakness, Off label use, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Body temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101637781

Write-up: High temperature; Weak; Pain across shoulders; Loss of power in left arm; Pain at injection site; Slight headache; Patient received first and second dose of Non-Pfizer vaccines and booster dose of COMIRNATY; Patient received first and second dose of Non-Pfizer vaccines and booster dose of COMIRNATY; Patient received booster dose of COMIRNATY; 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-202111211433335260-HIZDD (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232534 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis", notes: Taking medicines for multiple sclerosis. Unsure if patient has had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Past drug history included: Lansoprazole; Gabapentin; Avonex, notes: Taking Avonex - injection, once per week. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 13Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Patient received first and second dose of Non-Pfizer vaccines and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "High temperature"; ASTHENIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "Weak"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "Pain across shoulders"; MUSCULAR WEAKNESS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Loss of power in left arm"; VACCINATION SITE PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "Pain at injection site"; HEADACHE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Slight headache". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) high. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Immunisation, Interchange of vaccine products, Muscle rigidity, Off label use, Pain in extremity, SARS-CoV-2 test, Vaccination site mass
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN [SERTRALINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637737

Write-up: Redness/red mark; Injection site lump; Very painful arm; muscle hardness; 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 Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111211448041970-ARZBN (RA). Other Case identifier(s): GB-MHRA-ADR 26232529 (RA). A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 19Nov2021 (Lot number: Fk0) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALIN [SERTRALINE] taken for depression. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; ERYTHEMA (medically significant), outcome "not recovered", described as "Redness/red mark"; VACCINATION SITE MASS (medically significant), outcome "not recovered", described as "Injection site lump"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Very painful arm"; MUSCLE RIGIDITY (medically significant), outcome "unknown", described as "muscle hardness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Very painful arm, injection site lump, muscle hardness, redness/red mark. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1926643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Malaise, Off label use, Palpitations, Vomiting
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BETAHISTINE DIHYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy; Tinnitus aggravated
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637815

Write-up: unwell; Heart racing; Vomited; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Dose 3; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111211648340410-O2YTH (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232664 (MHRA). A 50-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 09:15 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tinnitus aggravated" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included: BETAHISTINE DIHYDROCHLORIDE taken for tinnitus, start date: 01Oct2021, stop date: 20Nov2021; INFLUENZA VIRUS taken for immunisation, administration date 24Sep2021. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified; Primary Immunization 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 19Nov2021 09:15, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021 09:15, outcome "unknown", described as "Dose 3"; MALAISE (medically significant) with onset 20Nov2021 02:00, outcome "recovering", described as "unwell"; PALPITATIONS (medically significant) with onset 20Nov2021 02:00, outcome "recovered" (20Nov2021), described as "Heart racing"; VOMITING (medically significant) with onset 20Nov2021 02:00, outcome "recovered" (21Nov2021), described as "Vomited". Clinical course: had Pfizer vac at 9:15 am; at 2 am the following morning (20Nov2021) had a racing heart, felt very unwell and vomited. Continued to feel very unwell for a few hours and gradually felt better after two days. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction - Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". Details of any relevant investigations or tests conducted: "None, self-managed". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926663 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
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, Blood pressure measurement, Blood test, Body temperature, Chest X-ray, Chest pain, Computerised tomogram thorax, Dizziness, Echocardiogram, Electrocardiogram, Fatigue, Fibrin D dimer, Generalised tonic-clonic seizure, Heart rate, Hypertension, Immunisation, Oxygen saturation, Palpitations, Platelet count, Pyrexia, SARS-CoV-2 test, Syncope, Tachycardia, Tremor, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocarditis; Non-smoker; Pericarditis
Allergies:
Diagnostic Lab Data: Test Name: Anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown Results; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: blood pressure was 187 over 110; Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown Results; Test Name: Fever; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211119; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown Resultts; Test Date: 20211119; Test Name: Chest CT; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211119; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211119; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Results; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown Results; Test Name: Heart rate; Result Unstructured Data: Test Result:Unknown Results; Comments: heart rate shot straight; Test Name: Oxygen; Result Unstructured Data: Test Result:Unknown Results; Test Name: Platelet counts; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202101637597

Write-up: Chest Pain; Palpitations; Fever; Syncope; Tachycardia; Fatigue; Grand mal epileptic fit; Shaking; Lightheadedness; Booster; Blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111211852422480-7218S (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232795 (MHRA). A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-smoker" (unspecified if ongoing); "Myocarditis" (unspecified if ongoing); "Pericarditis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Heparin. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunisation; Comirnaty (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, life threatening) with onset 19Nov2021, outcome "unknown", described as "Booster"; HYPERTENSION (hospitalization, life threatening) with onset 19Nov2021, outcome "recovered" (2021), described as "Blood pressure"; CHEST PAIN (hospitalization, life threatening), outcome "unknown", described as "Chest Pain"; DIZZINESS (hospitalization, life threatening) with onset 19Nov2021, outcome "recovered with sequelae", described as "Lightheadedness"; FATIGUE (hospitalization, life threatening), outcome "unknown", described as "Fatigue"; GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant, life threatening) with onset 19Nov2021, outcome "recovered with sequelae", described as "Grand mal epileptic fit"; PALPITATIONS (hospitalization, life threatening), outcome "unknown", described as "Palpitations"; PYREXIA (hospitalization, life threatening), outcome "unknown", described as "Fever"; SYNCOPE (hospitalization, medically significant, life threatening), outcome "unknown", described as "Syncope"; TACHYCARDIA (hospitalization, life threatening), outcome "unknown", described as "Tachycardia"; TREMOR (hospitalization, life threatening) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Shaking". The patient underwent the following laboratory tests and procedures: anti-platelet factor 4 antibody test: (unspecified date) unknown results; blood pressure measurement: (unspecified date) high, notes: blood pressure was 187 over 110; blood test: (unspecified date) unknown results; body temperature: (unspecified date) unknown results; chest x-ray: (19Nov2021) unknown resultts; computerised tomogram thorax: (19Nov2021) unknown results; echocardiogram: (19Nov2021) unknown results; electrocardiogram: (19Nov2021) unknown results; fibrin d dimer: (unspecified date) unknown results; heart rate: (unspecified date) unknown results, notes: heart rate shot straight; oxygen saturation: (unspecified date) unknown results; platelet count: (unspecified date) unknown results; sars-cov-2 test: (unspecified date) negative, notes: No-Negative COVID-19 test; x-ray: (unspecified date) unknown results. Clinical course: He has not had symptoms associated with COVID-19. He was Hospitalized via an ambulance high blood pressure couldn''t stable his heart rate. Epileptic fit all this straight after COVID 19 booster within seconds. He has not tested positive for COVID-19 since having the vaccine. He was not enrolled in clinical trial. The report was related to possible blood clots or low platelet counts. The report was related to possible myocarditis or pericarditis. He went for C19 booster sat in waiting room for 10 mins after straight away light headed then put on bed and had a fit then put on oxygen and blood pressure was 187 over 110 heart rate shot straight. He did not have any previous reactions to medications, especially heparin or anticoagulants. He was not confirmed or suspected autoimmune or inflammatory disease, including vasculitis. He did not have history of, or current, malignancy. He did not have a history of, or concurrent, intracranial malignancy. He did not have concurrent or recent intracranial infections. He did not have recent surgical or medical interventions to the central nervous system (including lumbar puncture. He did not have a recent trauma/head injury. He was hospitalized and stayed in hospital for 2 days. He was seen by a cardiologist. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast pain, Chills, Headache, Hyperhidrosis, Illness, Immunisation, Influenza like illness, Interchange of vaccine products, Limb discomfort, Off label use, Pain in extremity, SARS-CoV-2 test, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (I had covid in January before any vaccines.)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637520

Write-up: Vomiting; Aches (hands and joints as well as flu like aches); Flu like aches; Pain and aching in my injection site; Breast pain; Sickness; Sweating; Arm discomfort; Off label use; Interchange of vaccine products; Booster; Chills worsened; Aching pain in hands, forearms, elbows; Head pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111212029307970-V5EAK (RA). Other Case identifier(s): GB-MHRA-ADR 26232888 (RA). A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing), notes: I had covid in January before any vaccines. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 19Nov2021. Past drug history included: Cerelle, notes: I do take the Cerelle Contraceptive Pill. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: Feb2021, for COVID-19 immunisation, reaction(s): "tired"; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), administration date: Feb2021, for COVID-19 immunisation, reaction(s): "sick". The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant), outcome "recovering", described as "Vomiting"; CHILLS (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Chills worsened"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "recovering", described as "Aching pain in hands, forearms, elbows"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Head pain"; ILLNESS (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Sickness"; HYPERHIDROSIS (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Sweating"; LIMB DISCOMFORT (medically significant) with onset 19Nov2021, outcome "recovering", described as "Arm discomfort"; BREAST PAIN (medically significant) with onset 20Nov2021, outcome "recovering", described as "Breast pain"; ARTHRALGIA (medically significant), outcome "unknown", described as "Aches (hands and joints as well as flu like aches)"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "Flu like aches"; VACCINATION SITE PAIN (medically significant), outcome "recovering", described as "Pain and aching in my injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course no illness. Fit abs healthy. I do take the Cerelle Contraceptive Pill. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Not been ill or had previous treatment for anything else. I had covid in January before any vaccines. I felt tired and sick for a day with my initial vaccine in February. Was ok with my second dose. I have felt really ill over the weekend. I had horrendous sickness, chills, aches (hands abs joints as well as flu like aches) and sore head Friday. This lasted into most of Saturday. Saturday evening I woke with pain and aching in my hand arm, injection site, but also under arm and my left breast. This did not ease for most of Sunday. I would say I am just recovering now at 9pm. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible blood clots or low platelet counts. Report did not relate to possible myocarditis or pericarditis. Relevant investigations or tests conducted was none. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926679 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Headache, Immunisation, Insomnia, Interchange of vaccine products, Nausea, Off label use, Oropharyngeal discomfort, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: July 2021 had partial removal of prostate
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101637532

