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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: 1991476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-11-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Chest pain, N-terminal prohormone brain natriuretic peptide, Troponin I
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:222 IU/l; Test Date: 20211127; Test Name: CK-MB; Result Unstructured Data: Test Result:4.3 ng/ml; Test Date: 20211127; Test Name: NT-proBNP; Result Unstructured Data: Test Result:less than 70 pg/mL; Test Date: 20211127; Test Name: Troponin I; Result Unstructured Data: Test Result:26.6 pg/mL
CDC Split Type: TWPFIZER INC202101836666

Write-up: CHEST PAIN; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014539 (Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS006882 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014539. A 19-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 08-Oct-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced chest pain on 25-Nov-2021. On 08-Oct-2021, the patient received the inoculation of BNT vaccine. On 25-Nov-2021, the patient felt chest pain. On 27-Nov-2021, the chest pain continued to improve, and the patient went to the hospital emergency for medical treatment. Creatine phosphokinase (CPK): 222 IU/L, Troponin I: 26.6 Pg/ml, CK-MB: 4.3 ng/ml, NT-probnp: <70 pg/ml. On 28-Nov-2021, the chest pain improved. Chest pain met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of reporting, the outcome of the event was recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality assessment Chest pain Per Reporter=Possible Per Company=Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1992454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOMAC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836125

Write-up: Thrombosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682329 (ADR#). A 40 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: SOMAC. The following information was reported: THROMBOSIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Thrombosis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1992886 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Nausea, Pyrexia, Salivary hypersecretion
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101810146

Write-up: Booster; Fever; intense fatigue; Headache; Nausea; Hypersalivation; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-110646. A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunisation; Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 2, single), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; PYREXIA (disability) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Fever"; FATIGUE (disability) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "intense fatigue"; HEADACHE (disability) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Headache"; NAUSEA (disability) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Nausea"; SALIVARY HYPERSECRETION (disability) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Hypersalivation". Therapeutic measures were not taken as a result of pyrexia, fatigue, headache, nausea, salivary hypersecretion. Reporter Comment: Treatment - No, Evolution of the ADR - Recovery: 5 days, Situations - None of those options, ADR description - hypersalivation, headache, intense fatigue, fever, nausea No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993344 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G047A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101820032

Write-up: Edema Quincke''s; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Agency-WEB. Regulatory number: FR-AFSSAPS-PP20211701. A 52 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 1G047A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, lot EJ6795, left arm, intramuscular injection), administration date: 14Jan2021, for Covid-19 immunisation; Comirnaty (dose 2, lot EJ6789, left arm, intramuscular injection), administration date: 11Feb2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; ANGIOEDEMA (medically significant) with onset 26Nov2021, outcome "recovered", described as "Edema Quincke''s". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101805669

Write-up: Heavy periods; OFF LABEL USE; BOOSTER; INTERCHANGE OF VACCINE PRODUCTS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112151333515050-07OZN. Other Case identifier(s): GB-MHRA-ADR 26339043. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (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, unknown manufacturer), for COVID-19 IMMUNISATION; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 IMMUNISATION. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "OFF LABEL USE"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "INTERCHANGE OF VACCINE PRODUCTS"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 14Dec2021, outcome "not recovered", described as "Heavy periods". Additional information: Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Neither the patient had symptoms associated with COVID-19 nor had a COVID-19 test. Patient is not currently breastfeeding No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Lymph node pain, Musculoskeletal stiffness, Off label use, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101805822

Write-up: Neck stiff; Headache; Lymph node pain; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112152226423320-FZFGS (RA). Other Case identifier: GB-MHRA-ADR 26341583 (RA). A 43-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 26Nov2021, outcome "recovered" (04Dec2021), described as "Neck stiff"; HEADACHE (medically significant) with onset 26Nov2021, outcome "recovered" (28Nov2021), described as "Headache"; LYMPH NODE PAIN (medically significant) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Lymph node pain". Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. Therapeutic measures were taken as a result of musculoskeletal stiffness. Chiropractor on the 01Dec2021 to tried and resolved neck. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Condition aggravated, Deep vein thrombosis, Fibrin D dimer, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Peripheral swelling, Platelet count, Prothrombin time, Pyrexia, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hyperthyroidism; Pain; Swelling of legs
Allergies:
Diagnostic Lab Data: Test Name: Activated Partial Thromboplastin Clotting Time (aPTT); Result Unstructured Data: Test Result:27.5 (unspecified units); Test Date: 20211204; Test Name: Fibrin D dimer/D-dimer test; Result Unstructured Data: Test Result:D-dimer was not $g4000; Test Date: 20210316; Test Name: Platelet count; Result Unstructured Data: Test Result:platelet count 338 (unspecified units); Test Date: 20211204; Test Name: Platelet count; Result Unstructured Data: Test Result:Lowest count 422 (unspecified units); Test Name: Prothrombin time (PT); Result Unstructured Data: Test Result:12.9 (unspecified units); Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211204; Test Name: US doppler; Result Unstructured Data: Test Result:showed soleal vein DVT.
CDC Split Type: GBPFIZER INC202101813835

Write-up: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority RA). Regulatory number: GB-MHRA-WEBCOVID-202112161451156260-PRBGW (RA). Other Case identifier(s): GB-RA-ADR 26345341 (RA). A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: Jun2013 (unspecified if ongoing); "Hyperthyroidism", start date: Oct2010 (unspecified if ongoing); "Pain" (unspecified if ongoing); "Swelling of legs" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Astrazenecacovid-19vaccine (DOSE 2, SINGLE), administration date: 08May2021, for COVID-19 immunisation; Astrazenecacovid-19vaccine (DOSE 1, SINGLE), administration date: 17Feb2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) all with onset 25Nov2021, outcome "unknown" and all described as "Primary immunisation series: COVID-19 VACCINE ASTRAZENECA; Booster: COMIRNATY"; IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset 01Dec2021, outcome "recovering", described as "Deep vein thrombosis leg"; HEADACHE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Headache"; PYREXIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Fever"; PAIN IN EXTREMITY (hospitalization, medically significant), PERIPHERAL SWELLING (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "history of left leg swelling and pain worse"; CONDITION AGGRAVATED (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "History of left leg swelling and pain worse". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, deep vein thrombosis, pyrexia, pain in extremity, peripheral swelling, condition aggravated (start date: 2021). The patient underwent the following laboratory tests and procedures: activated partial thromboplastin time: (unspecified date) 27.5 (unspecified units); fibrin d dimer: (04Dec2021) d-dimer was not $g4000; platelet count (150-450): (16Mar2021) platelet count 338 (unspecified units); (04Dec2021) lowest count 422 (unspecified units); prothrombin time: (unspecified date) 12.9 (unspecified units); sars-cov-2 test: (unspecified date) negative; ultrasound doppler: (04Dec2021) showed soleal vein dvt. Clinical course: The patient had not tested positive for COVID-19 since having the vaccine. The patient was unsure if patient was enrolled in clinical trial. This report related to possible blood clots or low platelet counts. This report did not relate to possible myocarditis or pericarditis. Relevant investigations or tests conducted: "D-dimer (raised). US doppler showed soleal vein DVT." Details of the event: "After vaccination on 25Nov2021, headache and fever post this. The patient developed some reactive axillary lymph nodes which resolved. 72 hour history of left leg swelling and pain worse after a long drive to Coventry." This was diagnosed by "D-dimer test and US doppler" on 04Dec2021. No additional medical history, not already provided, that relates to previous venous or arterial thromboses. The patient did not have history of, or concurrent, intracranial malignancy. The lowest platelet count after vaccine (usual normal range 150-450): "422". The last platelet count before vaccine if known, and what date was this measured (usual normal range 150-450): "338 (bloods taken on 16Mar2021)". The patient did not have concurrent or recent intracranial infections. The patient had not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). PT: "12.9". Activated Partial Thromboplastin Clotting Time (aPTT): "27.5". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation, Interchange of vaccine products, Off label use, Pain, Periorbital swelling, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; VENLAFAXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101813957

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112161903137550-4K5XI (RA). Other Case identifier(s): GB-MHRA-ADR 26346439 (RA). A 64-year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOL, start date: 2020; VENLAFAXIN, start date: 2017. Vaccination history included: Covid-19 vaccine (Dose 01, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 02, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19; not had a COVID-19 test. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 10Dec2021, outcome "recovering", described as "Hives giant"; PERIORBITAL SWELLING (medically significant), outcome "unknown", described as "Eyes puffed up"; SWELLING FACE (medically significant), outcome "unknown", described as "Mouth puffy"; PAIN (medically significant), outcome "unknown", described as "Painful"; PRURITUS (medically significant), outcome "unknown", described as "Burning itch". The clinical course was reported as following: Hives spread rapidly from across chest over body, down arms, hands, legs to knees. Eyes puffed up and mouth puffy. Large hives that joined together. Painful, burning itch. It was reported that events started 2 weeks after vaccine. Patient was referred to hospital, given steroids for 3 days and was advised to also take antihistamines. Therapeutic measures were taken as a result of angioedema, periorbital swelling, swelling face, pain, pruritus with steroids. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994009 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Rheumatoid arthritis, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (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: INFLUENZA VIRUS
Current Illness: Osteoarthritis (Mild osteoarthritis in fingers. Take no medication.going through menopause.)
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: stiffness; Rheumatoid arthritis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26358010) on 19-Dec-2021 and was forwarded to Moderna on 19-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Osteoarthritis (Mild osteoarthritis in fingers. Take no medication.going through menopause.). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Dec-2021 to an unknown date for Flu vaccination. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion disability). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) (seriousness criterion disability). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) had not resolved and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient has not had symptoms associated with COVID-19. The first two days after the vaccine every joint in the patient''s entire body was sore. When she removed fats and meat from my diet the joints improve, but stiffness and pain remains in her feet. The patient feel the bones in her feet all the time. When the patient put meats and dairy back in her diet the joint problem returns. The patient find it difficult to walk or stand for a long time. She have not sought doctor advice yet as she knew that would entail steroids. Patient has not tested positive for COVID-19 since having the vaccine Adverse reaction did not occur as a result of an exposure during pregnancy This report was not related to possible inflammation of the heart (myocarditis or pericarditis). This is a regulatory authority case concerning a 51-year-old, female patient with Concurrent medical conditions of Osteoarthritis, who experienced the unexpected serious events of Rheumatoid arthritis, Musculoskeletal stiffness. The events occurred approximately 1 day after the third dose of mRNA-1273 COVID 19 Vaccine. The event Rheumatoid arthritis had not resolved, while event Musculoskeletal stiffness was resolving. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical condition of Osteoarthritis remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 51-year-old, female patient with Concurrent medical conditions of Osteoarthritis, who experienced the unexpected serious events of Rheumatoid arthritis, Musculoskeletal stiffness. The events occurred approximately 1 day after the third dose of mRNA-1273 COVID 19 Vaccine. The event Rheumatoid arthritis had not resolved, while event Musculoskeletal stiffness was resolving. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical condition of Osteoarthritis remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 1994259 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDDN7 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITPFIZER INC202101808320

Write-up: Booster; Pericardite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-820853 (MINISAL02). A 47-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: SDDN7) at the age of 47 years as dose 3 (booster), 0.3 ml, single for covid-19 immunisation. The patient relevant medical history and 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: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster", PERICARDITIS (medically significant) with onset 25Nov2021, outcome "recovered" (2021), described as "pericardite".


VAERS ID: 1994359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO115 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, C-reactive protein, Immunisation, Interchange of vaccine products, Malaise, Oedema, Oedema peripheral, Off label use, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: C-reactive protein; Result Unstructured Data: Test Result:60
CDC Split Type: NOPFIZER INC202101810274

Write-up: off label use; Interchange of vaccine products; edema in several joints like knees, wrist, elbow; Intermittent malaise; body edema with weight gain 2-3 kg; Arthritis. fluctuating arthralgia/edema in several joints like knees, wrist, elbow - several finger joints with arthritis feature; Rash, arthritis. Persistent rash / uricaria over large parts of the body; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: NO-NOMAADVRE-FHI-2021-Umm411 Regulatory Authority. Other Case identifier(s): NO-NOMAADVRE-E2B_00064807 Regulatory Authority. A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 10:30 (Lot number: FKO115) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Urticaria" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Spikevax (DOSE 1, lot number: unknown), administration date: 29Mar2021, for Vaccination; Spikevax (DOSE 2, lot number: unknown), administration date: 12May2021, for Vaccination. 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) with onset 25Nov2021, outcome "unknown", described as "booster"; ARTHRITIS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Arthritis. fluctuating arthralgia/edema in several joints like knees, wrist, elbow - several finger joints with arthritis feature"; URTICARIA (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Rash, arthritis. Persistent rash / uricaria over large parts of the body"; OEDEMA PERIPHERAL (non-serious), outcome "unknown", described as "edema in several joints like knees, wrist, elbow"; MALAISE (non-serious), outcome "unknown", described as "Intermittent malaise"; OEDEMA (non-serious), outcome "unknown", described as "body edema with weight gain 2-3 kg". The events "arthritis. fluctuating arthralgia/edema in several joints like knees, wrist, elbow - several finger joints with arthritis feature", "rash, arthritis. persistent rash / uricaria over large parts of the body", "edema in several joints like knees, wrist, elbow", "intermittent malaise" and "body edema with weight gain 2-3 kg" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: (Dec2021) 60. Therapeutic measures were taken as a result of arthritis, urticaria, oedema peripheral, malaise, oedema. Clinical Course: The reactions/case were considered to be Serious due to (Other Serious (Important Medical Events)). The patient stated that She developed urticaria-like rash in the evening the day she got the 3rd vaccine dose. Debut of arthralgia in right knee the next day. Then persistent rash/urticaria covering large parts of her body, as well as fluctuating arthralgia/edema in several joints like knees, wrist, elbow, several finger joints with arthritis feature. Body edema with weight gain 2-3 kg. Intermittent malaise, but no fever noticed. The symptoms persisted and she went to her GP 11 days after vaccination. Received prednisolone cure and double dose Zyrtec. Several blood tests taken (CRP 60 not yet result of other tests). Referred to dermatologist for follow-up of urticaria. No regular use of medication. No known allergies.Relevant med history- Urticaria(One episode with eruption (no accompanying symptoms) about 8 years ago. Examined by dermatologist incl. various blood tests cause not found, possibly stressrelated Short period of urticarial rash in spring 2021. Not seen a doctor for this) . The Agency assessed the causal relationship between bnt162b2 (COMIRNATY) and Arthritis, Urticaria as Possible. Reporter Comment: Treatment with prednisolone cure and double dose Zyrtec. Referred to dermatologist for follow-up of urticaria. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment with prednisolone cure and double dose Zyrtec. Referred to dermatologist for follow-up of urticaria.


VAERS ID: 1994377 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-11-25
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101804670

Write-up: ASYMPTOMATIC COVID 19 CONFIRMED; ASYMPTOMATIC COVID 19 CONFIRMED; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300125014. A 63 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Apr2021 (Lot number: EW0162) as dose 2, single and intramuscular, administration date 02Apr2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25Nov2021, outcome "recovered" and all described as "ASYMPTOMATIC COVID 19 CONFIRMED". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1995460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Muscular weakness, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Neuropathy (neuropathies); Postural orthostatic tachycardia syndrome (POTS)
Preexisting Conditions: Comments: POTS, neuropathies
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211263860

Write-up: This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300053290) on 30-DEC-2021 and concerned a 35-year-old female of unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was not reported. The patient''s concurrent conditions and pre-existing medical history included neuropathies, and postural orthostatic tachycardia syndrome (POTS). The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) 0.5 ml, dose number in series 1, 1 total, administered on 24-NOV-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-NOV-2021, the patient experienced fatigue. On 27-NOV-2021, the patient experienced syncope, tachycardia, numbness of extremities (of legs and arm), headache, dizziness, weakness in extremity (in legs and arms). On an unspecified date the patient was hospitalized, and number of days and discharge information was not reported (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from syncope, tachycardia, fatigue, numbness of extremities, headache, dizziness, and weakness in extremity (dose number in series 1). This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability or Permanent Damage).


VAERS ID: 1995701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebrovascular accident, Hemiplegia, Immunisation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101817091

Write-up: booster; Stroke; the right side is paralyzed.; can''t talk anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: AT-BASGAGES-2021-063376. A 88 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FH9951) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, 1st dose), for COVID-19 immunisation; Covid-19 vaccine (MANUFACTURER UNKNOWN, 2nd dose), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, life threatening, medically significant), outcome "unknown", described as "booster"; CEREBROVASCULAR ACCIDENT (hospitalization, life threatening, medically significant) with onset 25Nov2021, outcome "not recovered", described as "Stroke"; HEMIPLEGIA (life threatening, medically significant) with onset 25Nov2021, outcome "not recovered", described as "the right side is paralyzed."; APHASIA (life threatening) with onset 25Nov2021, outcome "not recovered", described as "can''t talk anymore". Reporter Comment: Treatment of side effect 1: The stroke occurred 2 days after the 3rd vaccination. He was on intensive for 2 days. My father can no longer talk and the right side is paralyzed. The day before the stroke he still rode his car and bicycle and now he is a nursing case. Clinical course: PATIENT MEDICAL HISTORY: He was very healthy for his age. No special pre-existing conditions. Just the normal signs of age. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment of side effect 1: The stroke occurred 2 days after the 3rd vaccination. He was on intensive for 2 days. My father can no longer talk and the right side is paralyzed. The day before the stroke he still rode his car and bicycle and now he is a nursing case


VAERS ID: 1996282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1018A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Disease recurrence, Hypercoagulation, Optical coherence tomography, Pulmonary embolism, Superficial vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; ARIXTRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Deep vein thrombosis leg (Mother); Drug allergy (Allergy to INNOHEP); Embolism pulmonary (bilateral non-severe pulmonary embolism at 3 months postpartum); Gravida (Gravida 4 para 2: 1 abortion in 2015, 1 early spontaneous miscarriage); Lipedema (lower limbs awaiting possible bariatric surgery); Live birth; Migraine with aura; Obesity; Thrombosis of leg deep venous (Right lower limb deep vein thrombosis); Thrombosis venous superficial (Right leg; treated with Lovenox); TOP; Varicose vein operation (left leg); Venous insufficiency (Mother and sister)
Allergies:
Diagnostic Lab Data: Test Name: thoracic computed tomography angiography; Result Unstructured Data: Test Result:revealed right inferior segmental; Comments: revealed right inferior segmental and subsegmental as well as right superior subsegmental pulmonary embolism, with associated right heart symptoms; Test Name: thrombophilia; Test Result: Negative ; Comments: thrombophilia assessment was negative; Test Name: tomography; Result Unstructured Data: Test Result:Unknown result; Test Name: venous Doppler ultrasound; Result Unstructured Data: Test Result:thrombosis of the right great saphenous vein; Comments: did not reveal any evidence of recent deep vein thrombosis of the lower limbs, but a recent thrombosis of the right great saphenous vein was found
CDC Split Type: FRPFIZER INC202101799318

