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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)

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VAERS ID: 1941523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-11-17
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C19-02 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive international unit(s)
CDC Split Type: PTJNJFOC20211220729

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, PT-INFARMED-T202111-2485] concerned a 22 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C19-02 and expiry: unknown) 0.5 ml, 1 total, administered on 16-AUG-2021 for covid-19 immunisation (Dose number in series 1). No concomitant medications were reported. On 17-NOV-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 PCR (polymerase chain reaction) test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.


VAERS ID: 1945518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-11-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Platelet count decreased, Venous thrombosis limb
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HELLP syndrome
Allergies:
Diagnostic Lab Data: Test Name: low platelets; Result Unstructured Data: Test Result:122; Comments: Gpt/l
CDC Split Type: DEPFIZER INC202101678581

Write-up: calf pain on the right; platelet count decreased: 122 Gpt/l; Leg venous thrombosis; This is a spontaneous report received from a non-contactable reporter (physician) from the Regulatory number: DE-PEI-CADR2021202540 (PEI). Other Case identifier(s): DE-CADRPEI-2021202540 (PEI Webportal), DE-PEI-202100227888 (PEI). A 35-year-old female patient received bnt162b2 (COMIRNATY), administration date 02Nov2021 (Lot number: 1F1010A) as dose number unknown, 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Zn HELLP", start date: 2014 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "intolerance". The following information was reported: VENOUS THROMBOSIS LIMB (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Leg venous thrombosis"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "calf pain on the right"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "platelet count decreased: 122 Gpt/l". The patient underwent the following laboratory tests and procedures: platelet count decreased: 122, notes: Gpt/l. Therapeutic measures were taken as a result of venous thrombosis limb, pain in extremity, platelet count decreased. Additional information: Information on risk factors or pre-existing conditions. Days after vaccination sudden. Calf pain on the right. Diagnostics a few days later. Conspicuous. Further laboratory checks are pending. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1945523 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematoma, Haemorrhage, Immunisation, Petechiae, Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Thrombocytes; Result Unstructured Data: Test Result:< 1000
CDC Split Type: DEPFIZER INC202101678551

Write-up: Petechia; Thrombocytopenia; BOOSTER; Hematoma; bleeding; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021202905 . Other Case identifier(s): DE-CADRPEI-2021202905 (Web portal), DE-PEI-202100227645. A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster 0.3ml, 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: PETECHIAE (hospitalization) with onset 21Nov2021, outcome "not recovered", described as "Petechia"; THROMBOCYTOPENIA (hospitalization) with onset 21Nov2021, outcome "not recovered", described as "Thrombocytopenia"; HAEMATOMA (non-serious), outcome "unknown", described as "Hematoma"; HAEMORRHAGE (non-serious), outcome "unknown", described as "bleeding"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "BOOSTER". The patient underwent the following laboratory tests and procedures: platelet count: < 1000. Therapeutic measures were taken as a result of petechiae, thrombocytopenia, haematoma, haemorrhage. Additional information: It was reported that patient had inpatient stay on the surveillance ward. Administration of cortisone shock therapy, platelet concentrate, and Octagam therapy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1945638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Electrocardiogram, Muscular weakness, Myocarditis, Pain, Pyrexia, Troponin T, Troponin T increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ecg; Result Unstructured Data: Test Result:UNKNOWN RESULT; Test Date: 20211117; Test Name: tnt; Result Unstructured Data: Test Result:40
CDC Split Type: FIPFIZER INC202101679136

Write-up: screwdrivers under my ribs twisting my insides; When breathing, stinging on the left side; Chills; Lower extremities weakness of/legs do not support; Arthralgia/joint aches; Troponin T increased/TnT: 40; Myocarditis; Pyrexia/fever; Chest pain/chest feels like being run over by a roller/Strong chest pain on the left side when leaning forwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: FI-FIMEA-20216912. A 22 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for covid-19 immunisation. The following information was reported: CHILLS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chills"; MUSCULAR WEAKNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Lower extremities weakness of/legs do not support"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Arthralgia/joint aches"; TROPONIN T INCREASED (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Troponin T increased/TnT: 40"; MYOCARDITIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Myocarditis"; PYREXIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pyrexia/fever"; CHEST PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chest pain/chest feels like being run over by a roller/Strong chest pain on the left side when leaning forwards"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "screwdrivers under my ribs twisting my insides"; PAIN (non-serious), outcome "unknown", described as "When breathing, stinging on the left side". The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) unknown result; troponin t: (17Nov2021) 40. Additional Information: "suspected myocarditis, new tests later this week. Vaccine 2/2". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1945784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Fatigue, Immunisation, Lymphadenopathy, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: blood test; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101695862

Write-up: Chest pain; Fatigue/unusual tiredness; Heart palpitations; Shortness of breath; Swollen lymph nodes; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202111212317172670-KW0XV. Other Case identifier(s): GB-MHRA-ADR 26233047. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 and Dose 2), for COVID-19 immunization. Patient is not pregnant, Patient is not currently breastfeeding, Patient is not enrolled in clinical trial. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; DYSPNOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Shortness of breath". Covid-19 was suspected, therefore on 18Nov2021 the patient underwent sars-cov-2 test with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1945787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101688831

Write-up: Chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202111221249206440-ERIOS (RA). Other Case identifier(s): GB-MHRA-ADR 26234444 (RA). A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH0114) 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 05Nov2021. The following information was reported: CHEST PAIN (medically significant) with onset 17Nov2021, outcome "unknown", described as "Chest pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Chest pain that settled overnight. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. This report relate to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. Diagnosis was not made by a medical professional. Patient not contacted GP or treating physician. Any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were not taken. There had been not any other recent or ongoing illness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1945892 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Body temperature, Body temperature fluctuation, Dyspepsia, Dyspnoea, Fatigue, Feeling abnormal, Feeling of body temperature change, Heart rate, Heart rate abnormal, Muscular weakness, Palpitations, Paraesthesia, Pyrexia, SARS-CoV-2 test, Sensation of foreign body, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Body temperature; Result Unstructured Data: Test Result:fluctuation; Test Date: 20211117; Test Name: Heart rate; Result Unstructured Data: Test Result:abnormal; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101697819

Write-up: Heart palpitations; Racing heart (tachycardia); Feeling abnormal; Sensation of foreign body/felt like something was stuck in her pipe; Balance disorder/unsteady; Fever; indigestion; suddenly feel hot, or cold; pins and needles; Body temperature fluctuation; Muscle weakness; Tiredness; Short of breath; Heart rate abnormal; 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-202111281110214800-XYBBG. Other Case identifier(s): GB-MHRA-ADR 26262900. A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FK5475) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Additional information: Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication(s) included: CO-CODAMOL taken for pain. The following information was reported: PARAESTHESIA (medically significant), outcome "not recovered", described as "pins and needles"; HEART RATE ABNORMAL (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Heart rate abnormal"; BODY TEMPERATURE FLUCTUATION (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Body temperature fluctuation"; MUSCULAR WEAKNESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle weakness"; DYSPNOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Short of breath"; FATIGUE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Tiredness"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "Feeling abnormal"; SENSATION OF FOREIGN BODY (medically significant), outcome "unknown", described as "Sensation of foreign body/felt like something was stuck in her pipe"; BALANCE DISORDER (medically significant), outcome "unknown", described as "Balance disorder/unsteady "; PYREXIA (medically significant), outcome "unknown", described as "Fever"; DYSPEPSIA (medically significant), outcome "unknown", described as "indigestion"; FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "unknown", described as "suddenly feel hot, or cold". Case narrative: Body temperature fluctuation. Fever. Heart rate abnormal. Muscle weakness. Palpitations. Pins and needles. Tachycardia. Tiredness. Not yet contacted her doctor. Symptoms seem to come and go, but a consistent underlying feeling of not being quite right. Her heart felt out of sorts. Sometimes it felt like something was stuck in her pipe, a bit like indigestion. Will be incredibly short lived and not after having eaten. She will suddenly become short of breath, even if not moving around. Tying her laces caused her to need a minute or two to recover before getting up and moving around. Walking upstairs can catch her breath and talking too. She may suddenly feel hot, or cold. She can feel unsteady at times, like not enough blood was circulating, and can have a fuzzy pins and needles sensation in her hands and feet. It''s very uncomfortable and bothersome. No pain in her chest. Relevant investigations or tests conducted: Not yet approached her GP yet, but she will. The symptoms did not lead to a hospital stay. Not yet resolved or investigated, so didn''t yet know the outcome. No diagnosis made by a medical professional. Patient has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. The patient underwent the following laboratory tests and procedures: body temperature: (23Nov2021) fluctuation; heart rate: (17Nov2021) abnormal; sars-cov-2 test: (unspecified date) no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1945977 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Immunisation, Lymphadenopathy, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMOXIFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy (Had chemotherapy 5 years ago for breast cancer); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101689453

Write-up: swollen gland; It felt like someone had stamped on my collar bone; Headache; Glands swollen; Tiredness; Ache; Swollen arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111282142134880-MUXXB (RA). Other Case identifier(s): GB-MHRA-ADR 26263325 (RA). A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Chemotherapy" (unspecified if ongoing), notes: Had chemotherapy 5 years ago for breast cancer; "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Concomitant medication(s) included: INFLUENZA VIRUS taken for antiviral prophylaxis, administration date 19Oct2021; TAMOXIFEN taken for breast cancer female, start date: 15Nov2016. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "swollen gland"; PAIN (medically significant) with onset 17Nov2021, outcome "recovered" (22Nov2021), described as "Ache"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "recovered" (23Nov2021), described as "Glands swollen"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Tiredness"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; PERIPHERAL SWELLING (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Swollen arm"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "It felt like someone had stamped on my collar bone". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient last menstrual period date was 06Nov2021. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The swollen gland in her neck was enormous and extremely painful for days. It felt like someone had stamped on her collar bone. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1946039 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKU596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, Peripheral coldness, SARS-CoV-2 test, Skin discolouration, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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: Allergic asthma (Diagnosed with allergic asthma); Clinical trial participant (Study details:); Osteoporosis (Diagnosed with osteoporosis); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
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 INC202101697838

Write-up: violently/vomiting; flu like symptoms; shaking; feeling very weak; Off label use; Interchange of vaccine products; Booster; Shaking of hands; Fingers cold feeling of/hands and fingers turning white and feeling very cold; hands and fingers turning white and feeling very cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111291104351920-CXSDA. Other Case identifier(s): GB-MHRA-ADR 26264840. A 66-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FKU596) at the age of 66 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "Allergic asthma" (unspecified if ongoing), notes: diagnosed with allergic asthma; "Osteoporosis" (unspecified if ongoing), notes: diagnosed with osteoporosis; "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Clinical trial participant" (unspecified if ongoing), notes: Study details: (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine Astrazeneca (Dose 1), for COVID-19 immunisation, reactions: "felt very weak", "flu like symptoms", "hands and fingers turning white and feeling very cold", and "shaking violently"; 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant), outcome "not recovered", described as "violently/vomiting"; INFLUENZA LIKE ILLNESS (medically significant), outcome "not recovered", described as "flu like symptoms"; TREMOR (medically significant), outcome "not recovered", described as "shaking"; TREMOR (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Shaking of hands"; PERIPHERAL COLDNESS (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Fingers cold feeling of/hands and fingers turning white and feeling very cold"; SKIN DISCOLOURATION (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "hands and fingers turning white and feeling very cold"; and ASTHENIA (medically significant), outcome "unknown", described as "feeling very weak". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that the patient had the same reaction with first AZ vaccine and Pfizer booster: shaking violently, hands and fingers turning white and feeling very cold. Following day, flu like symptoms and feeling very weak. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946088 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Influenza like illness, Muscular weakness, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101697901

Write-up: Throbbing headache; Flu-like aching; Feverish; Frequent headaches; Muscular weakness; Off-label use; 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-202111291756351350-HJKZV. Other Case identifier(s): GB-MHRA-ADR 26266357. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient is not pregnant nor currently breastfeeding. Vaccination history included: dose 1 & 2 of Bnt162b2 for COVID-19 immunisation. The patient experienced throbbing headache, flu-like aching, feverish, frequent headaches & muscular weakness on 18Nov2021. The events were considered medically significant. The patient was recovering from the events. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (19Nov2021) negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1946378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-11-17
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardiomegaly, Myocardial ischaemia
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

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: ITPFIZER INC202101702413

Write-up: dilated hypokinetic ischemic heart disease; dilated hypokinetic ischemic heart disease; acute pulmonary edema in dilated hypokinetic ischemic heart disease; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-814935 (MINISAL02). A 65-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 26May2021 18:50 (Lot number: FC2229, Expiration Date: 30Sep2021) as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), for covid-19 immunisation. The following information was reported: ACUTE PULMONARY OEDEMA (life threatening) with onset 17Nov2021, outcome "unknown", described as "acute pulmonary edema in dilated hypokinetic ischemic heart disease"; CARDIOMEGALY (life threatening), MYOCARDIAL ISCHAEMIA (life threatening), outcome "unknown" and all described as "dilated hypokinetic ischemic heart disease". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-11-17
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-GAD antibody, Blood glucose, Glycated albumin, Glycosylated haemoglobin, Insulin C-peptide, Investigation, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: anti-GAD antibody; Result Unstructured Data: Test Result:116.1; Test Date: 20211117; Test Name: Blood glucose level at any time; Test Result: 248 mg/dl; Test Date: 20211117; Test Name: glycoalbumin; Test Result: 30.3 %; Test Date: 20211117; Test Name: HbA1c; Test Result: 8.5 %; Test Date: 20211117; Test Name: CPR; Result Unstructured Data: Test Result:1.8; Test Date: 20211117; Test Name: IRI; Result Unstructured Data: Test Result:4.0
CDC Split Type: JPPFIZER INC202101707223

Write-up: Type 1 diabetes mellitus; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132020 (RA). A 36-year and 1-month-old male patient received bnt162b2 (COMIRNATY), administration date 11May2021 (the day of vaccination), (Lot number: EY2173, Expiration Date: 30Nov2021) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Vaccination history included: Comirnaty (first dose, Lot number ER7449, Expiration date 30Jun2021), administration date: 20Apr2021, for COVID-19 immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant) with onset 17Nov2021 (6 months after the vaccination), outcome "not recovered", described as "Type 1 diabetes mellitus". The event "type 1 diabetes mellitus" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: anti-gad antibody: (17Nov2021) 116.1; blood glucose: (17Nov2021) 248 mg/dl; glycated albumin: (17Nov2021) 30.3 %; glycosylated haemoglobin: (17Nov2021) 8.5 %; insulin c-peptide: (17Nov2021) 1.8; investigation: (17Nov2021) 4.0. Therapeutic measures were taken as a result of type 1 diabetes mellitus. The course of the event was as follows: From the beginning of Nov2021, Thirst, Excessive drinking and Polyuria occurred. On 17Nov2021, the patient visited the hospital, Blood glucose level at any time was 248 mg/dl, HbA1c 8.5%, glycoalbumin 30.3%, IRI 4.0, CPR 1.8, anti-GAD antibody 116.1. The patient was diagnosed with Type 1 diabetes mellitus and have introduced enhanced insulin therapy and Self Monitoring of Blood Glucose. Because of the autoimmune disease, the relevance to COVD-19 vaccination was not denied. The reporting physician classified the event as serious (Can lead to disability) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: From the beginning of Nov2021, Thirst, Excessive drinking and Polyuria occurred. On 17Nov2021, the patient visited the hospital, Blood glucose level at any time 248 mg/dl, HbA1c 8.5%, glycoalbumin 30.3%, IRI 4.0, CPR 1.8, anti-GAD antibody 116.1. The patient was diagnosed with Type 1 diabetes mellitus and have introduced enhanced insulin therapy and Self Monitoring of Blood Glucose. Because of the autoimmune disease, the relevance to COVD-19 vaccination was not denied. On 29Nov2021 (6 months after the vaccination), the outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1948911 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
SMQs:, 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: 11/17/2021; Test Name: PCR; Test Result: Positive.
CDC Split Type: DEPFIZER INC202101710145

Write-up: This is a spontaneous report received from a contactable physician (105338). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Nov 16, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient developed COVID-19/PCR positive (medically significant) and nasopharyngitis/cold symptoms (medically significant), both onset Nov 17, 2021, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov 17, 2021) positive. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender''s comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, and etc., as appropriate.