Write-up: Aches and pains in legs; throat feels odd; Lost appetite; shivering; Headache; knuckles began aching; Nausea/nauseous; Insomnia; Spiking temperature; Off label use; Booster; Interchange of vaccine products; 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-202111212038596850-PE8GQ (RA). Other Case identifier(s): GB-MHRA-ADR 26232883 (RA). A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 10:40 (Lot number: FH4751) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 30Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; CHILLS (medically significant) with onset 19Nov2021 18:00, outcome "not recovered", described as "shivering"; HEADACHE (medically significant) with onset 19Nov2021 18:00, outcome "recovering", described as "Headache"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Spiking temperature"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "recovered", described as "Aches and pains in legs"; NAUSEA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Nausea/nauseous"; INSOMNIA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Insomnia"; PAIN (medically significant) with onset 19Nov2021 15:30, outcome "unknown", described as "knuckles began aching"; DECREASED APPETITE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Lost appetite"; OROPHARYNGEAL DISCOMFORT (medically significant) with onset 21Nov2021, outcome "unknown", described as "throat feels odd". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2020) positive, notes: Yes - Positive COVID-19 test. Clinical course had vaccine at 10:40. By 15:30 knuckles began aching. By 18:00 was shivering with a headache. Went to bed but no sleep. Woke on the 2oth with same symptoms and aches in legs. Could not brush teeth as felt nauseous. Lost appetite. Woke 21st feeling a lot better but throat feels odd. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations or tests conducted was none. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926683 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Dizziness, Dysarthria, Illness, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637915

Write-up: Sick; Confused; Slurry on words; Off label use; Interchange of vaccine product; Booster; Dizzy spells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111212144088730-40HU1 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232934 (MHRA). A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2 Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Dizzy spells"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; CONFUSIONAL STATE (medically significant), outcome "unknown", described as "Confused"; DYSARTHRIA (medically significant), outcome "unknown", described as "Slurry on words". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not 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 pregnant and not currently breastfeeding. Report was 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: 1926688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Injection site erythema, Injection site mass, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Off label use, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637521

Write-up: lightly swollen arm and lymph nodes day after injection; Lightly swollen arm; red hot bump at injection site; painful swollen arm; swelling in arm; red hot bump at injection site; Swollen lymph nodes; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111212218083110-RDHHR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232956 (MHRA). A 25-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose-2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; LYMPH NODE PAIN (medically significant), outcome "not recovered", described as "lightly swollen arm and lymph nodes day after injection"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; PERIPHERAL SWELLING (medically significant), outcome "not recovered", described as "Lightly swollen arm"; INJECTION SITE ERYTHEMA (medically significant), INJECTION SITE MASS (medically significant), outcome "unknown" and all described as "red hot bump at injection site"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "painful swollen arm"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "swelling in arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) negative, notes: No - Negative COVID-19 test. Additional information: The patient had Lightly swollen arm and lymph nodes day after injection, as well as red hot bump on injection site. Two days after injection very painful swollen arm and increased swelling in arm which has become very painful. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient last menstrual period date: 1-NOV-2021 The report do not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Diarrhoea, Dizziness, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101637634

Write-up: diarrhea; Diarrhoea; Fever chills; Armpit pain; Light headedness; Fever; Nausea; Ache; 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-202111220711210810-3HLOW. Other Case identifier(s): GB-MHRA-ADR 26233467. A 25 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "BOOSTER"; DIARRHOEA (medically significant), outcome "not recovered", described as "diarrhea"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fever"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Nausea"; PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Ache"; DIARRHOEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Diarrhoea"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Fever chills"; AXILLARY PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Armpit pain"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Light headedness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The day after was the worst and since then it has gradually gotten better, however today (22Nov21) I woke up with diarrhoea and nausea which before today only happened on the first morning after. After taking paracetamol on the first day after it slowly got a little better. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926721 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erectile dysfunction, Immunisation, Insomnia, Interchange of vaccine products, Myalgia, Off label use, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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 INC202101646377

Write-up: couldn''''t get comfortable; every bit of the patient from head to foot hurt; couldn''t sleep; Muscle pain; Feverish; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111220832009240-HKBL0 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26233618 (MHRA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; ERECTILE DYSFUNCTION (medically significant), outcome "not recovered", described as "couldn''''t get comfortable"; MYALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Muscle pain"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Feverish"; PAIN (medically significant), outcome "unknown", described as "every bit of the patient from head to foot hurt"; INSOMNIA (medically significant), outcome "unknown", described as "couldn''t sleep". Clinical course: Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient felt like body was on fire, every bit of the patient from head to foot hurt. Couldn''t get comfortable, couldn''t sleep. Muscle aches and pains. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lip swelling, Malaise, Nausea, Off label use, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insulin dependent diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646205

Write-up: swollen tongue; Swollen face; nauseous; unwell; Swollen lips; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable Consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111221057181080-GDZPU (RA). Other Case identifier(s): GB-MHRA-ADR 26234152 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Patient is Insulin diabetic. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Past drug history included: Insulin degludec. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (disability) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; SWOLLEN TONGUE (disability), outcome "not recovered", described as "swollen tongue"; LIP SWELLING (disability) with onset 20Nov2021, outcome "recovering", described as "Swollen lips"; SWELLING FACE (disability), outcome "unknown", described as "Swollen face"; NAUSEA (disability), outcome "unknown", described as "nauseous"; MALAISE (disability), outcome "unknown", described as "unwell". Clinical course: Swollen tongue, face, felt very nauseous feel unwell. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow up attempts are needed. No further information is expected.


VAERS ID: 1926764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Embolism, Fibrin D dimer, Heparin-induced thrombocytopenia test, Immunisation, Myocarditis, Platelet count, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:unknown result; Test Name: anti-PF4; Result Unstructured Data: Test Result:unknown result; Test Name: platelet count; Result Unstructured Data: Test Result:unknown result; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646481

Write-up: Booster; myocarditis; Chest pain; Thromboembolic event; Breathlessness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111221146256180-SEOGJ (RA). Other Case identifier(s): GB-MHRA-ADR 26234343 (RA). A female patient (pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient was 27 weeks pregnant at the event onset. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization; Bnt162b2 (Dose-2), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant, life threatening), outcome "unknown", described as "Booster"; DYSPNOEA (hospitalization, medically significant, life threatening) with onset 19Nov2021, outcome "not recovered", described as "Breathlessness"; MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "myocarditis"; CHEST PAIN (hospitalization, medically significant, life threatening), outcome "unknown", described as "Chest pain"; EMBOLISM (hospitalization, medically significant, life threatening), outcome "unknown", described as "Thromboembolic event". The patient underwent the following laboratory tests and procedures: fibrin d dimer: unknown result; heparin-induced thrombocytopenia test: unknown result; platelet count: unknown result; sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926768 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Immunisation, Interchange of vaccine products, Lymphadenopathy, Nausea, Off label use, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646458

Write-up: felt weak; Chills; Glands swollen; Off label use; Interchange of vaccine products; Booster; Nausea; Tiredness/felt wiped out; Slept for 11 hours/ slept most of the day/slept for over 9 hour; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221214341860-4GLYO (RA). Other Case identifier: GB-MHRA-ADR 26234391 (RA). A 64-year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) at the age of 64 years as dose3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. Concomitant medication included: ATENOLOL taken for hypertension. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 vaccination; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, SINGLE), for Covid-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Nausea"; FATIGUE (medically significant) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "Tiredness/felt wiped out"; SOMNOLENCE (medically significant) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "Slept for 11 hours/ slept most of the day/slept for over 9 hour"; ASTHENIA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "felt weak"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Chills"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Glands swollen". Clinical course: within 1 hour of vaccine (19Nov2021), patient was nauseous, later that night patient felt very tired. Slept for 11 hours. Next day (20Nov2021) felt weak and very tired, had severe chills, nausea, swollen glands and slept most of the day. That night patient slept for over 9 hours. Still very tired next day (21Nov2021), slept for most of afternoon but chills and nausea had lessened. Glands remained swollen. Next day (Monday) 3 days after vaccine (22Nov2021) patient had recovered but felt wiped out. Took it easy that day! Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1926786 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lip swelling, Rash pruritic, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646465

Write-up: Lip swelling; Itchy rash; Red circle growing bigger at injection site; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-RA-WEBCOVID-202111221333063760-XTJ2Y (RA). Other Case identifier(s): GB-RA-ADR 26234575 (RA). A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fko112) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; LIP SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lip swelling"; RASH PRURITIC (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Itchy rash"; VACCINATION SITE ERYTHEMA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Red circle growing bigger at injection site". Therapeutic measures were taken as a result of lip swelling, rash pruritic, vaccination site erythema. Additional Information: Patient experienced red circle growing bigger at injection site, red itchy rash on neck and arms, and swollen bottom lip. Patient was advised to take antihistamines and draw around red lump on arm to see if it spreads. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate increased, Immunisation, Insomnia, Interchange of vaccine products, Nausea, Off label use, Palpitations, Sleep disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAFFEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646172

Write-up: Off label use; Interchange of vaccine products; booster; nauseous; fast heart rate and increased respiration; felt sleep; Nausea; Heart racing; Insomnia; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221351003660-PDIPW (MHRA). Other Case identifier: GB-MHRA-ADR 26234759 (MHRA). A 60-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 22Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. Concomitant medication(s) included: CAFFEINE. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 06Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 21May2021, for COVID-19 immunisation. 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"; NAUSEA (medically significant), outcome "recovered", described as "nauseous"; HEART RATE INCREASED (medically significant), outcome "recovered", described as "fast heart rate and increased respiration"; SLEEP DISORDER (medically significant), outcome "recovered", described as "felt sleep"; PALPITATIONS (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Heart racing"; INSOMNIA (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Insomnia"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Nausea". Patient has not tested positive for COVID-19 since having the vaccine.