Write-up: Embolism pulmonary/ recurrence of pulmonary embolism; Embolism pulmonary/ recurrence of pulmonary embolism; Saphenous vein thrombosis; Saphenous vein thrombosis; This is a spontaneous report received from a contactable reporter (Other HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-DJ20214601. A 44 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: 1F1018A) as dose 2,single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Thrombosis of leg deep venous", start date: 2016 (unspecified if ongoing), notes: Right lower limb deep vein thrombosis; "Embolism pulmonary" (unspecified if ongoing), notes: bilateral non-severe pulmonary embolism at 3 months postpartum; "TOP", start date: 2015 (unspecified if ongoing); "Appendectomy" (unspecified if ongoing); "Lipedema" (unspecified if ongoing), notes: lower limbs awaiting possible bariatric surgery; "Migraine with aura" (unspecified if ongoing); "Varicose vein operation NOS", start date: 2019 (unspecified if ongoing), notes: left leg; "Drug allergy" (unspecified if ongoing), notes: Allergy to INNOHEP; "Thrombosis venous superficial", start date: Jul2016 (unspecified if ongoing), notes: Right leg; treated with Lovenox; "Gravida 4 para" (unspecified if ongoing), notes: Gravida 4 para 2: 1 abortion in 2015, 1 early spontaneous miscarriage; "Given birth in 2016", start date: 2016 (unspecified if ongoing). Family history included: "Deep vein thrombosis leg", start date: 2015 (unspecified if ongoing), notes: Mother; "venous insufficiency " (unspecified if ongoing), notes: Mother and sister. A first thrombotic episode in Jun2015: left suro-popliteal deep vein thrombosis in a post-abortion context, treated with vitamin K antagonists. Vitamin K antagonists were relayed by INNOHEP. INNOHEP was complicated in Nov2015 by an allergic skin reaction, ultimately replaced by LOVENOX. The patient gives birth in May2016. In Jul2016, she had a superficial venous thrombosis in varicose veins of the right leg, treated with LOVENOX at a curative dose for 10 days, then relayed at a semi-curative dose. In Aug2016, 3 months postpartum and in the context of car and boat travel, she developed a deep vein thrombosis of the right lower limb as an extension of the superficial venous thrombosis described above, complicated by a non-serious bilateral pulmonary embolism. She is treated with LOVENOX anticoagulation at a curative dose, relayed with vitamin K antagonists. The thrombophilia assessment was negative. Vitamin K antagonists were discontinued in Mar2017. In Jul2019, she had a superficial venous thrombosis of the left great saphenous vein treated with ELIQUIS for 3 months. The varicose veins of the left leg were operated in the same year. In Jun2021, the patient had a superficial venous thrombosis of the right great saphenous vein treated with ELIQUIS 5 mg 2 times per day, followed in September by ELIQUIS 2.5 mg 2 times per day until the varicose veins were treated, which was scheduled to take place shortly. Concomitant medication included: ELIQUIS taken for deep vein thrombosis, start date: Jun2021 (ongoing); ARIXTRA. Past drug history included: Innohep, reaction(s): "allergic skin reaction (Rash)". Vaccination history included: Comirnaty (Received Dose 1 of COMIRNATY, 03Nov2021, Left arm, Intramuscular injection, Batch Number: 1F1003A), administration date: 03Nov2021, when the patient was 44 years old, for covid-19 immunisation. The following information was reported: PULMONARY EMBOLISM (hospitalization), DISEASE RECURRENCE (hospitalization) all with onset 29Nov2021, outcome "recovering" and all described as "Embolism pulmonary/ recurrence of pulmonary embolism"; SUPERFICIAL VEIN THROMBOSIS (hospitalization), DISEASE RECURRENCE (hospitalization) all with onset 25Nov2021, outcome "recovering" and all described as "Saphenous vein thrombosis". The patient was hospitalized for pulmonary embolism, disease recurrence, superficial vein thrombosis, disease recurrence (start date: 30Nov2021, discharge date: 02Dec2021, hospitalization duration: 2 day(s)). The events "embolism pulmonary/ recurrence of pulmonary embolism", "embolism pulmonary/ recurrence of pulmonary embolism", "saphenous vein thrombosis" and "saphenous vein thrombosis" were evaluated at the physician office visit. The events were reported as serious for hospitalization. Clinical course was reported as follows: Initial nursing report for tingling in the leg and pain the day after a Dose 2 of COMIRNATY then hospitalisation on 30Nov2021. The patient reports since Thursday 25Nov2021 the progressive onset of right lower limb pain. Note that a medical observation reports a "swollen red right leg with progressive pain since 18Nov". This is in the context of a right ankle sprain that occurred on 12Oct2021 with the right lower limb almost never being used for support until 28Nov2021. There is also a vaccination context with the 2nd dose of vaccine against COVID (COMIRNATY) on Wednesday 24Nov2021.The patient reported, following this pain of the right lower limb, the onset of a sensation of tightness in the chest with mediosternal thoracic pain. Given this context, the patient consulted an angiologist. The venous Doppler ultrasound performed did not reveal any evidence of recent deep vein thrombosis of the lower limbs, but a recent thrombosis of the right great saphenous vein was found. Because of her respiratory symptoms, a thoracic computed tomography angiography was performed, which revealed right inferior segmental and subsegmental as well as right superior subsegmental pulmonary embolism, with associated right heart symptoms. The patient received an injection of ARIXTRA 10 mg in angiology and was transferred to hospital. Relay of curative anticoagulation with ELIQUIS 10 mg 2 times per day for 7 days then 5 mg 2 times per day, to be continued. The patient was discharged on 02Dec2021. The patient underwent the following laboratory tests and procedures: angiogram: revealed right inferior segmental, notes: revealed right inferior segmental and subsegmental as well as right superior subsegmental pulmonary embolism, with associated right heart symptoms; hypercoagulation: negative, notes: thrombophilia assessment was negative; optical coherence tomography: unknown result; ultrasound doppler: thrombosis of the right great saphenous vein, notes: did not reveal any evidence of recent deep vein thrombosis of the lower limbs, but a recent thrombosis of the right great saphenous vein was found. Therapeutic measures were taken as a result of pulmonary embolism, disease recurrence, superficial vein thrombosis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-11-25
   Days after vaccination:251
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vertigo
SMQs:, Vestibular disorders (narrow), COVID-19 (broad)

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

Write-up: Vertigo; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26373814) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 21-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had Flu like symptoms, hot and cold, muscle aches, dizziness, loss of balance, extreme vomiting, cough, sore throat, head ache, tired all the time Patient had not tested positive for COVID-19 since having the vaccine Patient had not symptoms associated with COVID-19 Concomitant product use was not provided Treatment information was not provided Patient had not enrolled in clinical trial Company comment: This is a regulatory authority case concerning a female patient of unknown age with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious event of vertigo. The event vertigo occurred the same day with the third dose of mRNA-1273 vaccine administration. The patient reported signs and symptoms of flu like symptoms, hot and cold, muscle aches, dizziness, loss of balance, extreme vomiting, cough, sore throat, headache and tired all the time however the occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the event vertigo was recovered with sequel from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a female patient of unknown age with vaccine history of receiving another brand of Covid-19 (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious event of vertigo. The event vertigo occurred the same day with the third dose of mRNA-1273 vaccine administration. The patient reported signs and symptoms of flu like symptoms, hot and cold, muscle aches, dizziness, loss of balance, extreme vomiting, cough, sore throat, headache and tired all the time however the occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the event vertigo was recovered with sequel from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1996676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-11-25
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C19-02 / 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? 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: PTJNJFOC20211256828

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-2394) on 27-DEC-2021 concerned a 22 year old male of unspecified 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: 21C19-02 expiry: unknown) 0.5 ml (dose number in series was 1), 01 total administered on 15-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-NOV-2021, the patient experienced vaccination failure (ineffective vaccination) (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 11-DEC-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209380; Reporter''s Comments: "Other information: N91 FACIAL PARALYSIS / PARALYSIS OF BELL 06-Aug-2018 A91 RESEARCH WITH ANORMAL RESULT 28-Mar-2016 T83 OVERWEIGHT 21-Jan-2016 A92 ALLERGY / ALERGIC REACTION 23-Nov-2011 R80 FLU Dec-2009"


VAERS ID: 1997106 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Coma, Dizziness, Fatigue, Hemiplegia, Magnetic resonance imaging head, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211206; Test Name: MRI; Result Unstructured Data: Test Result:very severe brain damage
CDC Split Type: VNPFIZER INC202101799284

Write-up: fell into a state of coma; dizziness; continuous vomiting; very severe brain damage; his right arm, right leg and right eye are extremely weak, almost unable to move; feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 12 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 (first dose on 01Nov2021., Adverse events are slight fatigue and dizziness.), administration date: 01Nov2021; Comirnaty, for COVID-19 immunisation, reaction(s): "dizziness", "slight fatigue". The following information was reported: COMA (hospitalization, medically significant) with onset 06Dec2021, outcome "unknown", described as "fell into a state of coma"; DIZZINESS (hospitalization) with onset 06Dec2021, outcome "not recovered", described as "dizziness"; VOMITING (hospitalization) with onset 06Dec2021, outcome "not recovered", described as "continuous vomiting"; BRAIN INJURY (hospitalization, medically significant) with onset 06Dec2021, outcome "not recovered", described as "very severe brain damage"; HEMIPLEGIA (hospitalization, medically significant) with onset 06Dec2021, outcome "not recovered", described as "his right arm, right leg and right eye are extremely weak, almost unable to move"; FATIGUE (non-serious) with onset 25Nov2021, outcome "unknown", described as "feeling tired". The events "fell into a state of coma" and "dizziness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (06Dec2021) very severe brain damage. Clinical course: The reporter and his wife took him to the emergency room at [PRIVACY] Hospital, but because his condition was too serious, he was transferred to the another hospital called [PRIVACY]. Here, the doctors did all the tests but couldn''t find anything cause those symptoms. On the morning of 15Dec2021, the doctor wanted to send him home even he did not get any better. His apartment is on the 4th floor of the building which does not have any elevator. So that, it is impossible for his son to walk that far with his current situation. Moreover, according to the doctors working at [PRIVACY] said , this sequelae will affect his son for the rest of his life and he would never get fully recover. This is the worst thing he has heard so far in his life, and this is why He was sitting here writing these words to company. In his opinion, somehow, his son got sick because of the vaccine. From a perfectly healthy boy, after being vaccinated. He was suffering every second without knowing when he would fully recover. The reporter would like company to research, diagnose, and help them. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : VN-PFIZER INC-202101797667 PFIZER INC.


VAERS ID: 1998165 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Nasopharyngitis, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Cold; Painful arm; Appetite lost; Fatigue; Feverish; Large arm swelling; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26360091) on 20-Dec-2021 and was forwarded to Moderna on 20-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, NASOPHARYNGITIS, PAIN IN EXTREMITY, DECREASED APPETITE, FATIGUE, and PYREXIA in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PERIPHERAL SWELLING (seriousness criterion medically significant). On 26-Nov-2021, the patient experienced NASOPHARYNGITIS (seriousness criterion medically significant), PAIN IN EXTREMITY (seriousness criterion medically significant), DECREASED APPETITE (seriousness criterion medically significant), FATIGUE (seriousness criterion medically significant), and PYREXIA (seriousness criterion medically significant). On 27-Nov-2021, FATIGUE had resolved. On 28-Nov-2021, PERIPHERAL SWELLING, NASOPHARYNGITIS, PAIN IN EXTREMITY, DECREASED APPETITE, and PYREXIA had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. Patient had no medical history reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patients last menstrual period was on 06 Dec 2021. No relevant concomitant medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. This case concerns a 32-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Peripheral swelling, Nasopharyngitis, Pain in extremity, decreased appetite, Fatigue and Pyrexia. The event of Peripheral swelling occurred on the same day after the third dose of mRNA-1273 vaccine while the events of Nasopharyngitis, Pain in extremity, decreased appetite, Fatigue and Pyrexia occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as medically significant and retained for consistency with the RA report.


VAERS ID: 2000522 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006322 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea exertional, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Pulmonary hypertension (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: ITMODERNATX, INC.MOD20214

Write-up: Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward; Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward; Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-818939) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward), DYSPNOEA EXERTIONAL (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) and CHEST DISCOMFORT (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3006322) for COVID-19 vaccination. No Medical History information was reported. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .25 ml. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) (seriousness criterion medically significant) and CHEST DISCOMFORT (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward), DYSPNOEA EXERTIONAL (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) and CHEST DISCOMFORT (Dyspnoea at the slightest effort and chest oppression, pain in the right arm. Right hemithorax pain worsening in clinostatism, improvement in sitting position inclined forward) 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 medication was given. It was reported that patient received first dose vaccine from comirnaty on 13-Apr-2021 with lot number EP2166 on left shoulder and second dose on 04-May-2021 with lot number EX7389 on left shoulder. No treatment medication was given. Company Comment - This case concerns a 50 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, dyspnea exertional and chest discomfort. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 50 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, dyspnea exertional and chest discomfort. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2002648 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Headache, Skin disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: headache; Angioedema forehead, lips and eyelids; Skin Problem; This case was received via RA (Reference number: BE-FAMHP-DHH-N2021-109974) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEADACHE (headache), ANGIOEDEMA (Angioedema forehead, lips and eyelids) and SKIN DISORDER (Skin Problem) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), ANGIOEDEMA (Angioedema forehead, lips and eyelids) (seriousness criterion medically significant) and SKIN DISORDER (Skin Problem) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), ANGIOEDEMA (Angioedema forehead, lips and eyelids) and SKIN DISORDER (Skin Problem) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Company comment: This is a regulatory authority case concerning a 30-year-old female patient with no medical history reported, who experienced events of headache, angioedema (Angioedema forehead, lips and eyelids) and skin disorder. The events occurred 1 day after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 30-year-old female patient with no medical history reported, who experienced events of headache, angioedema (Angioedema forehead, lips and eyelids) and skin disorder. The events occurred 1 day after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2002776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Stillbirth, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836032

Write-up: Stillbirth; Vaginal haemorrhage; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 681469 (RA). A 31 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (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: STILLBIRTH (medically significant) with onset 25Nov2021, outcome "recovered", described as "Stillbirth"; VAGINAL HAEMORRHAGE (non-serious) with onset 25Nov2021, outcome "recovered", described as "Vaginal haemorrhage". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2002798 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 3 - / OT

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

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: BEMODERNATX, INC.MOD20214

Write-up: Muscle pain; fatigue; Joint Pain; Feeling unwell; headache; This case was received via Agency (Reference number: BE-FAMHP-DHH-N2021-110037) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS, MYALGIA (Muscle pain), PYREXIA, FATIGUE (fatigue), ARTHRALGIA (Joint Pain), MALAISE (Feeling unwell) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: SPIKEVAX on 01-Feb-2021 and SPIKEVAX on 25-Feb-2021. Past adverse reactions to the above products included No adverse event with SPIKEVAX and SPIKEVAX. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced CHILLS (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), PYREXIA (seriousness criterion disability), FATIGUE (fatigue) (seriousness criterion disability), ARTHRALGIA (Joint Pain) (seriousness criterion disability), MALAISE (Feeling unwell) (seriousness criterion disability) and HEADACHE (headache) (seriousness criterion disability). On 27-Nov-2021, CHILLS, MYALGIA (Muscle pain), PYREXIA, FATIGUE (fatigue), ARTHRALGIA (Joint Pain), MALAISE (Feeling unwell) and HEADACHE (headache) had resolved. Concomitant medications were not provided. Treatment included Dafalgan and Neurofen. Company comment: This is a regulatory authority case concerning a 46-year-old female patient with no medical history reported, who experienced events of chills, myalgia, pyrexia, fatigue, arthralgia, malaise and headache. The events occurred on the same date after the third dose of mRNA-1273 vaccine. Treatment included Dafalgan and Neurofen. At the time of report events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: Treatment - Ja Dafalgan and Neurofen Evolution of the ADR - Restored: 3 days ADR description - Check the observed side effect (s). You can describe this update (s) in detail in the Description field of the update (s).; Sender''s Comments: This is a regulatory authority case concerning a 46-year-old female patient with no medical history reported, who experienced events of chills, myalgia, pyrexia, fatigue, arthralgia, malaise and headache. The events occurred on the same date after the third dose of mRNA-1273 vaccine. Treatment included Dafalgan and Neurofen. At the time of report events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2002803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ3438 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Fatigue, Headache, Immunisation, Malaise, Nausea, Palpitations, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (before vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: blood pressure; Result Unstructured Data: Test Result:dropped; Test Date: 20211126; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: BEPFIZER INC202101817638

Write-up: Drop in blood pressure the night after the injection of the 3rd dose of the vaccine; Fatigue the day after the injection; Joint pain; Fever; Vomiting; Nausea; Malaise; Headache; Shivering; Heart palpitations; Booster; This is a spontaneous report received from a contactable Consumer from the Agency WEB. Regulatory number: BE-FAMHP-DHH-N2021-110210 (RA). A 31 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FJ3438) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19 infection", notes: before vaccination. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 2), administration date: 08Mar2021, for COVID-19 immunisation; Comirnaty (DOSE 1), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; BLOOD PRESSURE DECREASED (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Drop in blood pressure the night after the injection of the 3rd dose of the vaccine"; FATIGUE (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Fatigue the day after the injection"; ARTHRALGIA (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Joint pain"; PYREXIA (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Fever"; VOMITING (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Vomiting"; NAUSEA (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Nausea"; MALAISE (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Malaise"; HEADACHE (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Headache"; CHILLS (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Shivering"; PALPITATIONS (disability) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Heart palpitations". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (26Nov2021) dropped; body temperature: (26Nov2021) fever. Therapeutic measures were taken as a result of arthralgia, headache, chills. Reporter Comment: Treatment - Yes Dafalgan 1g every 4h for chills and pain. Evolution of the ADR - Cure: 1 day. ADR description - Heart palpitations/vomiting/chills/blood pressure drop the night after the 3rd dose of the vaccine. Blood pressure drop/chills/joint pain/headache/fatigue the day after the injection. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes Dafalgan 1g every 4h for chills and pain Evolution of the ADR - Cure: 1 day ADR description - Heart palpitations/vomiting/chills/blood pressure drop the night after the 3rd dose of the vaccine. Blood pressure drop/chills/joint pain/headache/fatigue the day after the injection


VAERS ID: 2003052 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cardiac infection, Contusion, Fall, Heart rate increased, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101876719

Write-up: Syncope; I lost consciousness for about ten seconds; fell to the ground; Increased heart rate; My head hit the tiles, I had bruises on my arm and thigh but fortunately not serious; heart inflammation; pain in my heart; 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. An adult male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FG7369) as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19", start date: Oct2020 (unspecified if ongoing). Concomitant medication(s) included: PARACETAMOL. Vaccination history included: Comirnaty, administration date: 05Nov2021, for covid-19 immunization, reaction(s): "Tachycardia", "Shortness of breath", "Syncope", "Chest pain", "vaccination site reaction", "Malaise", "Shivering", "Fatigue", "heart inflammation". The following information was reported: SYNCOPE (medically significant) with onset 03Dec2021, outcome "unknown", described as "Syncope"; ANGINA PECTORIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "pain in my heart"; LOSS OF CONSCIOUSNESS (medically significant) with onset 03Dec2021, outcome "not recovered", described as "I lost consciousness for about ten seconds"; CARDIAC INFECTION (medically significant) with onset 25Nov2021, outcome "not recovered", described as "heart inflammation"; FALL (non-serious) with onset 03Dec2021, outcome "unknown", described as "fell to the ground"; HEART RATE INCREASED (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Increased heart rate"; CONTUSION (non-serious) with onset 03Dec2021, outcome "not recovered", described as "My head hit the tiles, I had bruises on my arm and thigh but fortunately not serious". Therapeutic measures were not taken as a result of syncope, angina pectoris, loss of consciousness, cardiac infection, heart rate increased, contusion. Clinical course included the day after the 2nd dose, the side effects returned and the heart inflammation started again. The spikes in the heart were still present alternately and without any particular effort. One week after the 2nd dose, patient was woken up on the night of Friday 03Dec2021 to Saturday 04Dec2021 because heart was beating at a high rate. Patient got up to drink a glass of water and after 5 minutes of standing,he had a very rapid syncope and fell to the ground too quickly to catch himself. Patient lost consciousness for about ten seconds. His head hit the tiles, he had bruises on arm and thigh but fortunately not serious. On 06Dec2021, patient still had a pain in heart and a feeling of inflammation. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101818039 Same patient, different events after different vaccine doses.


VAERS ID: 2003183 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative.
CDC Split Type: CZPFIZER INC202101828271

Write-up: Loss of taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: CZ-CZSUKL-21013024 (CZSUKL). A 21 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) as dose 2, 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, SINGLE, Pharmaceutical form (Dosage form): Solution for injection , Route of Administration: Intramuscular), administration date: 03Nov2021, for Covid-19 immunization. The following information was reported: AGEUSIA (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Loss of taste". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) negative. Clinical course: As of (2Dec2021) it has been 10 days since the vaccination, and she still does not have the taste. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003296 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H049A / 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: Medical History/Concurrent Conditions: Factor V Leiden heterozygote
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101827910

Write-up: Deep vein thrombosis; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100277751 (RA). A 24-year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: 1H049A) at the age of 24 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden heterozygote" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, LOT# unknown, Strength: 0.3mL), administration date: 01Apr2021, for COVID-19 immunisation; Comirnaty (2nd dose, LOT# unknown, Strength: 0.3mL), administration date: 11May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Deep vein thrombosis". Additional information: Relatedness of drug to reaction(s)/event(s), Source of assessment: PEI, Result of Assessment: D. Unclassifiable.