VAERS ID: 1949328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Immunisation, Interchange of vaccine products, Musculoskeletal chest pain, Myalgia, Myocarditis, Off label use, Pericarditis
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (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: DABIGATRAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712800

Write-up: Fatigue/unusual tiredness; Pain under arm pits; Myocarditis; Pericarditis; Sharp stabbing chest pain on both sides; Muscle 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 Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111291214204160-SSZ7D (MHRA). Other Case identifier(s): GB-MHRA-ADR 26265096 (MHRA). A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing). Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication(s) included: DABIGATRAN taken for atrial fibrillation, start date: Sep2021. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer, Batch/lot number: not reported), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer, Batch/lot number: not reported), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Muscle ache"; MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Sharp stabbing chest pain on both sides"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; AXILLARY PAIN (medically significant), outcome "unknown", described as "Pain under arm pits"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis". Clinical course: Pain lasted for spilt seconds. The report was related to possible inflammation of the heart (Myocarditis or pericarditis). The symptoms did not lead to a hospital stay and no diagnosis was made by a medical professional. Reportedly, there were no symptoms. No imaging was carried out such as chest X-ray, echocardiogram, cardiac MRI or chest computerised tomography (CT). It was unknown if any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Body temperature, Fatigue, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Petit mal epilepsy, Pyrexia, SARS-CoV-2 test, Sinus headache, Sleep disorder, Somnambulism
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (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 Date: 20211119; Test Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20211127; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101697502

Write-up: Absence seizure; Chronic fatigue; Sleep walking; Sleep disturbed; High temperature; Sinus headache; Vivid dreams; Swollen glands; 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-202111291624317840-57C0O. Other Case identifier(s): GB-MHRA-ADR 26265986. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) 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. Patient last menstrual period date: (04Nov2021). 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "recovering", described as "Swollen glands"; FATIGUE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Chronic fatigue"; SOMNAMBULISM (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Sleep walking"; SLEEP DISORDER (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Sleep disturbed"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "High temperature"; SINUS HEADACHE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Sinus headache"; ABNORMAL DREAMS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Vivid dreams"; PETIT MAL EPILEPSY (medically significant) with onset 21Nov2021, outcome "recovered" (26Nov2021), described as "Absence seizure". The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) high; sars-cov-2 test: (27Nov2021) negative, notes: No - Negative COVID-19 test. Absences were happening regularly and the patient had be at work and then almost nod off and wake instantly. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The reporter did not relate the event to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949449 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: cough; High temperature; Dry cough; Aches & pains in legs; Generalised muscle aches; Headache; Sore throat; Fever; Chills; This case was received (Reference number: GB-MHRA-ADR 26270272) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (cough), PYREXIA (Fever), CHILLS (Chills), PYREXIA (High temperature), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough), PAIN IN EXTREMITY (Aches & pains in legs) and MYALGIA (Generalised muscle aches) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. 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 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and COUGH (Dry cough) (seriousness criterion medically significant). On an unknown date, the patient experienced COUGH (cough) (seriousness criterion medically significant). On 18-Nov-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 19-Nov-2021, PYREXIA (Fever), CHILLS (Chills), PYREXIA (High temperature) and PAIN IN EXTREMITY (Aches & pains in legs) had resolved. On 20-Nov-2021, HEADACHE (Headache) and MYALGIA (Generalised muscle aches) had resolved. At the time of the report, COUGH (cough) and COUGH (Dry cough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Reporter mentioned that patient had Left with a cough (and a bit of phlegm) almost 2 weeks later, Patient had not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Company comment: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) events of cough. The events started the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the previous doses has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) events of cough. The events started the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the previous doses has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1949694 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Localised alternating hot and cold therapy, Malaise, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test-Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: sweating; generally unwell; Localised alternating hot and cold therapy; This case was received via RA (Reference number: GB-MHRA-ADR 26282781) on 03-Dec-2021 and was forwarded to Moderna on 03-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), MALAISE (generally unwell) and LOCALISED ALTERNATING HOT AND COLD THERAPY (Localised alternating hot and cold therapy) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-May-2020 to 11-Feb-2021 for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced LOCALISED ALTERNATING HOT AND COLD THERAPY (Localised alternating hot and cold therapy) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and MALAISE (generally unwell) (seriousness criterion medically significant). On 02-Dec-2021, LOCALISED ALTERNATING HOT AND COLD THERAPY (Localised alternating hot and cold therapy) had not resolved. At the time of the report, HYPERHIDROSIS (sweating) and MALAISE (generally unwell) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) COVID-19 virus test-Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. last date of COVID-19 VACCINE ASTRAZENECA is reported as to be 1-JAN-2021 last date of COVID-19 VACCINE ASTRAZENECA is reported as to be 11-FEB-2021 No treatment were reported. Patient is not enrolled in clinical trial COmpany Comment: This is a regulatory authority case concerning a 49-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) events of Localised alternating hot and cold therapy, malaise and hyperhidrosis. The event localised alternating hot and cold therapy occurred approximately on the day of the third dose of mRNA 1273 vaccine, the of the event�s time to onset are unknown . Patient was previously vaccinated with another brand of COVID 19 vaccine, CHADOX1 NCOV-19, last dose approximately 6 months ago. 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 49-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) events of Localised alternating hot and cold therapy, malaise and hyperhidrosis. The event localised alternating hot and cold therapy occurred approximately on the day of the third dose of mRNA 1273 vaccine, the of the event�s time to onset are unknown . Patient was previously vaccinated with another brand of COVID 19 vaccine, CHADOX1 NCOV-19, last dose approximately 6 months ago. The rechallenge is reported as unknown. The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1949846 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5778 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Headache, Pyrexia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy (Allergies); Gastritis (gastritis)
Preexisting Conditions: Comments: Allergies, Gastritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211224575

Write-up: PYREXIA; URTICARIA; HEADACHE; CHILLS; VOMITING; WEAKNESS; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, HR-HALMED-300052517] concerned a 44 year old female. Initial information was processed along with the additional information received on 13-DEC-2021. The patient''s weight was 63 kilograms, and height was not reported. The patient''s concurrent conditions included: gastritis, and allergy. The patient received covid-19 vaccine ad26.cov2.s (janssen series 1)(suspension for injection, intramuscular, batch number: ACA5778) 0.5 ml, 1 total, administered on 17-NOV-2021 for covid-19 immunisation. The duration of drug administration was 1 days. No concomitant medications were reported. On 17-NOV-2021, the patient experienced pyrexia, urticaria, headache, chills, vomiting and weakness. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. The date of outcome given was 24-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pyrexia, urticaria, headache, chills, vomiting, and weakness. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1949912 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-27
Onset:2021-11-17
   Days after vaccination:905
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Cough, Dysphagia, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use, Sensation of foreign body, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; FOLINA [FOLIC ACID]; DOBETIN [CYANOCOBALAMIN]; DIURESIX [TORASEMIDE SODIUM]; ZOFENOPRIL; COLECALCIFEROL; DELTACORTENE; OTEZLA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Arthritis rheumatoid
Allergies:
Diagnostic Lab Data: Test Name: Chest auscultation; Result Unstructured Data: Test Result:unknown results; Test Name: vital parameters; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101696092

Write-up: Off label use; interchange of vaccine products; booster; shortness of breath, difficulty in breathing; increasingly insistent cough; dysphagia; feeling of lump in the throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-813821. A 59 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 10:46 (Lot number: 1F1016A, Expiration Date: 31Jan2022) as dose 3 (booster), single for covid-19 immunisation; prednisone (DELTACORTENE), oral (Lot number: Unknown) at 5 mg 1x/day; apremilast (OTEZLA), oral since 27May2019 (Lot number: Unknown) at 60 mg 1x/day for rheumatoid arthritis. Covid-19 vaccination performed in hospital unit in a protected environment. Relevant medical history included: "Allergy" (unknown if ongoing); "Arthritis rheumatoid", start date: 01Jan2019 (unknown if ongoing). Concomitant medication(s) included: BISOPROLOL FUMARATE; FOLINA [FOLIC ACID]; DOBETIN [CYANOCOBALAMIN]; DIURESIX [TORASEMIDE SODIUM]; ZOFENOPRIL; COLECALCIFEROL. Vaccination history included: Spikevax (1st dose, lot:3000494 exp. Date 01Sep2021), administration date: 17Mar2021, for covid-19 immunisation; Spikevax (2n dose, lot:3001655 exp. Date 12Oct2021), administration date: 14Apr2021, 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"; DYSPNOEA (medically significant) with onset 17Nov2021 11:01, outcome "recovered" (18Nov2021), described as "shortness of breath, difficulty in breathing"; COUGH (medically significant) with onset 17Nov2021 11:01, outcome "recovered" (18Nov2021), described as "increasingly insistent cough"; DYSPHAGIA (medically significant) with onset 17Nov2021 11:01, outcome "recovered" (18Nov2021), described as "dysphagia"; SENSATION OF FOREIGN BODY (medically significant) with onset 17Nov2021 11:01, outcome "recovered" (18Nov2021), described as "feeling of lump in the throat". The patient underwent the following laboratory tests and procedures: auscultation: unknown results; vital signs measurement: unknown results. The action taken for prednisone and apremilast was unknown. Therapeutic measures were taken as a result of dyspnoea, cough, dysphagia, sensation of foreign body including an intravenous drip of cortisone immediately administered, vital parameters monitored for 1 hour. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Immunisation, Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Grass allergy; Mite allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101693146

Write-up: Booster; Strong feeling of nausea; Belly ache/stomach ache; Blackout/fainting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA)-WEB. Regulatory number: IT-RA-813981 (RA). A 26 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 16Nov2021 17:35 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Mites, Molds, Grasses and pollens" (unspecified if ongoing); "Allergies: Molds" (unspecified if ongoing); "Asthma - Allergies: Mites, Molds, Grasses and pollens" (unspecified if ongoing); "Asthma - Allergies: Mites, Molds, Grasses and pollens -" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (1st vaccination), for covid-19 immunisation; Comirnaty (2nd vaccination), for covid-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Nov2021 03:30, outcome "unknown", described as "Blackout/fainting"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 17Nov2021 03:30, outcome "unknown", described as "Strong feeling of nausea"; ABDOMINAL PAIN (non-serious) with onset 17Nov2021 03:30, outcome "unknown", described as "Belly ache/stomach ache". Reporter Comment: Same vaccination as previous doses. Reason for recall: Other or not known. - Influenza vaccination was not carried out - Concomitant conditions: Asthma - Allergies: Mites, Molds, Grasses and pollens - Reaction time: 03:30 - Posted No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Same vaccination as previous doses. Reason for recall: Other or not known. - Influenza vaccination was not carried out - Concomitant conditions: Asthma - Allergies: Mites, Molds, Grasses and pollens - Reaction time: 03:30 - Posted


VAERS ID: 1950325 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM4289 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Immunisation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (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: DERMOVAT [CLOBETASOL PROPIONATE]; OMEPRAZOLE; PANODIL; LOCOBASE LPL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; INNOVAIR; ELIQUIS; BETNOVAT [BETAMETHASONE VALERATE]; SIMVASTATIN; ATARAX [HYDROXYZINE]
Current Illness: Arthrosis; Hyperlipidaemia; Psoriasis
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101696334

Write-up: DOSE 3 (BOOSTER), SINGLE; Fall in home; Fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the RA. Regulatory number: SE-MPA-2021-094204 (MPA). Other Case identifier(s): SE-VISMA-1637318453140 (RA). A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FM4289) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing); "Hyperlipidaemia" (ongoing); "Pulmonary embolism" (not ongoing); "Arthrosis" (ongoing). Concomitant medication(s) included: DERMOVAT [CLOBETASOL PROPIONATE]; OMEPRAZOLE, start date: 26Nov2020; PANODIL, start date: 24Aug2018; LOCOBASE LPL, start date: 23Apr2020; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE], start date: 27Nov2020; INNOVAIR; ELIQUIS, start date: 26Nov2020; BETNOVAT [BETAMETHASONE VALERATE]; SIMVASTATIN; ATARAX [HYDROXYZINE], start date: 08Dec2017. Vaccination history included: Comirnaty (1st dose; batch/lot number: EJ6136), administration date: 28Jan2021, for COVID-19 immunisation; Comirnaty (2nd dose; batch/lot number: EJ6790), administration date: 18Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; FALL (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Fall in home"; PYREXIA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Fever". Clinical course: The reporter describes that the man had fever and then fell during the night. He was lying on the floor for several hours, do not remember what had happened and why he ended up on the floor. Denies dyspnea. No chest pain or headache. No nausea. No neurological loss. The patient feels tired and dull in the body and lack energy. Lives alone home. Has not been able to eat or drink. Concomitant medications were Eliquis - dosage text: 1 tablet 2 times daily until further notice, Atarax-dosage text: 1 tablet as needed 1-2 times daily until further notice, Betnovat - dosage text: by special prescription: by prescription, Dermovat - dosage text: According to specific prescription: according to prescription, Innovair - dosage text: 1-2 inhalations 2 times daily until further notice, Locobase LPL - dosage text: 1 application 1-2 times daily until further notice, Movicol - dosage text: 2 sachets as needed 1 time daily until further notice, Panodil - dosage text: 1-2 tablets as needed 4 times daily until further notice, maximum 8 tablets per day; Selexid, mometasone furoate, omeprazole, simvastatin - dosage text: 1 tablet at 20:00 until further notice No follow-up attempts are possible. No further information is expected.


VAERS ID: 1951082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaesthesia, Circulatory collapse, Disturbance in attention, Headache, Pupils unequal
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tooth extraction
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101719814

Write-up: Circulatory collapse; total anesthesia in both lower extremities- hospitalized; Anisocoria; massive headache; somewhat decreased vigilance; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory agency-WEB. Regulatory number: AT-BASGAGES-2021-062461 (RA). A 14 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Tooth extraction" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PUPILS UNEQUAL (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Anisocoria"; HEADACHE (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "massive headache"; DISTURBANCE IN ATTENTION (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "somewhat decreased vigilance"; CIRCULATORY COLLAPSE (hospitalization, medically significant) with onset 17Nov2021 15:00, outcome "recovered" (2021), described as "Circulatory collapse"; ANAESTHESIA (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "total anesthesia in both lower extremities- hospitalized". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951113 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram ST segment, Electrocardiogram ST segment elevation, Myocarditis, Pyrexia, Troponin, Troponin increased, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
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: Electrocardiogram ST segment; Result Unstructured Data: Test Result:elevation; Test Date: 20211117; Test Name: Troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101698482

Write-up: Electrocardiogram ST segment elevation; Myocarditis; Chest pain; Injection site pain; Pyrexia; Troponin increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 669311 (regulatory authority). A 16 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: ELECTROCARDIOGRAM ST SEGMENT ELEVATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Electrocardiogram ST segment elevation"; MYOCARDITIS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Myocarditis"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "unknown", described as "Chest pain"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "unknown", described as "Injection site pain"; PYREXIA (non-serious) with onset 17Nov2021, outcome "unknown", described as "Pyrexia"; TROPONIN INCREASED (non-serious) with onset 17Nov2021, outcome "unknown", described as "Troponin increased". The patient underwent the following laboratory tests and procedures: electrocardiogram ST segment: (17Nov2021) elevation; troponin: (17Nov2021) increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Chest discomfort, Chest pain, Confusional state, Dyspnoea, Gait disturbance, Headache, Hypotension, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
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: body temperature; Result Unstructured Data: Test Result:increased Centigrade
CDC Split Type: AUPFIZER INC202101698541

Write-up: Syncope; Body temperature increased; Chest discomfort; Chest pain; Confusional state; Dyspnoea; Gait disturbance; Headache; Hypotension; Nausea; This is a spontaneous report received from a contactable reporter (healthcare professional) from Regulatory Authority. Regulatory number: 669647 (RA ADR#). A 16-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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 that the patient had syncope (medically significant) with onset of 17Nov2021 and outcome of recovering which was described as "syncope"; and body temperature increased which was described as "body temperature increased", chest discomfort which was described as "chest discomfort", chest pain which was described as "chest pain", confusional state which was described as "confusional state", dyspnoea which was described as "dyspnoea", gait disturbance which was described as "gait disturbance", headache which was described as "headache", hypotension which was described as "hypotension", and nausea which was described as "nausea"; all (non-serious) with onset of 17Nov2021 and outcome of recovering. The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Influenza like illness, Palpitations, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101698855

Write-up: Pulmonary congestion; Chest discomfort; Dyspnoea; Fatigue; Headache; Influenza like illness; Palpitations; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 670708 Regulatory Authority. A 52-year-old female patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (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: PULMONARY CONGESTION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pulmonary congestion"; CHEST DISCOMFORT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest discomfort"; DYSPNOEA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Dyspnoea"; FATIGUE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Influenza like illness"; PALPITATIONS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Palpitations". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951255 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Cardiomegaly, Chest discomfort, Electrocardiogram ST segment, Electrocardiogram ST segment elevation, Pericarditis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (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:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased; Test Date: 20211117; Test Name: Electrocardiogram ST segment; Result Unstructured Data: Test Result:elevation
CDC Split Type: AUPFIZER INC202101698929

Write-up: Electrocardiogram ST segment elevation; Pericarditis; Syncope; C-reactive protein increased; Cardiomegaly; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 670946 Regulatory Authority. A 21-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: ELECTROCARDIOGRAM ST SEGMENT ELEVATION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Electrocardiogram ST segment elevation"; PERICARDITIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pericarditis"; SYNCOPE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Syncope"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset 17Nov2021, outcome "not recovered", described as "C-reactive protein increased"; CARDIOMEGALY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Cardiomegaly"; CHEST DISCOMFORT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest discomfort". The patient underwent the following laboratory tests and procedures: c-reactive protein: (17Nov2021) increased; Electrocardiogram ST segment: (17Nov2021) elevation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: AUPFIZER INC202101699182

Write-up: Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 670995 Regulatory Authority. A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: PNEUMONIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Pneumonia". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-17
Onset:2021-11-17
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Electrocardiogram T wave inversion, Fatigue, Headache, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:T wave inversion
CDC Split Type: AUPFIZER INC202101699338

Write-up: Electrocardiogram T wave inversion; Pericarditis; Chest pain; Dyspnoea; Fatigue; Headache; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 671561 Regulatory Authority. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Oct2021 (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: ELECTROCARDIOGRAM T WAVE INVERSION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Electrocardiogram T wave inversion"; PERICARDITIS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Pericarditis"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset 17Nov2021, outcome "unknown", described as "Dyspnoea"; FATIGUE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: electrocardiogram: (17Nov2021) t wave inversion. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-11-17
   Days after vaccination:261
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary vein thrombosis, Computerised tomogram thorax, Erythema, Immunisation, Jugular vein thrombosis, Pain in extremity, Subclavian vein thrombosis, Vena cava thrombosis, Venous thrombosis limb
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypersensitivity (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENLAFAXINE; PERTUZUMAB; TRASTUZUMAB; ZOMETA
Current Illness: Breast cancer (Invasive ductal carcinoma type, grade 2; Estrogen receptive 100%, progesterone receptive 100%...); Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Cigarette smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Thoracic computed tomography; Result Unstructured Data: Test Result:Thrombosis of the right internal jugular vein; Comments: opposite Cervical vertebra 2-Cervical vertebra 3 extending to the confluence of the brachiocephalic venous trunks. Minimal thrombus of the superior vena cava opposite the free edge of the implantable chamber. Thrombosis of the right subclavian, axillary and humeral veins
CDC Split Type: FRPFIZER INC202101728737