VAERS ID: 1926824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK059G / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Heavy menstrual bleeding, Nausea, Pain, Thrombosis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Contraceptive implant (stopped her periods for the 7 years she had it)
Preexisting Conditions: Medical History/Concurrent Conditions: Spotting menstrual
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646137

Write-up: pain; nausea; Prolonged heavy periods; clots; headaches; 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-202111221545303880-LOOC2. Other Case identifier(s): GB-MHRA-ADR 26235010. A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK059G) as dose 2, single for covid-19 immunisation. Relevant medical history included: "contraceptive implant" (ongoing), notes: stopped her periods for the 7 years she had it; "occasionally spotting" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 23Sep2021, for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. When patient had the second dose on 19Nov2021, she got home and within a couple of hours she had the worst period she have had since before starting the implant. She has to change sanitary towel every hour, she has clots, extreme pain, nausea and headaches from this period and its still ongoing 3 days later. Patient does not know it''s to do with the vaccine since she hasn''t had periods in years because of implant and then she has the vaccine and has the heaviest period she has had in years. Outcome of events was recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EDOXABAN; LEVOTHYROXINE; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Protein C deficiency; Splenectomy (Spleen has been removed, it was severely damaged by multiple splenic infarcts); Splenic infarction; Thoracic aortic thrombus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646548

Write-up: Off label use; Interchange of vaccine products; Booster; Swollen lymph nodes; Fever chills; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202111221615490740.Safety Report Unique Identifier GB-RA-ADR 26235073. A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Splenectomy", start date: 2013 (unspecified if ongoing), notes: Spleen has been removed, it was severely damaged by multiple splenic infarcts in 2013 and there is very little of it left; "multiple splenic infarcts" (unspecified if ongoing); "Thoracic aortic thrombus" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Protein C deficiency" (unspecified if ongoing). Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication(s) included: EDOXABAN taken for protein c deficiency; LEVOTHYROXINE taken for hypothyroidism; SIMVASTATIN taken for aortic thrombosis. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation. The following information was reported: 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 19Nov2021, outcome "recovering", described as "Swollen lymph nodes"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Fever chills". The report did not think the events 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: 1926866 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: PRIVACY)
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646514

Write-up: Armpit pain; Injection site warmth; Injection site swelling; Fever; Muscle ache; Persistent headache; Chills; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111221855524910-HCTP0 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235363 (MHRA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fk0112) at the age of 49 years as dose 1, single for covid-19 immunisation; sars-cov-2 vaccine (SARS-COV-2 VACCINE) (Lot number: Novavax trial). Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: PRIVACY; The patient''s concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (medically significant) with onset 20Nov2021, outcome "recovering", described as "Injection site swelling"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fever"; MYALGIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Muscle ache"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Persistent headache"; VACCINATION SITE WARMTH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Injection site warmth"; AXILLARY PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Armpit pain"; CHILLS (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Chills". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (21Nov2021) no - negative covid-19 test. The action taken for sars-cov-2 vaccine was unknown. 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. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis).


VAERS ID: 1926868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751/V1487 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (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: ALLOPURINOL; BISOPROLOL; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gout; Heart rate abnormal; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646204

Write-up: Palpitation; tiring; off label use; interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221904331500-C2O8S (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235382 (MHRA). A 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751/V1487) as dose 3 (booster), single for covid-19 immunisation. Patient was not enrolled in clinical trial. Relevant medical history included: "Pulmonary embolism" (unspecified if ongoing); "Heart rate" (unspecified if ongoing); "Gout" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19. Concomitant medication(s) included: ALLOPURINOL taken for gout; BISOPROLOL taken for heart rate abnormal; INFLUENZA VIRUS taken for influenza immunisation, administration date 27Sep2021; RIVAROXABAN taken for pulmonary embolism, start date: 27Nov2018. Vaccination history included: Covid-19 vaccine (Dose number unknown/Primary Immunization series complete but unknown manufacturer), administration date: 17May2021, for COVID-19 Immunisation; Covid-19 vaccine (Dose number unknown/ Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; PALPITATIONS (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Palpitation"; FATIGUE (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "tiring". Clinical course: the palpitations started about 24 hours after the vaccine was administered and lasted for about 6 hours. It was very uncomfortable and tiring and patient slept. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) negative. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Back pain, Cough, Dysmenorrhoea, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain, Sputum test
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Sputum test; Test Result: Negative ; Comments: On day 4
CDC Split Type: GBPFIZER INC202101646581

Write-up: cough; Pain menstrual; Off label use; Interchange of vaccine products; Booster; I did not feel well/ feel unwell; pain in my left armpit; Lower back pain; general aches; 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-202111230709577370-9OCY2. Other Case identifiers: GB-MHRA-ADR 26236638. A 52 year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 29Dec2019 (unspecified if ongoing), notes: Unsure when symptoms stopped. Patient was not pregnant, not currently breastfeeding and was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine nor had a COVID-19 test. Concomitant medication included: INFLUENZA VIRUS, administration date 24Sep2021. Vaccination history included: COVID-19 vaccine astrazeneca (Dose number unknown, single, Lot number: Unknown, Primary immunization series complete), administration date: 21May2021, for COVID-19 vaccination; COVID-19 vaccine astrazeneca (Dose number unknown, single, Lot number: Unknown, Primary immunization series complete), administration date: 2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DYSMENORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain menstrual"; COUGH (medically significant) with onset 23Nov2021, outcome "recovering", described as "cough"; MALAISE (medically significant) with onset 2021, outcome "not recovered", described as "I did not feel well/ feel unwell"; AXILLARY PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain in my left armpit"; BACK PAIN (medically significant) with onset 2021, outcome "recovering", described as "Lower back pain"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "general aches". The clinical course reported by patient was as follows: Had no period for nearly two years but after having booster dose, the next day she had some light bleeding but after two days was like a full period. The patient also reported that due to weekend, she had to contact her general practitioner (GP) surgery with the details on their online consultation which they received and was told to her that someone would message/ call her but as of today (23Nov2021), she was still waiting. She had to take of time from work as she still felt unwell. The patient underwent the following laboratory tests and procedures: sputum test: (23Nov2021) negative, notes: On day 4. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sore throat; Stiff neck; This case was received via RA (Reference number: GB-MHRA-ADR 26243238) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and MUSCULOSKELETAL STIFFNESS (Stiff neck) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was provided. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiff neck) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Patient experienced sore throat. Patient was not enrolled in clinical trail. This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected events of oropharyngeal pain and musculoskeletal stiffness. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.; Sender''s Comments: This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected events of oropharyngeal pain and musculoskeletal stiffness. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1926931 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Lethargy, Lymphadenopathy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen glands; Generalized joint pain; Lethargy; This case was received via regulatory authority. (Reference number: GB-MHRA-ADR 26245674) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Generalized joint pain) and LETHARGY (Lethargy) in a 46-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 31-Mar-2020 to 05-May-2020. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), ARTHRALGIA (Generalized joint pain) (seriousness criterion medically significant) and LETHARGY (Lethargy) (seriousness criterion medically significant). On 22-Nov-2021, ARTHRALGIA (Generalized joint pain) and LETHARGY (Lethargy) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen glands) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. This case concerns a 46 year old female patient with no relevant medical history, who experienced the serious unexpected event of lymphadenopathy, arthralgia and lethargy. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 46 year old female patient with no relevant medical history, who experienced the serious unexpected event of lymphadenopathy, arthralgia and lethargy. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1926943 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Ear pain, Injection site erythema, Injection site mass, Injection site pain, Oropharyngeal pain, Sinus congestion, Sinus headache
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Cough; Sinus congestion; Headache sinus; Earache; Sore throat; Injection site redness; Injection site lump; Injection site pain; Injection site tenderness; Injection site burning; This case was received via RA (Reference number: GB-MHRA-ADR 26256063) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headache sinus), SINUS CONGESTION (Sinus congestion), INJECTION SITE PAIN (Injection site pain), INJECTION SITE PAIN (Injection site tenderness), INJECTION SITE PAIN (Injection site burning), EAR PAIN (Earache), COUGH (Cough), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE MASS (Injection site lump) and OROPHARYNGEAL PAIN (Sore throat) in a 40-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Mar-2021 to an unknown date for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site tenderness) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site burning) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant) and INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced SINUS HEADACHE (Headache sinus) (seriousness criterion medically significant) and EAR PAIN (Earache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced SINUS CONGESTION (Sinus congestion) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant). On 22-Nov-2021, INJECTION SITE PAIN (Injection site burning) and INJECTION SITE MASS (Injection site lump) had resolved. On 23-Nov-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, SINUS HEADACHE (Headache sinus) and SINUS CONGESTION (Sinus congestion) had not resolved and INJECTION SITE PAIN (Injection site pain), INJECTION SITE PAIN (Injection site tenderness), EAR PAIN (Earache), COUGH (Cough) and INJECTION SITE ERYTHEMA (Injection site redness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided by the reporter. Patient had two negative lateral flow tests. Awaiting PCR. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Company comment: This regulatory authority case concerns a 40-year-old female patient with relevant medical history who experienced serious unexpected events of injection site pain, injection site erythema, injection site mass, oropharyngeal pain, sinus headache, ear pain, sinus congestion, cough. The events occurred approximately 1, 2 and 4 days after the third dose of the mRNA-1273 . Rechallenge was not applicable since the events occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 40-year-old female patient with relevant medical history who experienced serious unexpected events of injection site pain, injection site erythema, injection site mass, oropharyngeal pain, sinus headache, ear pain, sinus congestion, cough. The events occurred approximately 1, 2 and 4 days after the third dose of the mRNA-1273 . Rechallenge was not applicable since the events occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1926964 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUVAC
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Mar-2021 to an unknown date and INFLUENZA VACCINE INACT SAG 3V (INFLUVAC) for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion disability). At the time of the report, CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negetive (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No medical history reported. Patient Taken paracetamol and ibuprofen but shown to little effect. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Patient taken VIRUS INFLUENZA contains active substance strains includes Company Comment: This is a regulatory authority case concerning a 60-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of chills. The event occurred approximately 1 days after the third dose of mRNA 1273 vaccine. Patient was previously vaccinated with another COVID 19 vaccine, CHADOX1 NCOV-19 , and the influenza vaccine. The rechallenge is reported as unknown. Treatment with paracetamol and ibuprofen had minimal effect. The event is resolving. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 60-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of chills. The event occurred approximately 1 days after the third dose of mRNA 1273 vaccine. Patient was previously vaccinated with another COVID 19 vaccine, CHADOX1 NCOV-19 , and the influenza vaccine. The rechallenge is reported as unknown. Treatment with paracetamol and ibuprofen had minimal effect. The event is resolving. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1927024 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, SARS-CoV-2 test positive
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: 20211121; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: GRPFIZER INC202101633809