VAERS ID: 2003560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hypotension, Immunisation, Interchange of vaccine products, Loss of consciousness, Off label use, Somnolence, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma (currently without therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101827821

Write-up: Off-label use; Interchange of vaccine product; Booster; Loss of consciousness; Hypotension grade III according to Ring and Messmer; Tachycardia grade III according to Ring and Messmer; Fatigue; Currently sleepy; This is a spontaneous report received from a non-contactable Consumer from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021205708. Other Case identifier(s): DE-CADRPEI-2021205708 (Webportal), DE-PEI-202100231862. A 46 year-old female patient received bnt162b2 (COMIRNATY strength 0.3ml), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Bronchial asthma notes: currently without therapy". The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1, SINGLE), for COVID-19 immunization reaction(s): "Systemic side effect; Comirnaty (DOSE 2 (INITIAL PFIZER DOSE), SINGLE), for COVID-19 immunization, reaction(s): "Systemic side effect", "Interchange of vaccine products", "Off label use".The following information was reported: OFF LABEL USE (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Loss of consciousness"; HYPOTENSION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Hypotension grade III according to Ring and Messmer"; TACHYCARDIA (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Tachycardia grade III according to Ring and Messmer"; FATIGUE (hospitalization) with onset 2021, outcome "recovering", described as "Fatigue"; SOMNOLENCE (hospitalization) with onset 2021, outcome "unknown", described as "Currently sleepy". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, loss of consciousness, hypotension, tachycardia, fatigue, somnolence (start date: 2021). The events "loss of consciousness", "hypotension grade iii according to ring and messmer" and "tachycardia grade iii according to ring and messmer" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of loss of consciousness, hypotension, tachycardia which includes : 1 mg adrenaline intramuscular, Subdural hematoma 250mg intravenous, Fenestil 4mg intravenous/ Dormicum . Causality assessment: The Health Authority''s assessment of the causal relationship of the events with BNT162b2 was A. Consistent causal association to immunisation for event fatigue and not reported for the other events. Sendercomment: Are you or the person concerned known to have any allergies? If so, which ones? Bronchial asthma, currently without therapy Information on risk factors or previous illnesses Bronchial asthma / today booster vaccination COVID-19 with Biontech (1st Astra and 2nd Biontech: both also with systemic side effect). Vaccination refused by family doctor, thereupon presentation to the doctor in the vaccination centre. Vaccination has already taken place under infusion protection. Immediate reaction after vaccination with loss of consciousness, hypotension and tachycardia (grade III according to Ring and Messmer). Rescue car and emergency care: 1 mg adrenaline intramuscular, Subdural hematoma 250mg intravenous, Fenestil 4mg intravenous/ Dormicum. Patient currently sleepy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003610 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVK4 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Immunisation, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Thrombophlebitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101828459

Write-up: Occurrence of a massive deep vein thrombosis up to the pelvic area 9 days after booster vaccination; swollen leg; booster; This is a spontaneous report received from a non-contactable reporter (consumer) from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021217195. Other Case identifiers: DE-CADRPEI-2021217195 (web portal), DE-PEI-202100270431. An 87 year-old male patient received BNT162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: SCVK4) as dose 3 (booster), 0.3 mL single for COVID-19 immunisation. Relevant medical history included: "Thrombophlebitis" and "Arterial hypertension", both ongoing. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown) and Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (hospitalization) with onset 04Dec2021, outcome "recovering", described as "Occurrence of a massive deep vein thrombosis up to the pelvic area 9 days after booster vaccination"; PERIPHERAL SWELLING (hospitalization) with onset 04Dec2021, outcome "recovering", described as "swollen leg". The patient was hospitalized for the events in 2021 and evaluated at the emergency room (ER) visit. Additional information: Primary Immunization series was complete but unknown manufacturer. Patient noticed swollen leg 9 days after vaccination. A deep leg vein thrombosis left to pelvis was confirmed in ER. Sender''s comment: Do you or the person concerned have any known allergies? If yes, which ones? no. Information on risk factors or previous illnesses: arterial hypertension, use of diuretics and antihypertensives, older age, state after Thrombophlebitis years ago / Patient noticed swollen leg 9 days after vaccination, in emergency room deep leg vein thrombosis left to pelvis confirmed. The regulatory authority assessed the causal relationship between Comirnaty and Herpes ophthalmic as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003744 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-11-25
   Days after vaccination:211
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Pain in extremity, Pyrexia, Vaccination site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FAMOTIDINA; NEURONTIN; SUTRILNEO; TRYPTIZOLE; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain loin (Severe chronic low back pain evolved despite these and support measures); Shoulder pain (due joint disorder) (Acromo-Clavicular osteoarthritis on both shoulders due to MRI); Spinal arthrodesis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20214

Write-up: Acute inflammation left arm from shoulder to wrist. Pain that makes mobility impossible. Persistent heat. tenths of fever and general malaise.; General malaise; Vaccination site warmth; Fever; This case was received via the RA (Reference number: ES-AEMPS-1062639) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Acute inflammation left arm from shoulder to wrist. Pain that makes mobility impossible. Persistent heat. tenths of fever and general malaise.) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3001177, 3002614 and 214029) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pain loin (Severe chronic low back pain evolved despite these and support measures), Spinal arthrodesis and Shoulder pain (due joint disorder) (Acromo-Clavicular osteoarthritis on both shoulders due to MRI). Concomitant products included GABAPENTIN (NEURONTIN), AMITRIPTYLINE HYDROCHLORIDE (TRYPTIZOLE) and FENTANYL (DUROGESIC) for Ache, TORASEMIDE (SUTRILNEO) for Bladder neurogenic, FAMOTIDINE (FAMOTIDINA) for Stomach discomfort. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 26-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 ml. On 24-Nov-2021, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .25 ml. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (Acute inflammation left arm from shoulder to wrist. Pain that makes mobility impossible. Persistent heat. tenths of fever and general malaise.) (seriousness criterion medically significant), MALAISE (General malaise), VACCINATION SITE WARMTH (Vaccination site warmth) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Acute inflammation left arm from shoulder to wrist. Pain that makes mobility impossible. Persistent heat. tenths of fever and general malaise.), MALAISE (General malaise), VACCINATION SITE WARMTH (Vaccination site warmth) and PYREXIA (Fever) had not resolved. No treatment medications were provided. This case concerns an 84-year-old female patient with relevant medical history of Shoulder pain (Acromo-Clavicular osteoarthritis on both shoulders due to MRI), who experienced the unexpected serious event of Pain in Extremity, the event was medically significant as reported by the regulatory authority. The event occurred approximately 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. No other clinical or treatment details were disclosed. The medical history of Shoulder pain (Acromo-Clavicular osteoarthritis on both shoulders due to MRI) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns an 84-year-old female patient with relevant medical history of Shoulder pain (Acromo-Clavicular osteoarthritis on both shoulders due to MRI), who experienced the unexpected serious event of Pain in Extremity, the event was medically significant as reported by the regulatory authority. The event occurred approximately 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. No other clinical or treatment details were disclosed. The medical history of Shoulder pain (Acromo-Clavicular osteoarthritis on both shoulders due to MRI) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2003911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH IF1019A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Body temperature, C-reactive protein, Computerised tomogram head, Dysaesthesia, Electrocardiogram, Gamma-glutamyltransferase, Haemoglobin, Heart rate, Hypertension, Immunisation, Interchange of vaccine products, Neurological examination, Off label use, Physical examination, Platelet count, Prothrombin level, White blood cell count
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; TAHOR; TECFIDERA; RAMIPRIL; LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Blindness, one eye; Dyslipidemia; Ex-smoker; Gestational diabetes; Ischemic stroke; Multiple sclerosis (disease stability, last MRI check-up in Jun2021); Obesity; Sleep apnoea syndromes; Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:0.96; Test Date: 20211202; Test Name: ALAT; Result Unstructured Data: Test Result:19 IU/l; Test Date: 20211202; Test Name: ASAT; Result Unstructured Data: Test Result:21 IU/l; Test Date: 20211202; Test Name: PAL; Result Unstructured Data: Test Result:55 IU/l; Test Date: 20211202; Test Name: bilirubin; Result Unstructured Data: Test Result:9.4 umol/l; Test Date: 20211202; Test Name: creatinine; Result Unstructured Data: Test Result:66 umol/l; Test Date: 20211202; Test Name: potassium; Result Unstructured Data: Test Result:4.0 mmol/L; Test Date: 20210530; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 20211202; Test Name: blood pressure; Result Unstructured Data: Test Result:195/115 mmHg; Test Date: 20211202; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20211202; Test Name: TSH; Result Unstructured Data: Test Result:6.56 MiU/L; Test Date: 20211202; Test Name: urea; Result Unstructured Data: Test Result:5.9 mmol/L; Test Date: 20211202; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20211202; Test Name: Brain CT without and with injection; Result Unstructured Data: Test Result:ischemic sequel; Comments: pre-existing right sylvian ischemic sequel, hypodensities of the white matter, no enhancement after injection; Test Date: 20211202; Test Name: CRP; Result Unstructured Data: Test Result:<3.0 mg/l; Test Date: 20211202; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm at 81bpm, axis normal, thin QRS, no sign of ischemia; Test Date: 20211202; Test Name: GGT; Result Unstructured Data: Test Result:22 uiU/L; Test Date: 20211202; Test Name: Hb; Result Unstructured Data: Test Result:13.6 g/dl; Test Date: 20211202; Test Name: heart rate; Result Unstructured Data: Test Result:81/min; Test Date: 20211202; Test Name: neurological examination; Result Unstructured Data: Test Result:patient vigilant, oriented; Comments: - no phasic disorder, arthritis - no memory complaint - no facial paralysis - no oculomotor paralysis - blindness of the right eye known without other impairment of the visual field - no motor deficit of the upper limbs, slight fall of the left lower limb at Mingazzini - dysesthesia of the upper right limb without objective hypoesthesia on examination, no clear hypoesthesia of the right lower limb on examination, no sensory thoracic or abdominal level - osteotendinous reflexes perceived in all four limbs, not alive - plantar skin flexion reflex - no sphincter disorder; Test Date: 20211202; Test Name: physical examination; Result Unstructured Data: Test Result:regular heart sounds; Comments: - regular heart sounds, no perceived murmur, perceived peripheral pulses - bilateral and symmetrical vesicular murmur, no added noise, eupneic in ambient air - supple, depressible, painless, plethoric abdomen; Test Date: 20211202; Test Name: platelets; Result Unstructured Data: Test Result:217 g/l; Test Date: 20211202; Test Name: prothrombin; Test Result: 100 %; Test Date: 20211202; Test Name: leucocytes; Result Unstructured Data: Test Result:4.2 g/l
CDC Split Type: FRPFIZER INC202101830572

Write-up: Off label; interchange of vaccine products; Booster; Dysaesthesia/the patient describes paresthesias in her right hand. She noted an extension of paresthesias over 3-4 days to the entire upper limb then 48 hours later to the lower right limb.; Arterial hypertension; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-AN20214798 (AFSSAPS). A 53 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: IF1019A) as dose 3 (booster),single for covid-19 immunisation; influenza vaccine inact sag 4v (INFLUVAC TETRA), intramuscular, administration date 23Nov2021 (Lot number: Unknown) as 1 df, single for influenza immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Sleep apnoea syndromes" (unspecified if ongoing); "Gestational diabetes" (unspecified if ongoing); "Dyslipidemia" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Ex-smoker" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing), notes: disease stability, last MRI check-up in Jun2021; "Ischemic stroke" (unspecified if ongoing); "blindness of the right eye known" (unspecified if ongoing). Concomitant medication(s) included: KARDEGIC; TAHOR; TECFIDERA, start date: 2017; RAMIPRIL; LEVOTHYROX. Vaccination history included: Covid-19 vaccine astra (1st dose, batch number: ABV8139), administration date: 13Mar2021, for covid-19 immunization; Comirnaty (2nd dose, batch number: FC3143), administration date: 04Jun2021, for covid-19 immunization. The following information was reported: OFF LABEL USE (hospitalization), outcome "unknown", described as "Off label"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (hospitalization), outcome "unknown", described as "Booster"; DYSAESTHESIA (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "Dysaesthesia/the patient describes paresthesias in her right hand. She noted an extension of paresthesias over 3-4 days to the entire upper limb then 48 hours later to the lower right limb."; HYPERTENSION (medically significant) with onset 03Dec2021, outcome "not recovered", described as "Arterial hypertension". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, dysaesthesia (start date: 02Dec2021). The events "dysaesthesia/the patient describes paresthesias in her right hand. she noted an extension of paresthesias over 3-4 days to the entire upper limb then 48 hours later to the lower right limb." and "arterial hypertension" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: activated partial thromboplastin time: (02Dec2021) 0.96; alanine aminotransferase: (02Dec2021) 19 IU/l; aspartate aminotransferase: (02Dec2021) 21 IU/l; blood alkaline phosphatase: (02Dec2021) 55 IU/l; blood bilirubin: (02Dec2021) 9.4 umol/l; blood creatinine: (02Dec2021) 66 umol/l; blood potassium: (02Dec2021) 4.0 mmol/L; blood pressure measurement: (30May2021) 140/80 mmHg; (02Dec2021) 195/115 mmHg; blood sodium: (02Dec2021) 141 mmol/L; blood thyroid stimulating hormone: (02Dec2021) 6.56 MiU/L; blood urea: (02Dec2021) 5.9 mmol/L; body temperature: (02Dec2021) 36.5 Centigrade; computerised tomogram head: (02Dec2021) ischemic sequel, notes: pre-existing right sylvian ischemic sequel, hypodensities of the white matter, no enhancement after injection; c-reactive protein: (02Dec2021) <3.0 mg/l; electrocardiogram: (02Dec2021) regular sinus rhythm, notes: regular sinus rhythm at 81bpm, axis normal, thin QRS, no sign of ischemia; gamma-glutamyltransferase: (02Dec2021) 22 uiU/L; haemoglobin: (02Dec2021) 13.6 g/dl; heart rate: (02Dec2021) 81/min; neurological examination: (02Dec2021) patient vigilant, oriented, notes: - no phasic disorder, arthritis - no memory complaint - no facial paralysis - no oculomotor paralysis - blindness of the right eye known without other impairment of the visual field - no motor deficit of the upper limbs, slight fall of the left lower limb at Mingazzini - dysesthesia of the upper right limb without objective hypoesthesia on examination, no clear hypoesthesia of the right lower limb on examination, no sensory thoracic or abdominal level - osteotendinous reflexes perceived in all four limbs, not alive - plantar skin flexion reflex - no sphincter disorder; physical examination: (02Dec2021) regular heart sounds, notes: - regular heart sounds, no perceived murmur, perceived peripheral pulses - bilateral and symmetrical vesicular murmur, no added noise, eupneic in ambient air - supple, depressible, painless, plethoric abdomen; platelet count: (02Dec2021) 217 g/l; prothrombin level: (02Dec2021) 100 %; white blood cell count: (02Dec2021) 4.2 g/l. Therapeutic measures were not taken as a result of dysaesthesia, hypertension. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-25
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, C-reactive protein, COVID-19, Drug ineffective, Influenza virus test, Investigation, Oxygen saturation, SARS-CoV-2 test, White blood cell count
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMERATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Ex-tobacco user (Smoking cessation 10 years ago); Obesity (Body Mass Index 30)
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: Serum creatinine; Result Unstructured Data: Test Result:124 umol/l; Comments: (for a baseline value a priori around 60 �mol / L); Test Date: 20211202; Test Name: C-reactive protein; Result Unstructured Data: Test Result:360 g/l; Test Name: Flu test; Test Result: Negative ; Test Name: Screening; Result Unstructured Data: Test Result:L452R screening; Comments: Sequencing not carried out; Test Date: 20211202; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:95% on arrival under 15L / min %; Test Date: 20211129; Test Name: Antigen test; Test Result: Positive ; Test Date: 20211206; Test Name: polymerase chain reaction COVID test; Test Result: Positive ; Test Date: 20211202; Test Name: white blood cells; Result Unstructured Data: Test Result:16 g/l
CDC Split Type: FRPFIZER INC202101828154

Write-up: Positive COVID-19 test with flu-like syndrome with myalgia, cough, fever and diarrhoea/Acute hypoxemic respiratory failure due to Covid infection; Positive COVID-19 test with flu-like syndrome with myalgia, cough, fever and diarrhoea/Acute hypoxemic respiratory failure due to Covid infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Agency WEB. Regulatory number: FR-AFSSAPS-LY202113405 (RA). A 64 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Ex-tobacco user" (unspecified if ongoing), notes: Smoking cessation 10 years ago; "Obesity" (unspecified if ongoing), notes: Body Mass Index 30; "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL FUMERATE. Vaccination history included: COVID-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization) all with onset 25Nov2021, outcome "not recovered" and all described as "Positive COVID-19 test with flu-like syndrome with myalgia, cough, fever and diarrhoea/Acute hypoxemic respiratory failure due to COVID infection". The patient was hospitalized for drug ineffective, COVID-19 (start date: 2021). The patient underwent the following laboratory tests and procedures: blood creatinine: (02Dec2021) 124 umol/l, notes: (for a baseline value a priori around 60 �mol / L); c-reactive protein: (02Dec2021) 360 g/l; influenza virus test: (unspecified date) negative; investigation: (unspecified date) l452r screening, notes: Sequencing not carried out; oxygen saturation: (02Dec2021) 95% on arrival under 15l / min; sars-cov-2 test: (29Nov2021) positive; (06Dec2021) positive; white blood cell count: (02Dec2021) 16 g/l. Therapeutic measures were taken as a result of COVID-19. Clinical course: On 25Nov2021: onset of flu-like syndrome with myalgia, cough, fever and diarrhoea. 02Dec2021: deterioration of the clinical condition with increasing dyspnoea, leading to his hospitalisation. Oxygen saturation at 95% on arrival under 15L / min, biological inflammatory syndrome with C-reactive protein at 360 g / L, white blood cells 16 G / L, serum creatinine 124 �mol / L (for a baseline value a priori around 60 �mol / L). Parenchyma affected at 40-50%, no pulmonary embolism. Diagnosed with acute hypoxemic respiratory failure due to Covid infection and was transferred to intensive care. Initial medical care: dexamethasone 6 mg / day, anticoagulation through low molecular weight heparin and alternation with High Flow Oxygenation/non-invasive ventilation. On 11Dec2021: With a refractory hypoxia, intubation, mechanical ventilation, prone position session, antibiotic therapy with TAZOCILLINE. No improvement subsequently with persisting several hypoxemia. On 13Dec2021: installation of venovenous extracorporeal membrane oxygenation on refractory hypoxemia in prone position. Patient not yet recovered as of 15Dec2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-11-25
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Covid-19 antigenic test; Test Result: Positive; Test Date: 20211125; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101820968

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 FR-AFSSAPS-MP20218879. A 58 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20May2021 (Lot number: EX7823, Expiration Date: 31Aug2021) as dose 2, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 25Nov2021, outcome recovering; COVID-19 (medically significant) with onset 25Nov2021, outcome recovering. The employee reported cold-like symptoms on 26Nov2021. The antigenic tests performed on 27Nov2021 were positive for the patient. The patient underwent the following laboratory tests and procedures sars-cov-2 test (27Nov2021) positive; (25Nov2021) positive. Provided investigational results on 23Dec2021 for bnt162b2 included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX7823. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2004051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture, Computerised tomogram, Immunisation, Immunisation reaction, Pyrexia, Somnolence, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; LOSARTAN; ATORVASTATINE [ATORVASTATIN]; OXAZEPAM; REPAGLINIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Melanoma (Metastatic melanoma in complete response after 4 infusions)
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result:Negative; Test Name: thoraco-abdomino-pelvic computerised tomography; Result Unstructured Data: Test Result:Negative; Test Name: high fever of 40� with chills; Result Unstructured Data: Test Result:high fever of 40�; Comments: high fever of 40� with chills; Test Name: cytobacteriological urine examination; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101828291