Write-up: Thrombus of the superior vena cava; Thrombosis of the right subclavian; Thrombosis of the right axillaryvein; Thrombosis of the right humeral vein; Jugular vein thrombosis; Pain of the right arm; Local redness; 3rd dose of covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-PP20211673. A 48-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation; tamoxifene [tamoxifen], oral since Mar2021 (Lot number: Unknown) at 20 mg 1x/day for breast cancer. Relevant medical history included: "Hypertension arterial" (ongoing); "Breast cancer" (ongoing), notes: Invasive ductal carcinoma type, grade 2; Estrogen receptive 100%, progesterone receptive 100%, ki67 20%, HER2 3+, Tumour infiltrating lymphocytes <10%, metastatic (lymph node and bone) and currently treated with hormone-chemotherapy.; "Active smoker" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; PERTUZUMAB; TRASTUZUMAB; ZOMETA. 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: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "3rd dose of covid-19 vaccine"; JUGULAR VEIN THROMBOSIS (hospitalization) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Jugular vein thrombosis"; PAIN IN EXTREMITY (hospitalization) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Pain of the right arm"; ERYTHEMA (hospitalization) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Local redness"; VENA CAVA THROMBOSIS (hospitalization) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Thrombus of the superior vena cava"; SUBCLAVIAN VEIN THROMBOSIS (hospitalization) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Thrombosis of the right subclavian"; AXILLARY VEIN THROMBOSIS (hospitalization) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Thrombosis of the right axillaryvein"; VENOUS THROMBOSIS LIMB (hospitalization) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Thrombosis of the right humeral vein". The events "jugular vein thrombosis", "pain of the right arm", "local redness", "thrombus of the superior vena cava", "thrombosis of the right subclavian", "thrombosis of the right axillaryvein" and "thrombosis of the right humeral vein" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (20Nov2021) thrombosis of the right internal jugular vein, notes: opposite Cervical vertebra 2-Cervical vertebra 3 extending to the confluence of the brachiocephalic venous trunks. Minimal thrombus of the superior vena cava opposite the free edge of the implantable chamber. Thrombosis of the right subclavian, axillary and humeral veins. The action taken for tamoxifene [tamoxifen] was unknown. Therapeutic measures were taken as a result of jugular vein thrombosis, pain in extremity, erythema, vena cava thrombosis, subclavian vein thrombosis, axillary vein thrombosis, venous thrombosis limb which included initiation of curative heparin therapy (Innohep). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Off label use
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: FOSTAIR; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712280

Write-up: Prolonged menses; 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-202111262348315400-LIPIW (RA). Other Case identifier(s): GB-MHRA-ADR 26259648 (RA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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: FOSTAIR, start date: 01Sep2020; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL], start date: 20Feb2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dosage text: Dose 1), administration date: 26Feb2021, for COVID-19 immunisation, reaction(s): "heavy period", "prolonged period"; Covid-19 vaccine astrazeneca (Dosage text: Dose 2), administration date: 08May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Prolonged menses". Clinical course: Patient last menstrual period date was 25Nov2021. Patient has not had symptoms associated with covid 19 and not had a covid 19 test. Since the first dose of the vaccine, she has had issues with her menstrual cycle. At first this displayed as an extremely heavy period, the heaviest in her life, and then in a prolonged period of 25 days. Since the booster she has been bleeding in a similar way with no sign of it stopping. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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: 1953078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Inflammation, Interchange of vaccine products, Off label use
SMQs:, Medication errors (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: GBPFIZER INC202101712596

Write-up: Inflammation; 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-202111301234324390-VIX0F. Other Case identifier: GB-MHRA-ADR 26271297. A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient had 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. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INFLAMMATION (medically significant) with onset 23Nov2021, outcome "recovered" (26Nov2021), described as "Inflammation". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953380 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia, SARS-CoV-2 test, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal cramps (some abdominal cramps and pain and take omeprazole and Gaviscon for this); Pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dizzy; Fever; Visual disturbance; Dizziness; Tiredness; Headache; Shivering; Head pain; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26281416) on 03-Dec-2021 and was forwarded to Moderna on 03-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PYREXIA (Fever), VISUAL IMPAIRMENT (Visual disturbance), DIZZINESS (Dizziness), FATIGUE (Tiredness), HEADACHE (Headache), CHILLS (Shivering) and HEADACHE (Head pain) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Abdominal cramps (some abdominal cramps and pain and take omeprazole and Gaviscon for this) and Pain. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 08-Jan-2021 to an unknown date for Vaccination. In November 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), VISUAL IMPAIRMENT (Visual disturbance) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 02-Dec-2021, HEADACHE (Head pain) was resolving. At the time of the report, DIZZINESS (Dizzy), PYREXIA (Fever), VISUAL IMPAIRMENT (Visual disturbance), DIZZINESS (Dizziness), FATIGUE (Tiredness), HEADACHE (Headache) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. The day following the vaccine patient woke up at 3am with fever type symptoms. shivering, headache, aches in joints. The following day she felt very dizzy and was having sharp pains in head at the right side and at the back. She also started to vomit due to the dizziness. She also had visual disturbance in her right eye. The symptoms had subsided, but patient still had constant headache, tiredness and some dizziness. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Suspect Reactions Patient mentioned that she had appointment with gp today Company comment: This case concerns a 55-year-old, female patient with no relevant medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of headache(two events), dizziness(two events), pyrexia, visual impairment, fatigue and chills. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the day following the vaccine patient woke up at 3am with fever type symptoms. shivering, headache, aches in joints. The following day she felt very dizzy and was having sharp pains in head at the right side and at the back. She also started to vomit due to the dizziness and had visual disturbance in her right eye. The symptoms had subsided, but patient still had constant headache, tiredness and some dizziness. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. However, the rechallenge was assessed as unknown by Regulatory Authority and it was retained as such. 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 resulted in a serious medical condition.; Sender''s Comments: This case concerns a 55-year-old, female patient with no relevant medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of headache(two events), dizziness(two events), pyrexia, visual impairment, fatigue and chills. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the day following the vaccine patient woke up at 3am with fever type symptoms. shivering, headache, aches in joints.The following day she felt very dizzy and was having sharp pains in head at the right side and at the back. She also started to vomit due to the dizziness and had visual disturbance in her right eye. The symptoms had subsided, but patient still had constant headache, tiredness and some dizziness. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. However, the rechallenge was assessed as unknown by Regulatory Authority and it was retained as such. 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 resulted in a serious medical condition.


VAERS ID: 1953593 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Palpitations, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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
Current Illness: Osteoarthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; Shortness of breath; Racing heart (tachycardia); Heart palpitations; headache; Fatigue/unusual tiredness; Fever; Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26293389) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart palpitations), HEADACHE (headache), FATIGUE (Fatigue/unusual tiredness), PYREXIA (Fever) and PYREXIA (Fever chills) in a 66-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Osteoarthritis. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 18-Feb-2021 to an unknown date for COVID-19. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion disability). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion disability), DYSPNOEA (Shortness of breath) (seriousness criterion disability), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion disability), PALPITATIONS (Heart palpitations) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On 24-Nov-2021, PYREXIA (Fever chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart palpitations), HEADACHE (headache), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. On day 2, patient could not lift arm, teeth were chattering and felt awful. Headache, Joint and muscle pains are severe. Painkillers did not help. On Day 3, patient had bad chest pains and painful to breathe, lasted around 24 hours.Took over a week to feel better. No reaction of any sort after 2nd Astra Zeneca jab. The report is related to possible inflammation of the heart (myocarditis or pericarditis). Treatment information was not provided. Company Comment: This case concerns a 66-year-old, female patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca, who experienced the unexpected serious events of Chest pain, Dyspnea, Tachycardia, Palpitations, Headache, Fatigue and Pyrexia. The events occurred on the first week after the third dose of mRNA-1273 Vaccine which resulted in a disabling condition. At the time of report the outcome of the events was unknown. The rechallenge is not applicable, since no further dosing is expected. The patient''s medical history of vaccination with COVID-19 Vaccine AstraZeneca remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 66-year-old, female patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca, who experienced the unexpected serious events of Chest pain, Dyspnea, Tachycardia, Palpitations, Headache, Fatigue and Pyrexia. The events occurred on the first week after the third dose of mRNA-1273 Vaccine which resulted in a disabling condition. At the time of report the outcome of the events was unknown. The rechallenge is not applicable, since no further dosing is expected. The patient''s medical history of vaccination with COVID-19 Vaccine AstraZeneca remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1953714 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDDN7 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dysentery, Headache, Nausea, Pyrexia, Quality of life decreased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101693098

Write-up: dysentery; persistent headache; nausea; joint pain; fever; Impact on quality of life (8/10); This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-814296. A 48 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: SDDN7) at the age of 48 years as dose 2,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), for covid-19 immunisation. It was reported that reaction following second dose covid pfizer vaccine includes: DYSENTERY (medically significant) with onset 17Nov2021, outcome "recovering", described as "dysentery"; HEADACHE, described as "persistent headache", NAUSEA, described as "nausea", ARTHRALGIA, described as "joint pain", PYREXIA, described as "fever" and QUALITY OF LIFE DECREASED, described as "Impact on quality of life (8/10)", all (non-serious) with onset 17Nov2021, outcome "recovering". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: IUD NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101702007

Write-up: inappropriate schedule of vaccine administered; drug ineffective; nowI have corona; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: NL-LRB-00715399 (LRB). A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) as dose number unknown,single and administration date 03May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). Concomitant medication(s) included: IUD NOS taken for contraception.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "drug ineffective"; COVID-19 (medically significant) with onset 17Nov2021, outcome "not recovered", described as "nowI have corona"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "inappropriate schedule of vaccine administered". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101749213 the same patient different dose of COMIRNATY


VAERS ID: 1953820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Malaise
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: IUD NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101749213

Write-up: Heavy menstrual bleeding; severely unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). Concomitant medication(s) included: IUD NOS taken for contraception. Vaccination history included: Comirnaty (Dose number unknown), administration date: 03May2021, for covid-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Heavy menstrual bleeding"; MALAISE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "severely unwell". Patient had become severely unwell. Normally she never got this due to spiral. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953888 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 321558A / 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? 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: Blood pressure measurement; Result Unstructured Data: Test Result:150/100 mmHg; Comments: 13:00
CDC Split Type: PHPFIZER INC202101713119

Write-up: ELEVATED BLOOD PRESSURE 150/100; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121497 (RA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 321558A) at the age of 17 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 17Nov2021 13:00, outcome "recovering", described as "ELEVATED BLOOD PRESSURE 150/100". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 150/100 mmHg, notes: 13:00. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953926 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32155BA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101713570

Write-up: Elevated blood pressure; Fainting; Dizziness; This is a spontaneous report from a contactable Other HCP from Regulatory Authority. Regulatory number: PH-PHFDA-300122298 (RA). A 16-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 32155BA) at the age of 16 years as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: syncope (medically significant) with onset 17Nov2021 14:55, outcome "recovered" (17Nov2021 16:00), described as "fainting"; dizziness (non-serious) with onset 17Nov2021 14:55, outcome "recovered" (17Nov2021 16:00), described as "dizziness"; blood pressure increased (non-serious), outcome "unknown", described as "elevated blood pressure". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954035 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Abdominal pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: Astrazeneca vaccine (Skin rash with dyspnea, reporting adverse vaccine reactions) on 06-Aug-2021 and Astrazeneca vaccine on 06-Aug-2021. Past adverse reactions to the above products included Dyspnea with Astrazeneca vaccine; and Skin rash with Astrazeneca vaccine. On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL PAIN (Abdominal pain) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. COMPANY COMMENT: This is a regulatory case concerning a 49-year-old female patient with clinical history of Astrazeneca vaccine (Skin rash with dyspnea, reporting adverse vaccine reactions) on 06-Aug-2021 and Astrazeneca vaccine on 06-Aug-2021 who experienced the unexpected event of Abdominal pain The event occurred 9 days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 49-year-old female patient with clinical history of Astrazeneca vaccine (Skin rash with dyspnea, reporting adverse vaccine reactions) on 06-Aug-2021 and Astrazeneca vaccine on 06-Aug-2021 who experienced the unexpected event of Abdominal pain The event occurred 9 days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1956055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVT5 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Dizziness, Fatigue, Hypoaesthesia, Myocarditis, Nausea, Paraesthesia, Pyrexia, Tachycardia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101720030

Write-up: Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021203535 (RA). Other Case identifier(s): DE-CADRPEI-2021203535 ( regulatory authority), DE-PEI-202100229058 (RA). A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: SCVT5) 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: MYOCARDITIS (hospitalization, medically significant), ARRHYTHMIA (hospitalization, medically significant), PARAESTHESIA (hospitalization), ASTHENIA (hospitalization), TACHYCARDIA (hospitalization), HYPOAESTHESIA (hospitalization), NAUSEA (hospitalization), DIZZINESS (hospitalization), FATIGUE (hospitalization) all with onset 17Nov2021, outcome "not recovered" and all described as "Suspicion of myocarditis with fever, nausea, cardiac arrhythmia, rapid pulse, numbness and tingling, dizziness, fatigue and weakness"; PYREXIA (hospitalization) with onset 17Nov2021, outcome "recovered" (2021). The patient was hospitalized for myocarditis, arrhythmia, paraesthesia, asthenia, tachycardia, hypoaesthesia, pyrexia, nausea, dizziness, fatigue (start date: 2021). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956091 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRP9 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Asthenia, Dizziness, Dyspnoea, Fatigue, Headache, Hypoaesthesia, Language disorder, Malaise, Myalgia, Nausea, Paraesthesia, Vaccination site pain, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101719881

Write-up: Myalgia; Headache; Dizziness; Fatigue; Tingling feet/hands/Tingling/Tingling of extremity; Nausea; Malaise; Arthralgia; Vaccination site pain; Dizziness; Acute dyspnea; Anxiety; Visual disturbance; Language disorder; Strength loss of; Numbness of lower extremities; SAFEVAC 2.0 This is a non-interventional study report from the Regulatory Authority-WEB. Regulatory number: DE-SVPEI-202100934774. A 34 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 16:00 (Lot number: SCRP9) at the age of 34 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Myalgia"; HEADACHE (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Headache"; DIZZINESS (hospitalization) with onset 17Nov2021, outcome "recovering", FATIGUE (hospitalization) with onset 17Nov2021, outcome "recovering" and all described as "Fatigue"; PARAESTHESIA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Tingling feet/hands/Tingling/Tingling of extremity"; NAUSEA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Nausea"; MALAISE (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Malaise"; ARTHRALGIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Arthralgia"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Vaccination site pain"; DIZZINESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Dizziness"; DYSPNOEA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Acute dyspnea"; ANXIETY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Anxiety"; VISUAL IMPAIRMENT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Visual disturbance"; LANGUAGE DISORDER (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Language disorder"; ASTHENIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Strength loss of"; HYPOAESTHESIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Numbness of lower extremities". The patient was hospitalized for myalgia, headache, dizziness, fatigue, paraesthesia, nausea, malaise (start date: 2021). The events myalgia, headache, dizziness, fatigue, tingling feet/hands, tingling of extremity, nausea, malaise, were also reported as non-serious with outcome not resolved. The PEI assessment of events arthralgia, myalgia, vaccination site pain, nausea, fatigue, dizziness, headache, malaise with suspect product bnt162b2 was B. indeterminate, the PEI assessment of the rest events with suspect product bnt162b2 was D. unclassifiable. The reporter''s assessment of the causal relationship of the "myalgia", "headache", "dizziness", "fatigue", "tingling feet/hands/tingling/tingling of extremity", "nausea", "malaise", "arthralgia", "vaccination site pain", "acute dyspnea", "anxiety", "visual disturbance", "language disorder", "strength loss of" and "numbness of lower extremities" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Myalgia, Headache, Dizziness, Fatigue, Paraesthesia, Nausea, Malaise, Arthralgia, Vaccination site pain, Dyspnoea, Anxiety, Visual Impairment, Language Disorder, Asthenia and Hypoesthesia and the suspect drug cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1956304 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-11-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F038A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Fatigue, Immunisation, Nausea, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PLAVIX; COAPROVEL; ROSUVASTATIN; AERIUS [DESLORATADINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anginal syndrome; Asthma; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101719155

Write-up: first booster dose of the COMIRNATY vaccine; Embolism pulmonary; shortness of breath; fatigue; chest pain; nausea; decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-MA20215365. An 83 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 26Oct2021 (Lot number: 1F038A) at the age of 83 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Anginal syndrome" (unspecified if ongoing); "Obesity" (unspecified if ongoing). She had no history of pulmonary embolism. Concomitant medication(s) included: clopidogrel bisulfate (PLAVIX); hydrochlorothiazide/ irbesartan (COAPROVEL); rosuvastatin; desloratadine (AERIUS). Vaccination history included: Comirnaty (Dose 1), for Covid-19 immunisation, reaction(s): "significant asthenia"; Comirnaty (Dose 2), for Covid-19 immunisation, reaction(s): "significant asthenia". The following information was reported: PULMONARY EMBOLISM (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Embolism pulmonary"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite". Following her admission to hospital for a pulmonary embolism, her treatment with clopidogrel bisulfate (PLAVIX) was modified, and she was given apixaban (ELIQUIS) 5 mg at a curative dose of 1-0-1 for 15 days pending consultation with her attending physician and her cardiologist. The event "embolism pulmonary" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) negative. Therapeutic measures were taken as a result of pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101758135 same patient, different dose, different adverse event


VAERS ID: 1956373 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Muscle spasms, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hypersensitivity (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: Allergy; Asthma; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101718933

Write-up: Booster; Generalised pruritus; Spasm of muscle; tingling all over the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-ST20214422. A 34-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing). No medical history of COVID-19. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The patient noted that he had not presented with those symptoms with the first two doses. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PRURITUS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Generalised pruritus"; MUSCLE SPASMS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Spasm of muscle"; PARAESTHESIA (non-serious) with onset 17Nov2021, outcome "unknown", described as "tingling all over the body". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1956499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Eye pain, Immunisation, Ocular hyperaemia, SARS-CoV-2 test, Swelling, Uveitis, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypoglycaemia (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: ACICLOVIR; ATORVASTATIN; DAPAGLIFLOZIN; EVOREL CONTI; GABAPENTIN; GLICLAZIDE; LANSOPRAZOLE; MAXIDEX [BENZALKONIUM CHLORIDE;DEXAMETHASONE;PHENYLMERCURIC NITRATE]; METFORMIN; RAMIPRIL; TURMERIC [CURCUMA LONGA ROOT]; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Uveitis flare up
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101721671