Write-up: Covid-19 rapid test positive; Covid-19 rapid test positive; third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (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: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "Covid-19 rapid test positive"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "third dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1927515 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Headache, Injection site reaction, Nausea, Pyrexia, Toothache, Visual impairment
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seafood allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHJNJFOC20211202455

Write-up: VISUAL DISTURBANCE; INJECTION SITE REACTION; TOOTHACHE; BACK ACHE; HEADACHE; FEVER; NAUSEA; FATIGUE EXTREME; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, CH-SM-2021-28770] concerned a 44 year old male. The patient''s weight was 79 kilograms, and height was 173 centimeters. The patient''s concurrent conditions included: seafood allergy. The patient received covid-19 vaccine ad26.cov2.s Janssen series 1 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 18-NOV-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced headache, fever (the legs were moving alone in the night), visual disturbance (Visual disturbance with confusion of numbers (seeing 27/28 at the same time)), injection site reaction, nausea, fatigue extreme, toothache, and back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, visual disturbance, nausea, fatigue extreme, and toothache, and had not recovered from headache, injection site reaction, and back ache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20211202455-COVID-19 VACCINE AD26.COV2.S Visual disturbance, Injection site reaction, Backache. Toothache . 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). 20211202455-COVID-19 VACCINE AD26.COV2.S-Headache, Fever, Nausea, Fatigue extreme. This event(s) is labeled per the regulatory authority and is therefore considered potentially related.


VAERS ID: 1928227 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Influenza, Pain
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Flu symptoms; chills; aches; headaches; tiredness; Flu symptoms; chills; aches; headaches; tiredness; Flu symptoms; chills; aches; headaches; tiredness; Flu symptoms; chills; aches; headaches; tiredness; Flu symptoms; chills; aches; headaches; tiredness; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26237734) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms; chills; aches; headaches; tiredness), PAIN (Flu symptoms; chills; aches; headaches; tiredness), HEADACHE (Flu symptoms; chills; aches; headaches; tiredness), CHILLS (Flu symptoms; chills; aches; headaches; tiredness) and FATIGUE (Flu symptoms; chills; aches; headaches; tiredness) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (Flu symptoms; chills; aches; headaches; tiredness) (seriousness criterion medically significant), PAIN (Flu symptoms; chills; aches; headaches; tiredness) (seriousness criterion medically significant), HEADACHE (Flu symptoms; chills; aches; headaches; tiredness) (seriousness criterion medically significant), CHILLS (Flu symptoms; chills; aches; headaches; tiredness) (seriousness criterion medically significant) and FATIGUE (Flu symptoms; chills; aches; headaches; tiredness) (seriousness criterion medically significant). On 20-Nov-2021, INFLUENZA (Flu symptoms; chills; aches; headaches; tiredness), PAIN (Flu symptoms; chills; aches; headaches; tiredness), HEADACHE (Flu symptoms; chills; aches; headaches; tiredness), CHILLS (Flu symptoms; chills; aches; headaches; tiredness) and FATIGUE (Flu symptoms; chills; aches; headaches; tiredness) had resolved. No concomitant drugs and treatment reported. The patient was taken Vaccine Moderna for Covid 19 booster. company comment : This case concerns a 55 year old female patient with no relevant medical history, who experienced the serious expected events of influenza, pain, headache, chills and fatigue. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 55 year old female patient with no relevant medical history, who experienced the serious expected events of influenza, pain, headache, chills and fatigue. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928232 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVAMYS; FLUTICASONE FUROATE; HYLO TEAR; IBUPROFEN; LACTULOSE; LANSOPRAZOLE; LEVOTHYROXINE; MOMETASONE; PARACETAMOL; STUGERON; SUNVIT [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Acute urticaria; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26239980) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of URTICARIA (Acute urticaria) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE ASTRAZENECA and COVID-19 VACCINE ASTRAZENECA. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE ASTRAZENECA and COVID-19 VACCINE ASTRAZENECA. Concomitant products included CINNARIZINE (STUGERON) from 30-Mar-2021 to an unknown date for Dizziness, FLUTICASONE FUROATE (AVAMYS) from 06-Nov-2019 to 27-Oct-2021, FLUTICASONE FUROATE from 17-Feb-2021 to an unknown date, HYALURONATE SODIUM (HYLO TEAR) from 17-Feb-2021 to an unknown date, IBUPROFEN from 06-Nov-2019 to an unknown date, LACTULOSE from 06-Nov-2019 to an unknown date, LANSOPRAZOLE from 17-Feb-2021 to an unknown date, LEVOTHYROXINE from 17-Feb-2021 to an unknown date, MOMETASONE from 27-Oct-2021 to 10-Nov-2021, PARACETAMOL from 17-Feb-2021 to an unknown date and COLECALCIFEROL (SUNVIT [COLECALCIFEROL]) from 06-Nov-2019 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced URTICARIA (Acute urticaria) (seriousness criterion medically significant). At the time of the report, URTICARIA (Acute urticaria) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment Medication use information was not provided by reporter. Widespread urticaria was occur within 24 hours of after Moderna booster dose vaccination. Patient previously had AstraZeneca for 2 Vaccine. Company comment: This is a regulatory authority case concerning a 69-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of Acute urticaria. The event occurred approximately 1 day after the third dose of mRNA 1273 vaccine. Patient was vaccinated previously with two doses of another brands COVID 19 vaccine. The rechallenge is reported as unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 69-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of Acute urticaria. The event occurred approximately 1 day after the third dose of mRNA 1273 vaccine. Patient was vaccinated previously with two doses of another brands COVID 19 vaccine. The rechallenge is reported as unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1928252 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Illness, 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.MOD20213

Write-up: Sickness; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26246477) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 23-Nov-2021, ILLNESS (Sickness) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication was reported. It was reported patient experienced pain in stomach, rash on arm were vaccine was placed , swollen face ,hands and feet, high temperature and shakes and very hot head rest of the body very cold to touch, headache and sneezing. Patient has not tested positive for COVID-19 since having the vaccine and Patient was not enrolled in clinical trial Treatment information was not provided by reporter. Company Comment: This case concerns a 57-year-old female subject, with no medical history reported, who experienced the unexpected and serious event of Illness. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. 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 subject, with no medical history reported, who experienced the unexpected and serious event of Illness. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930160 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
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: FIMODERNATX, INC.MOD20214

Write-up: Loss of consciousness; Chills; Epileptic seizure; This case was received via regulatory Agency (Reference number: FI-FIMEA-20217144) on 05-Dec-2021 and was forwarded to Moderna on 05-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness), CHILLS (Chills) and EPILEPSY (Epileptic seizure) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and EPILEPSY (Epileptic seizure) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), CHILLS (Chills) and EPILEPSY (Epileptic seizure) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. Company comment:This is a regulatory case concerning a 44 year-old, female patient with no medical history reported, who experienced the serious unexpected events of chills and loss of consciousness and the serious unexpected AESI event of epilepsy. The events occurred approximately 1day after the first dose of mRNA-1273 vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was unknown as information on the first dose only was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 44 year-old, female patient with no medical history reported, who experienced the serious unexpected events of chills and loss of consciousness and the serious unexpected AESI event of epilepsy. The events occurred approximately 1day after the first dose of mRNA-1273 vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was unknown as information on the first dose only was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930283 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Cough, Dyspnoea, Hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOLADEX
Current Illness: Allergy to chemicals (Thiomersal.); Allergy to metals (Cobalt.); Asthmatic; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654581

Write-up: Asthmatic attack; Allergic reaction; Generalized itching; Breathlessness; Coughing; Chest tightness; This is a spontaneous report received from a contactable other health care professional from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-EYC 00267137 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235164 (MHRA). A 31 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FK0596) at the age of 31-years-old as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (ongoing); "Penicillin allergy" (ongoing); "Allergy to chemicals" (ongoing), notes: Thiomersal.; "Allergy to metals" (ongoing), notes: Cobalt. Concomitant medication(s) included: ZOLADEX. The following information was reported: HYPERSENSITIVITY (hospitalization, medically significant) with onset 19Nov2021 23:00, outcome "not recovered", described as "Allergic reaction"; PRURITUS (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Generalized itching"; ASTHMA (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Asthmatic attack"; DYSPNOEA (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Breathlessness"; COUGH (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Coughing"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Chest tightness". The patient was hospitalized for hypersensitivity, pruritus, asthma, dyspnoea, cough, chest discomfort (start date: 2021). The events "allergic reaction", "generalized itching", "asthmatic attack", "breathlessness", "coughing" and "chest tightness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of asthma, pruritus, hypersensitivity, dyspnoea, cough, chest discomfort (oral antihistamines, intravenous hydrocortisone 200mg, intravenous Chlorphenamine 4mg, intravenous fluids, oral prednisolone and salbutamol inhaler). Clinical course reported as: Asthmatic attack generalized itching. Patient had her COVID vaccine at an early hour on Friday the 19th, came down with severe allergic reaction at 23:00. She used her oral antihistamines which didn''t have any effect, she went down to accident and emergency where she was admitted, she was administered intravenous hydrocortisone 200mg, intravenous Chlorphenamine 4mg, intravenous fluids. Continuous oral Prednisolone till date as she is still itching, she became breathless at work with continuous coughing and chest tightness, used Prednisolone and salbutamol inhaler, still struggling. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930396 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Arthritis (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: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646395