Write-up: Reactogenicity event; high fever of 40� with chills; major drowsiness; asthenia; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Physician) from the WEB. Regulatory number: FR-AFSSAPS-PA20212914 (AFSSAPS). A 73-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: Unknown) as dose 3 (booster), 0.3ml single for covid-19 immunisation. Relevant medical history included: "Melanoma" (unspecified if ongoing), notes: Metastatic melanoma in complete response after 4 infusions of Nivolumab+Ipilimumab followed by Nivolumab maintenance (C1 on 15Apr2021). Concomitant medication(s) included: HYDROCORTISONE; LOSARTAN; ATORVASTATINE [ATORVASTATIN]; OXAZEPAM; REPAGLINIDE. Vaccination history included: Covid-19 vaccine (Dose: 1, product name: COVID-19 vaccine (MANUFACTURER UNKNOWN)); Covid-19 vaccine (Dose: 2, product name: COVID-19 vaccine (MANUFACTURER UNKNOWN)). The following information was reported: IMMUNISATION (non-serious) with onset 25Nov2021, outcome "unknown", described as "BOOSTER"; IMMUNISATION REACTION (hospitalization) with onset 26Nov2021, outcome "recovered", described as "Reactogenicity event"; PYREXIA (non-serious), outcome "unknown", described as "high fever of 40 degree celsius with chills"; SOMNOLENCE (non-serious), outcome "unknown", described as "major drowsiness"; ASTHENIA (non-serious), outcome "unknown", described as "asthenia". The event "reactogenicity event" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood culture: negative; computerised tomogram: negative; pyrexia: high fever of 40 degree celsius, notes: high fever of 40 degree celsius with chills; urine analysis normal: negative. Additional information: There was concomitant abdominal pain but no other clinical findings. On Saturday 27Nov Introduction of Tazocillin and then Cefotaxime for septic presentation; stopped on 29Nov due to apyrexia and negativity of samples. Notion found in the hospitalisation report of consciousness disorders with abnormal movements. The patient describes having had a reaction of the same type at the time of the 2nd injection of this vaccine, with shivering, alteration of the general state, which did not require hospital care. Negative infectious assessment: Trans-thoracic echocardiography and head computed tomography injected 01Dec2021: no argument for a secondary cerebral location. Clinical course: Booster 1 reactogenicity events requiring hospital management in a 73-year-old man treated with immunotherapy for melanoma - negative etiology - worsening compared to Dose 2. Note: A drug is coded as a substance when the commercial name is not known. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Sinusitis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chikungunya virus infection; Dengue; Infection; Malaria; Pneumonia; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low; Test Date: 20211125; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101821475

Write-up: Oxygen saturation low; COVID-19 pneumonia; Vomiting; Breathlessness; Persistent cough; Sinus infection; SARS-CoV-2 infection; Chronic fever; 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-202112181657311520-EG4MX (RA). Other Case identifier(s): GB-MHRA-ADR 26357979 (RA). A 36-year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: Relevant medical history included: "Infection" (unspecified if ongoing); "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; pneumonia during secondary school. In last 10 years (2011) had Malaria, Dengue and chikungunya. During this his chest and lungs were severely affected. But recovered after the infection cleared. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 27Nov2021, outcome "recovering", described as "COVID-19 pneumonia"; COVID-19 (hospitalization) with onset 25Nov2021, outcome "recovering", described as "SARS-CoV-2 infection"; PYREXIA (hospitalization) with onset 25Nov2021, outcome "recovered" (07Dec2021), described as "Chronic fever"; VOMITING (hospitalization) with onset 27Nov2021, outcome "recovered" (07Dec2021), described as "Vomiting"; DYSPNOEA (hospitalization) with onset 27Nov2021, outcome "recovering", described as "Breathlessness"; COUGH (hospitalization) with onset 27Nov2021, outcome "recovering", described as "Persistent cough"; SINUSITIS (hospitalization) with onset 27Nov2021, outcome "recovering", described as "Sinus infection"; OXYGEN SATURATION DECREASED (hospitalization) with onset 30Nov2021, outcome "recovered" (07Dec2021), described as "Oxygen saturation low". The patient underwent the following laboratory tests and procedures: oxygen saturation: (30Nov2021) low; sars-cov-2 test: (25Nov2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2006975 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: BEMODERNATX, INC.MOD20214

Write-up: nausea; Rillingen; Koorts; Muscle pain; Injection site response; fatigue; Feeling unwell; headache; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-110041) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (Rillingen), PYREXIA (Koorts), MYALGIA (Muscle pain), INJECTION SITE REACTION (Injection site response), FATIGUE (fatigue), MALAISE (Feeling unwell) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: COMIRNATY on 24-Feb-2021 and COMIRNATY on 17-Mar-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY and COMIRNATY. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced NAUSEA (nausea) (seriousness criterion disability), CHILLS (Rillingen) (seriousness criterion disability), PYREXIA (Koorts) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), INJECTION SITE REACTION (Injection site response) (seriousness criterion disability), FATIGUE (fatigue) (seriousness criterion disability), MALAISE (Feeling unwell) (seriousness criterion disability) and HEADACHE (headache) (seriousness criterion disability). On 27-Nov-2021, NAUSEA (nausea), CHILLS (Rillingen), PYREXIA (Koorts), MYALGIA (Muscle pain), INJECTION SITE REACTION (Injection site response), FATIGUE (fatigue), MALAISE (Feeling unwell) and HEADACHE (headache) had resolved. Treatment information was not provided. Concomitant medication was not reported. COMPANY COMMENT: This is a regulatory case concerning a 55-year-old female patient with no clinical history who experienced the unexpected event of MALAISE, INJECTION SITE REACTION, NAUSEA, PYREXIA, MYALGIA, FATIGUE, CHILLS and HEADACHE The event occurred 1 days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: Treatment - No Evolution of the ADR - Restored: After 2 days ADR description - Check the observed side effect (s). You can describe this update (s) in detail in the Description field of the update (s).; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 55-year-old female patient with no clinical history who experienced the unexpected event of MALAISE, INJECTION SITE REACTION, NAUSEA, PYREXIA, MYALGIA, FATIGUE, CHILLS and HEADACHE The event occurred 1 days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2007013 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Immunisation
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOORTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101845513

Write-up: arthritis (left shoulder + arm + wrist); joint pain (ankles, right knee, right elbow); 3rd dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the -WEB. Regulatory number: BE-FAMHP-DHH-N2021-111434. A 80 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lumbar trauma" (unspecified if ongoing). Concomitant medication(s) included: LOORTAN. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, described as "3rd dose"; ARTHRITIS (disability) with onset 09Dec2021, outcome "unknown", described as "arthritis (left shoulder + arm + wrist)"; ARTHRALGIA (disability) with onset 09Dec2021, outcome "unknown", described as "joint pain (ankles, right knee, right elbow)". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2007162 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVT5 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Cardiovascular disorder, Dizziness, Electrocardiogram, Immunisation, Palpitations, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Exclusion of heart failure; Comments: outpatient treatment
CDC Split Type: DEPFIZER INC202101830397

Write-up: Vasovagal collapse pain; Light headedness; Abdominal pain upper; Circulatory instability; Heart racing; 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-202100277813. A 49 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: SCVT5) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunisation. The following information was reported: CARDIOVASCULAR DISORDER (medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Circulatory instability"; PALPITATIONS (medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Heart racing"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; PRESYNCOPE (non-serious), outcome "unknown", described as "Vasovagal collapse pain"; DIZZINESS (non-serious) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Light headedness"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Abdominal pain upper". The patient underwent the following laboratory tests and procedures: electrocardiogram: exclusion of heart failure, notes: outpatient treatment. Sender Comment: Vasovagal collapse pain typically Electrocardiogram. Exclusion of heart failure, outpatient treatment, Electrocardiogram attached No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007169 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31101TB / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Congestive cardiomyopathy, Immunisation
SMQs:, Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101845725

Write-up: Dilated cardiomyopathy; Dose 3 (Booster); This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: DE-PEI-202100283834. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: 31101TB) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1), administration date: 15Apr2021, for COVID-19 immunisation; Comirnaty (dose 2), administration date: 26May2021, for COVID-19 immunisation. The following information was reported: CONGESTIVE CARDIOMYOPATHY (hospitalization, life threatening) with onset 30Nov2021, outcome "not recovered", described as "Dilated cardiomyopathy"; IMMUNISATION (hospitalization, life threatening) with onset 25Nov2021, outcome "unknown", described as "Dose 3 (Booster)". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007299 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1022A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral disorder, Cerebral infarction, Magnetic resonance imaging, Specialist consultation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Infarction; Pollen allergy; Sinusitis
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211129; Test Name: Family Doctor; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101830319

Write-up: Failures in the brain; Cerebral infarction; 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-CADR2021224505 (PEI). Other Case identifier(s): DE-CADRPEI-2021224505 (PEI Webportal), DE-PEI-202100277935 (PEI). A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: 1F1022A) as dose number unknown, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (unspecified if ongoing); "Posterior infarction", start date: 2001 (unspecified if ongoing); "Asthma", start date: 2018 (unspecified if ongoing); "Sinusitis", start date: 2017 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Acetylsalicylic acid, reaction(s): "Drug hypersensitivity"; Ibuprofen, reaction(s): "Drug hypersensitivity". The following information was reported: CEREBRAL INFARCTION (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Cerebral infarction"; BRAIN INJURY (hospitalization), outcome "unknown", described as "Failures in the brain". The patient was hospitalized for cerebral infarction, brain injury (start date: 29Nov2021). On the night of 24Nov2021-25Nov2021, the patient had a stroke. The patient experienced Right-hand twist and failures in the brain. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (30Nov2021) unknown results; specialist consultation: (29Nov2021) unknown results. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007690 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Colonoscopy, Crohn's disease, Diarrhoea, Immunisation, Malaise, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (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: LOPERAMIDE; PARACETAMOL AND CODEINE PHOSPHATE (I)
Current Illness: Crohn''s disease (mild crohn''s symptoms)
Preexisting Conditions: Medical History/Concurrent Conditions: Bowel resection; Rotator cuff tear
Allergies:
Diagnostic Lab Data: Test Name: colonoscopy; Result Unstructured Data: Test Result:Results unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101839056

Write-up: abdominal pain; feeling so ill; Feels exactly like a bad crohn''s flareup; Diarrhea; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112161927201230-BFDPO (RA). Other Case identifier(s): GB-MHRA-ADR 26346644 (RA). A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "crohn''s disease" (ongoing), notes: mild crohn''s symptoms; "bowel resection", start date: May2021 (unspecified if ongoing); "Rotator cuff tear" (unspecified if ongoing). Concomitant medication(s) included: LOPERAMIDE taken for crohn''s disease; PARACETAMOL AND CODEINE PHOSPHATE (I) taken for rotator cuff syndrome, start date: 16Oct2021. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (disability) with onset 27Nov2021, outcome "not recovered", described as "Diarrhea"; ABDOMINAL PAIN (disability), outcome "recovering", described as "abdominal pain"; MALAISE (disability), outcome "unknown", described as "feeling so ill"; CROHN''S DISEASE (disability) with onset 27Nov2021, outcome "not recovered", described as "Feels exactly like a bad crohn''s flareup". The patient underwent the following laboratory tests and procedures: colonoscopy: results unknown; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient has crohn''s disease. Since having a bowel resection in May this year she has had only mild crohn''s symptoms. 2 days after the booster vaccination she had severe abdominal pain and diarrhoea. Feels exactly like a bad crohn''s flareup and is ongoing 3 weeks later. Unlikely to be a coincidence, the patient would think long and hard before having future covid vaccinations. In fact, she has been feeling so ill and doubt if will ever have one again. Would like to see some research into this issue, particularly in relation to IBD sufferers. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-25
Onset:2021-11-25
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Myocarditis, Palpitations, Paraesthesia, Pericarditis, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101837835

Write-up: myocarditis; pericarditis; Chest pain; Heart palpitations; Tingling; Heart fluttering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112171519219200-EFVZZ. Other Case identifier(s): GB-MHRA-ADR 26352590. A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Oct2021 (Lot number: FF8288) as dose 2, 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: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Heart fluttering"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: About a month after jab 2 patient left hand was drawn up to his heart and become aware it does not feel right it was like fluttering/tingling and uncomfortable. This was every day or so. He tested every week and have never had covid. He was concerned as seeing reports over 300,000 men with similar. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was related to possible inflammation of the heart (myocarditis or pericarditis). Patient had requested his local general practitioner (GP) refer him privately to cardiologist. Symptoms did not lead to a hospital stay. The patient accepted to contact GP or treating physician. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007714 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9143 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac function test, Dyspnoea, Fatigue, Heart rate, Heart rate irregular, Immunisation, Interchange of vaccine products, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dental caries (often got a similar response to caries, but in that case it persisted until the tooth was treated)
Allergies:
Diagnostic Lab Data: Test Name: Cardiac function test; Result Unstructured Data: Test Result:unknown results; Test Date: 20211130; Test Name: Pulse; Result Unstructured Data: Test Result:irregular; Test Date: 20211210; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101839323

Write-up: Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; Pulse irregular; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112181156557160-QSSGV Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26357533 Regulatory Authority. A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FK9143) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dental caries" (unknown if ongoing), notes: often got a similar response to caries, but in that case it persisted until the tooth was treated. It was unsure if patient had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Vaccination history included: Sars-cov-2 virus (Dose 1, manufacturer unknown), for COVID-19 immunisation; Sars-cov-2 virus (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; HEART RATE IRREGULAR (medically significant) with onset 30Nov2021, outcome "recovered" (14Dec2021), described as "Pulse irregular"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations". Patient had been tested for irregular heartbeat in relation to caries, but he had not had tests for this recent situation since in any case it would take many months to arrange. Patient experienced very irregular heartbeats, particularly at night. But very variable, some days no problem. Problem persisted for about 3 weeks. Patient often got a similar response to caries, but in that case it persisted until the tooth was treated. In this case he visited the dentist and there was no problem. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. His report related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: cardiac function test: (unspecified date) unknown results; sars-cov-2 test: (10Dec2021) negative, notes: No - Negative COVID-19 test; heart rate: (30Nov2021) irregular. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Fatigue, Immunisation, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101830464

Write-up: Dyspnoea; Fever; Chills; body aches; fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: DE-PEI-CADR2021210616. Other Case identifier(s): DE-CADRPEI-2021210616, DE-PEI-202100263346. A 31-year-old female patient received BNT162B2 (COMIRNATY), administration date 25Nov2021 (Lot number: Unknown) as dose 3 (booster),single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Paracetamol, reaction(s): "allergies". 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: DYSPNOEA (hospitalization) with onset 26Nov2021, outcome "recovering", described as "Dyspnoea"; PYREXIA (hospitalization) with onset 26Nov2021, outcome "recovering", described as "Fever"; CHILLS (hospitalization) with onset 26Nov2021, outcome "recovering", described as "Chills"; PAIN (hospitalization) with onset 26Nov2021, outcome "recovering", described as "body aches"; FATIGUE (hospitalization) with onset 26Nov2021, outcome "recovering", described as "fatigue"; IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of dyspnoea, pyrexia, chills, pain, fatigue which includes inpatient stay, inhalation, antipyretic drugs, pain relievers, antibiotics No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2008559 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Dry skin, Erythema, Headache, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Hot dry skin; Redness; Itching; Nauseous; Temperature elevation; Headache; This case was received via Regulator Authority, MHRA (Reference number: GB-MHRA-ADR 26371927) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DRY SKIN (Hot dry skin), ERYTHEMA (Redness), PRURITUS (Itching), NAUSEA (Nauseous), BODY TEMPERATURE INCREASED (Temperature elevation) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and SALBUTAMOL, SALBUTAMOL BASE, SALBUTAMOL SULPHATE, SALBUTAMOL SULPHATE MICRONISED (VENTOLIN) for COPD, CODEINE for Degenerative disc disease, INFLUENZA VACCINE (INFLUENZA VIRUS) from 19-Nov-2021 to an unknown date for an unknown indication. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced DRY SKIN (Hot dry skin) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Dec-2021, DRY SKIN (Hot dry skin) and ERYTHEMA (Redness) had resolved. On 04-Dec-2021, BODY TEMPERATURE INCREASED (Temperature elevation) and HEADACHE (Headache) had resolved. On 06-Dec-2021, PRURITUS (Itching) and NAUSEA (Nauseous) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Medical History information was reported. Patient had to ring out of hours surgery , was put on antibiotics as they said could be an adverse reaction or possible site infection, antibiotics as a precaution but it did clear the problem within 3 days of starting them . Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 64-year-old female patient with no medical history provided, who experienced serious unexpected events of Dry skin, Erythema, Pruritus, Nausea, Body temperature increased and Headache. The events occurred the day after the patient had received the mRNA-1273 vaccine, as third dose (booster). The patient was treated with antibiotic therapy due to possible infection. At the time of this report, all events had resolved. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 64-year-old female patient with no medical history provided, who experienced serious unexpected events of Dry skin, Erythema, Pruritus, Nausea, Body temperature increased and Headache. The events occurred the day after the patient had received the mRNA-1273 vaccine, as third dose (booster). The patient was treated with antibiotic therapy due to possible infection. At the time of this report, all events had resolved. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009274 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: muscle weakness; joint pain; Joint ache; Tendon pain; Muscle ache; This case was received via regulatory authority on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), ARTHRALGIA (joint pain), ARTHRALGIA (Joint ache), TENDON PAIN (Tendon pain) and MYALGIA (Muscle ache) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criteria disability and medically significant), TENDON PAIN (Tendon pain) (seriousness criteria disability and medically significant) and MYALGIA (Muscle ache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness) (seriousness criteria disability and medically significant) and ARTHRALGIA (joint pain) (seriousness criteria disability and medically significant). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), ARTHRALGIA (joint pain), ARTHRALGIA (Joint ache), TENDON PAIN (Tendon pain) and MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug was provided by reporter. Usual post vax 48 hours symptoms. However weeks on total joint pain and muscle weakness. Both groins in pain. Patient fit and healthy so no reason to feel like this. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: This case concerns a 47-year-old male subject, with no medical history reported, who experienced the unexpected and serious events of Muscular weakness, Arthralgia, Tendon pain, and Myalgia. Seriousness assessed due to disability. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old male subject, with no medical history reported, who experienced the unexpected and serious events of Muscular weakness, Arthralgia, Tendon pain, and Myalgia. Seriousness assessed due to disability. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
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: 20211028; Test Name: LFT/PCR; Test Result: Negative ; Comments: (pre booster) blood sample tested negative for antibodies; Test Date: 20211204; Test Name: LFT/PCR; Result Unstructured Data: Test Result:tested negative for current infection; Comments: positive for antibodies; Test Date: 20211217; Test Name: LFT/PCR; Test Result: Negative ; Test Date: 20211219; Test Name: LFT/PCR; Test Result: Positive ; Test Date: 20211220; Test Name: LFT/PCR; Test Result: Positive ; Comments: at 03:02 a.m.
CDC Split Type: GBPFIZER INC202101832678

Write-up: SARS-CoV-2 test positive upon self-administered LFT; SARS-CoV-2 test positive upon self-administered LFT; Off label use; Interchange of vaccine product; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (first dose), administration date: 16Mar2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (second dose), administration date: 24May2021, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "SARS-CoV-2 test positive upon self-administered LFT"; OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Oct2021) negative, notes: (pre booster) blood sample tested negative for antibodies; (04Dec2021) tested negative for current infection, notes: positive for antibodies; (17Dec2021) negative; (19Dec2021) positive; (20Dec2021) positive, notes: at 03:02 a.m.


VAERS ID: 2009734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematuria
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101830686

Write-up: Hematuria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: GR-GREOF-202109926 (RA). A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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: Covid-19 vaccine (Dose 1 , Manufacture Unkown), for COVID-19 immunisation. The following information was reported: HAEMATURIA (medically significant, life threatening) with onset 25Nov2021, outcome "unknown", described as "Hematuria". Health Authority Comment: The reporter is relative of the male patient 71 years old. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009804 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Heart rate increased, Palpitations
SMQs:, Neuroleptic malignant 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? 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: HRPFIZER INC202101845568

Write-up: Heart rate increased; Heart pounding; Headache; This is a spontaneous report received from a contactable consumer from the regulatory authority-WEB. The reporter is the patient. Regulatory number: -HALMED-300052996 . Other Case identifier(s): 10-224-548-410 . A 45-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection), intramuscular, administration date 25Nov2021 (Lot number: FE8244) at the age of 45 years as dose 1, 0.3 ml, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: On 25Nov2021 (a couple hours after the vaccination), the patient''s heart was pounding and it lasted for a few minutes. On 05Dec2021 (10 days after the vaccination), the patient''s pulse was increased throughout the evening. The strong pounding of the heart continued into the night. The next day, the doctor prescribed the patient comfort pills. Her head had been aching for ten days. Therapeutic measures were taken as result of events heart rate increased, palpitations. The outcome of event heart pounding was recovered on 02Dec2021 while the event headache was recovered on 07Dec2021. The outcome of event heart rate increased was unknown. The regulatory authority assessed the causal relationship between BNT162B2 (COMIRNATY) and all the events as possible. Method of assessment: Causality.