Write-up: blurred vision; swelling; Ocular hyperaemia; Eye pain; Uveitis; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111301545389990-O5LYI (RA). Other Case identifier(s): GB-MHRA-ADR 26273032 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0112) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unknown if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Uveitis flare up", start date: Feb2019 (unknown if ongoing). Concomitant medication(s) included: ACICLOVIR; ATORVASTATIN; DAPAGLIFLOZIN; EVOREL CONTI; GABAPENTIN; GLICLAZIDE; INFLUENZA VIRUS taken for influenza immunisation, administration date 17Nov2021; LANSOPRAZOLE; MAXIDEX [BENZALKONIUM CHLORIDE;DEXAMETHASONE;PHENYLMERCURIC NITRATE]; METFORMIN; RAMIPRIL; TURMERIC [CURCUMA LONGA ROOT]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose-1), administration date: 13Jan2021, for Covid-19 immunisation, reaction(s): "red eyes", "soreness", "swelling", "blurred vision", "uveitis"; Bnt162b2 (Dose-2), administration date: Mar2021, for Covid-19 immunisation, reaction(s): "flare up". The following information was reported: IMMUNISATION (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; UVEITIS (disability, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Uveitis"; VISION BLURRED (disability, medically significant), outcome "not recovered", described as "blurred vision"; SWELLING (disability, medically significant), outcome "not recovered", described as "swelling"; OCULAR HYPERAEMIA (disability, medically significant), outcome "not recovered", described as "Ocular hyperaemia"; EYE PAIN (disability, medically significant), outcome "not recovered", described as "Eye pain". The patient underwent the following laboratory tests and procedures: blood test: unknown results; chest x-ray: unknown results; sars-cov-2 test: no - negative covid-19 test. Clinical course: 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 and the report does not relate to possible inflammation of the heart (myocarditis or pericarditis) and the report does not relate to possible blood clots or low platelet counts.First vaccine given 13th Jan, 10 days after had a flare up of her uveitis (red eyes, soreness, swelling, blurred vision). Had a hospital appointment - had eye drops (Maxidex) all year - has been ongoing since. 2nd dose March - flare up within 14 days. Same treatment - steroid injection into eye (does not know name) in April and started aciclovir. Could see for 3 months after. In july, had another injection that didn''t work (does not know which). Booster in November - 5 days after you had a third flare up with the same symptoms. Has been into hospital (routine uveitis follow up), increased steroids by herself as was weaning off- restarted on Maxidex and Accular yesterday for 8 weeks. Prior to vaccines, had only ever had 1 flare up (feb 2019). Seems to have been triggered by vaccine and has impacted her work, cannot drive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer (low risk Prostate Cancer and have been on Active Surveillance for 30 months.)
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101721368

Write-up: Shingles; The patient received the primary immunization series with ASTRAZENECA vaccine and received a third dose of COMIRNATY vaccine; The patient received the primary immunization series with ASTRAZENECA vaccine and received a third dose of COMIRNATY vaccine; Patient received booster/third dose of COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112021149541510-IJPDB (Regulatory Authority). Other Case identifier(s): GB-MHRA-ADR 26280759 (Regulatory Authority). A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing), notes: low risk Prostate Cancer and have been on Active Surveillance for 30 months. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE,Lot number: unknown, Route of administration: unspecified.), administration date: 24May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE,Lot number: unknown, Route of administration: unspecified.), administration date: 21Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "The patient received the primary immunization series with ASTRAZENECA vaccine and received a third dose of COMIRNATY vaccine"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Patient received booster/third dose of COMIRNATY"; HERPES ZOSTER (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Shingles". The event "shingles" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of herpes zoster. Additional Information: Patient has not had symptoms associated with COVID-19. The patient was suspicious that 1 week after having Covid booster and Flu jab, that a shingkes infection started which was still ongoing. The patient was taking Aciclovir 800mg tablets 5 times a day. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was not considered as related to possible inflammation of the heart (myocarditis or pericarditis). The patient had Gp appointment as well as appointment at ENT. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1956673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Scan, Thrombotic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Echo; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 2021; Test Name: Scan X3; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101721264

Write-up: Thrombotic stroke; Off label use; Interchange of vaccine products; Patient received booster dose of COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Physician)Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112021524458990-YMFLX (MHRA). Other Case identifier(s): GB-MHRA-ADR 26281734 (MHRA). A 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-smoker" (unspecified if ongoing). The patient not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The concomitant medications was unknown. Past drug history included: Heparin. 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 (hospitalization, disability) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, disability) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, disability) with onset 17Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; THROMBOTIC STROKE (hospitalization, disability) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Thrombotic stroke". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, thrombotic stroke (start date: 2021). The reporter was a general physician (GP), and the patient was her husband. The reporter stated that: understood it may not be related to the vaccine. The patient was a fit 64 year old non smoker, with normal cholesterol and BMI, low BP not diabetic. The patient had a large thrombotic stroke in left middle cerebral artery (MCA) which extended over the first 12 hours despite prompt thrombolysis. No obvious cardiac clot source. The report was related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. Details of the event: "Left brain stroke in middle cerebral artery (MCA); Thrombotic infarct not haemorraghic. It was diagnosed at a stroke unit on 19Nov2021. Any additional medical history, not already provided, that related to previous venous or arterial thromboses: platelet count was normal. No risk factors or past medical history (PMH). The patient not had any previous reactions to medications, especially heparin or anticoagulants. The patient not had confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient not had history of, or current, malignancy; or concurrent, intracranial malignancy. Haemorrhage was not identified, it was a Thrombotic event. The patient not had concurrent or recent intracranial infections. The patient not had recent surgical or medical interventions to the central nervous system including lumbar puncture. The patient not had a recent trauma/head injury. It was unknown if the D-dimer was more than 4000 (unspecified units). It was unknown if anti-PF4 antibodies identified, platelet count less than 150 A, 109 per Litre. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; echocardiogram: (2021) unknown results; electrocardiogram: (2021) unknown results; sars-cov-2 test: (19Nov2021) no - negative covid-19 test; scan: (2021) unknown results. Therapeutic measures were taken as a result of thrombotic stroke. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956810 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Chest X-ray, Chest discomfort, Electrocardiogram normal, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Polymerase chain reaction, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL SANDOZ; LOSARTAN SANDOZ [LOSARTAN POTASSIUM]; ATORVASTATIN CALCIUM; VITAMIN D 2000
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: Zoe Covid 19 study); Hypertension; Tachycardia sinus; Unspecified vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:135/85 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:165/90-95 mmHg; Test Date: 2010; Test Name: Blood pressure; Result Unstructured Data: Test Result:117 mmHg; Test Name: Blood tests; Result Unstructured Data: Test Result:Normal; Test Name: Crx; Result Unstructured Data: Test Result:Normal; Test Name: serial ecgs; Result Unstructured Data: Test Result:Normal; Test Name: PCR; Result Unstructured Data: Test Result:Normal; Test Date: 20211128; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Lateral flow test; Result Unstructured Data: Test Result:Normal; Test Name: troponins normal; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202101722298

Write-up: headache; nausea; chest tightness; Rise in blood pressure; 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-202112031108394120-K38FI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26286536 (MHRA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: Zoe Covid 19 study; "Tachycardia sinus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Unspecified vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: PNEUMOCOCCAL POLYSACCHARIDE VACCINE taken for immunisation, administration date 21Oct2021; BISOPROLOL SANDOZ taken for sinus tachycardia, start date: 07Feb2018; LOSARTAN SANDOZ [LOSARTAN POTASSIUM] taken for hypertension, start date: 2012; ATORVASTATIN CALCIUM, start date: 28Feb2018; VITAMIN D 2000 taken for vitamin d deficiency, start date: 2012. Vaccination history included: Covid-19 vaccine Astrazeneca (Dose 1), administration date: 01Mar2021, for COVID-19 immunisation; Covid-19 vaccine Astrazeneca (Dose 2), administration date: 17May2021, for COVID-19 immunisation; Influenza virus, administration date: 02Oct2021, for Immunisation. The following information was reported: On 17Nov2021 rise in bp from evening of vaccination from previous average reading 135/85 to around 165/90-95. Weekend of 27/28th had rising bp with pounding headache, nausea, chest tightness. Attended A&E for further investigations. Tests done included serial ECGs normal, cardiac& bp monitoring, standard blood tests + troponins normal, CXR normal, PCR & lateral flow tests normal. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956824 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Eye pain, Feeling cold, Headache, Injection site pain, Malaise, Myalgia, Nausea, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Unwell; Rash; Fever; Headache; Muscle ache; Joint pain; Injection site pain; Nausea; Eye pain; Feeling cold; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26286753) 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 EYE PAIN (Eye pain), FEELING COLD (Feeling cold), MALAISE (Unwell), RASH (Rash), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain), INJECTION SITE PAIN (Injection site pain) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 15-Mar-2020 to 20-Mar-2020. Concomitant products included FINASTERIDE (ACCORD FINASTERIDE) from 31-Jan-2020 to an unknown date for BPH, RAMIPRIL from 31-Jan-2020 to an unknown date for Blood pressure high, ROSUVASTATIN CALCIUM (TEVA ROSUVASTATIN) from 31-Jan-2020 to an unknown date for Cholesterol. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant), FEELING COLD (Feeling cold) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Unwell) (seriousness criterion medically significant). On 19-Nov-2021, RASH (Rash), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) had resolved. On 20-Nov-2021, FEELING COLD (Feeling cold) had resolved. On 21-Nov-2021, MYALGIA (Muscle ache) and INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, EYE PAIN (Eye pain) was resolving and MALAISE (Unwell) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient generally felt fit for his age and had no major health concerns. Pt generally felt very unwell. Maybe at the time he caught another virus. As the symptoms started later in the day of receiving the vaccine to him it seems likely that it was a side effect to the vaccine. Patient received the vaccine on the 17 Nov 2021 and in the early hours of the 18 Nov 2021 felt he was deteriorating and was considering calling the ambulance service. He spent all day in bed and started to feel a bit better on the 19 Nov 2021 and was able to do things for himself but was about 7 to 10 days before he totally recovered. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medication reported. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 70-year-old male patient with no relevant medical history who experienced serious unexpected events of eye pain, feeling cold, rash. headache, pyrexia, myalgia, arthralgia, injection site pain, nausea and malaise. The events occurred on the same day after the third dose of the mRNA-1273 . 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 70-year-old male patient with no relevant medical history who experienced serious unexpected events of eye pain, feeling cold, rash. headache, pyrexia, myalgia, arthralgia, injection site pain, nausea and malaise. The events occurred on the same day after the third dose of the mRNA-1273 . 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957065 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211010; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Aching joints; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26298328) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints) in a 66-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Previously administered products included for Asthma: SYMBICORT. Past adverse reactions to the above products included No adverse event with SYMBICORT. Concurrent medical conditions included Asthma. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 31-Oct-2021 to an unknown date for Influenza. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 01-Dec-2021, ARTHRALGIA (Aching joints) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Patient had Appointment arthritis test and investigations conducted. Company comment: This regulatory case from the UK concerns a 66-year-old male patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of ARTRHARLGIA. The event occurred 1 day after receiving a dose of mRNA-1273. Dose is reported to be the third, but no information about previous vaccination schedule has been provided. Event had resolved at the time of this report. The benefit-risk relationship is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory case from the UK concerns a 66-year-old male patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of ARTRHARLGIA. The event occurred 1 day after receiving a dose of mRNA-1273. Dose is reported to be the third, but no information about previous vaccination schedule has been provided. Event had resolved at the time of this report. The benefit-risk relationship is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 1957103 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F114751 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIRCADIN; FLUPENTIXOL; LAMOTRIGIN; MIRTAZAPINE; DULOXETINE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Autism; Borderline personality; Chronic fatigue syndrome (chronic fatigue syndrome also known as M.E.); Delayed sleep phase; Depression; High cholesterol; Mood depression; Obesity; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021354713

Write-up: booster; Ache; Armpit pain; This is a report from a contactable consumer or other non-healthcare professional. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202102241410465450. Safety Report Unique Identifier is GB-MHRA-ADR 25052307. A 32-year-old non-pregnant female patient received the third dose of BNT162B2 (PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: F114751), via an unspecified route of administration on 17Nov2021, at the age of 32 years old, as dose 3 (booster), single for COVID-19 immunisation. Medical history included autism spectrum disorder, depression, borderline personality disorder, obesity, type 2 diabetes mellitus, delayed sleep phase, anxiety, depressed mood, high cholesterol, chronic fatigue syndrome also known as M.E. from an unknown date and unknown if ongoing. The patient has had symptoms associated with COVID-19 was unsure. The patient was not enrolled in a clinical trial. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since had the vaccine. Concomitant medication included melatonin (CIRCADIN) for delayed sleep phase, flupentixol for anxiety, lamotrigine (LAMOTRIGIN) for depressed mood from 02Feb2020 to an unspecified stop date, mirtazapine for depression from 01Jan2017 to an unspecified stop date, duloxetine for depression from 22Jul2021 to unspecified stop date, astorvastatin via an unspecified route of administration from 01Jul2021 to an unspecified date, at unspecified dose for blood cholesterol increased. Historical vaccine included the first dose of BNT162B2 (PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER1741), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation and experienced sneezing on 23Mar2021, second dose of BNT162B2 (PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: Ew4109), via an unspecified route of administration on 14May2021 as dose 2, single for COVID-19 immunisation. On 17Nov2021, the patient experienced armpit pain and ache. The event ache was reported as medically significant. On an unspecified date, the patient underwent lab tests and procedures which included the SARS-COV-2 test negative (no-negative COVID-19 test). The outcome of the event armpit pain was recovering, and ache was recovered on 22Nov2021. The reporter''s assessment of the causal relationship of the events sneezing with the suspect product was Relatedness of the drug to the event: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: Definitive. No follow-up attempts are possible. No further information is expected. Follow up: No new information reported. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202102241410465450. Safety Report Unique Identifier is GB-MHRA-ADR 25052307. No follow-up attempts are possible. No further information is expected. Follow-up (24Nov2021): New information was received from a contactable reporter via Regulatory Agency (RA). Suspect product and historical vaccine were updated, new event was added (armpit pain). No follow-up attempts are possible. No further information is expected. Follow-up (06Dec2021): This is a follow up solicited report from the RA the same contactable consumer. This is a report received from the Regulatory Agency (RA). Updated information: Study description was updated, event ache and a new case cerate for dose 1 and cross linked. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-202101774817 Same patient,product,different dose/event (Dose 1)


VAERS ID: 1957115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Illness, Immunisation, Migraine, Pain in extremity, Product use issue
SMQs:, 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 INC202101737149

Write-up: Sickness; Painful arm; Migraine; Coldness; Booster; COVID vaccine was administered on the same date as another vaccine; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA) for a sponsored program. A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 11Sep2020; FLUAD taken for immunisation, administration date 17Nov2021. Vaccination history included: Bnt162b2 (dose number unknown, lot number: EL7834), administration date: 16Feb2021, for COVID-19 immunisation; Bnt162b2 (dose number unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (medically significant) with onset 17Nov2021, outcome "unknown", described as "COVID vaccine was administered on the same date as another vaccine"; MIGRAINE (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Migraine"; FEELING COLD (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Coldness"; ILLNESS (medically significant) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Sickness"; PAIN IN EXTREMITY (medically significant) with onset 18Nov2021, outcome "recovering", described as "Painful arm". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : -PFIZER INC-2021239427 same patient/reporter, different dose/events;GB-MHRA-YCVM-202102161506024120 MHRA;GB-MHRA-ADR 24864779 MHRA


VAERS ID: 1957118 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate, Immunisation, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Fit, healthy and well.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Date: 2021; Test Name: Exercising ECG; Result Unstructured Data: Test Result:normal with no occurrences during exercising; Test Date: 2021; Test Name: 24 Holter monitoring; Result Unstructured Data: Test Result:unknown result; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101747956

Write-up: palpitations; Booster; This is a spontaneous report received from a contactable reporter from the Regulatory Authority. The reporter is the patient. A 40 year-old male patient received bnt162b2, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE;Lot number: UNKNOWN), administration date: 13Apr2021, for COVID-19 immunisation, reaction(s): "palpitations"; Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN), administration date: 13Apr2021, for COVID-19 Immunisation, reaction(s): "Heartbeats skipped"; Covid-19 vaccine (DOSE 1, SINGLE;Lot number: UNKNOWN: Route of administration: Unspecified; MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was fit, healthy and well. It was unsure if patient has had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PALPITATIONS (medically significant), outcome "unknown", described as "palpitations". The event "palpitations" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (2021) unknown result; (2021) normal with no occurrences during exercising; electrocardiogram ambulatory: (2021) unknown result; heart rate: (2021) increased; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Clinical course: Chest went tight for a brief period before missing a beat, misses a beat then a very large beat behind the one that was missed. Chest aches a little afterwards. Consultant Cardiologist seen following A&E attendance. When at resting heart rate, heart missed beats on a regular basis. ECGs confirmed. 24hr Holter worn which also picked up the occurrences. Exercising EGC normal with no occurrences during exercising.Consultant believed that post 2nd vaccine, symptoms were asymptomatic for a period before becoming symptomatic. Frequency of missing beats/palpitations reduced in late October/early November. Had booster vaccine and within 36 hours heart palpitations resumed on a very regular basis that remains to date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101721243 Same patient/different dose number/different events


VAERS ID: 1957374 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005241 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life 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: LVMODERNATX, INC.MOD20214

Write-up: Syncope; Urination involuntary; Nausea; This case was received via a regulatory authority (Reference number: LV-SAM-2021117126) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope), URINARY INCONTINENCE (Urination involuntary) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005241) for Prophylactic vaccination. No Medical History information was reported. On 17-Nov-2021 at 12:21 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 17-Nov-2021 at 12:40 PM, the patient experienced SYNCOPE (Syncope) (seriousness criterion hospitalization), URINARY INCONTINENCE (Urination involuntary) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (Syncope), URINARY INCONTINENCE (Urination involuntary) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported. Company comment: This is a regulatory authority case concerning a 49-year-old, female patient with no reported medical history, who experienced the unexpected serious events of syncope, nausea and urinary incontinence which resulted to hospitalization. The events syncope, nausea and urinary incontinence occurred 19 minutes after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. 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 49-year-old, female patient with no reported medical history, who experienced the unexpected serious events of syncope, nausea and urinary incontinence which resulted to hospitalization. The events syncope, nausea and urinary incontinence occurred 19 minutes after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957401 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Dizziness, Gait disturbance, Muscular weakness, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; VENLAFAXINE
Current Illness: Allergy to antibiotic (allergy: amoxeline); Allergy to NSAIDs (allergy: diclofinac); Fruit allergy; Peanut allergy (allergy: Pinda''s)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101719580

Write-up: difficulty walking; Burning sensation of lower limb; severe shaking in body: Lost control of my body; Dizziness; burning sensation in legs causing them to fall out; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) Regulatory number: NL-LRB-00716232. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) at the age of 35 years DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (ongoing); "Allergy to NSAIDs" (ongoing), notes: allergy: diclofinac; "Allergy to antibiotic" (ongoing), notes: allergy: amoxeline; "Peanut allergy" (ongoing), notes: allergy: Pinda''s. The patient did not infect with covid-19 previously. Concomitant medication(s) included: ALPRAZOLAM; VENLAFAXINE. The following information was reported: BURNING SENSATION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Burning sensation of lower limb"; TREMOR (medically significant) with onset 17Nov2021, outcome "not recovered", described as "severe shaking in body: Lost control of my body"; DIZZINESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Dizziness"; MUSCULAR WEAKNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "burning sensation in legs causing them to fall out"; VOMITING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Vomiting"; GAIT DISTURBANCE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "difficulty walking". Therapeutic measures were not taken as a result of burning sensation, tremor, dizziness, muscular weakness, vomiting, gait disturbance. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957412 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Heart rate, Pruritus, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Heart rate; Result Unstructured Data: 150 bpm
CDC Split Type: NLJNJFOC20211223954

Write-up: PRURITUS; TACHYCARDIA; ARRHYTHMIA; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, NL-LRB-00720194] concerned an 81 year old female. The patient''s weight was 48 kilograms, and height was 150 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: XD974 expiry: Unknown) 1 dosage forms, 1 total administered on 17-NOV-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-NOV-2021, the patient experienced arrhythmia, tachycardia and on the same day, the patient went for laboratory tests included: Heart rate (NR: not provided) 150 bpm. On an unspecified date, the patient experienced pruritus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pruritus, and was recovering from arrhythmia, and tachycardia. This report was serious (Life Threatening).