Write-up: Aching in limb; Swollen arm; Fatigue; Dizziness; Off label use; Patient received first and second dose of non-Pfizer vaccine and booster dose of COMIRNATY; Patient received booster dose of COMIRNATY; Headache dull; Joint ache; 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-202111221829130220-QUM21. Other Case identifier(s): GB-MHRA-ADR 26235331. A 68 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH3220) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing); "Clinical trial participant" (unspecified if ongoing), notes: . The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 24May2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received first and second dose of non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Headache dull"; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Joint ache"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "recovering", described as "Aching in limb"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen arm"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: It was reported that the patient had COVID in Mar2020 and then ASTRAZENECA vaccine and now Pfizer and patient knew that she had antibodies from COVID when had her first ASTRAZENECA vaccine as she was part of the Clinical Trial. Patient just wonder if reaction was due to having too many antibodies from three different sources. The patient did not have symptoms associated with COVID-19. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930422 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Malaise, Night sweats, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654592

Write-up: Night sweat; Ill feeling; Sore throat; Coughing; 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-202111230832576420-OJ80B (RA). Other Case identifier(s): GB-MHRA-ADR 26236991 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH4751) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 30Sep2021 (unspecified if ongoing), unsure when symptoms stopped. Patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (disability) with onset 19Nov2021, outcome "not recovered", described as "Sore throat"; COUGH (disability) with onset 19Nov2021, outcome "not recovered", described as "Coughing"; MALAISE (disability) with onset 20Nov2021, outcome "not recovered", described as "Ill feeling"; NIGHT SWEATS (disability) with onset 21Nov2021, outcome "not recovered", described as "Night sweat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Sep2021) yes - positive covid-19 test. Therapeutic measures included paracetamol and ibuprofen taken as a result of oropharyngeal pain, cough, malaise, night sweats. Additional Information: The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930441 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Immunisation, Malaise, Ocular hyperaemia, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (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: 20211119; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101654607

Write-up: Eye blood shot; booster; High temperature; Feeling unwell; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111231034242300-2H8YS (MHRA). Other Case identifiers: GB-MHRA-ADR 26237611 (MHRA). A 75 year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 75 years as dose 3 (booster), single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, Lot number: Unknown), for COVID-19 Immunization; BNT162B2 (Dose 2, single, Lot number: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; PYREXIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "High temperature"; MALAISE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Feeling unwell"; OCULAR HYPERAEMIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Eye blood shot". The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) high; sars-cov-2 test: (unspecified date) negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Lymph node pain, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Sinus headache, Sneezing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); TB
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101654644

Write-up: Runny nose; Cough/Painful cough; Sneezing excessive; Swollen lymph nodes, under arms, throat neck.; Painful swollen sore throat; Sinus headache; Terrible headaches; terrible headaches swollen lymph nodes; sneezing; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111231901176060-RKG4R (RA). Other Case identifier(s): GB-MHRA-ADR 26240163 (RA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 2, single for COVID-19 immunisation. Patient''s last menstrual period was on 20Nov2021. Patient had not tested positive for COVID-19 since having the vaccine and had no symptoms associated with COVID-19 . Patient was not enrolled in clinical trial and was not breastfeeding at the time of report. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response; "TB", start date: 1985 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Bisoprolol, start date: 2010, notes: Bisoprolol beta blockers since 2010. Vaccination history included: COVID-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: SINUS HEADACHE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Sinus headache"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen lymph nodes, under arms, throat neck."; OROPHARYNGEAL PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Painful swollen sore throat"; RHINORRHOEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Runny nose"; COUGH (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Cough/Painful cough"; SNEEZING (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Sneezing excessive"; HEADACHE (medically significant) with onset 2021, outcome "unknown", described as "Terrible headaches"; LYMPH NODE PAIN (medically significant) with onset 2021, outcome "not recovered", described as "terrible headaches swollen lymph nodes"; SNEEZING (medically significant) with onset 2021, outcome "not recovered", described as "sneezing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. No follow up attempts are possible. No further information is expected.


VAERS ID: 1930517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Backache
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654539

Write-up: shooting pain; severe headaches; Occipital neuralgia; Itchy; 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 Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111231950150070-XPQXG. Other Case identifier(s): GB-MHRA-ADR 26240227. A 47 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Backache" (unspecified if ongoing). The patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Concomitant medication(s) included: NAPROXEN taken for back pain, start date: 22Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE: 1, Single, Batch/Lot number: Unknown), administration date: 24Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE: 2, Single, Batch/Lot number: Unknown), administration date: 17Jun2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; PAIN (medically significant), outcome "not recovered", described as "shooting pain"; OCCIPITAL NEURALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Occipital neuralgia"; PRURITUS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Itchy"; HEADACHE (medically significant), outcome "not recovered", described as "severe headaches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical Course: Severe headaches. Shooting pain from base of skull to top of head and left ear. Constant headache and pain behind eyes. Never had it before. No physical activity or movement different from before that could have triggered it. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930585 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Painful arm; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26248516) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26248516) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 immunisation. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 22-Nov-2021, FATIGUE (Tiredness) had resolved. On 24-Nov-2021, PAIN IN EXTREMITY (Painful arm) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test.Patient has not tested positive for COVID-19 since having the vaccine.; Sender''s Comments: This case concerns a 34-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of pain in extremity and fatigue. The event fatigue occurred the same day after the third dose of mRNA-1273. The event pain in extremity occurred one day after the third dose of mRNA-1273. Both events recovered. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1930625 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry skin, Fatigue, Oropharyngeal pain, Pharyngitis, Pruritus, Pyrexia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XYZAL
Current Illness: Immunochemotherapy (immunotherapy allergyshots for the last 3 years (currently 2 shots per 2 weeks))
Preexisting Conditions: Medical History/Concurrent Conditions: Drug-induced hepatitis; Immunodeficiency (Taking other treatments or medicines, known to lower the immune response)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: throat infection; after 4 days; hives; Fatigue; Sore throat; Dry scalp; Itching; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26253760) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PHARYNGITIS (throat infection), PYREXIA (after 4 days), URTICARIA (hives), PRURITUS (Itching), OROPHARYNGEAL PAIN (Sore throat), DRY SKIN (Dry scalp) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Drug-induced hepatitis, Immunodeficiency (Taking other treatments or medicines, known to lower the immune response) and Immunochemotherapy (immunotherapy allergyshots for the last 3 years (currently 2 shots per 2 weeks)) since an unknown date. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy. On 12-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and DRY SKIN (Dry scalp) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced PHARYNGITIS (throat infection) (seriousness criterion medically significant), PYREXIA (after 4 days) (seriousness criterion medically significant) and URTICARIA (hives) (seriousness criterion medically significant). At the time of the report, PHARYNGITIS (throat infection), PYREXIA (after 4 days), URTICARIA (hives), PRURITUS (Itching), OROPHARYNGEAL PAIN (Sore throat) and DRY SKIN (Dry scalp) was resolving 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 (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The symptoms started with severe itching and body hives that were recurring every 6-8 hours a week after the booster shot. The excess mucus production resulted in throat infection. After 4 days, the patient was treated with oral steroids and now the patient believed that the patient was recovering. Patient lives on antihistamines. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient met the allergist and confirmed that it was a reaction to the booster shot. Company Comment This case concerns a 31-year-old, female patient with relevant medical history of drug induced liver injury, immunodeficiency and Immunochemotherapy, who experienced the unexpected events of pharyngitis, pyrexia, urticaria, pruritus, oropharyngeal pain, dry skin and fatigue. The events occurred 7 days after the third dose of mRNA-1273.The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 31-year-old, female patient with relevant medical history of drug induced liver injury, immunodeficiency and Immunochemotherapy, who experienced the unexpected events of pharyngitis, pyrexia, urticaria, pruritus, oropharyngeal pain, dry skin and fatigue. The events occurred 7 days after the third dose of mRNA-1273.The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1930674 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