VAERS ID: 2010887 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 immunisation, Fatigue, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (narrow)

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: BEMODERNATX, INC.MOD20214

Write-up: Revaccination with different COVID-19 vaccine; fatigue; Feeling unwell; Muscle pain everywhere, worse than ever experienced. Self to the fingers.; This case was received via regulatory authority (Reference number: BE-FAMHP-DHH-N2021-110834) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), FATIGUE (fatigue), MALAISE (Feeling unwell) and MYALGIA (Muscle pain everywhere, worse than ever experienced. Self to the fingers.) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Previously administered products included for COVID-19 immunisation: Comirnaty on 22-Jan-2021 and Comirnaty on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with Comirnaty and Comirnaty. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion disability), MALAISE (Feeling unwell) (seriousness criterion disability) and MYALGIA (Muscle pain everywhere, worse than ever experienced. Self to the fingers.) (seriousness criterion disability). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion disability). On 26-Nov-2021, FATIGUE (fatigue), MALAISE (Feeling unwell) and MYALGIA (Muscle pain everywhere, worse than ever experienced. Self to the fingers.) had resolved. At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) had resolved. Concomitant product use was not provided by the reporter. The patient was treated with painkillers. Painkiller only works for a very short period. The adverse drug event recovered in 1.5 day.; Reporter''s Comments: Treatment - Yes Painkillers Evolution of the ADR - Recovered: 1.5 day ADR description - Muscle pain everywhere. Worse than ever experienced. Self to the fingers. When taking painkiller, this only works for a very short period of time.; Sender''s Comments: This case concerns a 24-year-old female patient, with medical history not reported, who experienced the serious (hospitalization) unexpected event(s) of COVID-19 immunisation, fatigue, malaise and myalgia. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2011141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chills, Dizziness, Fatigue, Headache, Hyperhidrosis, Loss of consciousness, Malaise, Pharyngeal swelling, Visual impairment, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: Allergic asthma; Anaemia iron deficiency (as a child); Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101845383

Write-up: Malaise; Anaphylactic reaction; Visual impairment; Headache; Chills; Hyperhidrosis; Fatigue; Dizziness; Loss of consciousness; Vomiting; throat began to swell; 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. Regulatory number: FI-FIMEA-20217934 (RA). A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. Relevant medical history included: "Allergic asthma" (unspecified if ongoing); "iron anaemia" (unspecified if ongoing), notes: as a child; "psoriasis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: MALAISE (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Malaise"; ANAPHYLACTIC REACTION (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Anaphylactic reaction"; VISUAL IMPAIRMENT (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Visual impairment"; HEADACHE (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Headache"; CHILLS (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Chills"; HYPERHIDROSIS (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Hyperhidrosis"; FATIGUE (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Fatigue"; DIZZINESS (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Dizziness"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Loss of consciousness"; VOMITING (hospitalization) with onset 25Nov2021, outcome "recovered", described as "Vomiting"; PHARYNGEAL SWELLING (hospitalization) with onset 25Nov2021, outcome "unknown", described as "throat began to swell". The events "anaphylactic reaction" and "throat began to swell" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction, pharyngeal swelling. Immediately after the vaccination an allergic reaction (anaphylaxis) occurred and throat began to swell. The patient got the antihistamines and was there for about an hour. An ambulance came to the house and went to the hospital after the examination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101847580

Write-up: Syncope; This is a spontaneous report received from a contactable reporter Other HCP from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112211423048400-WF5BA. Other Case identifier(s): GB-MHRA-ADR 26371949. A male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (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 patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The following information was reported: SYNCOPE (medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Syncope". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101846608

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Racing heart (tachycardia); Myocarditis; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112211905578010-8ZHXT. Other Case identifier(s): GB-MHRA-ADR 26373940. A 27 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; MYOCARDITIS (medically significant) with onset 13Dec2021, outcome "not recovered", described as "Myocarditis"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (non-serious), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Additional information: Patient last menstrual period date was 21Dec2021. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The symptoms did not lead to a hospital stay. A diagnosis was not made by a medical professional. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012007 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Condition aggravated, Haemoglobin, Haemoglobin decreased, Hypotension, Immunisation, Interchange of vaccine products, Off label use, Pleural effusion, SARS-CoV-2 test, Skin exfoliation, Skin ulcer, Weight bearing difficulty, Wound necrosis
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Leg ulcer; RA; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Low; Test Name: HB; Result Unstructured Data: Test Result:Low; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101851759

Write-up: Worsening of skin leg ulcer; Worsening of skin leg ulcer; low HB; unable to weightbare; forming black necrotic skin around wound; pleural effusions; Low blood pressure; Off label use; Interchange of vaccine products; Booster; Skin loss; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112222211343710-8KWHA. Other Case identifier(s): GB-MHRA-ADR 26381943. A female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "RA" (unspecified if ongoing); "Skin leg ulcer" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Booster"; SKIN EXFOLIATION (hospitalization) with onset 25Nov2021, outcome "recovered with sequelae", described as "Skin loss"; HYPOTENSION (hospitalization) with onset 17Dec2021, outcome "not recovered", described as "Low blood pressure"; SKIN ULCER (hospitalization), CONDITION AGGRAVATED (hospitalization), outcome "unknown" and all described as "Worsening of skin leg ulcer"; HAEMOGLOBIN DECREASED (hospitalization), outcome "unknown", described as "low HB"; WEIGHT BEARING DIFFICULTY (hospitalization), outcome "unknown", described as "unable to weightbare"; WOUND NECROSIS (hospitalization), outcome "unknown", described as "forming black necrotic skin around wound"; PLEURAL EFFUSION (hospitalization), outcome "unknown", described as "pleural effusions". The events "skin loss", "low blood pressure", "worsening of skin leg ulcer", "low hb", "unable to weightbare", "forming black necrotic skin around wound" and "pleural effusions" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: low; Haemoglobin: low; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that patient experienced worsening of skin leg ulcer forming black necrotic skin around wound, guild retention and unable to weightbare. It was also reported that whilst in hospital, patient had low BP, low HB, and pleural effusions. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101856698

Write-up: Headache; Tiredness; Muscle pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112231245263400-AXZQK. Other Case identifier(s): GB-MHRA-ADR 26385055. A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19 and was not breastfeeding. Patient was not enrolled in clinical trial. 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 25Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Tiredness"; MYALGIA (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Muscle pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012570 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ear pain, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

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

Write-up: Earache; Ear ringing; Ear pain; This case was received (Reference number: GB-RA-ADR 26395623) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EAR PAIN (Earache), TINNITUS (Ear ringing) and EAR PAIN (Ear pain) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced EAR PAIN (Ear pain) (seriousness criteria disability and medically significant). On 26-Nov-2021, the patient experienced EAR PAIN (Earache) (seriousness criteria disability and medically significant) and TINNITUS (Ear ringing) (seriousness criteria disability and medically significant). At the time of the report, EAR PAIN (Earache), TINNITUS (Ear ringing) and EAR PAIN (Ear pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information were reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 37 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition and disability) unexpected, according CCDS, events of ear pain (reported as Earache and Ear pain) and tinnitus. Events were assessed as serious by the Regulatory Authority. The events occurred approximately 2 to 3 days after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 37 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition and disability) unexpected, according CCDS, events of ear pain (reported as Earache and Ear pain) and tinnitus. Events were assessed as serious by the Regulatory Authority. The events occurred approximately 2 to 3 days after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012613 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Extensive swelling of vaccinated limb, Influenza like illness, Injection site reaction, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: BEMODERNATX, INC.MOD20214

Write-up: Extensive swelling of the arm; Injection site response; flu feeling; Fever; nausea; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-110076) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), INJECTION SITE REACTION (Injection site response), INFLUENZA LIKE ILLNESS (flu feeling), PYREXIA (Fever) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. Previously administered products included for Drug use for unknown indication: COMIRNATY on 14-Jan-2021 and COMIRNATY on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY and COMIRNATY. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm) (seriousness criterion disability), INJECTION SITE REACTION (Injection site response) (seriousness criterion disability), INFLUENZA LIKE ILLNESS (flu feeling) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability) and NAUSEA (nausea) (seriousness criterion disability). On 27-Nov-2021, EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), INJECTION SITE REACTION (Injection site response), INFLUENZA LIKE ILLNESS (flu feeling), PYREXIA (Fever) and NAUSEA (nausea) had resolved. Relevant concomitant medications were not reported. Fever with flu feeling. Injection site was painful and looked red with swelling and felt warm to the touch. Treatment information included Dafalgan. Company comment: This case concerns a 56-year-old female patient with no medical history reported, who experienced the unexpected, serious (disability) events of extensive swelling of vaccinated limb, pyrexia and influenza like illness. The events occurred the same day after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reporter''s Comments: Treatment - Dafalgan and Rest Evolution of the ADR - Restored: 2 days ADR description - Fever with flu feeling. Injection site was painful and looked red with swelling and felt warm to the touch.; Sender''s Comments: This case concerns a 56-year-old female patient with no medical history reported, who experienced the unexpected, serious (disability) events of extensive swelling of vaccinated limb, pyrexia and influenza like illness. The events occurred the same day after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2013001 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214023 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Headache, Hemiparesis, Vertigo
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: Brain CT; Test Result: Inconclusive ; Result Unstructured Data: Results not reported
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis; Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis; Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-820200) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis), VERTIGO (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) and HEADACHE (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214023) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 25-Nov-2021, the patient experienced HEMIPARESIS (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) (seriousness criterion life threatening), VERTIGO (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) (seriousness criterion life threatening) and HEADACHE (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) (seriousness criterion life threatening). At the time of the report, HEMIPARESIS (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis), VERTIGO (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) and HEADACHE (Headache and dizziness onset within hours of the 2nd dose of COVID 19 Vaccine Moderna; in the night, worsening with the onset of right hemiparesis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, Computerised tomogram head: results not reported (Inconclusive) Results not reported. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Medication use information was not provided by reporter. Treatment Medication use information was provided by reporter included Non drug therapy. Treated with medical therapy with slight improvement in symptoms. Patient was admitted, for stroke with right hemisindrome after administration of dose booster with Moderna vaccine. Patient was on neuromotor rehabilitation. This case concerns a 74-year-old male patient with relevant medical history of Hypertension, who experienced the unexpected serious events of Hemiparesis, Vertigo, and Headache, all events were life-threatening for the patient as reported by the regulatory authority. The events occurred 1 day after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge is not applicable as no information on other doses were disclosed. No clinical or treatment details were given. The medical history of Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reporter''s Comments: RLF (12.12.2021) - reported contact to request the following information: clinical report, outcome update, instrumental/laboratory examination reports available, clinical history, drugs/supplements concomitant.; Sender''s Comments: This case concerns a 74-year-old male patient with relevant medical history of Hypertension, who experienced the unexpected serious events of Hemiparesis, Vertigo, and Headache, all events were life-threatening for the patient as reported by the regulatory authority. The events occurred 1 day after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge is not applicable as no information on other doses were disclosed. No clinical or treatment details were given. The medical history of Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2013357 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 090F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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? 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: Dizzy spells; Vomiting; Pyrexia; Chills; Fever; This case was received via a regulatory authority (Reference number: LV-SAM-2021117251) on 21-Dec-2021 and was forwarded to Moderna on 21-Dec-2021. This case was received via a regulatory authority (Reference number: LV-SAM-2021117251) on 21-Dec-2021 and was forwarded to Moderna on 21-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of VOMITING (Vomiting) and DIZZINESS (Dizzy spells) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 090F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 25-Nov-2021 at 10:00 PM, the patient experienced PYREXIA (Pyrexia), CHILLS (Chills) and PYREXIA (Fever). On 27-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and DIZZINESS (Dizzy spells) (seriousness criterion hospitalization). On 27-Nov-2021, PYREXIA (Pyrexia) had resolved. On 28-Nov-2021, VOMITING (Vomiting) and DIZZINESS (Dizzy spells) had resolved. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) had resolved. 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 provided by the reporter. No treatment information was provided by the reporter.; Sender''s Comments: This is a regulatory case concerning a 71-year-old female patient with no medical history provided, who experienced the serious and non serious expected events of Vomiting, Dizziness(seriousness criterion hospitalization). The events Pyrexia, Chills, Vomiting, Dizziness occurred on the same day the patient received the second dose of mRNA-1273 (Spikevax). The rechallenge was unknown since there''s only information about the second dose.. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2013528 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH6495 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Immunisation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:"uptake" in the pericardium
CDC Split Type: NOPFIZER INC202101828155

Write-up: CHEST PAIN; dyspnoea/heavy breathing; The patient received booster dose of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. The reporter is the patient. Regulatory number: NO-NOMAADVRE-FHI-2021-Uggm1q (RA). Other Case identifier(s): NO-NOMAADVRE-E2B_00064862 (RA). A 23 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 12:00 (Lot number: FH6495) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021 12:00, outcome "unknown", described as "The patient received booster dose of Comirnaty"; CHEST PAIN (medically significant) with onset 02Dec2021, outcome "recovering", described as "CHEST PAIN"; DYSPNOEA (medically significant) with onset 02Dec2021, outcome "recovering", described as "dyspnoea/heavy breathing". The patient underwent the following laboratory tests and procedures: echocardiogram: (Dec2021) "uptake" in the pericardium. The RA assessed the casual relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter Comment: Reporter''s qualifications: auxuliary nurse / nurse No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter''s qualifications: auxuliary nurse / nurse


VAERS ID: 2013530 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound scan
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: Medical History/Concurrent Conditions: Factor V Leiden mutation; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: Ultrasound scan; Result Unstructured Data: Findings of deep vein thrombosis
CDC Split Type: NOMODERNATX, INC.MOD20214

Write-up: DEEP VEIN THROMBOSIS; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00063875) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. UNK) for COVID-19 vaccination. The patient''s past medical history included Pulmonary embolism in 2015. Previously administered products included for Prophylaxis: KLEXANE. Past adverse reactions to the above products included No adverse reaction with KLEXANE. Concurrent medical conditions included Factor V Leiden mutation. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Nov-2021, the patient experienced DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, Ultrasound scan: abnormal (abnormal) Findings of deep vein thrombosis. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS) to be possibly related. No concomitant drugs were reported. No treatment information was reported. Company comment: This case concerns a 66-year-old female patient with relevant medical history of Pulmonary embolism and Factor V Leiden mutation who experienced serious unexpected event of special interest Deep vein thrombosis. The event occurred two days after the third dose of mRNA-1273. It was reported that Ultrasound scan showed findings of deep vein thrombosis. At the time of the report, outcome of the event was unknown and no further information regarding clinical course of the event was provided at this time. Causality is confounded with patient''s reported medical history and patient''s advanced age. The Reporter assessed the event as possibly related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 66-year-old female patient with relevant medical history of Pulmonary embolism and Factor V Leiden mutation who experienced serious unexpected event of special interest Deep vein thrombosis. The event occurred two days after the third dose of mRNA-1273. It was reported that Ultrasound scan showed findings of deep vein thrombosis. At the time of the report, outcome of the event was unknown and no further information regarding clinical course of the event was provided at this time. Causality is confounded with patient''s reported medical history and patient''s advanced age. The Reporter assessed the event as possibly related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2015288 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Pulmonary embolism, Ventilation/perfusion scan
SMQs:, Embolic and thrombotic events, venous (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood sampling; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: lung perfusion scintigraphy; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202200002275

Write-up: Pulmonary embolism; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Other HCP) received from the regulatory agency-WEB. Regulatory number: DE-PEI-202100286245. A 34 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 1E028A) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (hospitalization, life threatening) with onset 25Nov2021, outcome "not recovered", described as "Pulmonary embolism". The patient underwent the following laboratory tests and procedures: blood test: unknown results; electrocardiogram: unknown results; ventilation/perfusion scan: unknown results. Sender Comment: ECG, blood sampling, lung perfusion scintigraphy Relatedness of Comirnaty to Pulmonary embolism assessed. Indeterminate.


VAERS ID: 2015472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101859580

Write-up: the booster vaccination; Seizure (two seizures after the booster vaccination); 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-CADR2021222568 (RA). Other Case identifier(s): DE-CADRPEI-2021222568 (RA), DE-PEI-202100276175 (RA). A 76 year-old female patient received bnt162b2 (COMIRNATY (mRNA TOZINAMERAN)), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Seizure", start date: 20Mar2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation, reaction(s): "seizure"; Covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "the booster vaccination"; SEIZURE (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "Seizure (two seizures after the booster vaccination)". The casual relationship of Comirnaty and seizure assessed as D by the Regulatory Authority. Health authority comment: Do you or the person concerned have any known allergies? If so, which ones? None/two seizures after the booster vaccination. One seizure after the first vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2015541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM3809 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, SARS-CoV-2 test
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Metastatic breast cancer; Pleural effusion recurrent; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101860020

Write-up: Booster; Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: EE-SAM-641721120728. A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Nov2021 (Lot number: FM3809) as dose 3 (booster), 0.3 ml single for covid-19 immunisation; covid-19 vaccine (VAXZEVRIA), intramuscular, administration date 23Apr2021 (Lot number: 9941) as 0.5 ml, single and intramuscular, administration date 12Mar2021 (Lot number: ABV5443) as 0.5 ml, single for covid-19 immunisation. Relevant medical history included: "Type II diabetes mellitus" (ongoing); "Metastatic breast cancer" (ongoing); "Pleural effusion recurrent" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "not recovered", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 25Nov2021, outcome "not recovered", described as "Interchange of vaccine products"; DRUG INEFFECTIVE (hospitalization, medically significant) with onset 25Nov2021, outcome "not recovered", described as "Drug ineffective"; COVID-19 (hospitalization, medically significant) with onset 25Nov2021, outcome "not recovered", described as "COVID-19". The patient was hospitalized for immunisation, interchange of vaccine products, drug ineffective, covid-19 (start date: 25Nov2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The course of the disease was moderate. Treatment included supplemental oxygen. Sender Comment: Serious vaccine ineffectiveness report. The causal link is considered possible. No follow-up attempts are possible. No further information is expected


VAERS ID: 2016067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101857456

Write-up: Vertigo; 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-202112251301288830-DQRFD. Other Case identifier(s): GB-MHRA-ADR 26394673. A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 24Sep2021, stop date: 10Oct2021. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; VERTIGO (disability) with onset 28Nov2021, outcome "not recovered", described as "Vertigo". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016406 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac failure, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (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: CORIPREN; CARDIOASPIRIN; LASIX P
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.; Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.; Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-822318) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.), PULMONARY EMBOLISM (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) and CARDIAC FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 prophylaxis. Concomitant products included FUROSEMIDE (LASIX P) for Diuretic effect, ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE (CORIPREN) for Hypertension, ACETYLSALICYLIC ACID (CARDIOASPIRIN) for Prevention. On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 25-Nov-2021, the patient experienced ACUTE RESPIRATORY FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) (seriousness criterion hospitalization), PULMONARY EMBOLISM (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) (seriousness criterion hospitalization) and CARDIAC FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) (seriousness criterion hospitalization). At the time of the report, ACUTE RESPIRATORY FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.), PULMONARY EMBOLISM (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) and CARDIAC FAILURE (Acute respiratory failure in the framework of heart failure and pulmonary embolism in cancer patients.) had resolved with sequelae. Treatment medication information was not provided by the reporter. Hypertensive heart disease, chronic pleural effusion on the right recently undergoing thoracentesis, locally advanced prostate neoplasm . This case concerns an 82-year-old male patient with no relevant medical history, who experienced the unexpected serious adverse events of special interest, Acute Respiratory Failure, Pulmonary Embolism, and Cardiac Failure, all events caused hospitalization of the patient as reported by the regulatory authority. The events occurred 1 day after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge was not applicable since vaccine dose number was unspecififed. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Hypertensive heart disease, chronic pleural effusion on the right recently undergoing thoracentesis, locally advanced prostate neoplasm .; Sender''s Comments: This case concerns an 82-year-old male patient with no relevant medical history, who experienced the unexpected serious adverse events of special interest, Acute Respiratory Failure, Pulmonary Embolism, and Cardiac Failure, all events caused hospitalization of the patient as reported by the regulatory authority. The events occurred 1 day after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge was not applicable since vaccine dose number was unspecififed. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2016737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-11-25
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchiolitis; Back pain (without radiation); Respiratory disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101862499