VAERS ID: 1957537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-11-17
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dyslipidemia; Gout; Hepatitis viral; Hypertension arterial; Hypothyroidism; Neoplasm of unspecified nature of digestive system; Obesity; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101735298

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number PT-INFARMED-T202111-1604. A 55 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Jun2021 (Lot number: FD8274) as dose 2, 0.3 ml single and intramuscular, administration date 01Jun2021 (Lot number: FA8142) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included Obesity, start date: 12Aug2016 (unknown if ongoing); Neoplasm of unspecified nature of digestive system (unknown if ongoing); Dyslipidemia (unknown if ongoing); Hepatitis viral (unknown if ongoing); Hypertension arterial, start date: 2016 (unknown if ongoing); Hypothyroidism, start date: 21Jul2017 (unknown if ongoing); Type 2 diabetes mellitus, start date: 08May2020 (unknown if ongoing); Gout, start date: 2016 (unknown if ongoing). Relevant medical history included DROP, start date: 2016 (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome recovered (26Nov2021); COVID-19 (medically significant) with onset 17Nov2021, outcome recovered (26Nov2021). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960077 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Balance disorder, Diarrhoea, Dizziness, Fatigue, Feeling cold, Headache, Hypoaesthesia, Immunisation, Interchange of vaccine products, Muscular weakness, Nausea, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Hepatosplenomegaly (past)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101732058

Write-up: Abdominal pain; Feverish; Numbness in feet; Numbness in hand; Palpitations; Diarrhoea; Feeling cold; Muscle weakness; Balance difficulty; Dizziness; Off label use; Interchange of vaccine products; Booster; Nausea; Shaking; Headache; Fatigue; 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-202111211859495310-WONYQ. Other Case identifier(s): GB-MHRA-ADR 26289079. A 22 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hepatosplenomegaly" (unspecified if ongoing), notes: past. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 04Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 12Mar2021, for covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 14May2021, for covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Nausea"; TREMOR (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Shaking"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; MUSCULAR WEAKNESS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Muscle weakness"; BALANCE DISORDER (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Balance difficulty"; DIZZINESS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Dizziness"; DIARRHOEA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Diarrhoea"; FEELING COLD (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Feeling cold"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Feverish"; HYPOAESTHESIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Numbness in feet"; HYPOAESTHESIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Numbness in hand"; PALPITATIONS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Palpitations"; ABDOMINAL PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Abdominal pain". 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 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: 1960148 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Chest X-ray, Computerised tomogram, Echocardiogram, Fatigue, Immunisation, Interchange of vaccine products, Ischaemic stroke, Lethargy, Magnetic resonance imaging heart, Myocarditis, Off label use, Pain in extremity, Pericarditis, SARS-CoV-2 test, Thrombosis
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Name: Chest computerized tomography (CT); Result Unstructured Data: Test Result:unknown results; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: cardiac MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 20211130; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101721247

Write-up: Thrombosis; Ischemic stroke; arm pain; off label use; Interchange of vaccine products; booster; lethargic; Fatigue/unusual tiredness; Fatigue; Apathy; myocarditis; pericarditis; 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-202111301624280330-VIOLG (RA). Other Case identifier(s): GB-MHRA-ADR 26273075 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Sayana press. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 Immunization; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (hospitalization, disability, medically significant, life threatening) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, disability, medically significant, life threatening) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, disability, medically significant, life threatening) with onset 17Nov2021, outcome "unknown", described as "booster"; LETHARGY (hospitalization, disability, medically significant, life threatening), outcome "not recovered", described as "lethargic"; PAIN IN EXTREMITY (hospitalization, disability, medically significant, life threatening) with onset 18Nov2021, outcome "recovered" (24Nov2021), described as "arm pain"; ISCHAEMIC STROKE (hospitalization, disability, medically significant, life threatening) with onset 27Nov2021 14:55, outcome "recovering", described as "Ischemic stroke"; FATIGUE (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Fatigue/unusual tiredness"; FATIGUE (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Fatigue"; APATHY (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Apathy"; THROMBOSIS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Thrombosis"; MYOCARDITIS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "myocarditis"; PERICARDITIS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "pericarditis". The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; computerised tomogram: (unspecified date) unknown results; echocardiogram: (unspecified date) unknown results; magnetic resonance imaging heart: (unspecified date) unknown results; sars-cov-2 test: (30Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of lethargy, pain in extremity, ischaemic stroke, fatigue, fatigue, apathy, thrombosis, myocarditis, pericarditis. Clinical course: Patient has not had symptoms associated with COVID-19. On Saturday 27th around 2:55pm the patient suffered a stroke and was treated with a clot buster and kept in Hospital until the following day. It was the patient belief as had NO side effects from either dose of AstraZeneca vaccine doses- that the Pfizer booster caused a severe reaction over 11 days culminating in me suffering a stroke. Since the vaccination patient has not tested positive for COVID-19. Patient was not enrolled in clinical trial. The report was related to possible inflammation of the heart myocarditis or pericarditis. The symptoms lead to a hospital stay 28-29 hours. Medication prescribed was Asprin, Statins. The healthcare professional (cardiologist, GP etc) that provided this diagnosis and any specific details of the diagnosis given IV Thrombosis. Imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerized tomography (CT). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731509

Write-up: vomiting; diarrhea; nauseous; Diarrhoea; Nausea; Vomited; Stomach cramps; 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-202112041732499620-IWHB7 (RA). Other Case identifier(s): GB-MHRA-ADR 26289162 (RA). A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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: Bnt162b2 (Dose 1), administration date: 17Feb2021, for COVID-19 vaccination; Bnt162b2 (Dose 2), administration date: 06May2021, for COVID-19 vaccination, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VOMITING (disability, medically significant), outcome "recovering", described as "vomiting"; DIARRHOEA (disability, medically significant), outcome "recovering", described as "diarrhea"; NAUSEA (disability, medically significant), outcome "recovering", described as "nauseous"; NAUSEA (disability, medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Nausea"; VOMITING (disability, medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Vomited"; ABDOMINAL PAIN UPPER (disability, medically significant) with onset 18Nov2021, outcome "recovered" (24Nov2021), described as "Stomach cramps"; DIARRHOEA (disability, medically significant) with onset 19Nov2021, outcome "recovered" (24Nov2021), described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of diarrhoea, diarrhoea. Clinical course: Patient has not had symptoms associated with COVID-19, not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient reported that felt nauseous the day after the vaccine which only resolved after vomited later that day. The day after vomiting, the stomach cramps started of terribly and was in agony over the weekend. These continued until the following Wednesday but slowly got better. The cramps were accompanied by severe diarrhoea and anything ate/ drank went straight through him. It only got better after taking dioralyte and immodium as advised by a pharmacist. It was reported that this report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101742196 Original Case : 202101731509


VAERS ID: 1960992 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-11-17
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: PTPFIZER INC202101777378

Write-up: Vaccine Failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB. Regulatory number: PT-INFARMED-T202111-2032 (INFARMED). A 48 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 27Jul2021 (Lot number: FD8274) as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Vaccine Failure"; COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "COVID-19". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1961006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDFE2 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Eczema, Pain in extremity, Spider vein
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (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: Medical History/Concurrent Conditions: Suspected SARS-CoV-2 infection (diagnosed with SARS-CoV-2 infection before vaccination (no details about date and test confirmation))
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101730858

Write-up: 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: RO-NMA-2021-SPCOV15223 (RA). A 22-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Nov2021 (Lot number: SDFE2) as dose 1, single for covid-19 immunisation. Relevant medical history included: "SARS-CoV-2 infection" (unspecified if ongoing), notes: diagnosed with SARS-CoV-2 infection before vaccination (no details about date and test confirmation). The patient took concomitant medications. The following information was reported: SPIDER VEIN (life threatening) with onset 17Nov2021, outcome "not recovered", described as "broken blood vessels"; ECZEMA (life threatening) with onset 17Nov2021, outcome "not recovered", described as "Eczema"; CONTUSION (life threatening) with onset 17Nov2021, outcome "not recovered", described as "Bruise"; PAIN IN EXTREMITY (life threatening) with onset 17Nov2021, outcome "not recovered", described as "Pain in leg". Therapeutic measures were taken as a result of spider vein, eczema, contusion, pain in extremity. Clinical course: It was stated that these events required treatment (no details about medications). The Reporter considered that these events as life-threatening.


VAERS ID: 1962672 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Illness, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Painful arm; Sickness; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26308058) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), ILLNESS (Sickness) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Blood pressure high. Previously administered products included for Product used for unknown indication: CANDESARTAN (candesartan 8mg). Past adverse reactions to the above products included No adverse effect with CANDESARTAN. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), ILLNESS (Sickness) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. No treatment information mentioned. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. very bad aching arm, had high blood pressure called an ambulance, taking to hospital thought it might be middle ear problems but cleared up after 2-3 days. Patient was not enrolled in clinical trial. Company Comment - This regulatory authority case concerns a 66-year-old female patient with medical history of high blood pressure, who experienced the unexpected serious (medically significant) events of pain in extremity, illness and dizziness after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule. The events occurred 1 day after the dose of mRNA- 1273 vaccine. Patient''s medical history of high blood pressure remains a confounder. The rechallenge was reported as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 66-year-old female patient with medical history of high blood pressure, who experienced the unexpected serious (medically significant) events of pain in extremity, illness and dizziness after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule. The events occurred 1 day after the dose of mRNA- 1273 vaccine. Patient''s medical history of high blood pressure remains a confounder. The rechallenge was reported as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1963140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (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: ATPFIZER INC202101730212

Write-up: Dyspnoea; Constriction throat; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063910 (BASGAGES). A 50 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FF2834) 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: DYSPNOEA (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Dyspnoea"; THROAT TIGHTNESS (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Constriction throat". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964124 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Immunisation, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101733874

Write-up: booster; Fatigue; Nausea; Shivering; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-109583 (FAMHP). A 19-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 17Nov2021 (Lot number: FH8469) at the age of 19 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN; Batch/Lot no. unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN; Batch/Lot no. unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 17Nov2021, described as "booster"; FATIGUE (disability) with onset 17Nov2021, outcome "recovering", described as "Fatigue"; NAUSEA (disability) with onset 17Nov2021, outcome "recovering", described as "Nausea"; CHILLS (disability) with onset 17Nov2021, outcome "recovering", described as "Shivering"; MALAISE (disability) with onset 17Nov2021, outcome "recovering", described as "feeling unwell" (event stop dates for all events were reported as 20Nov2021 - cannot be confirmed). Therapeutic measures were not taken as a result of fatigue, nausea, chills, malaise. Reporter Comment: Treatment - No; Evolution of the ADR - Recovering; ADR description - Tick the observed side effect(s). You can describe these side effect(s) in detail in the Description of the side effect(s) field. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - No; Evolution of the ADR - Recovering; ADR description - Tick the observed side effect(s). You can describe these side effect(s) in detail in the Description of the side effect(s) field.


VAERS ID: 1964326 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Immunisation
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
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: DEPFIZER INC202101728704

Write-up: Deep vein thrombosis leg; booster; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100261123 (RA). A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) 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. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACURE UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACURE UNKNOWN), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Deep vein thrombosis leg". Source of assessment RA; Result of Assessment D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30891TB / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Fatigue, Immunisation, Magnetic resonance imaging, Myocarditis, Palpitations, Somnolence, Troponin
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:showed muscle change; Test Name: Troponin; Result Unstructured Data: Test Result:greatly increased; Test Name: Troponin; Result Unstructured Data: Test Result:declines; Comments: due to tranquility and rest
CDC Split Type: DEPFIZER INC202101734318

Write-up: Myocarditis; Heart pain; Heart pain; Fatigue; Tiredness; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021208958 (PEI). Other Case identifier(s): DE-CADRPEI-2021208958 (PEI Webportal), DE-PEI-202100260891 (PEI). An 18 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 30891TB) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected allergy to hazelnut" (unspecified if ongoing). The patient''s 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 17Nov2021, outcome "unknown", described as "Booster"; PALPITATIONS (hospitalization), ANGINA PECTORIS (hospitalization) all with onset 18Nov2021, outcome "not recovered" and all described as "Heart pain"; SOMNOLENCE (hospitalization) with onset 18Nov2021, outcome "not recovered", described as "Fatigue"; MYOCARDITIS (hospitalization) with onset 18Nov2021, outcome "not recovered", described as "Myocarditis"; FATIGUE (hospitalization) with onset 18Nov2021, outcome "not recovered", described as "Tiredness". The clinical course was reported as follows: First heart pain after 1 day, exhaustion, still worked on the dementia unit, but light activity, after 6 days hospitalization with rest prescription, MRI showed muscle changes, troponin greatly increased, troponin decreased due to rest and protection, slight subjective improvement. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: showed muscle change; troponin: greatly increased; declines, notes: due to tranquility and rest. The causality assessment of the events, heart racing, groggy, myocarditis, tiredness, was reported as unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964805 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Body mass index, Body surface area, Chest pain, Diarrhoea, Dysuria, Interchange of vaccine products, Migraine, Nausea, Off label use, Pyrexia, Vulvovaginal mycotic infection
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (symptomatic (loss of taste))
Allergies:
Diagnostic Lab Data: Test Name: Body Mass Index; Result Unstructured Data: Test Result:23.2; Test Name: Body area; Result Unstructured Data: Test Result:1.88
CDC Split Type: FRPFIZER INC202101728776

Write-up: Vulvovaginal mycotic infection; Thorax pain; Nausea; Pyrexia; Micturition burning; Migraine headache; Diarrhoea; smell loss; off label use; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NY20215210 (RA). A 56 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (not ongoing), notes: symptomatic (loss of taste). The patient''s concomitant medications were not reported. Vaccination history included: Janssen (Dose 1. MANUFACTURER UNKNOWN), administration date: Jun2021, for COVID-19 immunization. The following information was reported: ANOSMIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "smell loss"; VULVOVAGINAL MYCOTIC INFECTION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Vulvovaginal mycotic infection"; CHEST PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Thorax pain"; NAUSEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Nausea"; PYREXIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pyrexia"; DYSURIA (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Micturition burning"; MIGRAINE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Migraine headache"; DIARRHOEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Diarrhoea"; OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products". The patient underwent the following laboratory tests and procedures: body mass index: 23.2; body surface area: 1.88. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: loss of sense of smell, migraines, fever, nausea, diarrhea, chest pain, burning while urinating, vaginal yeast infection in a 56-year-old female with a medical history of COVID-19, the day after the second COVID-19 vaccination by COMIRNATY (batch unknown). Notion of a medical consultation. Sick leave. Patient not recovered as of the date of the declaration.


VAERS ID: 1965305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood test, Chest discomfort, Electrocardiogram, Feeling of body temperature change, Heart rate, Immunisation, Interchange of vaccine products, Muscle spasms, Myalgia, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain in arm
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:no indicators; Comments: no indicators of heart attack, angina, virus, infection or significant inflammmation; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 202111; Test Name: Pulse rate; Result Unstructured Data: Test Result:pulse range 38 - 120; Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739268

Write-up: Leg cramps; Feeling hot and cold; Arrhythmia (pulse range 38 - 120); Palpitations; Tight chest; Muscle ache; Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine; Third dose of COMIRNATY; 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-202112061108382550-DVJ6E (RA). Other Case identifier(s): GB-MHRA-ADR 26294987 (RA). A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pain in arm" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 02Oct2021. Vaccination history included: Astrazenecacovid-19vaccine (DOSE 2, SINGLE;Lot number: unknown: Route of administration: unspecified), for COVID-19 immunisation; Astrazenecacovid-19vaccine (DOSE 1, SINGLE;Lot number: unknown, lasting no more than a day or two), for COVID-19 immunisation, reaction(s): "very mild flu-like symptoms", "sore arm". The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine"; IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Third dose of COMIRNATY"; PALPITATIONS (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "Palpitations"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "Tight chest"; MYALGIA (hospitalization, medically significant) with onset 18Nov2021, outcome "recovered" (25Nov2021), described as "Muscle ache"; FEELING OF BODY TEMPERATURE CHANGE (hospitalization, medically significant) with onset 20Nov2021, outcome "recovered" (26Nov2021), described as "Feeling hot and cold"; MUSCLE SPASMS (hospitalization, medically significant) with onset 21Nov2021, outcome "recovered" (28Nov2021), described as "Leg cramps"; ARRHYTHMIA (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "Arrhythmia (pulse range 38 - 120)". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, palpitations, chest discomfort, myalgia, feeling of body temperature change, muscle spasms, arrhythmia (start date: Nov2021). The events "palpitations" and "arrhythmia (pulse range 38 - 120)" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) no indicators, notes: no indicators of heart attack, angina, virus, infection or significant inflammmation; electrocardiogram: (2021) unknown results; heart rate: (Nov2021) pulse range 38 - 120; sars-cov-2 test: (20Nov2021) no - negative covid-19 test. Clinical cause: I am normally fit, active and in good health. I have no conditions that require regular prescription medication. Arrhythmia continued throughout, with pulse varying up and down every few minutes. On returning home the arrhythmia has continued, although episodes are reducing in length and frequency - more like palpitations. 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 needed. No further information is expected


VAERS ID: 1965332 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erectile dysfunction, Immunisation, Injection site muscle weakness, Muscular weakness, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; LEVETIRACETAM; PNEUMOCOCCAL POLYSACCHARIDE VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739405

Write-up: Booster; injection site muscle weakness; Localised muscle weakness; it was sore when arm muscle being used/arm extended; Erectile dysfunction; 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-202112061326163060-ZT1PO. Other Case identifier(s): GB-MHRA-ADR 26295527. A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing); "epilepsy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for epilepsy; LEVETIRACETAM taken for epilepsy; PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; ERECTILE DYSFUNCTION (medically significant) with onset 2021, outcome "not recovered", described as "Erectile dysfunction"; INJECTION SITE MUSCLE WEAKNESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "injection site muscle weakness"; MUSCULAR WEAKNESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Localised muscle weakness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "it was sore when arm muscle being used/arm extended". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Nov2021) no - negative covid-19 test. Clinical course: She had injection site muscle weakness, not sore on palpation but it was sore when arm muscle being used/arm extended etc. Not debilitating but getting worse, not resolving. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient had symptoms associated with COVID-19. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739474

Write-up: Shingles; DOSE 1/2; MANUFACTUERER UNKNOWN; DOSE 1/2; MANUFACTUERER UNKNOWN; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory . Regulatory number: GB-MHRA-WEBCOVID-202112061552487410-IQNIJ. Other Case identifier(s): GB-MHRA-ADR 26296256. A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date Sep2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "DOSE 1/2; MANUFACTUERER UNKNOWN"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; HERPES ZOSTER (medically significant) with onset 28Nov2021, outcome "recovering", described as "Shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of herpes zoster. The patient was prescribed anti-viral medication - Aciclovir on 01Dec2021. 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. No further information is expected.