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

Write-up: Menstruation delayed; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26256509) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Menstruation delayed) in a 30-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MENSTRUATION DELAYED (Menstruation delayed) (seriousness criterion medically significant). At the time of the report, MENSTRUATION DELAYED (Menstruation delayed) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment drug information was not provided. Following the moderna vaccination Patient did not have a period as normal. Patient have never missed a period and there was no possibility patient could be pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 30-year-old female patient with no relevant medical history, who experienced unexpected event of Menstruation delayed. The event occurred 3 days after the third dose of mRNA-1273 vaccine. It was reported that following the moderna vaccination patient did not have a period as normal. Patient have never missed a period and there was no possibility patient could be pregnant. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 30-year-old female patient with no relevant medical history, who experienced unexpected events of Menstruation delayed. The event occurred 3 days after the third dose of mRNA-1273 vaccine. It was reported that following the moderna vaccination patient did not have a period as normal. Patient have never missed a period and there was no possibility patient could be pregnant. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930683 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; BENDROFLUAZIDE; CETIRIZINE; FOSTAIR; INFLUENZA VIRUS; LOSARTAN POTASSIUM; MONTELUKAST; RHINOCORT AQUA; SIMVASTATIN
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach pain; Joint ache; Stiffness; Muscle ache; Nausea; Fever; Chills; Tiredness; This case was received (Reference number: GB-MHRA-ADR 26257364) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), ARTHRALGIA (Joint ache), MUSCULOSKELETAL STIFFNESS (Stiffness), MYALGIA (Muscle ache), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. Concomitant products included BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR) and MONTELUKAST for Asthmatic, BENDROFLUMETHIAZIDE (BENDROFLUAZIDE) and LOSARTAN POTASSIUM for Blood pressure, SIMVASTATIN for Cholesterol, CETIRIZINE and BUDESONIDE (RHINOCORT AQUA) for Multiple allergies, AMITRIPTYLINE and INFLUENZA VACCINE (INFLUENZA VIRUS) from 18-Sep-2021 to an unknown date for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 20-Nov-2021, ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 25-Nov-2021, ARTHRALGIA (Joint ache), MUSCULOSKELETAL STIFFNESS (Stiffness) and MYALGIA (Muscle ache) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Treatment information was not provided by reporter. It was also reported vaccine given in the afternoon of the 18th November, during the night experienced nausea, stomach pains, muscle and joint aches and found it difficult to even stand felt so ill. The next day was unable to eat although the nausea and stomach pains were easing - spent most of this day asleep as felt so ill and was exhausted. As the day wore on developed a slight fever and chill, temperature had raised and took some paracetamol to help reduce it. Since then slowly started to improve but the muscle and joint aches were still persistent 5 days after. It is now 8 days since the vaccination and although feeling a lot better still tire very easily. Patient is not enrolled in clinical trial Company comment: This case concerns a 66-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of abdominal pain upper, arthralgia, musculoskeletal stiffness, myalgia, nausea, pyrexia, fatigue and chills. The events occurred one day after the third dose of mRNA-1273 and are currently recovered. The rechallenge is unknown, according to SD. The concomitant medication amitriptyline may suggest a chronic pain disorder, that could be a confounder for the events. 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 66-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of abdominal pain upper, arthralgia, musculoskeletal stiffness, myalgia, nausea, pyrexia, fatigue and chills. The events occurred one day after the third dose of mRNA-1273 and are currently recovered. The rechallenge is unknown, according to SD. The concomitant medication amitriptyline may suggest a chronic pain disorder, that could be a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1930765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery spasm; Coronavirus disease 2019; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101697354

Write-up: Pins and needles; Dose 3; 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-202111292039016590-ERMDC (RA). Other Case identifier(s): GB-MHRA-ADR 26266998 (RA). A female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "Coronary artery spasm" (unspecified if ongoing); "Coronavirus disease 2019", start date: 2019 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 11May2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Dose 3"; PARAESTHESIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pins and needles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. It was reported that the patient experienced continuous pins and needles in right hand (vaccination was in the opposite arm). Initially pins and needles were in both the right hand and arm. At the time of this report the patient had symptoms primarily just in the right hand but sometimes in the left hand. The patient had not tested positive for COVID-19, since having the vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101722981 Same patient/different dose/different events


VAERS ID: 1930887 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31100TB / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101688947

Write-up: booster; PARESTHESIA HALF FACE LEFT; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-813352 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 19Nov2021 08:42 (Lot number: 31100TB) at the age of 59 years 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 (1st dose, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (2nd dose, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 19Nov2021 08:42, outcome "unknown", described as "booster"; PARAESTHESIA (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "PARESTHESIA HALF FACE LEFT". The events "booster" and "paresthesia half face left" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of immunisation, paraesthesia. Actions taken (access to emergency room with consequent administration of trimeton vials (intramuscular) flebocortid vials (intravenous). No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930911 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0108 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Eyelid oedema, Respiratory disorder, Stridor, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101648678

Write-up: anaphylaxis; Stridor; upper airway swelling; pharynx closed sensation of; eyelid oedema; This is a spontaneous report from a contactable Pharmacist received from the regulatory authority. Regulatory authority report number is v21131565. The patient was a 53-year-old female(age at the 2nd vaccination). Body temperature before vaccination was 36.4 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status): Allergy to several drugs and food. On 19Nov2021 at 12:37 (the day of the 2nd vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number FK0108 & Expiration date 30Apr2022) at the age of 53-years-old, via an unspecified route of administration as a dose 2, single for COVID-19 immunization. On 19Nov2021 at 12:49 (same day of the 2nd vaccination), stridor, upper airway swelling, pharynx closed sensation of, eyelid oedema occurred. On 20Nov2021 (1 day after the 2nd vaccination), the outcome of the event was Recovered. The course of the event was as follows: The above symptoms developed after receiving the vaccine. And after that, the patient was treated with drugs including steroid and adrenaline. Although the symptoms other than eyelid oedema was recovering, it was considered that the patient had risks for onset of anaphylaxis and worsening to serious condition, the patient was admitted for follow-up. The patient was discharged on the following day. The outcome of all events was recovered on 20Nov2021. The reporting Pharmacist classified the event as serious (hospitalization from 19Nov2021 to 20Nov2021) and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting Pharmacist commented as follows: None.


VAERS ID: 1931031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza, Nasal congestion, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
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.MOD20213

Write-up: Headache; Fever; Flu; Nasal congestion; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26262523) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), INFLUENZA (Flu) and NASAL CONGESTION (Nasal congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant) and NASAL CONGESTION (Nasal congestion) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Headache) and NASAL CONGESTION (Nasal congestion) was resolving and INFLUENZA (Flu) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by the reporter. Treatment information was not provided Company Comment: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of Headache, Pyrexia. Influenza, and Nasal Congestion. The events, which were medically significant occurred approximately 2-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of Headache, Pyrexia. Influenza, and Nasal Congestion. The events, which were medically significant occurred approximately 2-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1931808 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-11-19
   Days after vaccination:279
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER AB0011 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL; AMITRIPTYLINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210925; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen arm; This case was received via RA (Reference number: GB-MHRA-ADR 26264669) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Concomitant products included ATENOLOL from 11-Jul-2003 to an unknown date and AMITRIPTYLINE from 11-Jul-2003 to an unknown date for Vestibular migraine. On 13-Feb-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 01-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 20-Nov-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided by the reporter. Patient was not enrolled in clinical trial Company Comment : This is a regulatory case concerning a 68-year-old female patient with medical history of vestibular migraine, who experienced the unexpected event of peripheral swelling. A co-suspect product in this case is the Covid-19 AstraZeneca vaccine. The event occurred approximately 2 days after the third dose of mRNA � 1273 vaccine. Peripheral swelling was reported as medically significant but resolved after only 1 day upon occurrence. The rechallenge was unknown since the first two doses were of a different brand. 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 68-year-old female patient with medical history of vestibular migraine, who experienced the unexpected event of peripheral swelling. A co-suspect product in this case is the Covid-19 AstraZeneca vaccine. The event occurred approximately 2 days after the third dose of mRNA � 1273 vaccine. Peripheral swelling was reported as medically significant but resolved after only 1 day upon occurrence. The rechallenge was unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1933656 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-08
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:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: CZPFIZER INC202101666870

Write-up: PCR confirmed positivity SARS-CoV2; PCR confirmed positivity SARS-CoV2; patient recevied dose 3 booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 50 years 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. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "PCR confirmed positivity SARS-CoV2"; IMMUNISATION (medically significant) with onset 19Nov2021, described as "patient received dose 3 booster". The patient had symptoms include cold, nausea, fatigue, headache and back pain. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) positive. Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with covid prior to vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1933781 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, Venous thrombosis limb
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101696638

Write-up: Pain in arm; Thrombosis venous arm; Hand swelling; This is a spontaneous report received from a contactable reporter Consumer or other non-health care professional from the RA. Regulatory number: FI-FIMEA-20217151 (RA). A 57-years-old male patient received BNT162B2 (Comirnaty, solution for injection, Batch/Lot: unknown), via unspecified route of administration on unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient medical history and concomitant medications not reported. On 19Nov2021 patient experienced pain in the arm and the next day the whole blood vessel blackened in the arm where a thrombosis was noticed. In addition, the hand was swollen. Outcome of events was recovering.


VAERS ID: 1933893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Limb discomfort, Lymphadenopathy, Pain
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101662093

Write-up: Booster; pain/sore to touch; Swallon armpit lymph node; Axillary pain; make it difficult enough to rest your arm by your side properly; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-APPCOVID-20211123070459 (RA). Other Case identifier(s): GB-MHRA-ADR 26236607 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19, not had a COVID-19 test and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Swallon armpit lymph node". The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 2021, outcome "recovering", described as "pain/sore to touch"; LYMPHADENOPATHY (medically significant) with onset 2021, outcome "recovered" (2021), described as "Swallon armpit lymph node"; AXILLARY PAIN (medically significant) with onset 2021, outcome "unknown", described as "Axillary pain"; LIMB DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "make it difficult enough to rest your arm by your side properly". The events "pain/sore to touch", "swallon armpit lymph node", "axillary pain" and "make it difficult enough to rest your arm by your side properly" were evaluated at the physician office visit. Clinical course: The reaction occurred in the armpit on the side the vaccine was given. The lump was very big, about the size of a Tennis Ball. It was sore to touch and was large enough to make it difficult enough to rest arm by side properly. If the person lie on that side at night accidentally the pain will wake person as the lump is compressed into your body. The patient called her doctor the first time it happened as she was not sure what it was and was concerned she had developed a cancerous lump. After a telephone consultation and some questioning her doctor said it was a reaction to the Pfizer jab. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-11-19
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Fatigue, Myocarditis, 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), 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: Blood test; Result Unstructured Data: Test Result:high troponin; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654385

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Myopericarditis; 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-202111220125355880-GVSWY. Other Case identifier(s): GB-MHRA-ADR 26233091. A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 01Sep2021 (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: MYOCARDITIS (caused and prolonged hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Myopericarditis"; FATIGUE (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: blood test: high troponin; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient had not symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms were lead to a hospital stay. The hospital stay was for 3 days. A diagnosis made by a medical professional. The type of healthcare professional (cardiologist, GP etc) that provided this diagnosis and any specific details of the diagnosis given was confirmed as myopericarditis. There was any imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). There were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. The troponin was high. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933984 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Fatigue, Immunisation, Interchange of vaccine products, Joint stiffness, Off label use
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACLOFEN; INFLUENZA VIRUS; SERTRALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis); Stem cell therapy (Stem cell treatment for MS in 2019); Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654375