Write-up: COVID-19; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1126. A 44 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 31Jul2021 (Lot number: FE4728) as dose 2, 0.3 ml single and intramuscular, administration date 03Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Respiratory disorder NOS", start date: 03Jan2020 (unknown if ongoing); "Back pain (without radiation)" (unknown if ongoing); "Acute bronchiolitis", start date: 05Dec2014 (unknown if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 25Nov2021, outcome "recovered" (10Dec2021), described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 25Nov2021, outcome "recovered" (10Dec2021), described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive, notes: Iu international unit(s). Reporter Comment: Other information: R04 RESPIRATORY PROBLEM OTHER 03Jan2020 R78 BRONCHITIS / ACUTE BRONCHOLITIS 05Dec2014 L84 BACK PAIN SYNDROME WITHOUT PAIN IRRADIATION Additional information: The reporter''s assessment of the causal relationship of the (Vaccination failure) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of assessment: Possible. The reporter provided the seriousness for the case to be non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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? 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 INC202101845823

Write-up: COVID-19; COVID-19; This is a spontaneous report received from a contactable healthcare professional from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-2114. A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 31Aug2021 (Lot number: FE4721) as dose 2, 0.3ml single and intramuscular (Batch/Lot number: unknown) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2021, outcome "recovered" (06Dec2021) and all described as "COVID-19". Additional information: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation, investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot: FE4721. A complaint sample was not returned. No related quality issues were identified during the investigation. Reporter Comment: Concomitant Medicine 08-10-2021 "Comirnaty Lot:FE4728" Other information-PRIVACY. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Concomitant Medicine 08-10-2021 "Comirnaty Lot:FE4728" Other information-PRIVACY


VAERS ID: 2016798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-11-25
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
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: Medical History/Concurrent Conditions: Anxiety disorder; Circulatory failure; Dermatophytosis; Fibrocystic breast disease; Neck discomfort; Sleep disturbed.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101845815

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority and product quality group. Regulatory number: PT-INFARMED-T202112-2115 (RA). A 47 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15May2021 (Lot number: EX8680, Expiration Date: 31Aug2021) as dose 2, 0.3 ml single and administration date 17Apr2021 (Lot number: EW9127, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "NECK SYNDROME", start date: 18Oct2019 (unspecified if ongoing); "CIRCULATORY APPARATUS DISEASE", start date: 22Mar2019 (unspecified if ongoing); "DERMATOPHYTOSIS", start date: 22Mar2019 (unspecified if ongoing); "FIBROCHESTIC BREAST DISEASE", start date: 28Aug2018 (unspecified if ongoing); "ANXIOUS DISTURB / ANXIETY STATE", start date: 22Nov2017 (unspecified if ongoing); "SLEEP DISTURBED", start date: 18Oct2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Nov2021, outcome "recovered" (08Dec2021) and all described as "Vaccination failure". Therapeutic measures were taken as a result of suspected covid-19. Product Quality Group provided investigational results on 28Dec2021 for bnt162b2: (COMIRNATY, Batch/Lot Number: EX8680, expiration date: 31Aug2021 and Batch/Lot Number: EW9127, expiration date: 31Jul2021). For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX8680 and lot EW9127. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: Concomitant Medicine- 17Apr2021~"Comirnaty Lot:EW9127 " Other information-"L83 NECK SYNDROME 18Oct2019 P06 SLEEP DISTURBANCE 18Oct2019. K99 CIRCULATORY APPARATUS DISEASE OTHER 22Mar2019; S74 DERMATOPHYTOSIS 22Mar2019; X88 FIBROCHESTIC BREAST DISEASE 28Aug2018; P74 ANXIOUS DISTURB / ANXIETY STATE 22Nov2017; No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medicine- 17Apr2021~"Comirnaty Lot:EW9127 " Other information-"L83 NECK SYNDROME 18Oct2019 P06 SLEEP DISTURBANCE 18Oct2019; K99 CIRCULATORY APPARATUS DISEASE OTHER 22Mar2019 S74 DERMATOPHYTOSIS 22Mar2019; X88 FIBROCHESTIC BREAST DISEASE 28Aug2018 P74 ANXIOUS DISTURB / ANXIETY STATE 22Nov2017.


VAERS ID: 2016896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-11-25
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101867842

Write-up: drug ineffective; SARS-CoV-2 test positive; This is a spontaneous report received from a contactable reporter (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-537 (INFARMED). A 49 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 09Jul2021 (Lot number: FD1921) 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: DRUG INEFFECTIVE (medically significant) with onset 25Nov2021, outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant) with onset 25Nov2021, outcome "unknown", described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive. Clinical course: The reporter''s assessment of the causal relationship of the event Drug ineffective with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. The reporter assessed the events as non serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016911 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-11-25
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit
CDC Split Type: PTPFIZER INC202101874914

Write-up: Vaccination failure; sars-cov-2 test positive; This is a spontaneous report received from a contactable reporter (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-791 (INFARMED). A 45-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Jun2021 (Lot number: FA7083) as dose 1, 0.3 ml 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 25Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 25Nov2021, outcome "unknown", described as "sars-cov-2 test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive, notes: Iu international unit. The reporter''s seriousness assessment was non-serious. The reporter''s assessment of the casual relationship of the drug ineffective with the suspect product was assessed as possible by the reporter (Method of assessment: Unknown). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016913 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-11-25
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101875566

Write-up: Vaccine failure; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-795 (INFARMED). A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Jun2021 (Lot number: FA7083) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 25Nov2021, outcome "unknown", described as "covid-19". Case was reported as non-serious. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive, notes: Iu international unit(s). The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2020385 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pyrexia; Miscarriage; Palpitation; This case was received via RA (Reference number: FI-FIMEA-20217747) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia), ABORTION SPONTANEOUS (Miscarriage) and PALPITATIONS (Palpitation) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 25-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 25-Nov-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion disability), ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion disability) and PALPITATIONS (Palpitation) (seriousness criterion disability). The delivery occurred on 25-Nov-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, PYREXIA (Pyrexia), ABORTION SPONTANEOUS (Miscarriage) and PALPITATIONS (Palpitation) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. Company comment: This regulatory authority case concerns a 33-year-old female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious (disability) events of Abortion spontaneous, Palpitations and Pyrexia after mRNA- 1273 vaccine. The patient received the first dose of the vaccine at an unknow gestational period. The events occurred on the day after the first dose of mRNA- 1273 vaccine. The events could be in connection with each other. Pyrexia is consistent with the known safety profile of the vaccine, but since there is limited evidence to rule out its association with the spontaneous abortion, it is considered unexpected. Very limited information is available regarding baseline health condition before vaccination, pregnancy details and clinical course of the events. The serious criteria of disability was assessed as per the regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 33-year-old female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious (disability) events of Abortion spontaneous, Palpitations and Pyrexia after mRNA- 1273 vaccine. The patient received the first dose of the vaccine at an unknow gestational period. The events occurred on the day after the first dose of mRNA- 1273 vaccine. The events could be in connection with each other. Pyrexia is consistent with the known safety profile of the vaccine, but since there is limited evidence to rule out its association with the spontaneous abortion, it is considered unexpected. Very limited information is available regarding baseline health condition before vaccination, pregnancy details and clinical course of the events. The serious criteria of disability was assessed as per the regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2021965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Computerised tomogram, Disease recurrence, Fatigue, Immunisation, Sacroiliitis
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STELARA; PARACETAMOL; UTROGESTAN; MAGNESIUM; EUTHYROX; OMEPRAZOLE; SYMBICORT; CALCIUM CARBONATE; BUSCOPAN COMPOSITUM [HYOSCINE BUTYLBROMIDE;METAMIZOLE SODIUM MONOHYDRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Crohn''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Computed tomography; Result Unstructured Data: Test Result:Result not reported; Comments: lumbar; Test Date: 20210906; Test Name: Computed tomography; Result Unstructured Data: Test Result:Result not reported; Comments: Sacroiliac joints
CDC Split Type: BEPFIZER INC202200025231

Write-up: Sacroiliitis; Low back pain; Arthralgia; Sacroiliitis/ Low back pain/ Arthralgia; Sever fatigue; third dose; 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 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Crohn''s disease" (unspecified if ongoing). Concomitant medication(s) included: STELARA; PARACETAMOL; UTROGESTAN; MAGNESIUM; EUTHYROX; OMEPRAZOLE; SYMBICORT; CALCIUM CARBONATE; BUSCOPAN COMPOSITUM [HYOSCINE BUTYLBROMIDE;METAMIZOLE SODIUM MONOHYDRATE]. Vaccination history included: Comirnaty (DOSE 1, Lot number: EW6126), administration date: 12May2021, for COVID-19 immunisation, reaction(s): "Sacroiliitis", "Low back pain", "Arthralgia"; Comirnaty (DOSE 2, Lot number: FE2083), administration date: 16Jun2021, for COVID-19 immunisation, reaction(s): "Sacroiliitis", "Low back pain", "Arthralgia". The following information was reported: IMMUNISATION (disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "third dose"; SACROILIITIS (disability), outcome "not recovered", described as "Sacroiliitis"; BACK PAIN (disability), outcome "not recovered", described as "Low back pain"; ARTHRALGIA (disability), outcome "not recovered", described as "Arthralgia"; DISEASE RECURRENCE (disability), outcome "not recovered", described as "Sacroiliitis/ Low back pain/ Arthralgia"; FATIGUE (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Sever fatigue". The event "low back pain" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (10Jun2021) Result not reported, notes: lumbar; (06Sep2021) Result not reported, notes: Sacroiliac joints. Therapeutic measures were taken as a result of back pain, arthralgia, disease recurrence. Clinical course: Adverse drug reaction time relationship-First dose: A few days after the injection (12May2021) onset of atrocious pain in my lower back. Second dose: 16Jun2021 pain from the first dose still present, pain took months to fade. Third dose: a few days after the injection (25Nov2021) this pain in the lower back came back plus serious fatigue today, 16Dec2021, pain still present. Description of adverse drug reaction - horrible pain in the lower back - Doctor: Sacroiliac inflammation. Fatigue especially after the third dose. Side effect of the first dose, still present at the second dose, returned at the third dose. On 22Jul2021 patient had appointment with rheumatologist: 06Sep2021 sacroiliac computed tomography, 08Sep2021 rheumatologist appointment plus osteopath and physiotherapist plus prescription for pain relief by general practitioner: Tramadol. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101859448 Same patient/product, different dose/event


VAERS ID: 2022128 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9678 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Facial pain, Fatigue, Groin pain, Muscle twitching, Nausea, Oral herpes, Oropharyngeal pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Osteonecrosis (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101881858

Write-up: Oral herpes; Pyrexia; Facial pain; Oropharyngeal pain; Groin pain; Diarrhoea; Arthralgia; Pain in extremity; Fatigue extreme; Muscle twitching or similar in the area of the cheeks up to the ears, especially under the eye on the right as well as on the lips and around the mouth.; Nausea; 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: CH-SM-2021-29928 (RA). A 45 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH9678) at the age of 45 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: MUSCLE TWITCHING (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Muscle twitching or similar in the area of the cheeks up to the ears, especially under the eye on the right as well as on the lips and around the mouth."; OROPHARYNGEAL PAIN (medically significant) with onset 27Nov2021, outcome "recovered" (04Dec2021), described as "Oropharyngeal pain"; GROIN PAIN (medically significant) with onset 27Nov2021, outcome "recovered" (04Dec2021), described as "Groin pain"; FACIAL PAIN (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Facial pain"; ORAL HERPES (medically significant), outcome "unknown", described as "Oral herpes"; PYREXIA (medically significant) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Pyrexia"; FATIGUE (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Fatigue extreme"; DIARRHOEA (medically significant) with onset 27Nov2021, outcome "recovered" (04Dec2021), described as "Diarrhoea"; NAUSEA (medically significant) with onset 25Nov2021, outcome "recovered" (26Nov2021), described as "Nausea"; ARTHRALGIA (medically significant) with onset 27Nov2021, outcome "recovered" (04Dec2021), described as "Arthralgia"; PAIN IN EXTREMITY (medically significant) with onset 27Nov2021, outcome "recovered" (04Dec2021), described as "Pain in extremity". Causality assessment: A causal relationship between Comirnaty and Nausea, Muscle twitching, Fatigue extreme, Diarrhea, Pain in extremity, Pain pharynx, Inguinal pain, Pain in knee, Fever, Facial pain, Fever blister was assessed as Possible. (Source of assessment: SM / Method of assessment: Agency Assessment). Seriousness: Regulatory Authority assessed this case as serious (medically significant). Sender comment: The case is serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine the causality is assessed as possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Superficial vein thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplectic fit; Myositis; Thrombosis
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101865540

Write-up: Saphenous vein thrombosis; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: DE-PEI-CADR2021224183. Other Case identifier(s): DE-CADRPEI-2021224183, DE-PEI-202100278918. A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Apoplectic fit", start date: 2021 (unknown if ongoing); "Myositis" (unknown if ongoing); "Thrombosis" (unknown if ongoing). There were no concomitant medications. 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 (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; SUPERFICIAL VEIN THROMBOSIS (medically significant) with onset 01Dec2021, outcome "recovered with sequelae", described as "Saphenous vein thrombosis". The patient underwent the following laboratory tests and procedures: ultrasound scan: unknown results. Source of assessment: PEI and result of event assessment: D. Unclassifiable. Clinical course: In autumn media Infarct and Miositis / 1 week after vaccination, a hardening occurred on the vein on the leg. 3 weeks after vaccination presentation by general practitioner. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2022622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 3 - / OT

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: FRPFIZER INC202101865948

Write-up: Deep vein thrombosis leg (sural thrombosis); booster; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: -AFSSAPS-BX202111481. A 65 year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular, administration date 25Nov2021 (Lot number: 1F1006A) 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 (DOSE 1, SINGLE (Lot No: EW2239), intramuscularly in left arm), administration date: 05Apr2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE (Lot No: EX6537), intramuscularly in left arm), administration date: 05May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 02Dec2021, outcome "not recovered", described as "Deep vein thrombosis leg (sural thrombosis)". No follow-up attempts are needed. No further information is expected.


VAERS ID: 2022632 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F10121 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood bilirubin, Creatinine renal clearance, Deep vein thrombosis, Haemoglobin, Immunisation, Interchange of vaccine products, Off label use, Platelet count, Prothrombin time, Transaminases, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast reduction; Cessation of smoking; DVT of legs; Embolism pulmonary (Bilateral pulmonary embolism with deep vein thrombosis of the left lower limb in 2012); Pollen allergy (Allergy to pollen and certain fruits)
Allergies:
Diagnostic Lab Data: Test Date: 20211217; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:1.12; Test Date: 20211217; Test Name: bilirubin; Result Unstructured Data: Test Result:Normal; Test Date: 20211217; Test Name: clearance; Result Unstructured Data: Test Result:91/1.72m2 ml/min; Comments: Chronic Kidney Disease Epidemiology Collaboration clearance; Test Date: 20211217; Test Name: Haemoglobin; Result Unstructured Data: Test Result:13 g/dl; Test Date: 20211217; Test Name: platelets; Result Unstructured Data: Test Result:327 G/I; Test Date: 20211217; Test Name: PT; Test Result: 87 %; Test Date: 20211217; Test Name: transaminases; Result Unstructured Data: Test Result:Normal; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:lower limbs; Comments: Plantar venous thrombosis on one of the left posterior tibial veins (thrombus after compression about 4mm in diameter and 20mm long). There is no evidence of progressive right suropopliteal-femoral-iliac or left suropopliteal-femoral-iliac thrombosis. No sural haematoma or muscle rupture. No superficial venous thrombosis on the great or small saphenous veins.
CDC Split Type: FRPFIZER INC202101865393

Write-up: Deep vein thrombosis; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-DJ20214677 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 1F10121) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cessation of smoking", start date: 2012 (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing), notes: Allergy to pollen and certain fruits; "DVT of legs" (unspecified if ongoing); "Breast reduction" (unspecified if ongoing); "Embolism pulmonary", start date: Jan2012 (unspecified if ongoing), notes: Bilateral pulmonary embolism with deep vein thrombosis of the left lower limb in 2012. The patient''s concomitant medications were not reported. Vaccination history included: Vaxzevria (DOSE 1), administration date: 01Mar2021, for COVID-19 immunization; Comirnaty (DOSE 2), administration date: 20May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 28Nov2021, outcome "recovering", described as "Deep vein thrombosis". The patient underwent the following laboratory tests and procedures: activated partial thromboplastin time (0.80-1.20): (17Dec2021) 1.12; blood bilirubin: (17Dec2021) normal; creatinine renal clearance: (17Dec2021) 91/1.72m2, notes: Chronic Kidney Disease Epidemiology Collaboration clearance; haemoglobin (11.5-14.9): (17Dec2021) 13 g/dl; platelet count: (17Dec2021) 327 g/i; prothrombin time: (17Dec2021) 87 %; transaminases: (17Dec2021) normal; ultrasound doppler: (unspecified date) lower limbs, notes: Plantar venous thrombosis on one of the left posterior tibial veins (thrombus after compression about 4mm in diameter and 20mm long). There is no evidence of progressive right suropopliteal-femoral-iliac or left suropopliteal-femoral-iliac thrombosis. No sural haematoma or muscle rupture. No superficial venous thrombosis on the great or small saphenous veins. Clinical Information: On Day 3 or Day 4 after vaccination, the reporter mentioned pain in the sole of her left foot. On 16Dec2021, the female patient consulted an angiologist: On questioning, it is mentioned that the last mammography and gynaecological examination was less than a year ago. There is no notion of prolonged bed rest or surgery or hospitalisation in the previous three months. No family history of thrombophilia. Spontaneous pulmonary embolism on proximal deep vein thrombosis of the left lower limb occurred in 2012 while the female patient was on Nuvaring one and a half months after a plane trip. The female patient has no inflammatory disease or neoplasia. No hormonal treatment. No air travel. No usual treatment. On clinical examination, pedal pulses were present, the female patient weighs 64 kg. An injection of INNOHEP was administered the same evening, followed by ELIQUIS 5mg 2 tablets morning and evening the next day for 7 days, then 5mg daily. A doppler ultrasound is scheduled as well as a blood test and a search for neoplasia. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-DJ20130355


VAERS ID: 2022642 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Heart sounds, Immunisation, Pericarditis, Ultrasound Doppler
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENBREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal repolarisation; Comments: Sinus rhythm unremarkable. No repolarisation impairment. No rhythm or conduction problems.; Test Name: Heart sounds; Result Unstructured Data: Test Result:Regular. No vascular murmur; Comments: No friction. No sign of heart failure. The vascular arterial tension is correct at 12/7; Test Name: Cardiac Doppler ultrasound; Result Unstructured Data: Test Result:minimal pericardial detachment; Comments: especially visible in the infero-lateral basal area of 6 mm without any haemodynamic repercussions or chamber compression
CDC Split Type: FRPFIZER INC202101865922

Write-up: Pericarditis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency-WEB. Regulatory number: FR-AFSSAPS-LY202113117. A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Patient had not tested for COVID-19. Concomitant medication(s) included: ENBREL taken for ankylosing spondylitis. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; COVID-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; PERICARDITIS (medically significant) with onset 30Nov2021, outcome "recovering", described as "Pericarditis". The event "pericarditis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: normal repolarisation, notes: Sinus rhythm unremarkable. No repolarisation impairment. No rhythm or conduction problems; heart sounds: regular. no vascular murmur, notes: No friction. No sign of heart failure. The vascular arterial tension is correct at 12/7; ultrasound doppler: minimal pericardial detachment, notes: especially visible in the inferolateral basal area of 6 mm without any haemodynamic repercussions or chamber compression. Therapeutic measures were taken as a result of pericarditis which included aspirin at a curative dose for 5 weeks + colchicine for 1 month + lansoprazole for 1 month. Clinical course: Patient report medically confirmed. 30Nov2021: Day+5 of the booster, chest pain like transfixing burning sensation in the back which increased with deep inspiration and change of position. This was probably accompanied by paroxysmal palpitations. 06Dec2021: consultation with a cardiologist. Medical care: aspirin at a curative dose for 5 weeks + colchicine for 1 month + lansoprazole for 1 month. In summary, pericarditis coinciding with a third injection of the COMIRNATY vaccine in a 44-year-old patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2022683 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-11-25
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Toxoplasma serology
SMQs:, Termination of pregnancy and risk of abortion (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: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: Toxoplasma serology; Test Result: Positive ; Result Unstructured Data: Increased IgG but high greed that may exclude recent toxoplasmosis
CDC Split Type: FRMODERNATX, INC.MOD20224