VAERS ID: 1965475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Anxiety, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test, Sleep terror
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: BENDROFLUMETHIAZIDE; LERCANIDIPINE; ATORVASTATIN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101751834

Write-up: Off label use; Interchange of vaccine products; Booster; Anxiety state; Sleep terror; Memory blackout; Nausea; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112071442385970-S4KMO. Other Case identifier(s): GB-MHRA-ADR 26298599. A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation; administration date 2021; BENDROFLUMETHIAZIDE taken for hypertension; LERCANIDIPINE taken for hypertension; ATORVASTATIN; CLOPIDOGREL. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/Lot no. Unknown, 36 hours after initial AZ dose symptoms), administration date: 24Mar2021, for COVID-19 immunisation, reaction(s): "Adverse event NOS"; Covid-19 vaccine astrazeneca (Dose 2, Batch/Lot no. Unknown), administration date: 09Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; ANXIETY (medically significant) with onset 2021, outcome "not recovered", described as "Anxiety state"; SLEEP TERROR (medically significant) with onset 2021, outcome "not recovered", described as "Sleep terror"; AMNESIA (medically significant) with onset 2021, outcome "not recovered", described as "Memory blackout"; NAUSEA (medically significant) with onset 2021, outcome "not recovered", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course: 36 hours after initial AZ dose symptoms occurred at night consulted doctor on phone given few days of diazepam and advised to consult therapist. As above after second dose of AZ though different doctor would not give diazepam. 2 weeks after booster dose of Pfizer similar reaction (flu jab given at same time). Each time symptoms seemed to subside within a week but can occasionally recur in mild form. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The reporter did not consider the event 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: 1965770 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac flutter, Fatigue, Limb discomfort, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; NAPROXEN; OMEPRAZOL; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hip bursitis (Pretty fit person for age . Hip bursitis surprise but may be walked the dog too much never had reactions to drugs or vaccinations)
Allergies:
Diagnostic Lab Data: Test Date: 20211208; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Arm discomfort; Tiredness; Welts; Blood pressure; Heart fluttering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26312047) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), LIMB DISCOMFORT (Arm discomfort), FATIGUE (Tiredness), URTICARIA (Welts) and BLOOD PRESSURE MEASUREMENT (Blood pressure) in a 68-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 Hip bursitis (Pretty fit person for age . Hip bursitis surprise but may be walked the dog too much never had reactions to drugs or vaccinations). Concomitant products included RAMIPRIL from 14-Dec-2020 to an unknown date for Blood pressure, NAPROXEN from 23-Jul-2021 to 16-Sep-2021 and OMEPRAZOL from 16-Jul-2021 to 16-Sep-2021 for Bursitis, INFLUENZA VACCINE (INFLUENZA VIRUS) from 27-Oct-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced URTICARIA (Welts) (seriousness criterion medically significant) and BLOOD PRESSURE MEASUREMENT (Blood pressure) (seriousness criterion medically significant). On 23-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 05-Dec-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant). On 21-Nov-2021, BLOOD PRESSURE MEASUREMENT (Blood pressure) had resolved. On 22-Nov-2021, URTICARIA (Welts) had resolved. At the time of the report, CARDIAC FLUTTER (Heart fluttering) outcome was unknown and LIMB DISCOMFORT (Arm discomfort) and FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient rang 111, and then surgery opened talk referred to pharmacist, sent him photos he then referred back to gp. The patient spoke to gp at first they had twigged that patient had booster and thought that this reaction to rampiril. It was dreadful for two awful nights never had anything like it. Creeping up legs buttocks sides itched so awful no sleep. The patient prescribed antihistamine fexenadine patient forgot to add that to took that and took for about 10 days. But interestingly this arm ache did not experience very much first time now very apparent, arm sore for about a week getting worse affects sleep and hard to sleep on that side. Last night that side sore and lower arm had gone to sleep. The heart fluttering is back again fork time to time. patient do have it sometimes but it had gone away . patient pretty tired and normally very energetic. The patient do not want to lose the record as forgot to enter the anti histamine for welts it was fexofenadune 22 Nov taken for 10 days. Company comment This is a regulatory authority case concerning a 68-year-old, female patient with no relevant medical history reported, who experienced the serious unexpected, according to , events of CARDIAC FLUTTER (AESI), LIMB DISCOMFORT, FATIGUE, URTICARIA with another serious event. The event CARDIAC FLUTTER occurred a day after the third dose of mRNA-1273 vaccine. The event URTICARIA occurred approximately 2 days after the third dose of mRNA-1273 vaccine. The event FATIGUE occurred approximately 6 days after the third dose of mRNA-1273 vaccine. The event LIMB DISCOMFORT occurred approximately 19 days after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory authority case concerning a 68-year-old, female patient with no relevant medical history reported, who experienced the serious unexpected, according to CCDS, events of CARDIAC FLUTTER (AESI), LIMB DISCOMFORT, FATIGUE, URTICARIA with another serious event. The event CARDIAC FLUTTER occurred a day after the third dose of mRNA-1273 vaccine. The event URTICARIA occurred approximately 2 days after the third dose of mRNA-1273 vaccine. The event FATIGUE occurred approximately 6 days after the third dose of mRNA-1273 vaccine. The event LIMB DISCOMFORT occurred approximately 19 days after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1965915 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? Yes
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: GRMODERNATX, INC.MOD20214

Write-up: Syncope; Fall; This case was received via Regulatory Authority (Reference number: GR-GREOF-202109623) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope) in a 38-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion life threatening) and FALL (Fall). On 17-Nov-2021, SYNCOPE (Syncope) and FALL (Fall) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Company comment: This case concerns a 38-year-old male patient with no medical history provided who experienced serious unexpected event of Syncope and non-serious unexpected event of Fall. The events occurred and resolved one day after the first dose of mRNA-1273. No further information regarding clinical course of the events was provided. Furthermore, no information regarding concomitant or treatment medications was provided. 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 event Syncope was life threatening in nature.; Sender''s Comments: This case concerns a 38-year-old male patient with no medical history provided who experienced serious unexpected event of Syncope and non-serious unexpected event of Fall. The events occurred and resolved one day after the first dose of mRNA-1273. No further information regarding clinical course of the events was provided. Furthermore, no information regarding concomitant or treatment medications was provided. 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 event Syncope was life threatening in nature.


VAERS ID: 1966010 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Myalgia, Paraesthesia, Spontaneous haematoma
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101729474

Write-up: Paraesthesia lower limb; Myalgia; Arthralgia; Spontaneous haematoma; Asthenia; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority. Regulatory number: IT-MINISAL02-815777 (RA). A 28 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 09:57 (Lot number: 1F1005A, Expiration Date: 31Mar2022) at the age of 28 years 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: PARAESTHESIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Paraesthesia lower limb"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Myalgia"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Arthralgia"; SPONTANEOUS HAEMATOMA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Spontaneous haematoma"; ASTHENIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Asthenia". These symptoms have progressively worsened over the following 10 days, associated with the appearance of paresthesia in lower limbs and spontaneous hematoma in the right thigh. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966096 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: Atrial fibrillation (Patient on anticoagulant therapy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Brain CT; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Cardioembolic Ischemic Stroke in F in Anticoagulant (Rivaroxaban); This case was received via European Medicines Agency (Reference number: IT-MINISAL02-816722) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Cardioembolic Ischemic Stroke in F in Anticoagulant (Rivaroxaban)) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. Previously administered products included for COVID-19 immunization: COMIRNATY on 13-Apr-2021 and COMIRNATY on 04-May-2021; for Product used for unknown indication: RIVAROXABAN. Past adverse reactions to the above products included No adverse event with COMIRNATY, COMIRNATY and RIVAROXABAN. Concurrent medical conditions included Atrial fibrillation (Patient on anticoagulant therapy.). On 16-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced ISCHAEMIC STROKE (Cardioembolic Ischemic Stroke in F in Anticoagulant (Rivaroxaban)) (seriousness criteria hospitalization and medically significant). At the time of the report, ISCHAEMIC STROKE (Cardioembolic Ischemic Stroke in F in Anticoagulant (Rivaroxaban)) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Computerised tomogram head: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided. It was reported that patient had Ischemic stroke the day after 3 COVID dose on a cardioembolic basis in patient on anticoagulant therapy. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Translation received on 17-DEC-2021 contains Event verbatim and Reporter''s comment updated. On 16-Dec-2021: Medical history updated, Brain CT lab result updated from Inconclusive to Negative.; Sender''s Comments: This case concerns an 81-year-old female patient, with medical history of Atrial fibrillation, who experienced the serious (medically significant and hospitalization) unexpected event of Ischaemic stroke. The event occurred on the same day after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1966110 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101735934

Write-up: On 20Nov2021 syncopal episode; After 4 days from the first dose of Pfizer vaccine onset of paresthesias and dysesthesias in the left hemiface and left parieto-occipital region.; After 4 days from the first dose of Pfizer vaccine onset of paresthesias and dysesthesias in the left hemiface and left parieto-occipital region.; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: IT-MINISAL02-817124. A 30 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 13Nov2021 17:03 (Lot number: FG6270) 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: LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "recovering", described as "On 20Nov2021 syncopal episode"; PARAESTHESIA (non-serious), DYSAESTHESIA (non-serious) all with onset 17Nov2021, outcome "recovering" and all described as "After 4 days from the first dose of Pfizer vaccine onset of paresthesias and dysesthesias in the left hemiface and left parieto-occipital region.". The events "on 20nov2021 syncopal episode", "after 4 days from the first dose of pfizer vaccine onset of paresthesias and dysesthesias in the left hemiface and left parieto-occipital region." and "after 4 days from the first dose of pfizer vaccine onset of paresthesias and dysesthesias in the left hemiface and left parieto-occipital region." were evaluated at the emergency room visit on 22Nov2021. Reporter Comment: Four days after the first dose of Pfizer vaccine, onset of paresthesias in the left hemiface and left parieto-occipital region. Adverse effect with probable neuroinflammatory genesis on a disimmune basis. On 20Nov2021 syncopal episode. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Four days after the first dose of Pfizer vaccine, onset of paresthesias in the left hemiface and left parieto-occipital region. Adverse effect with probable neuroinflammatory genesis on a disimmune basis. On 20Nov2021 syncopal episode.


VAERS ID: 1966329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101729154

Write-up: PERICARDIAL EFFUSION; PERICARDITIS; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: NO-NOMAADVRE-FHI-2021-Uj1qej. Other Case identifier(s): NO-NOMAADVRE-E2B_00062767. A 87 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: FJ5782) 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, batch/lot# unknown), administration date: 12Jan2021, for COVID-19 immunisation; Comirnaty (2nd dose, batch/lot# unknown), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PERICARDIAL EFFUSION (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "PERICARDIAL EFFUSION"; PERICARDITIS (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "PERICARDITIS". The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and events Pericarditis and Pericardial effusion as Possible. Sender Comment: It is reported that the patient has received batch number J07BX03, but this information does not match the date recorded in the regulatory authority. The batch number is FJ5782. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Immunisation, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101730875

Write-up: General malaise; Dizziness; severe headaches; booster dose; This is a spontaneous report received from a contactable Other HCP from the regulatory authority. Regulatory number: PT-INFARMED-G202111-1876. A 38 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: FF2382) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1, 0.3 mL), for COVID-19 immunization; Comirnaty (Dose 2, 0.3 mL), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster dose"; MALAISE (disability) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "General malaise"; DIZZINESS (disability) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Dizziness"; HEADACHE (disability) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "severe headaches". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966506 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chills, Hypertension, Pyrexia, Vaccination site erythema, Vaccination site oedema
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (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: Medical History/Concurrent Conditions: COVID-19; Hemorrhage brain (cerebral hemorrhage two years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:220/224 mmHg; Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: SIPFIZER INC202101729230

Write-up: Hypertension arterial; increased body temperature 38,5; chills; red arm; oedematous arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: SI-JAZMP-NCPHV-2021SI1413_1413 (regulatory authority). Other Case identifier(s): JAZMP-300018444 (regulatory authority). A 78 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 17:00 (Lot number: FF2382) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hemorrhage brain", start date: 2019 (not ongoing), notes: cerebral hemorrhage two years ago; "COVID-19", start date: Apr2021 (not ongoing). The patient''s concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant) with onset 17Nov2021 18:00, outcome "recovered" (18Nov2021), described as "Hypertension arterial"; FEVER (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "increased body temperature 38,5"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "red arm"; VACCINATION SITE OEDEMA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "oedematous arm". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 220/224 mmHg; body temperature: (17Nov2021) 38.5 Centigrade. Reporter Comment: Where do I get the confirmation of covid-19 infection and vaccination. Additional information: "Today on 20Nov2021 the patient still has administration site oedema and erythema. My aunt had covid-19 infection in April 2021. Second dose of the vaccine was not advised by the GP."; Reporter''s Comments: Where do I get the confirmation of covid-19 infection and vaccination.


VAERS ID: 1968367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Peritonsillar abscess
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101741127

Write-up: Peritonsillar abscess; This is a spontaneous report received from a contactable healthcare professional from Regulatory Authority. Regulatory number: 677436 (ADR#). A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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: PERITONSILLAR ABSCESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Peritonsillar abscess". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1969353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Blood pressure measurement, C-reactive protein, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Fibrin D dimer, Full blood count, Heart rate, Hypertension, Immunisation, Insomnia, Investigation, Limb discomfort, Movement disorder, Musculoskeletal stiffness, Oxygen saturation, Pericarditis, Platelet count, Renal function test, Respiration abnormal, Speech disorder, Troponin I
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MINIDRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumopathy; Rhinitis allergic atopic; Tonsillectomy & Adenoidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: electrolytes; Result Unstructured Data: Test Result:No disturbance; Test Date: 20211120; Test Name: blood pressure; Result Unstructured Data: Test Result:149/103 mmHg; Test Date: 20211120; Test Name: C-reactive protein; Result Unstructured Data: Test Result:53.5 mg/l; Test Date: 20211120; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Non-dilated left ventricle at 50mm,; Comments: without left ventricular hypertrophy; without alteration of left ventricular ejection fraction, normal mitral profile for age. Dry pericardium, no dilation of the right ventricle or of the descending aorta; Test Date: 20211120; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Regular sinus rhythm, low on ST in V2; Comments: no conduction disturbance; Test Date: 20211120; Test Name: Dimer; Result Unstructured Data: Test Result:580 ng/ml; Test Date: 20211120; Test Name: complete blood count; Result Unstructured Data: Test Result:No disturbance; Test Date: 20211120; Test Name: heart rate; Result Unstructured Data: Test Result:62; Comments: bpm; Test Date: 20211120; Test Name: Investigation NOS; Result Unstructured Data: Test Result:Regular heart sounds, absence of murmurs; Comments: no oedema of the lower limbs, hard calf due to probable stiffness.; Test Date: 20211120; Test Name: oxygen saturation; Test Result: 100 %; Comments: in ambient air; Test Date: 20211120; Test Name: platelets; Result Unstructured Data: Test Result:191 g/l; Test Date: 20211120; Test Name: renal assessment; Result Unstructured Data: Test Result:No disturbance; Test Date: 20211120; Test Name: cardiac troponin I; Result Unstructured Data: Test Result:<2.5 mg/ml; Comments: High sensitivity
CDC Split Type: FRPFIZER INC202101734175