Write-up: Stiff joint; Tiredness; Lack of motivation; 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 (RA). Regulatory number: -MHRA-WEBCOVID-202111231038501910-1LS6X (RA). Other Case identifier(s): GB-MHRA-ADR 26237664 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: Taking medicines for multiple sclerosis; "Transplant" (unspecified if ongoing), notes: Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...; "Stem cell treatment", start date: 2019 (unspecified if ongoing), notes: Stem cell treatment for MS in 2019. Concomitant medication(s) included: BACLOFEN taken for multiple sclerosis; INFLUENZA VIRUS; SERTRALIN taken for multiple sclerosis. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; JOINT STIFFNESS (medically significant), outcome "recovering", described as "Stiff joint"; FATIGUE (medically significant), outcome "recovering", described as "Tiredness"; APATHY (medically significant), outcome "recovering", described as "Lack of motivation". Clinical course: Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. It was reported that, possible side effects for MS sufferers and previous stem cell patient. Patient had not tested positive for COVID-19 since having the vaccine. 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: 1933991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101654257

Write-up: Headache dull/ mild hovering headache; Less energy; Sore in the armpit same arm as vaccine site; Slight aches; Lethargy; Sore arm day 1 evening on injection site; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; Patient received booster dose of COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231157475810-5JYKO (MHRA). Other Case identifier: GB-MHRA-ADR 26238180 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK5475) as dose 3 (booster), 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 patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization 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 19Nov2021, outcome "unknown" and all described as "The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; VACCINATION SITE PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "Sore arm day 1 evening on injection site"; PAIN (medically significant) with onset 21Nov2021, outcome "unknown", described as "Slight aches"; LETHARGY (medically significant) with onset 21Nov2021, outcome "recovering", described as "Lethargy"; ASTHENIA (medically significant) with onset 22Nov2021, outcome "unknown", described as "Less energy"; AXILLARY PAIN (medically significant) with onset 22Nov2021, outcome "unknown", described as "Sore in the armpit same arm as vaccine site"; HEADACHE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Headache dull/ mild hovering headache". It had stopped her from doing anything other than rest and eat or drink. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative. Patient did not take relevant investigations or tests. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1934011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: African trypanosomiasis, Amnesia, Asthenia, Cardiac flutter, Fatigue, Feeling abnormal, Headache, Immunisation, Interchange of vaccine products, Malaise, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Somnolence
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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: QVAR; ZOPICLONE; AMITRIPTYLINE; LOPERAMIDE; LANSOPRAZOLE; CITALOPRAM; BUSPIRONE; SALBUTAMOL; MULTIVITAMIN [VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Stoma site bleeding; Suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped); Ulcerative colitis (removal of large intestines due to ulcerative colitis)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101662125

Write-up: Headache/severe head ache all over my head; Sleeping sickness; Heart fluttering; Off label use; Interchange of vaccine products; Booster; Heart palpitations; Sleeping more than usual/sleepy; spaced out feeling/feeling of dying; Fatigue/absolutely exhausted; Feel weak; feeling very unwell; lost with no memory; Myocarditis; Pericarditis; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111231837196930-PSXWS (MHRA). Other Case identifier: GB-MHRA-ADR 26240169 (MHRA). A 51-year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ulcerative colitis", notes: removal of large intestines due to ulcerative colitis, taking, Loperamide to try and slow down my digestion; "Stoma"; "Suspected COVID-19", notes: Unsure when symptoms started, Unsure when symptoms stopped; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.... Concomitant medications included: QVAR; ZOPICLONE; AMITRIPTYLINE; LOPERAMIDE; LANSOPRAZOLE; CITALOPRAM; BUSPIRONE; SALBUTAMOL; MULTIVITAMIN. Past drug history included: Lansoprazole; Citalopram; Zopiclone; Qvar; Amitriptyline; Buspirone. Vaccination history included: COVID-19 vaccine astrazeneca, administration date: May2021, for COVID-19 Immunisation; COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (disability) with onset 2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 2021, outcome "unknown", described as "Booster"; AFRICAN TRYPANOSOMIASIS (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Sleeping sickness"; CARDIAC FLUTTER (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Heart fluttering"; HEADACHE (disability) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Headache/severe head ache all over my head"; PALPITATIONS (disability) with onset 2021, outcome "unknown", described as "Heart palpitations"; SOMNOLENCE (disability) with onset 2021, outcome "unknown", described as "Sleeping more than usual/sleepy"; FEELING ABNORMAL (disability) with onset 2021, outcome "recovering", described as "spaced out feeling/feeling of dying"; FATIGUE (disability) with onset 2021, outcome "recovering", described as "Fatigue/absolutely exhausted"; ASTHENIA (disability) with onset 2021, outcome "unknown", described as "Feel weak"; MALAISE (disability) with onset 2021, outcome "recovering", described as "feeling very unwell"; AMNESIA (disability) with onset 2021, outcome "recovered" (2021), described as "lost with no memory"; MYOCARDITIS (disability) with onset 2021, outcome "unknown", described as "Myocarditis"; PERICARDITIS (disability) with onset 2021, outcome "unknown", described as "Pericarditis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course: Heart palpitations, day 5 to day 11 (today). Sleeping more than usual between day 7 and day 11 (today), after booster vaccination, 2 days lost with no memory. Day 11, feeling very unwell, woke up with severe head ache all over his head, absolutely exhausted, sleepy, spaced out feeling, feeling of dying. Improving in the evening but still feel weak. Taking, Loperamide to try and slow down his digestion. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Symptoms didn''t lead to a hospital stay. No imaging or blood tests were carried out. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934039 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue, Immunisation, Insomnia, Interchange of vaccine products, Nasopharyngitis, Off label use, Pain, Pain in extremity, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101662095

Write-up: felt very breathless; aching in both hands and arms; I felt very tired; felt faint; weak all day; vomited; cold; generally achy; Off label use; interchange of vaccine products; Booster; I didn''t sleep at all; Shivering; 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-202111241806111880-BFRWE. Other Case identifier(s): GB-MHRA-ADR 26245807. A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) at the age of 75 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine (Dose 1, single, (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Single, (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "recovering", described as "felt faint"; NASOPHARYNGITIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "cold"; PAIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "generally achy"; DYSPNOEA (medically significant) with onset 22Nov2021, outcome "unknown", described as "felt very breathless"; FATIGUE (medically significant) with onset 20Nov2021, outcome "unknown", described as "I felt very tired"; INSOMNIA (medically significant) with onset 19Nov2021, outcome "unknown", described as "I didn''t sleep at all"; ASTHENIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "weak all day"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "unknown", described as "aching in both hands and arms"; CHILLS (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Shivering"; VOMITING (medically significant) with onset 20Nov2021, outcome "recovering", described as "vomited". Clinical Course: The patient felt cold and shivery in the night after the vaccination and she was generally achy all night. She didn''t sleep at all and the next morning when she tried to get up, she felt faint and her legs very weak. Shortly after she vomited (her stomach was empty). Later in the day she had a coffee and small cake, but vomited them back. She felt very tired and weak all day. The following day she still felt tired and weak, and had to rest and temporarily developed aching in both hands and arms. She was able to eat a little. The day after that she was feeling slightly better, but after the slightest exertion her legs seemed to turn to jelly, and she felt very breathless for quite a while after. Similarly the following day. By day 6, she was more or less back to normal. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed; No further information is expected.


VAERS ID: 1934094 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cough, Headache, Hyperglycaemia, Nasal congestion, Nausea, Oropharyngeal pain, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GUAIFENESIN
Current Illness: Type 1 diabetes mellitus (Type 1 diabetes)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint ache; Nasal congestion; Shivers; Cough; Hyperglycaemia; Sore throat; Nausea; Vomiting; Headache; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 26260778) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Hyperglycaemia), OROPHARYNGEAL PAIN (Sore throat), ARTHRALGIA (Joint ache), COUGH (Cough), NASAL CONGESTION (Nasal congestion), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Shivers) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetes). Concomitant products included GUAIFENESIN for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycaemia) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and COUGH (Cough) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant), NASAL CONGESTION (Nasal congestion) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On 21-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, HYPERGLYCAEMIA (Hyperglycaemia), OROPHARYNGEAL PAIN (Sore throat), ARTHRALGIA (Joint ache), COUGH (Cough), NASAL CONGESTION (Nasal congestion), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Shivers) 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. Patient not had symptoms associated with COVID-19. It was reported patient was type 1 diabetic, had been following sick day rules to try to get blood glucose under control for over a week. And was Trying to manage other issues with OTC medicines (paracetamol, guaifenesin). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a patient with relevant medical history of diabetes mellitus type 1, who experienced serious unexpected events of nausea, vomiting, hyperglycemia, oropharyngeal pain, cough, nasal congestion, arthralgia and chills. The events occurred approximately within 24 hours, 1 and 2 days after the third dose of the mRNA-1273, respectively. The rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. Patient''s concurrent condition of diabetes mellitus type 1 is a possible confounder for the event of hyperglycemia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a patient with relevant medical history of diabetes mellitus type 1, who experienced serious unexpected events of nausea, vomiting, hyperglycemia, oropharyngeal pain, cough, nasal congestion, arthralgia and chills. The events occurred approximately within 24 hours, 1 and 2 days after the third dose of the mRNA-1273, respectively. The rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. Patient''s concurrent condition of diabetes mellitus type 1 is a possible confounder for the event of hyperglycemia. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1934138 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Muscle soreness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26257536) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26257536) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (Muscle soreness) (seriousness criterion medically significant). On 20-Nov-2021, MYALGIA (Muscle soreness) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Treatment Medication use information was not provided by reporter.; Sender''s Comments: This is a regulatory case concerning a 67-year-old male patient with no reported medical history, who experienced the serious (medically significant) event Myalgia, the next following day after the third dose of mRNA-1273. Events seriousness captured as per Regulatory Authority assessment in Source Document.. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1934235 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Haematoma, Paraesthesia, Sense of oppression, Tachycardia, Visual impairment
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101702537