Write-up: Pregnancy loss <20 weeks gestation; This case was received via Agency (Reference number: FR-AFSSAPS-NY20215502) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005285 and 214011) for COVID-19 vaccination. Concurrent medical conditions included Obesity. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. The patient''s last menstrual period was on 30-Aug-2021 and the estimated date of delivery was 06-Jun-2022. On 25-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) (seriousness criterion hospitalization). The patient received mRNA-1273 (Spikevax) beginning around the second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Toxoplasma serology: positive (Positive) Increased IgG but high greed that may exclude recent toxoplasmosis. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication reported. 34 year old woman who had a spontaneous miscarriage at the 12th week of amenorrhea, 10 weeks after the 2nd dose of the Spikevax COVID-19 vaccine. Company comment: This regulatory case concerns a 34-year-old, female patient with relevant medical history of obesity BMI$g40, who experienced the unexpected serious event of spontaneous abortion. The patient received first dose of mRNA-1273 around the second week of the pregnancy. Spontaneous abortion occurred approximately 68 day after the second dose of mRNA-1273. Additionally patient had increased IgG for toxoplasmosis, which be the possible confounder in this case. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This regulatory case concerns a 34-year-old, female patient with relevant medical history of obesity BMI$g40, who experienced the unexpected serious event of spontaneous abortion. The patient received first dose of mRNA-1273 around the second week of the pregnancy. Spontaneous abortion occurred approximately 68 day after the second dose of mRNA-1273. Additionally patient had increased IgG for toxoplasmosis, which be the possible confounder in this case. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2022874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac disorder, Chest X-ray, Chest pain, Deep vein thrombosis, Electrocardiogram, Erythema, Hypoaesthesia, Immunisation, Infection, Interchange of vaccine products, Muscle spasms, Off label use, Pain, Pain in extremity, Paralysis, Pyrexia, Swelling, Thrombosis, Troponin, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Hypercholesteremia; Hypertension; Muscle cramp; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:157/110; Test Date: 20211220; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Comments: NAD; Test Date: 20211226; Test Name: ECG; Result Unstructured Data: Test Result:Normal sinus rhythm; Test Date: 20211220; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:4; Comments: Normal
CDC Split Type: GBPFIZER INC202101863179

Write-up: paralysis; cardiac related; Chest Pain; Fever; Possible thrombosi based on symptoms; sharp pains occur in his whole left arm, radiating to back shoulder blade and central chest.; Painful L arm/sharp pains occur in his whole left arm; Injection site tingling; Numbness of limbs; Calf pain/left leg pain; left calf cramping; redness; swelling; dvt; normal systemic response to infection for 7/7 post Booster.; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112261629082910-LHU1Y. Other Case identifier(s): GB-MHRA-ADR 26395802. A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Muscle spasms" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Non-smoker" (unspecified if ongoing); "Hypercholestaremia" (unspecified if ongoing); "Back pain" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 25Feb2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 01May2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (disability) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; PARALYSIS (disability), outcome "not recovered", described as "paralysis"; CARDIAC DISORDER (disability), outcome "not recovered", described as "cardiac related"; DEEP VEIN THROMBOSIS (disability) with onset 02Dec2021, outcome "not recovered", described as "dvt"; PAIN IN EXTREMITY (disability) with onset 03Dec2021, outcome "not recovered", described as "Painful L arm/sharp pains occur in his whole left arm"; VACCINATION SITE PAIN (disability) with onset 03Dec2021, outcome "not recovered", described as "Injection site tingling"; HYPOAESTHESIA (disability) with onset 03Dec2021, outcome "not recovered", described as "Numbness of limbs"; PAIN IN EXTREMITY (disability) with onset 02Dec2021, outcome "recovered" (06Dec2021), described as "Calf pain/left leg pain"; MUSCLE SPASMS (disability) with onset 02Dec2021, outcome "recovered" (06Dec2021), described as "left calf cramping"; ERYTHEMA (disability) with onset 02Dec2021, outcome "recovered" (06Dec2021), described as "redness"; SWELLING (disability) with onset 02Dec2021, outcome "recovered" (06Dec2021), described as "swelling"; CHEST PAIN (disability), outcome "unknown", described as "Chest Pain"; PYREXIA (disability), outcome "unknown", described as "Fever"; THROMBOSIS (disability), outcome "unknown", described as "Possible thrombosi based on symptoms"; PAIN (disability), outcome "unknown", described as "sharp pains occur in his whole left arm, radiating to back shoulder blade and central chest."; INFECTION (disability) with onset 02Dec2021, outcome "unknown", described as "normal systemic response to infection for 7/7 post Booster.". The events "paralysis", "cardiac related", "dvt", "painful l arm/sharp pains occur in his whole left arm", "numbness of limbs", "calf pain/left leg pain", "left calf cramping", "redness", "swelling", "chest pain", "possible thrombosi based on symptoms", "sharp pains occur in his whole left arm, radiating to back shoulder blade and central chest." and "normal systemic response to infection for 7/7 post booster." were evaluated at the emergency room visit. Clinical course: the patient has had uncomfortable L arm pain and numbness since day 8 of his booster. Originally he was concerned it was cardiac related and contacted his GP who referred him to A&E. At A&E on the 20Dec2021 he showed unremarkable results and was referred onwards, with queries to a narrowing of his arteries. He had a visit from his friend over Christmas who had paralysis in her arm from the jab which has stopped her from working. He thought this may be the problem and today, as his pain has not improved over the month, he called emergency for some advice. They referred to hospital. O/A: Obs normal except his BP: 157/110. ECG normal. Patient appears well, but pain is obvious. States pain is eased if he is supine, but then his arm becomes numb. When he sits up, the numbness disappears and sharp pains occur in his whole left arm, radiating to back shoulder blade and central chest. He also mentions have a 4 day history of painful left calf where it was cramping, hard, red and swollen.?DVT This occurred 7/7 post Booster while he also experienced normal systemic response to infection for 7/7 post Booster. They have transported again to the nearest A&E. The report was related to possible blood clots or low platelet counts. It was possible thrombosi based on symptoms; patient did not attend hospital at the point of left leg pain, redness and swelling. It was not diagnosed, suspected based on symptoms. Patient had medical history that was related to previous venous or arterial thromboses: Hypertension, hypercholesteraemia; father passed from CVA. The patient didn''t have any previous reactions to medications, especially heparin or anticoagulants. He didn''t have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. He had no history of, or current, malignancy, intracranial malignancy. He didn''t have concurrent or recent intracranial infections. He hadn''t had recent surgical or medical interventions to the central nervous system (including lumbar puncture). He hadn''t had a recent trauma/head injury. The report was relate to possible myocarditis or pericarditis. About possible Myocarditis and pericarditis, the patient was not admitted to hospital. The patient hadn''t seen by a cardiologist. It was reported as symptomatic diagnosis, at A&E he was cleared under emergency conditions but referred to outpatients cardiology. The troponin was measured 20Dec2021: Normal - 4. ECG was carried out: Normal sinus rhythm on 26Dec2021. Echocardiogram was not carried out. Chest X-ray was performed on 20Dec2021: NAD. Chest Computed Tomography, Cardiac MRI, Cardiac Biopsy, Coronary angiography were not carried out. There were no presence of pericardial rub, or changes in heart sounds. There were no any signs of heart failure or arrhythmia. There was no evidence of fibrosis or myocardial oedema. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 157/110; chest x-ray: (20Dec2021) unknown results, notes: NAD; electrocardiogram: (26Dec2021) normal sinus rhythm; troponin: (20Dec2021) 4, notes: Normal. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101862905

Write-up: Tinnitus/Permanent Tinnatus in both ears; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority). Regulatory number: GB-MHRA-WEBCOVID-202112262254279720-ZYFGT. Other Case identifier(s): GB-MHRA-ADR 26396199. A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; TINNITUS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "Tinnitus/Permanent Tinnatus in both ears". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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: 2023013 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Menstrual disorder, Nausea, SARS-CoV-2 test, Vaccination site bruising
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101870333

Write-up: Menstrual disorder; Nausea; Booster; Injection site bruising; This is a spontaneous report received from a contactable reporter (Consumer) The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112271224050550-J8M7G. Other Case identifier(s): GB-MHRA-ADR 26398194. A 37-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), via an unspecified route of administration, administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number unknown), for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE BRUISING (medically significant) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Injection site bruising"; NAUSEA (medically significant) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Nausea"; MENSTRUAL DISORDER (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Menstrual disorder". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. Patient''s last menstrual period date: 27Dec2021. Patient is not currently breastfeeding. 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: 2023399 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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: shivering; bladder emptying; Fever chills; This case was received via RA (Reference number: GB-MHRA-ADR 26415529) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering), URINARY RETENTION (bladder emptying) and PYREXIA (Fever chills) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Feb-2021 to an unknown date for an unknown indication. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant) and URINARY RETENTION (bladder emptying) (seriousness criterion medically significant). On 27-Nov-2021, PYREXIA (Fever chills) had resolved. At the time of the report, CHILLS (shivering) and URINARY RETENTION (bladder emptying) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication mentioned. Patient stated around 24 hours after having the vaccine started shivering and felt cold, wrapping himself in a blanket, at the same time his wife described him as ''the ready brek kid'' as he was radiating heat, he checked his temperature and it was 38.7C, he was also feeling constantly thirsty and drinking water, quickly passed through with frequent bladder emptying, he had almost no effects other than a sore arm from the first 2 AZ vaccines. Company comment: This is a regulatory case concerning a male patient of unknown age, with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 9 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, event of chills, urinary retention and pyrexia. Events were assessed as serious by the Regulatory Authority. The event pyrexia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the events chills and urinary retention on an unknown date. The outcome of the event pyrexia was reported as recovered and the events chills and urinary retention as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a male patient of unknown age, with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 9 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, event of chills, urinary retention and pyrexia. Events were assessed as serious by the Regulatory Authority. The event pyrexia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the events chills and urinary retention on an unknown date. The outcome of the event pyrexia was reported as recovered and the events chills and urinary retention as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Chest pain, Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Blood pressure; Result Unstructured Data: Test Result:Fluctuation; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased (over 120)
CDC Split Type: GRPFIZER INC202101873405

Write-up: Chest pain; Heart rate increased (over 120); Blood pressure fluctuation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) Regulatory number: GR-GREOF-202110060. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Smoker" (ongoing). The patient does not have a medical history of diseases. The patient''s concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Chest pain"; HEART RATE INCREASED (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Heart rate increased (over 120)"; BLOOD PRESSURE FLUCTUATION (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Blood pressure fluctuation". No follow-up attempts are possible, information about lot/batch number cannot be obtained, No further information is expected.


VAERS ID: 2023596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Dyspnoea, Immunisation, Middle insomnia, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: Comments: Healthy active individual, never had covid 19
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Auscultation; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided; Test Date: 202111; Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided
CDC Split Type: IEPFIZER INC202101865674

Write-up: HEART PALPITATIONS / QUITE BAD HEART PALPITATIONS; HEART PALPITATIONS WAKE ME UP AT NIGHT; SHORTNESS OF BREATH; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-088537. Other Case identifier(s): IE-HPRA-CVARR2021122023420. A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Vaxzevria for COVID-19 immunisation, notes: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S). Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; PALPITATIONS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "HEART PALPITATIONS / QUITE BAD HEART PALPITATIONS"; MIDDLE INSOMNIA (medically significant) with onset 26Nov2021, outcome "not recovered", described as "HEART PALPITATIONS WAKE ME UP AT NIGHT"; DYSPNOEA (medically significant) with onset 26Nov2021, outcome "not recovered", described as "SHORTNESS OF BREATH". The patient underwent the following laboratory tests and procedures: auscultation: (Nov2021) unknown results, notes: Results not provided; blood pressure measurement: (Nov2021) unknown results, notes: Results not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023768 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acquired diaphragmatic eventration, Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Basophil count, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Blood urea, Body height, Body temperature, C-reactive protein, Cardiac telemetry, Chest X-ray, Chills, Chromaturia, Echocardiogram, Electrocardiogram, Eosinophil count, Eosinophil count decreased, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Headache, Heart rate, Inferior vena caval occlusion, Influenza like illness, International normalised ratio, Investigation, Lipase, Lymphocyte count, Magnetic resonance imaging, Mean cell haemoglobin, Mean cell volume, Monocyte count, Myocarditis, Nasopharyngitis, Neutrophil count, Oxygen saturation, Physical examination, Platelet count, Prothrombin time, Pyrexia, Red blood cell count, Respiratory rate, Respiratory rate increased, Stool analysis, Suspected COVID-19, Troponin T, Ultrasound scan, Urine analysis, Vomiting, White blood cell count, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker (Smoked for 1.5 years in the past)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (few months ago, was not yet vaccinated); Ex-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: ALANINE TRANSAMINASE; Result Unstructured Data: Test Result:53 IU/l; Comments: reference: less than 45; Test Date: 20211128; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:74 IU/l; Comments: reference: less than 35; Test Date: 20211128; Test Name: Basophils; Result Unstructured Data: Test Result:0.030 x10 9/l; Comments: reference: less than 0.20; Test Date: 20211128; Test Name: Direct Bilirubin; Result Unstructured Data: Test Result:not applicable umol/l; Comments: reference: less than 5.0; Test Date: 20211128; Test Name: Albumin; Result Unstructured Data: Test Result:44 g/l; Test Date: 20211128; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:86 IU/l; Test Date: 20211128; Test Name: Total Bilirubin; Result Unstructured Data: Test Result:6.5 umol/l; Comments: reference: less than 17; Test Date: 20211128; Test Name: Calcium; Result Unstructured Data: Test Result:2.36 mmol/L; Test Date: 20211128; Test Name: Chloride; Result Unstructured Data: Test Result:102 mmol/L; Test Date: 20211128; Test Name: CK; Result Unstructured Data: Test Result:max 487 IU/l; Comments: reference: less than 171; Test Date: 20211128; Test Name: CK; Result Unstructured Data: Test Result:331 IU/l; Comments: reference: less than 171; Test Date: 20211128; Test Name: CK; Result Unstructured Data: Test Result:411 IU/l; Comments: reference: less than 171; Test Date: 20211128; Test Name: Creatine kinase-MB; Result Unstructured Data: Test Result:max 52 IU/l; Comments: reference: less than 25; Test Date: 20211128; Test Name: Creatine kinase-MB; Result Unstructured Data: Test Result:36 IU/l; Comments: reference: less than 25; Test Date: 20211128; Test Name: Creatine kinase-MB; Result Unstructured Data: Test Result:46 IU/l; Comments: reference: less than 25; Test Date: 20211128; Test Name: Creatinine; Result Unstructured Data: Test Result:76 umol/l; Test Date: 20211128; Test Name: Glucose; Result Unstructured Data: Test Result:7.6 mmol/L; Test Date: 20211128; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:266 IU/l; Comments: reference: less than 248; Test Date: 20211128; Test Name: Potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Date: 20211128; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/67 mmHg; Test Date: 20211128; Test Name: Sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20211128; Test Name: Blood test; Result Unstructured Data: Test Result:elevated cardiac enzymes; Test Date: 20211128; Test Name: Urea; Result Unstructured Data: Test Result:4.7 mmol/L; Test Name: Height; Result Unstructured Data: Test Result:189; Comments: cm; Test Date: 20211125; Test Name: body termperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20211128; Test Name: Cardiac telemetry; Result Unstructured Data: Test Result:no arrythmia; Test Date: 20211128; Test Name: Thorax X ray; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20211128; Test Name: Thorax X ray; Result Unstructured Data: Test Result:Slight elevation of right hemidiaphragm on; Comments: cardiothoracic ratio less than 0.5, otherwise normal heart and lungs; Test Date: 20211128; Test Name: C-reactive protein; Result Unstructured Data: Test Result:26 mg/l; Comments: reference: less than 6.0; Test Date: 20211128; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:normal left ventricular function without cardiac; Comments: wall movement disorders or cardiac effusion; Test Date: 20211128; Test Name: ECG; Result Unstructured Data: Test Result:mild ST elevation sinferolateral without dynamics; Comments: normal left ventricular function and no pericardial effusion.; Test Date: 20211128; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm 64 beats per minute, axis interpret,; Comments: normal PQ time, slim QRS, incomplete right bundle branch block, concave ST elevation II/III/ augmented Vector Foot and V5-6, minimal depression augmented Vector Right and V1, QTc 397ms.; Test Date: 20211128; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.090 x10 9/l; Test Date: 20211128; Test Name: Fibrin d dimer; Result Unstructured Data: Test Result:less than 220 ng/ml; Test Date: 20211128; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:54 IU/l; Comments: reference: less than 55; Test Date: 20211128; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:greater than 90 ml/min; Comments: reference: greater than 90 Chronic Kidney Disease Epidemiology Collaboration; Test Date: 20211128; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.46; Comments: L/L; Test Date: 20211128; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.6 mmol/L; Test Date: 20211128; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: beats per min; Test Date: 20211128; Test Name: Prothrombin time - international normalized ratio; Result Unstructured Data: Test Result:0.94; Test Date: 20211128; Test Name: Abdomen; Result Unstructured Data: Test Result:No peristalsis, normal tympanic sound, supple; Test Date: 20211128; Test Name: Chest; Result Unstructured Data: Test Result:pain worsens on palpation at indicated point; Test Date: 20211128; Test Name: Extremities; Result Unstructured Data: Test Result:warm extremities, supple calves, no edema, radial; Comments: pulse +/+; Test Date: 20211128; Test Name: General impression; Result Unstructured Data: Test Result:moderately ill, suffering from pain, is clear and; Comments: alert and can speak in full sentences; Test Date: 20211128; Test Name: Heart; Result Unstructured Data: Test Result:normal heart sounds with no murmurs, no; Comments: pericardial friction rub.; Test Date: 20211128; Test Name: Lungs; Result Unstructured Data: Test Result:Vesicular breath sounds on both sides, no; Comments: additional sounds.; Test Date: 20211128; Test Name: Lipase; Result Unstructured Data: Test Result:28 IU/l; Comments: reference: less than 60; Test Date: 20211128; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.6 x10 9/l; Test Name: MRI; Result Unstructured Data: Test Result:perimyocarditis; Test Date: 20211127; Test Name: MRI; Result Unstructured Data: Test Result:myocarditis; Test Date: 20211128; Test Name: Mean corpuscular hemoglobin; Result Unstructured Data: Test Result:1.75 fmol; Test Date: 20211128; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:84; Comments: femtolitres; Test Date: 20211128; Test Name: Monocytes; Result Unstructured Data: Test Result:0.99 x10 9/l; Test Date: 20211128; Test Name: Neutrophils; Result Unstructured Data: Test Result:6.4 x10 9/l; Test Date: 20211128; Test Name: Oxygen saturation; Test Result: 98 %; Comments: in ambient air; Test Date: 20211128; Test Name: Physical exam; Result Unstructured Data: Test Result:Central venous pressure not elevated, no carotid; Comments: murmurs; Test Date: 20211128; Test Name: Platelets; Result Unstructured Data: Test Result:390 x10 9/l; Test Date: 20211128; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:390 ng/L; Test Date: 20211128; Test Name: Prothrombin time; Test Result: 12.3 s; Test Date: 20211128; Test Name: Erythrocytes; Result Unstructured Data: Test Result:5.5 x10 12/l; Test Date: 20211128; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20-30/min; Test Date: 20211128; Test Name: Stool; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20211128; Test Name: troponin T; Result Unstructured Data: Test Result:990 ng/L; Comments: reference: less than 14; Test Date: 20211128; Test Name: troponin T; Result Unstructured Data: Test Result:708 ng/L; Comments: reference: less than 14; Test Date: 20211128; Test Name: troponin T; Result Unstructured Data: Test Result:935 ng/L; Comments: reference: less than 14; Test Date: 20211128; Test Name: Trans-thoracic ultrasound; Result Unstructured Data: Test Result:Normal dimensions left ventricle/right ventricle,; Comments: normal systolic left ventricular function and right ventricular function, no wall motion abnormalities, no significant valve disease. No pericardial effusion. Vena cava inferior slim and collapses greater than 50%.; Test Date: 20211128; Test Name: Urine; Result Unstructured Data: Test Result:slightly darker than normal; Test Date: 20211128; Test Name: leukocyte count; Result Unstructured Data: Test Result:10.1 ng/L; Test Date: 20211128; Test Name: Leukocytes; Result Unstructured Data: Test Result:10.1 x10 9/l
CDC Split Type: NLPFIZER INC202101779867