Write-up: hard calf due to probable stiffness; stiffness; Blood pressure: 149/103 mmHg; increased with mobilization, speech and inspiration; increased with mobilization, speech and inspiration; increased with mobilization, speech and inspiration; Pericarditis; progressive worsening of chest pain/Has pain in the left latero-sternal increasing on palpation.; dyspnoea; insomnia; Booster; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-PO20215607 (RA). A 28-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FG7911) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Rhinitis allergic atopic" (unspecified if ongoing); "Pneumopathy" (unspecified if ongoing); "Tonsillectomy & Adenoidectomy" (unspecified if ongoing). Concomitant medication included: MINIDRIL, start date: 2016 (5 years ago). Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/lot number: ABV5300, Route of Administration INTRAMUSCULAR, 0.5 mL, Left arm), administration date: 02Mar2021, for COVID-19 immunisation; Comirnaty (Left arm, Intramuscular injection, Batch number: FC3558), administration date: 25May2021, for COVID-19 immunisation, reaction(s): "Interchange of vaccine products", "Off label use". The following information was reported: PERICARDITIS (medically significant) with onset 18Nov2021, outcome "recovered" (27Nov2021), described as "Pericarditis"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "progressive worsening of chest pain/Has pain in the left latero-sternal increasing on palpation."; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "unknown", described as "dyspnoea"; INSOMNIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "insomnia"; LIMB DISCOMFORT (non-serious) with onset 20Nov2021, outcome "unknown", described as "hard calf due to probable stiffness"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 20Nov2021, outcome "unknown", described as "stiffness"; MOVEMENT DISORDER (non-serious), SPEECH DISORDER (non-serious), RESPIRATION ABNORMAL (non-serious) all with onset 18Nov2021, outcome "unknown" and all described as "increased with mobilization, speech and inspiration"; HYPERTENSION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Blood pressure: 149/103 mmHg". The events "pericarditis" and "progressive worsening of chest pain/has pain in the left latero-sternal increasing on palpation." were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood electrolytes: (20Nov2021) no disturbance; blood pressure measurement: (20Nov2021) 149/103 mmHg; c-reactive protein: (20Nov2021) 53.5 mg/l; echocardiogram: (20Nov2021) non-dilated left ventricle at 50mm, notes: without left ventricular hypertrophy; without alteration of left ventricular ejection fraction, normal mitral profile for age. Dry pericardium, no dilation of the right ventricle or of the descending aorta; electrocardiogram: (20Nov2021) regular sinus rhythm, low on st in v2, notes: no conduction disturbance; fibrin d dimer: (20Nov2021) 580 ng/ml; full blood count: (20Nov2021) no disturbance; heart rate: (20Nov2021) 62, notes: bpm; investigation: (20Nov2021) regular heart sounds, absence of murmurs, notes: no oedema of the lower limbs, hard calf due to probable stiffness; oxygen saturation: (20Nov2021) 100 %, notes: in ambient air; platelet count: (20Nov2021) 191 g/l; renal function test: (20Nov2021) no disturbance; troponin i: (20Nov2021) <2.5 mg/ml, notes: High sensitivity. Therapeutic measures were taken as a result of pericarditis, chest pain, dyspnoea, insomnia, limb discomfort, musculoskeletal stiffness, movement disorder, speech disorder, respiration abnormal. On 18Nov2021, onset of progressive worsening of chest pain to the left side which subsides with the initial intake of paracetamol. The pain becomes increasingly intense associated with dyspnoea, insomnia, increased with mobilization, speech and inspiration. On 20Nov2021, the patient took an Ixprim tablet with no efficacy. The patient visits the emergency room. The patient is hemodynamically stable. Vesicular murmur +/+, no added murmur. Introduction of aspirin 1g x 3 per day for 7 days then decrease in doses. Pain clearly improved one week later. On 30Nov2021, the patient is doing well and is no longer in pain. She is still taking aspirin. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101789275 same patient/drug, different dose/events


VAERS ID: 1969407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein, Chest pain, Dyspnoea, Fatigue, Fibrin D dimer, Immunisation, Myocarditis, Neck pain, Palpitations, Pericarditis, SARS-CoV-2 test, Tachycardia, Thyroid function test, Troponin, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:elevated; Comments: elevated; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Test Date: 20211115; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: thyroid function testing; Result Unstructured Data: Test Result:Unknown; Test Name: Troponin; Result Unstructured Data: Test Result:normal; Comments: normal
CDC Split Type: GBPFIZER INC202101754011

Write-up: Heart palpitations; Racing heart (tachycardia); Fatigue/unusual tiredness; Chest pain; Shortness of breath; myocarditis; pericarditis; viral symptoms; Neck pain; Shoulder pain; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112021558492870-PVCJ1. Other Case identifier(s): GB-MHRA-ADR 26281854. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FG6431) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 13Nov2021 (ongoing). Patient is not pregnant at time of vaccination, patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; NECK PAIN (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Neck pain"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; ARTHRALGIA (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Shoulder pain"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; VIRAL INFECTION (medically significant), outcome "unknown", described as "viral symptoms". Racing heart (tachycardia), chest pain, palpitations. Initial symptoms post vaccine were overwhelming fatigue, viral symptoms, palpitations and shortness of breath. Now patient continues to experience these symptoms with shoulder and neck pain. She is a nurse of over 27 years experience and she has never endured this before and she is concerned that she may not recover back to my baseline. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report relate to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations or tests conducted: "D-dimer, C-reactive protein and thyroid function testing. C-reactive protein elevated ". The symptoms did not lead to a hospital stay. A diagnosis was made by a medical professional (general practitioner (GP)). No treatment was given. D-Dimer done. Rest advised. Blood tests, such as for certain proteins (called troponin) that signal heart muscle damage was taken and the troponin was normal. The patient underwent the following laboratory tests and procedures: c-reactive protein: (unspecified date) elevated, notes: elevated; fibrin d dimer: (unspecified date) unknown; sars-cov-2 test: (15Nov2021) negative, notes: No - Negative COVID-19 test; thyroid function test: (unspecified date) unknown; troponin: (unspecified date) normal, notes: normal. Therapeutic measures were not taken as a result of chest pain, dyspnoea, neck pain, palpitations, tachycardia, fatigue, arthralgia, myocarditis, pericarditis, viral infection. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac discomfort, Cardiac disorder, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Heart rate, Heart rate decreased, Immunisation, Maternal exposure timing unspecified, Myocarditis, Palpitations, Pericarditis, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asplenia (Isolated Congenital)
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown; Test Name: pulse; Result Unstructured Data: Test Result:Slow pulse; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101758795

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Heart rate decreased; Cardiac disorder; Maternal vaccine exposure; Fainting; myocarditis; pericarditis; Heart pressure sensation of; 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-202112062334468550-GCKDR. Other Case identifier(s): GB-MHRA-ADR 26297483. A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pregnancy" (not ongoing); "Asplenia" (ongoing), notes: Isolated Congenital; "Immunodeficiency" (unknown if ongoing), notes: Has an illness or condition, not listed above, which. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (disability, medically significant), outcome "unknown", described as "Fainting"; MYOCARDITIS (disability, medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (disability, medically significant), outcome "unknown", described as "pericarditis"; CARDIAC DISCOMFORT (disability, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Heart pressure sensation of"; FATIGUE (disability, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (disability, medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (disability, medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (disability, medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (disability, medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; HEART RATE DECREASED (disability, medically significant), outcome "unknown", described as "Heart rate decreased"; CARDIAC DISORDER (disability, medically significant), outcome "unknown", described as "Cardiac disorder"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Maternal vaccine exposure". The events "fainting", "myocarditis", "pericarditis", "heart pressure sensation of", "fatigue/unusual tiredness", "chest pain", "shortness of breath", "heart palpitations", "racing heart (tachycardia)", "heart rate decreased", "cardiac disorder" and "maternal vaccine exposure" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown; heart rate: slow pulse; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were not taken as a result of syncope, myocarditis, pericarditis, cardiac discomfort, fatigue, chest pain, dyspnoea, palpitations, tachycardia, heart rate decreased, cardiac disorder, maternal exposure timing unspecified. Clinical course: Constantly feel like patient going to have a heart attack. Symptoms stared after she received her first vaccine in February and are getting worse. She has now had 3 vaccines, and her heart feels very heavy, swollen, and blocked. She never had heart problems in her life until the vaccine. Her baby also died from heart problems after the vaccine. Heart beats very fast, then beats very slow. Heart feels very weak as if it may stop at any moment. This report relate to possible inflammation of the heart (myocarditis or pericarditis). Details of relevant investigations or tests conducted reported as been to accident and emergency A&E several times, and being referred for tests, haven''t had any tests yet. Feels like no-one was taking her symptoms seriously. The symptoms lead to a hospital stay, several A&E visits and ambulances to home. Patient happy for us to contact her GP or treating physician. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Patient has not tested positive for COVID-19 since having the vaccine. Patient 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.; Sender''s Comments: Linked Report(s) : GB-MHRA-ADR 26298771 ;GB-PFIZER INC-202101751847 mother case


VAERS ID: 1969541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Chest discomfort, Cough, Electrocardiogram, Heart rate, Immunisation, Lower respiratory tract infection, Palpitations, SARS-CoV-2 test, Supraventricular tachycardia, Vomiting, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood culture; Result Unstructured Data: Test Result:Result unknown; Test Date: 2021; Test Name: Ecg; Result Unstructured Data: Test Result:Result unknown; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:188-194; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Test Result:Result unknown.
CDC Split Type: GBPFIZER INC202101768584

Write-up: Heart rate; Booster; palpitations; chest discomfort; Cough increased; Vomited; LRTI; SVT; 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-202112090930421310-OXYXZ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26311564 (MHRA). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Booster"; PALPITATIONS (hospitalization) with onset 2021, outcome "unknown", described as "palpitations"; CHEST DISCOMFORT (hospitalization) with onset 2021, outcome "unknown", described as "chest discomfort"; COUGH (hospitalization) with onset 2021, outcome "not recovered", described as "Cough increased"; HEART RATE (hospitalization) with onset 27Nov2021, outcome "recovering", described as "Heart rate"; VOMITING (hospitalization) with onset 2021, outcome "unknown", described as "Vomited"; LOWER RESPIRATORY TRACT INFECTION (hospitalization) with onset 2021, outcome "unknown", described as "LRTI"; SUPRAVENTRICULAR TACHYCARDIA (hospitalization) with onset 2021, outcome "unknown", described as "SVT". The patient underwent the following laboratory tests and procedures: blood culture: (2021) result unknown; electrocardiogram: (2021) result unknown; heart rate: (2021) 188-194; sars-cov-2 test: (2021) negative, notes: No - Negative COVID-19 test; x-ray: (2021) result unknown. Clinical course: Had rapid heart rate 188-194, vomited, svt, lrti, chest discomfort, palpitations with sob. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-20
Onset:2021-11-17
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiocardiogram, Blood creatinine, Blood creatinine increased, Blood lactate dehydrogenase, C-reactive protein, COVID-19, Chest X-ray, Computerised tomogram thorax, Drug ineffective, Echocardiogram, Ejection fraction, Electrocardiogram, Fatigue, Fibrin D dimer, Heart sounds, Left ventricular dysfunction, Multisystem inflammatory syndrome in children, Myocarditis, Oropharyngeal pain, Pericarditis, Pleural effusion, Pyrexia, Renal impairment, SARS-CoV-2 test, Serum ferritin, Shock, Sinus tachycardia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

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: Suspected COVID-19 (Unsure when symptoms started.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:Unknown; Test Name: creatinine kinase; Result Unstructured Data: Test Result:high; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:high; Test Date: 20211206; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pleural effusions and possible fluid on right side; Test Name: Chest Computed Tomography; Result Unstructured Data: Test Result:Unknown; Test Name: CRP; Result Unstructured Data: Test Result:547; Comments: high; Test Date: 20211209; Test Name: Echocardiogram; Result Unstructured Data: Test Result:LV dysfunction (EF 45%), coronaries ok; Test Date: 20211209; Test Name: EF; Test Result: 45 %; Test Date: 20211206; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachy, no ST changes; Test Name: D-Dimers; Result Unstructured Data: Test Result:high; Test Name: heart sounds; Result Unstructured Data: Test Result:Unknown; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: Ferritin; Result Unstructured Data: Test Result:6,000 ug/L; Comments: high; Test Date: 20211208; Test Name: troponin; Result Unstructured Data: Test Result:437 ng/L; Comments: peak troponin value. Raised.
CDC Split Type: GBPFIZER INC202101768704

Write-up: Fatigue; Fever; pericarditis; Significant renal impairment; shock; Suspected paediatric inflammatory multisystem syndrome; sinus tachy; significan not renal impairment; sore throat; abdominal pain; lv dysfunction; pleural effusions; Myocarditis; SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112091614241640-DIETH . Other Case identifier(s): GB-MHRA-ADR 26313679 (MHRA). A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started. The patient''s concomitant medications were not reported. The following information was reported: BLOOD CREATININE INCREASED (hospitalization, life threatening), outcome "unknown", described as "significan not renal impairment"; OROPHARYNGEAL PAIN (hospitalization, life threatening), outcome "unknown", described as "sore throat"; ABDOMINAL PAIN (hospitalization, life threatening), outcome "unknown", described as "abdominal pain"; LEFT VENTRICULAR DYSFUNCTION (hospitalization, life threatening), outcome "unknown", described as "lv dysfunction"; PLEURAL EFFUSION (hospitalization, life threatening), outcome "unknown", described as "pleural effusions"; MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 05Dec2021, outcome "recovering", described as "Myocarditis"; FATIGUE (hospitalization, life threatening), outcome "unknown", described as "Fatigue"; PYREXIA (hospitalization, life threatening), outcome "unknown", described as "Fever"; PERICARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "pericarditis"; RENAL IMPAIRMENT (hospitalization, medically significant, life threatening), outcome "unknown", described as "Significant renal impairment"; SHOCK (hospitalization, medically significant, life threatening), outcome "unknown", described as "shock"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (hospitalization, medically significant, life threatening), outcome "unknown", described as "Suspected paediatric inflammatory multisystem syndrome"; SINUS TACHYCARDIA (hospitalization, life threatening), outcome "unknown", described as "sinus tachy"; COVID-19 (hospitalization, medically significant, life threatening) with onset 17Nov2021, outcome "recovered" (2021), described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (hospitalization, medically significant, life threatening) with onset 17Nov2021, outcome "recovered" (2021), described as "Drug ineffective". The patient underwent the following laboratory tests and procedures: angiocardiogram: (unspecified date) unknown; blood creatinine: (unspecified date) high; blood lactate dehydrogenase: (unspecified date) high; chest x-ray: (06Dec2021) pleural effusions and possible fluid on right side; computerised tomogram thorax: (unspecified date) unknown; c-reactive protein: (unspecified date) 547, notes: high; echocardiogram: (09Dec2021) lv dysfunction (ef 45%), coronaries ok; ejection fraction: (09Dec2021) 45 %; electrocardiogram: (06Dec2021) sinus tachy, no st changes; fibrin d dimer: (unspecified date) high; heart sounds: (unspecified date) unknown; sars-cov-2 test: (unspecified date) positive, notes: Yes - Positive COVID-19 test; serum ferritin: (unspecified date) 6,000 ug/L, notes: high; troponin (normal high range 34): (08Dec2021) 437 ng/L, notes: peak troponin value Raised. Therapeutic measures were taken as a result of left ventricular dysfunction, myocarditis, pericarditis. Clinical course: Patient had history of COVID (positive PCR) with mild symptoms 3 weeks ago (prior to this also had his COVID vaccination). Did not require hospitalisation at the time. Re-presented to A&E 3 weeks later with sore throat and generalised abdominal pain and in shock. Suspected paediatric inflammatory multisystem syndrome associated with COVID 19 or with vaccine (or combination of both). ECHO showed severe LV dysfunction, Started on inotropes and high dose steroids. Intubated and ventilated and on IV antibiotics. High CRP (547), high Ferritin (6,000ug/L), high creatinine kinase and lactate dehydrogenase. Significant renal impairment, high D-Dimers. Patient was not enrolled in clinical trial. His report was not related to possible blood clots or low platelet counts. His report was related to possible myocarditis or pericarditis. Myocarditis and pericarditis. The patient was admitted to hospital and still an inpatient. The patient was seen by a cardiologist. Treatments received of High dose steroids, inotropes, IV antibiotics. for IVIG. Severe LV dysfunction (EF 45%). The troponin was measured on 08Dec2021 was raised. The peak troponin value was 437ng/L. The troponin reference range was below 34ng/L. An ECG was carried out on 06Dec2021 and resulted into sinus tachycardia, no ST changes. Chest X-ray was performed on 06Dec2021 x-ray showed pleural effusions and possible fluid on right side. An Echocardiogram was carried out on 09Dec2021 and resulted into LV dysfunction (EF 45%), coronaries ok. A Chest Computed Tomography and Coronary angiography carried out and results were unknown. A Cardiac MRI and Cardiac Biopsy were not performed. It was unknown if presence of pericardial rub, or changes in heart sounds. It was unknown if patient was asymptomatic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1970169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Hemoglobin decreased (The last time The patient went to the hospital due to hemoglobin deficiency approx 5 years ago.); Hemorrhoids (The patient had an exacerbation of hemorrhoids a year ago, then she took detralex.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202101753593

Write-up: thrombophlebitis in both legs; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from the regulatory authority-WEB. Regulatory number: LT-SMCA-4388. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemorrhoids", start date: 2020 (unspecified if ongoing), notes: The patient had an exacerbation of hemorrhoids a year ago, then she took detralex.; "Hemoglobin decreased", start date: 2016 (unspecified if ongoing), notes: The last time The patient went to the hospital due to hemoglobin deficiency approx 5 years ago. There were no concomitant medications. Past drug history included: Detralex. 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 17Nov2021, outcome "unknown", described as "Booster"; THROMBOPHLEBITIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "thrombophlebitis in both legs". Therapeutic measures were taken as a result of thrombophlebitis. Symptomatic treatment was received: detralex, Troxevasin gel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1970257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-11-17
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
SMQs:, Lack of efficacy/effect (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19; Result Unstructured Data: Test Result:POSITIVE; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101735929

Write-up: 1st dose Astra Zeneca; 1st dose Astra Zeneca; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-1657 (INFARMED). A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Jun2021 (Lot number: unknown) as dose 2 (initial pfizer dose), 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 astrazeneca (1st dose, Lot#ABV5443), administration date: 27Mar2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Covid + 17Nov021"; COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "Covid +"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "1st dose Astra Zeneca". The patient underwent the following laboratory tests and procedures: covid-19: (17Nov2021) positive, notes: positive Iu international unit(s). Reporter Comment: Other information-First dose: 27Mar2021~AstraZeneca~ABV5443 The lot number for bnt162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Other information-First dose: 27Mar2021~AstraZeneca~ABV5443


VAERS ID: 1970265 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-11-17
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C16-03 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: PTJNJFOC20211243062

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202111-2495) concerned a 34 year old of an unspecified sex, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-03 expiry: unknown) 0.5 ml, 01 total, administered on 24-AUG-2021 for covid-19 immunisation (dose number in series 1). No concomitant medications were reported. On 17-NOV-2021, the patient had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was non-serious. This report was associated with a product quality complaint.