Write-up: Haematoma; Tightness in chest; Tingling in the arms; decreased vision; tachycardia; Tingling in the arms hematoma right hand tachycardia hematoma left side tightness Chest decreased vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IT-MINISAL02-814733 (RA). A 46 year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: 1F1008A, Expiration Date:31Dec2021),via intramuscular route of administration in arm left, on 15Nov2021, as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. It was reported that on 19Nov2021,The patient experienced Tingling in the arms hematoma right hand tachycardia hematoma left side tightness Chest decreased vision. The reporter also stated that Speaking with doctor of the vaccination hub Tomorrow emergency room) - Impact on quality of life (8/10).The outcome of the events HAEMATOMA (life threatening), CHEST DISCOMFORT (life threatening), PARAESTHESIA (life threatening), VISUAL IMPAIRMENT (life threatening), TACHYCARDIA (life threatening), "; SENSE OF OPPRESSION (life threatening) were reported as not recovered. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: allergy penicillin


VAERS ID: 1934343 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Blood pressure; Result Unstructured Data: Test Result: 160/100.
CDC Split Type: PHPFIZER INC202101663513

Write-up: This is a spontaneous report received from a contactable other HCP, via the regulatory authority (PH-PHFDA-300120600). A 37-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# PCB0002), at the age of 37, intramuscularly, on Nov 19, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient had increased blood pressure/elevated BP: 160/100 (medically significant), onset Nov 19, 2021, at 12:10, with outcome of recovered (Nov 19, 2021). The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 160/100. No follow-up attempts possible. No further information expected.


VAERS ID: 1934344 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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 Date: 20211119; Test Name: Blood pressure; Result Unstructured Data: Test Result:170/100 mmHg; Comments: 11:30
CDC Split Type: PHPFIZER INC202101663531

Write-up: ELEVATED BP (170/100); This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120597 Regulatory Authority. A 41 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: PCB0002) at the age of 41 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: BLOOD PRESSURE INCREASED (medically significant) with onset 19Nov2021 11:30, outcome "recovered" (19Nov2021), described as "ELEVATED BP (170/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 170/100 mmHg, notes: 11:30. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1934679 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004975 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Taking omeprazole; Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Frontal headache; Fever; Shivering; Painful arm; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26262820) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frontal headache), PYREXIA (Fever), CHILLS (Shivering) and PAIN IN EXTREMITY (Painful arm) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004975) for an unknown indication. Taking omeprazole Patient has not had symptoms associated with COVID-19. Previously administered products included for Product used for unknown indication: OMEPRAZOLE. Past adverse reactions to the above products included No adverse event with OMEPRAZOLE. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 09-Mar-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 17-Sep-2021 to an unknown date for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 20-Nov-2021, HEADACHE (Frontal headache), PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 24-Nov-2021, PAIN IN EXTREMITY (Painful arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medications were reported.; Sender''s Comments: This case concerns a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected events of headache, pyrexia, pain in extremity and chills one day after the third dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1937249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Condition aggravated, Immunisation, Interchange of vaccine products, Off label use, Postmenopausal haemorrhage, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT; Postmenopausal bleeding
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood tests; Result Unstructured Data: Test Result: normal; Test Date: 2021; Test Name: hysteroscopy and pelvic scan; Result Unstructured Data: Test Result: everything was fine.
CDC Split Type: GBPFIZER INC202101670797

Write-up: Off label use; Interchange of vaccine products; Booster; Post menopausal bleeding; getting worse each month like having a period again; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). The Regulatory number GB-MHRA-APPCOVID-202111252029588030-OPPRQ, other case identifier GB-MHRA-ADR 26253644. A 64 year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fk0596) as dose 3 (booster) single for COVID-19 immunisation. Relevant medical history included HRT (Hormone replacement therapy) (unspecified if ongoing); Postmenopausal, start date: Jun2021 (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test nor 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 astrazeneca (Dose 1, single, Lot number- Pv46664, Primary Immunization series complete), administration date 24Feb2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2, single, Lot number- 46688, Primary Immunization series complete), administration date: 12May2021, for COVID-19 immunisation, reaction Bleeding. The following information was reported OFF LABEL USE (medically significant) with onset 19Nov2021, outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome unknown; IMMUNISATION (medically significant) with onset 19Nov2021, outcome unknown; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 2021, outcome not recovered; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome not recovered. Patient report that she had post menopausal bleeding started in June that was only a small show but happened again in august and was fast tracked for investigation. All was clear and was advised to change tweak HRT which she have been on for a while pre vaccine and no problems. Now getting almost a monthly cycle and since booster have bleeding 9 days and getting significantly heavier. She is tweaking HRT but according to Health who she was under for HRT treatment said that she was not the first to whom was this has happened. It is getting worse each month like having a period again. The patient underwent the following laboratory tests and procedures: blood test: (2021) normal; scan: (2021) everything was fine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1937282 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysstasia, Hypoaesthesia, Monoplegia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; LANSOPRAZOLE; PAROXETINE; THEICAL D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal; Cognitive impairment; Nervous system disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101661547

Write-up: Hypoaesthesia; Dysstasia; Leg paralysis; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority. Regulatory number: GB-MHRA-TPP10616005C7797340YC1637317156272. Other Case identifier(s): GB-MHRA-ADR 26239968. A 79-year-old female patient received BNT162B2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Nervous system disorder" (unknown if ongoing); "Cognitive disorder" (unknown if ongoing); "Blood cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal, start date: 19Jul2021; LANSOPRAZOLE, start date: 19Jul2021; PAROXETINE, start date: 19Jul2021, stop date: 19Nov2021; THEICAL D3, start date: 19Jul2021. The following information was reported: MONOPLEGIA (disability, medically significant) with onset 19Nov2021, outcome "recovered", described as "Leg paralysis"; HYPOAESTHESIA (disability, medically significant), outcome "unknown", described as "Hypoaesthesia"; DYSSTASIA (disability, medically significant), outcome "unknown", described as "Dysstasia". Clinical course patient could not feel legs, numb, paraylsis, was unable to stand. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937359 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Immunisation, Interchange of vaccine products, Lower respiratory tract infection, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (broad), Infective pneumonia (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: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661675

Write-up: chest infection; Chest pain; Cough; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111240924097080-NTCAN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26242304 (MHRA). A 30 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose 1), for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; LOWER RESPIRATORY TRACT INFECTION (medically significant), outcome "not recovered", described as "chest infection"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Chest pain"; COUGH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of lower respiratory tract infection, chest pain. Clinical course included: Since receiving the vaccine the patient have had to attend the GP surgery in relation to chest pain under his left breast. Doctor states this is likely a chest infection. He was being treated with a strong course of antibiotics. Should this not work he was being referred to an ECG due to possible heart issues due to the Pfizer vaccine. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937398 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Fatigue, Headache, Immunisation, Interchange of vaccine products, Night sweats, Off label use, Pain, Pain in extremity, SARS-CoV-2 test, Somnolence, Sweating fever, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma aggravated; Blood pressure high; Cold; Flu; Labyrinthitis (labrynthitis for the previous 2 weeks); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201218; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101661935

Write-up: pain; Feeling of total lack of energy; Pain in arm; Injection site pain/a pain run over the top of my shoulder and up my neck 30 minutes after the injection; Headache; Joint ache; Chills; Decreased appetite; Sleepy; Tiredness; Sweating fever; Night sweat; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111241247572570-P7YL0 (RA). Other Case identifier(s): GB-MHRA-ADR 26243789 (RA). A 62-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Cold" (unspecified if ongoing); "Flu" (unspecified if ongoing); "Suspected COVID-19", start date: 18Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "labrynthitis" (unspecified if ongoing), notes: labrynthitis for the previous 2 weeks; "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: CANDESARTAN taken for hypertension, start date: 25Oct2021; LERCANIDIPINE taken for hypertension. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 06Mar2021, for Covid-19 immunization; Covid-19 vaccine astrazeneca (Dose 2), administration date: 14May2021, for Covid-19 immunization; Flu jab (had my flu jab 2 days before), administration date: Nov2021, for flu. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant), outcome "recovered", described as "pain"; SWEATING FEVER (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Sweating fever"; NIGHT SWEATS (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Night sweat"; DECREASED APPETITE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Decreased appetite"; SOMNOLENCE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Sleepy"; ASTHENIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Feeling of total lack of energy"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Pain in arm"; VACCINATION SITE PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Injection site pain/a pain run over the top of my shoulder and up my neck 30 minutes after the injection"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Joint ache"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Chills"; FATIGUE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2020) positive, notes: Yes - Positive COVID-19 test. Clinical Course: Above reactions resulted in 2 days in bed and further 1 day off work. I also had a pain run over the top of my shoulder and up my neck 30 minutes after the injection. It lasted approximately 20 minutes. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis).


VAERS ID: 1937422 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Immunisation, Influenza like illness, Interchange of vaccine products, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661722

Write-up: dizzy; aching all over; legs and arms feel like jelly; Flu-like aching; the patient received a third/booster dose; the patient received a third/booster dose; 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-202111241524576540-C6AI8. Other Case identifier(s): GB-MHRA-ADR 26244760. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (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. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "the patient received a third/booster dose "; DIZZINESS (medically significant), outcome "not recovered", described as "dizzy"; INFLUENZA LIKE ILLNESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Flu-like aching"; PAIN (medically significant), outcome "unknown", described as "aching all over"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "legs and arms feel like jelly". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course. The patient Woke up Sunday to aching all over, dizzy all the time, legs and arms feel like jelly. 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.


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