VAERS ID: 1972133 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Chills, Extensive swelling of vaccinated limb, Headache, Lethargy, Myalgia, Nausea, Pericarditis, Pyrexia, Rash, Seizure, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (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? 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: AUPFIZER INC202101740695

Write-up: Pericarditis; Seizure; Syncope; Abdominal pain; Arthralgia; Chills; Extensive swelling of vaccinated limb; Headache; Lethargy; Myalgia; Nausea; Pyrexia; Rash; Swelling; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 675513 Regulatory Authority. A 26 year-old male 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 and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Pericarditis"; SEIZURE (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Seizure"; SYNCOPE (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Syncope"; ABDOMINAL PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Abdominal pain"; ARTHRALGIA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Arthralgia"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Chills"; EXTENSIVE SWELLING OF VACCINATED LIMB (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Extensive swelling of vaccinated limb"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Headache"; LETHARGY (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Lethargy"; MYALGIA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Myalgia"; NAUSEA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Nausea"; PYREXIA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Pyrexia"; RASH (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Rash"; SWELLING (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Swelling". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Defaecation urgency, Fatigue, Frequent bowel movements, Haematochezia, Inflammation, Proctalgia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101741069

Write-up: Haematochezia; Abdominal pain; Chest pain; Defaecation urgency; Fatigue; Frequent bowel movements; Inflammation; Proctalgia; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 677195 Regulatory Authority. A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Oct2021 (Batch/Lot number: unknown) as dose 2, single for for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), administration date: 23Sep2021, for COVID-19 immunisation. The following information was reported: HAEMATOCHEZIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Haematochezia"; ABDOMINAL PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Abdominal pain"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest pain"; DEFAECATION URGENCY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Defaecation urgency"; FATIGUE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Frequent bowel movements"; INFLAMMATION (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Inflammation"; PROCTALGIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Proctalgia". Clinical course: Medicine (Onset Time in Days): COMIRNATY COVID-19 vaccine- Suspect (19 days); COMIRNATY COVID-19 vaccine - Suspect (55 days). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972304 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Muscular weakness, Vaccination site pain, Vaccination site paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
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: DEPFIZER INC202101753883

Write-up: Vaccination site paraesthesia; Acrocyanosis; Hand weakness; Site of vaccination painful; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-DCGMA-21194959 (RA). Other Case identifier(s): DE-PEI-202100265809 (RA). A 16 year-old female patient received bnt162b2 (COMIRNATY), intramuscular (Batch/Lot number: unknown) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PARAESTHESIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Vaccination site paraesthesia"; CYANOSIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Acrocyanosis"; MUSCULAR WEAKNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Hand weakness"; VACCINATION SITE PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Site of vaccination painful". Therapeutic measures were taken as a result of vaccination site paraesthesia, cyanosis, muscular weakness, vaccination site pain. Reporter comment: Measures: pain therapy, physiotherapy Source of assessment: RA for the events: Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972342 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTN4 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101762784

Write-up: Facial paresis right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100266094 (RA). A 49 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Oct2021 (Lot number: SCTN4) at the age of 49 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: FACIAL PARESIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Facial paresis right". Additional information: Result of Assessment: Comirnaty/event(s): Facial palsy/ RA: D. Unclassifiable. This case was reported as serious with seriousness criteria: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972825 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Sinus rhythm, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? 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; Test Date: 20211121; Test Name: sinus rhythm; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101758746

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA regulatory authority). Regulatory number: GB-MHRA-WEBCOVID-202112071603039300-1VB9C (RA). Other Case identifier(s): GB-MHRA-ADR 26298997 (RA). A 70 year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 immunisation, reaction(s): "Heart fluttering". The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Patient received first, second dose of ASTRAZENECA vaccine and booster dose of COMIRNATY"; IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; CARDIAC FLUTTER (hospitalization, medically significant) with onset 17Nov2021, outcome "recovered" (21Nov2021), described as "Heart fluttering"; DYSPNOEA (hospitalization) with onset 2021, outcome "not recovered", described as "breathlessness"; CHEST PAIN (hospitalization) with onset 2021, outcome "unknown", described as "Chest pain"; PALPITATIONS (hospitalization) with onset 2021, outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (hospitalization) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)"; SYNCOPE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Fainting"; FATIGUE (hospitalization) with onset 2021, outcome "not recovered", described as "Fatigue/unusual tiredness"; MYOCARDITIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PERICARDITIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "pericarditis". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, cardiac flutter, dyspnoea, chest pain, palpitations, tachycardia, syncope, fatigue, myocarditis, pericarditis (start date: 18Nov2021, discharge date: 21Nov2021, hospitalization duration: 3 day(s)). The events "heart fluttering", "breathlessness", "chest pain", "heart palpitations", "racing heart (tachycardia)", "fainting", "fatigue/unusual tiredness", "myocarditis" and "pericarditis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) no - negative covid-19 test; sinus rhythm: (21Nov2021) unknown results. Therapeutic measures were taken as a result of cardiac flutter, chest pain, palpitations, tachycardia, myocarditis, pericarditis. Medication prescribed.: "Cardioversion". Clinical course: Chest pain, fatigue/unusual tiredness, heart fluttering, heart palpitations, fainting, (racing heart) tachycardia. Diagnosed with heart flutter after first AstraZeneca vaccine unsure if related. 4 hours after booster flutter returned. Hospitalised on 18Nov2021. Cardioversion 20Nov2021. Returned home 21 Nov2021 in sinus rhythm but continuing to experience fatigue and mild breathlessness. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report was relate to possible inflammation of the heart (myocarditis or pericarditis). The symptoms lead to a hospital stay. hospital stay was "3 nights''''. A diagnosis was made by a medical professional. The type of healthcare professional that provided this diagnosis and any specific details of the diagnosis given was "Cardiologist". Happy to contact general practitioner or treating physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972849 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness, Myocarditis, Pain in extremity, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Yes - Positive COVID-19 test)
Allergies:
Diagnostic Lab Data: Test Date: 20211011; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101758831

Write-up: Chest pain/pain across my chest; Tight chest; Stiff neck; Pain in arm; Flu-like aching; Headache; Fatigue/unusual tiredness; Fever; myocarditis; pericarditis; Racing heart (tachycardia); Heart palpitations; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authorityy (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112072050164580-YABEK (MHRA). Other Case identifier(s): GB-MHRA-ADR 26300942 (MHRA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 11Oct2021 (not ongoing), notes: Yes - Positive COVID-19 test. Date of last menstrual period was 25Nov2021. The patient was not breastfeeding at the time of this report and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: TACHYCARDIA (medically significant) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; INFLUENZA LIKE ILLNESS (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Flu-like aching"; CHEST PAIN (medically significant) with onset 02Dec2021, outcome "not recovered", described as "Chest pain/pain across my chest"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Stiff neck"; PAIN IN EXTREMITY (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Pain in arm"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; CHEST DISCOMFORT (medically significant) with onset 02Dec2021, outcome "not recovered", described as "Tight chest"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; PYREXIA (medically significant) with onset 2021, outcome "unknown", described as "Fever"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "pericarditis". The events "racing heart (tachycardia)", "heart palpitations", "shortness of breath", "flu-like aching", "chest pain/pain across my chest", "stiff neck", "pain in arm", "headache", "tight chest", "fatigue/unusual tiredness", "fever", "myocarditis" and "pericarditis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Oct2021) yes - positive covid-19 test. The clinical course was reported as follows: the patient had chest pain and tightness that''s come on was the worse out of all side effects. The patient can''t take a deep breath in without a sharp shooting pain across chest. Constant aching. It was reported that patient was related to possible inflammation of the heart (myocarditis or pericarditis), unknown if symptoms led to a hospital stay, diagnosis was not made by a medical professional and no imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac magnetic resonance imaging (MRI), chest computerised tomography (CT). The patient was 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: 1972997 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Chemical burn of skin, Loss of consciousness, Malaise, Nausea, Necrosis, SARS-CoV-2 test, Thrombocytopenia, Vasculitis
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

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

Write-up: burns; blisters; lost consciousness; thrombocytopenia; vasculitis; nausea; feeling unwell; Necrosis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26310599) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEMICAL BURN OF SKIN (burns), BLISTER (blisters), LOSS OF CONSCIOUSNESS (lost consciousness), THROMBOCYTOPENIA (thrombocytopenia), VASCULITIS (vasculitis), NAUSEA (nausea), MALAISE (feeling unwell) and NECROSIS (Necrosis) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date, ENOXAPARIN, METHYLPREDNISOLONE and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced NECROSIS (Necrosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). On an unknown date, the patient experienced CHEMICAL BURN OF SKIN (burns) (seriousness criteria hospitalization, disability, medically significant and life threatening), BLISTER (blisters) (seriousness criteria hospitalization, disability, medically significant and life threatening), LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criteria hospitalization, disability, medically significant and life threatening), THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization, disability, medically significant and life threatening), VASCULITIS (vasculitis) (seriousness criteria hospitalization, disability, medically significant and life threatening), NAUSEA (nausea) (seriousness criteria hospitalization, disability, medically significant and life threatening) and MALAISE (feeling unwell) (seriousness criteria hospitalization, disability, medically significant and life threatening). At the time of the report, CHEMICAL BURN OF SKIN (burns), BLISTER (blisters), LOSS OF CONSCIOUSNESS (lost consciousness), THROMBOCYTOPENIA (thrombocytopenia), VASCULITIS (vasculitis), NAUSEA (nausea) and MALAISE (feeling unwell) outcome was unknown and NECROSIS (Necrosis) 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. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Right hand microvascular vasculitis with denuded skin and necrotic digits thought related to COVID19 vaccination. She has previously had x2 AZ COVID vaccines without any issues apart from some nausea after her first dose. She received her MODERNA vaccine to her left arm. Patient woke up a few times in the night feeling unwell. She felt lightheaded then collapsed for 10 minutes. head trauma but noted her right arm to be painful. When she woke up in the morning her right arm was very painful, and she realized it had become very swollen and blistered. She attended A+E where it was suspected this was a burn. She was kept in hospital overnight, blisters were deroofed and then discharged with outpatient review. On 22nd Nov, 5 days post presentation, she had a wound review, and it was noted two of the finger pulps were very cold. The surgeons were able to detect doppler signals all the way to the finger pulps suggesting there was still inflow. She was referred to the burns unit and seen on the 22nd Nov. She had a vascular and hematology consult. A CTA was performed, and no abnormalities were identified. Suggests mainstay of treatment will be expectant with debridement/terminalization as indicated. No convincing indication for anticoagulation at present (23/11). Suggested that as platelet count was normal that it was unlikely to be vaccine related thrombocytopenia. A bubble Echo was NAD. Skin biopsies were performed on the 19thNov by dermatology which suggested appearances could raise possibility of early vasculitis although not confirmatory. Seen by plastics - is planned for surgery in 2 weeks. Derm consult - biopsy 4/12/21.Haematology consult - 5/12/21 suggested to send certain blood tests and brain imaging. Management to date: Co-amoxicillin IV 1.2g TDS (switched from oral) started 4/12/21, 2x stat 500mg IV methylprednisolone, S/C therapeutic enoxaparin (weight is 57.6kg) 90mg daily, Analgesia - Regular paracetamol and prn codeine, Iloprost infusion started 5/12/21. Company comment: This case concerns a 62-year-old female patient with no medical history provided who experienced serious unexpected events of Necrosis, Chemical burn of skin, Blister, Loss of consciousness, Thrombocytopenia, Vasculitis, Nausea and Malaise following dose of mRNA-1273, reported as third dose, as the patient received Company product following the primary series with Astrazeneca vaccine. It was suspected that patient developed a burn as the patient''s arm was painful, swollen and blistered. Blisters were deroofed, however, after five days, it was noted that two of the patient''s finger pulps were cold, even though doppler signals could be detected. A CTA and echo were performed and no abnormalities were identified. Patient''s platelet count was normal. Skin biopsy suggested patient developed vasculitis. Patient was treated with Iloprost, antibiotics, steroids, anticoagulants and analgesics. At the time of the report patient was awaiting surgery. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that Interchange of vaccine products should have been considered in this particular case as the patient received Astrazeneca vaccine prior to Company product.; Sender''s Comments: This case concerns a 62-year-old female patient with no medical history provided who experienced serious unexpected events of Necrosis, Chemical burn of skin, Blister, Loss of consciousness, Thrombocytopenia, Vasculitis, Nausea and Malaise following dose of mRNA-1273, reported as third dose, as the patient received Company product following the primary series with Astrazeneca vaccine. It was suspected that patient developed a burn as the patient''s arm was painful, swollen and blistered. Blisters were deroofed, however, after five days, it was noted that two of the patient''s finger pulps were cold, even though doppler signals could be detected. A CTA and echo were performed and no abnormalities were identified. Patient''s platelet count was normal. Skin biopsy suggested patient developed vasculitis. Patient was treated with Iloprost, antibiotics, steroids, anticoagulants and analgesics. At the time of the report patient was awaiting surgery. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that Interchange of vaccine products should have been considered in this particular case as the patient received Astrazeneca vaccine prior to Company product.


VAERS ID: 1973368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blister, Dysmenorrhoea, Goitre, Insomnia, Malaise, Nausea, Retching, Skin burning sensation
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Osteoarthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202101753688

Write-up: Blistering; Pain menstrual; Nausea; Retching; Feeling unwell; Thyroid enlarged; Insomnia; My skin burns on body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: HR-HALMED-300052484 Regulatory Authority. Other Case identifier(s): 01-605-092-559 Regulatory Authority. A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Nov2021 (Lot number: FG4686) as dose 1, 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: SKIN BURNING SENSATION (medically significant) with onset 17Nov2021, outcome "recovering", described as "My skin burns on body"; BLISTER (medically significant) with onset 20Nov2021, outcome "recovering", described as "Blistering"; DYSMENORRHOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Pain menstrual"; NAUSEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Nausea"; RETCHING (medically significant) with onset 17Nov2021, outcome "recovering", described as "Retching"; MALAISE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Feeling unwell"; GOITRE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Thyroid enlarged"; INSOMNIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Insomnia". So the second week after the first dose of the Pfizer, blisters appear immediately after the injection from the first day, her skin burns on the body. Extremely severe menses and insomnia in addition. This is abnormal for her. Additional information received on 24Nov2021: Yesterday the patient reported Regulatory Authority and blisters and general bad state constant nausea and urge to vomit and she saw that her thyroid was enlarged. The patient called the free informational number and said it there. They said the second dose should be postponed and this should be checked for thyroid and blood. For thyroid all possible searches. The patient said she only had that stupid osteoarthritis left to be healthy. On Wednesday she needed a jab of Pfizer 2. And she didn''t feel good, especially after this menses never like that. The patient was not a hypochondriac or antivaxer, when she sailed she got vaccines and vaccines and everything was always ok. A casual relationship between Comirnaty and all events was assessing being possible Source of assessment: Regulatory Authority Method of assessment: Agency Causality No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760263

Write-up: Chest discomfort; Palpitations; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Regulatory number: AEFI-A-050866 (RA Case Number). A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (First dose), for COVID-19 immunisation. The following information was reported: CHEST DISCOMFORT (hospitalization) with onset 17Nov2021 10:15, outcome "recovering", described as "Chest discomfort"; PALPITATIONS (hospitalization) with onset 17Nov2021 10:15, outcome "recovering", described as "Palpitations"; TACHYCARDIA (hospitalization) with onset 17Nov2021 10:15, outcome "not recovered", described as "Tachycardia". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973727 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320258D / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Chest pain, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Malaise, Myalgia, Nausea, Pyrexia, Syncope, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101759352

Write-up: fainting; Abdominal pain; Diarrhoea; Body Malaise; fatigue; fever; joint pain; Injection site soreness; muscle pain; nausea; Vomiting; dizziness; Shortness of breath; chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300123281 (PHFDA). A 28 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 320258D) at the age of 28 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: SYNCOPE (medically significant) with onset 17Nov2021 14:05, outcome "recovered", described as "fainting"; ABDOMINAL PAIN (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Abdominal pain"; DIARRHOEA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Diarrhoea"; MALAISE (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Body Malaise"; FATIGUE (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "fatigue"; PYREXIA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "fever"; ARTHRALGIA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "joint pain"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Injection site soreness"; MYALGIA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Vomiting"; DIZZINESS (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "dizziness"; DYSPNOEA (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "Shortness of breath"; CHEST PAIN (non-serious) with onset 17Nov2021 14:05, outcome "recovered", described as "chest pain". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1013A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101765048

Write-up: Thrombosis in leg; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-095285 (RA). Other Case identifier: SE-VISMA-1638185973063 (RA). An 80-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1F1013A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (not ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Thrombosis in leg"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster". The event "thrombosis in leg" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of thrombosis. Additional information: The reporter stated that the patient felt "something in her lower leg" like a thrombosis. The patient sought the emergency, thrombosis was confirmed. The patient received anticoagulation medicine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973861 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3: 3005835 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chromaturia
SMQs:, Rhabdomyolysis/myopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness: Arthrosis (MOST LIKELY NOT IMPACTFUL. TAKING NO MEDICATIONS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: This case was received via (Reference number: SE-MPA-2021-095361) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHROMATURIA in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3: 3005835) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: ASTRAZENECA COVID-19 VACCINE (Dose 2) on 01-Jun-2021 and ASTRAZENECA COVID-19 VACCINE. Past adverse reactions to the above products included Chest abnormal feeling of with ASTRAZENECA COVID-19 VACCINE; and No adverse event with ASTRAZENECA COVID-19 VACCINE. Concurrent medical conditions included Arthrosis (MOST LIKELY NOT IMPACTFUL. TAKING NO MEDICATIONS) since 2017. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced CHROMATURIA (seriousness criterion, disability). On 24-Nov-2021, CHROMATURIA had resolved. Concomitant product was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 67-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Chromaturia which occurred 5 days after the patient had received the mRNA-1273 vaccine, as third (booster) dose. Reportedly, the patient had brown-colored urine and this discoloration persisted for one week. At the time of this report, the event had resolved and no further information regarding the clinical course of the event was provided. The re-challenge is not applicable, having in mind that the event occurred following the administration with the third dose and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Having in mind that this patient received the COVID-19 VACCINE ASTRAZENECA prior to vaccination with the company product, Interchange of vaccine products should have been considered in this specific case. This case was linked to SE-MPA-2021-047645 (E2B Linked Report).; Sender''s Comments: This case concerns a 67-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Chromaturia which occurred 5 days after the patient had received the mRNA-1273 vaccine, as third (booster) dose. Reportedly, the patient had brown-colored urine and this discoloration persisted for one week. At the time of this report, the event had resolved and no further information regarding the clinical course of the event was provided. The re-challenge is not applicable, having in mind that the event occurred following the administration with the third dose and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Having in mind that this patient received the COVID-19 VACCINE ASTRAZENECA prior to vaccination with the company product, Interchange of vaccine products should have been considered in this specific case. SE-MPA-2021-047645:


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