Write-up: Perimyocarditis/ symptom of perimyocarditis included chest pain; Thorax X ray: Slight elevation of right hemidiaphragm; Trans-thoracic ultrasound: Vena cava inferior slim and collapses greater than 50%; ALANINE TRANSAMINASE: 53 IU/l (reference: less than 45); Aspartate transaminase: 74 IU/l (reference: less than 35); Eosinophils (L): 0.090 x10^9/L (0.10-0.50); RR: 20-30/min; Urine: slightly darker than normal; Leukocytes (H): 10.1 x10^9/L (4.0-10.0); Flu-like symptoms; Headache; Suspected COVID-19; Fever: 38 to 40.5 degrees Celcius; Cold chills; Cold; Vomited; This is a spontaneous report received from a contactable reporter (physician) from the RA. Regulatory number: NL-LRB-00721914 (RA). Other Case identifier: NL-LRB-00729084 (RA). A 24-year-old male patient received BNT162B2 (COMIRNATY), administration date 24Nov2021 (lot number: Unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Smoked for 1.5 years in the past" (not ongoing); "Non-smoker" (ongoing), notes: Smoked for 1.5 years in the past; and "COVID infection", start date: 2021 (unspecified if ongoing), notes: few months ago, was not yet vaccinated. There were no concomitant medications. The following information was reported: MYOCARDITIS (hospitalization) with onset 27Nov2021, outcome "unknown", described as "Perimyocarditis/ symptom of perimyocarditis included chest pain"; ACQUIRED DIAPHRAGMATIC EVENTRATION (medically significant) with onset 28Nov2021, outcome "unknown", described as "Thorax X ray: Slight elevation of right hemidiaphragm"; INFERIOR VENA CAVAL OCCLUSION (medically significant) with onset 28Nov2021, outcome "unknown", described as "Trans-thoracic ultrasound: Vena cava inferior slim and collapses greater than 50%"; SUSPECTED COVID-19 (non-serious) with onset 25Nov2021, outcome "recovered" (27Nov2021), described as "Suspected COVID-19"; PYREXIA (non-serious) with onset 25Nov2021, outcome "unknown", described as "Fever: 38 to 40.5 degrees Celcius"; CHILLS (non-serious) with onset 25Nov2021, outcome "recovered" (27Nov2021), described as "Cold chills"; NASOPHARYNGITIS (non-serious) with onset 25Nov2021, outcome "recovered" (27Nov2021), described as "Cold"; HEADACHE (non-serious) with onset 26Nov2021, outcome "unknown", described as "Headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Nov2021, outcome "unknown", described as "Flu-like symptoms"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Vomited"; ALANINE AMINOTRANSFERASE INCREASED (non-serious) with onset 28Nov2021, outcome "unknown", described as "ALANINE TRANSAMINASE: 53 IU/l (reference: less than 45)"; ASPARTATE AMINOTRANSFERASE INCREASED (non-serious) with onset 28Nov2021, outcome "unknown", described as "Aspartate transaminase: 74 IU/l (reference: less than 35)"; EOSINOPHIL COUNT DECREASED (non-serious) with onset 28Nov2021, outcome "unknown", described as "Eosinophils (L): 0.090 x10^9/L (0.10-0.50)"; RESPIRATORY RATE INCREASED (non-serious) with onset 28Nov2021, outcome "unknown", described as "RR: 20-30/min"; CHROMATURIA (non-serious) with onset 28Nov2021, outcome "unknown", described as "Urine: slightly darker than normal"; and WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 28Nov2021, outcome "unknown", described as "Leukocytes (H): 10.1 x10^9/L (4.0-10.0)". The patient was hospitalized for myocarditis (start date: 28Nov2021, discharge date: 30Nov2021, hospitalization duration: 2 days). The event "perimyocarditis/ symptom of perimyocarditis included chest pain" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (28Nov2021) 53 IU/l, notes: reference: less than 45; aspartate aminotransferase: (28Nov2021) 74 IU/l, notes: reference: less than 35; basophil count: (28Nov2021) 0.030 x10 9/l, notes: reference: less than 0.20; bilirubin conjugated: (28Nov2021) not applicable umol/l, notes: reference: less than 5.0; blood albumin (35-50): (28Nov2021) 44 g/l; blood alkaline phosphatase (43-115): (28Nov2021) 86 IU/l; blood bilirubin: (28Nov2021) 6.5 umol/l, notes: reference: less than 17; blood calcium (2.10-2.55): (28Nov2021) 2.36 mmol/L; blood chloride (97-107): (28Nov2021) 102 mmol/L; blood creatine phosphokinase: (28Nov2021) max 487, notes: reference: less than 171; (28Nov2021) 331 IU/l, notes: reference: less than 171; (28Nov2021) 411 IU/l, notes: reference: less than 171; blood creatine phosphokinase mb: (28Nov2021) max 52, notes: reference: less than 25; (28Nov2021) 36 IU/l, notes: reference: less than 25; (28Nov2021) 46 IU/l, notes: reference: less than 25; blood creatinine (64-104): (28Nov2021) 76 umol/l; blood glucose (4.0-7.8): (28Nov2021) 7.6 mmol/L; blood lactate dehydrogenase: (28Nov2021) 266 IU/l, notes: reference: less than 248; blood potassium (3.5-5.0): (28Nov2021) 3.7 mmol/L; blood pressure measurement: (28Nov2021) 128/67 mmHg; blood sodium (135-145): (28Nov2021) 137 mmol/L; blood test: (28Nov2021) elevated cardiac enzymes; blood urea (2.5-6.4): (28Nov2021) 4.7 mmol/L; body height: (unspecified date) 189, notes: cm; body temperature: (25Nov2021) 38 to 40.5 Centigrade; cardiac telemetry: (28Nov2021) no arrythmia; chest x-ray: (28Nov2021) no abnormalities; (28Nov2021) slight elevation of right hemidiaphragm on, notes: cardiothoracic ratio less than 0.5, otherwise normal heart and lungs; c-reactive protein: (28Nov2021) 26 mg/l, notes: reference: less than 6.0; echocardiogram: (28Nov2021) normal left ventricular function without cardiac, notes: wall movement disorders or cardiac effusion; electrocardiogram: (28Nov2021) mild ST elevation sinferolateral without dynamics, notes: normal left ventricular function and no pericardial effusion; (28Nov2021) sinus rhythm 64 beats per minute, axis interpret, notes: normal PQ time, slim QRS, incomplete right bundle branch block, concave ST elevation II/III/ augmented Vector Foot and V5-6, minimal depression augmented Vector Right and V1, QTc 397ms; eosinophil count (0.10-0.50): (28Nov2021) 0.090 x10 9/l; fibrin d dimer: (28Nov2021) less than 220 ng/ml; gamma-glutamyltransferase: (28Nov2021) 54 IU/l, notes: reference: less than 55; glomerular filtration rate: (28Nov2021) greater than 90, notes: reference: greater than 90 Chronic Kidney Disease Epidemiology Collaboration; haematocrit (0.40-0.50): (28Nov2021) 0.46, notes: L/L; haemoglobin (8.5-11.0): (28Nov2021) 9.6 mmol/L; heart rate: (28Nov2021) 80, notes: beats per min; international normalised ratio: (28Nov2021) 0.94; investigation: (28Nov2021) no peristalsis, normal tympanic sound, supple; (28Nov2021) pain worsens on palpation at indicated point; (28Nov2021) warm extremities, supple calves, no edema, radial, notes: pulse +/+; (28Nov2021) moderately ill, suffering from pain, is clear and, notes: alert and can speak in full sentences; (28Nov2021) normal heart sounds with no murmurs, no, notes: pericardial friction rub; (28Nov2021) vesicular breath sounds on both sides, no, notes: additional sounds; lipase: (28Nov2021) 28 IU/l, notes: reference: less than 60; lymphocyte count (1.0-3.5): (28Nov2021) 2.6 x10 9/l; magnetic resonance imaging: (unspecified date) perimyocarditis; (27Nov2021) myocarditis; mean cell haemoglobin (1.70-2.10): (28Nov2021) 1.75 fmol; mean cell volume (80-100): (28Nov2021) 84, notes: femtolitres; monocyte count (0.10-1.0): (28Nov2021) 0.99 x10 9/l; neutrophil count (1.5-7.5): (28Nov2021) 6.4 x10 9/l; oxygen saturation: (28Nov2021) 98 %, notes: in ambient air; physical examination: (28Nov2021) central venous pressure not elevated, no carotid, notes: murmurs; platelet count (150-400): (28Nov2021) 390 x10 9/l; platelet count: (28Nov2021) 390 ng/L; prothrombin time (12.0-14.5): (28Nov2021) 12.3 seconds; red blood cell count (4.5-5.5): (28Nov2021) 5.5 x10 12/l; respiratory rate: (28Nov2021) 20-30/min; stool analysis: (28Nov2021) no abnormalities; troponin t: (28Nov2021) 990 ng/L, notes: reference: less than 14; (28Nov2021) 708 ng/L, notes: reference: less than 14; (28Nov2021) 935 ng/L, notes: reference: less than 14; ultrasound scan: (28Nov2021) normal dimensions left ventricle/right ventricle,, notes: normal systolic left ventricular function and right ventricular function, no wall motion abnormalities, no significant valve disease. No pericardial effusion. Vena cava inferior slim and collapses greater than 50%; urine analysis: (28Nov2021) slightly darker than normal; white blood cell count: (28Nov2021) 10.1 ng/L; white blood cell count (4.0-10.0): (28Nov2021) 10.1 x10 9/l. Therapeutic measures were taken as a result of myocarditis, acquired diaphragmatic eventration, inferior vena caval occlusion, suspected COVID-19, pyrexia, chills, nasopharyngitis, headache, influenza like illness, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, eosinophil count decreased, respiratory rate increased, chromaturia, and white blood cell count increased and included treatment with paracetamol, a non-specified NSAID, colchicine, pantoprazol, and acetylsalicylic acid. Clinical course: The patient had no underlying health issues and has never experienced cardiac problems before. He did not have an infection prior to onset of the symptoms (as reported). Familial risk factors were reported as none. Treatment approach included acetylsalicylic acid for 3 months on a phase-out schedule. Medications also included Pantoprazol gastro-resistant tablet 40 mg, oral, 1x/day 40 mg; Colchicine tablet 0.5 mg, oral, 2x/day 0.5 mg, stop date: 21Feb2022; Acetylsalicylic acid tablet 500 mg, oral, 3x/day 1000 mg, stop date 13Dec2021; Acetylsalicylic acid tablet 500 mg, oral, 1x/day 500 mg for 21 days; start date: 31Jan2022, stop date: 21Feb2022; and Acetylsalicylic acid tablet 500 mg, oral, 1x/day 1000 mg, for 21 days, start date: 10Jan2022, stop date: 31Jan2022. The patient was registered for cardiac rehab and will be followed by a cardiologist in the outpatient clinic. Appointment with cardiologist in 6-8 weeks was reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (28Dec2021): This is a spontaneous follow-up report received from the same contactable physician. Updated information: medical history, lab data, reaction data (onset, outcome, treatment, and hospitalization dates; "Flu-like symptoms", "Vomited", "ALANINE TRANSAMINASE: 53 IU/l (reference: less than 45)", "Aspartate transaminase: 74 IU/l (reference: less than 35)", "Eosinophils (L): 0.090 x10^9/L (0.10-0.50)", "RR: 20-30/min", "Urine: slightly darker than normal", "Leukocytes (H): 10.1 x10^9/L (4.0-10.0)", "Thorax X ray: Slight elevation of right hemidiaphragm", "Trans-thoracic ultrasound: Vena cava inferior slim and collapses greater than 50%" were added), and course of events. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 2023828 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Folliculitis, Immunisation, Myalgia, Nasopharyngitis, Oedema peripheral, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101869353

Write-up: intense trembling; Cold chills; Muscular pains; Folliculitis; Edema upper limb with difficulty when mobilizing; Cold chills; 3rd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: PT-INFARMED-G202112-2418 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: FG7898) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1 , MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 25Nov2021, outcome "unknown", described as "3rd dose of the vaccine"; TREMOR (medically significant) with onset 26Nov2021, outcome "recovering", described as "intense trembling"; CHILLS (medically significant), NASOPHARYNGITIS (medically significant) all with onset 26Nov2021, outcome "recovering" and all described as "Cold chills"; MYALGIA (medically significant) with onset 26Nov2021, outcome "recovering", described as "Muscular pains"; FOLLICULITIS (medically significant) with onset 26Nov2021, outcome "recovering", described as "Folliculitis"; OEDEMA PERIPHERAL (medically significant) with onset 26Nov2021, outcome "recovering", described as "Edema upper limb with difficulty when mobilizing". Therapeutic measures were taken as a result of tremor, chills, myalgia, folliculitis, oedema peripheral, nasopharyngitis. Reporter Comment: After the 3rd dose of the vaccine , a red, hard, painful papule appeared in the face in the temporal region (left side) with burning sensation and itching. After a few days, another lesion appeared in the supraorbital region (right side), other lesions continued to appear in the temporal region (right side). Some of the lesions burst and showed clear fluid, others formed pustules with yellow pus. Went for observation by Ophthalmology because of the possibility of Herpes Zooster. Diagnosis by dermatology: folliculitis. I went to observe. by Ophthalmology for the possibility of Herpes Zooster. Note dermatology diag. folliculitis. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: After the 3rd dose of the vaccine , a red, hard, painful papule appeared in the face in the temporal region (left side) with burning sensation and itching. After a few days, another lesion appeared in the supraorbital region (right side), other lesions continued to appear in the temporal region (right side). Some of the lesions burst and showed clear fluid, others formed pustules with yellow pus.


VAERS ID: 2023836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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 INC202101883724

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number PT-INFARMED-T202112-2608. A 25 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Aug2021 (Lot number: FE4728) as dose 2, 0.3 ml single, and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2021, outcome recovering. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of adverse reaction with unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8773 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthrogram, Embolism venous, Immunisation, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUTHYROX
Current Illness: Thyroid operation NOS (receives Euthyrox)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: CT arthrography; Result Unstructured Data: Test Result: pulmonary embolism
CDC Split Type: SIPFIZER INC202101869337

Write-up: Venous thromboembolism; Pulmonary embolism; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: SI-JAZMP-NCPHV-2021SI1780_1780 (JAZMP). Other Case identifier(s): JAZMP-300019657 (RA). A 69 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: FH8773, Expiration Date: 30Apr2022) as dose 3 (booster), 30 ug single for covid-19 immunisation. Relevant medical history included: "Thyroid operation NOS" (ongoing), notes: receives Euthyrox. Concomitant medication(s) included: EUTHYROX taken for thyroid operation. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown (the exact vaccine is not listed)), for COVID-19 immunisation, reaction(s): "No adverse reaction"; Covid-19 vaccine (2nd dose, manufacturer unknown (the exact vaccine is not listed)), for COVID-19 immunisation, reaction(s): "No adverse reaction". The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Booster"; EMBOLISM VENOUS (hospitalization) with onset 27Nov2021, outcome "unknown", described as "Venous thromboembolism"; PULMONARY EMBOLISM (hospitalization) with onset 27Nov2021, outcome "unknown", described as "Pulmonary embolism". The patient was hospitalized for immunisation, embolism venous, pulmonary embolism (discharge date: 02Dec2021). The patient underwent the following laboratory tests and procedures: arthrogram: (28Nov2021) pulmonary embolism. Clinical course: On 28Nov2021, pulmonary embolism was confirmed by RA, and treatment is planned for at least 6 months. the patient was hospitalized until 02Dec2021. No follow-up attempts were possible. No further information was expected.


VAERS ID: 2025782 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood calcium, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Dyspnoea, Full blood count, Glycosylated haemoglobin, Immunisation
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; RAMILICH; THYRONAJOD.
Current Illness: Hypertension; Hypothyroidism; Type 2 diabetes mellitus.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ca; Result Unstructured Data: Test Result:normal values; Test Name: Creatinine; Result Unstructured Data: Test Result:normal values; Test Name: Blood sugar; Result Unstructured Data: Test Result:153; Test Name: K; Result Unstructured Data: Test Result:normal values; Test Name: Na; Result Unstructured Data: Test Result:normal values; Test Name: TSH; Result Unstructured Data: Test Result:normal values; Test Name: Blood count; Result Unstructured Data: Test Result:normal values; Test Name: Hb A1c; Test Result: 7.9 %.
CDC Split Type: DEPFIZER INC202101873268

Write-up: Dyspnoea; Tachyarrhythmia absoluta; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority): DE-202100285707 (RA), DE-21195443 (RA). An 87-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 87 years as dose number unknown (booster), 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "Hypothyroidism" (ongoing); "Type 2 diabetes mellitus" (ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus; RAMILICH taken for hypertension; THYRONAJOD taken for hypothyroidism. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (medically significant) with onset 29Nov2021, outcome "not recovered", described as "Dyspnoea"; ATRIAL FIBRILLATION (medically significant) with onset 29Nov2021, outcome "not recovered", described as "Tachyarrhythmia absoluta". The patient underwent the following laboratory tests and procedures: blood calcium: normal values; blood creatinine: normal values; blood glucose: 153; blood potassium: normal values; blood sodium: normal values; blood thyroid stimulating hormone: normal values; full blood count: normal values; glycosylated haemoglobin: 7.9 %. Reporter Comment: ADR course: New atrial fibrillation, TAA (Tachyarrhythmia absoluta), dyspnoea with the least amount of stress in close temporal relation to the booster vaccination with Comirnaty - vaccination 25Nov2021 -$g diagnosis 29/30Nov2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reporter''s Comments: ADR course: New atrial fibrillation, TAA (Tachyarrhythmia absoluta), dyspnoea with the least amount of stress in close temporal relation to the booster vaccination with Comirnaty - vaccination 25Nov2021 -$g diagnosis 29/30Nov2021.


VAERS ID: 2025958 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31101TB / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Computerised tomogram head, Diarrhoea, Hypoaesthesia, Limb discomfort, Magnetic resonance imaging, Neurological examination, Sinus polyp, Toothache, Trigeminal neuralgia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (broad), Noninfectious diarrhoea (narrow), 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: Test Name: Blood values; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211126; Test Name: tomography; Result Unstructured Data: Test Result:no evidence of an acute intracranial pathology; Test Name: tomography; Result Unstructured Data: Test Result:Normal; Test Date: 20211130; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:Native, essentially age-appropriate cerebrum; Comments: Secondary finding of small maxillary sinus polyps on the left side; Test Name: neurological evaluation; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: DEPFIZER INC202101874247

Write-up: Hypoaesthesia facial, hypesthesia on the right side of the face+tongue+ear+bottom lip; trigeminal somatosensory evoked potentials: mild to moderate affection of the right trigeminal nerve with neuralgia-like pain symptoms; small maxillary sinus polyps; Diarrhoea; Limb discomfort; Site of vaccination painful; Toothache; 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-CADR2021209047. Other Case identifier(s): DE-CADRPEI-2021209047 (Webportal), DE-PEI-202100260527. A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: 31101TB) at the age of 53 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: HYPOAESTHESIA (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "Hypoaesthesia facial, hypesthesia on the right side of the face+tongue+ear+bottom lip"; DIARRHOEA (non-serious) with onset 25Nov2021, outcome "unknown", described as "Diarrhoea"; LIMB DISCOMFORT (non-serious) with onset 25Nov2021, outcome "unknown", described as "Limb discomfort"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021, outcome "unknown", described as "Site of vaccination painful"; TOOTHACHE (non-serious) with onset 25Nov2021, outcome "unknown", described as "Toothache"; SINUS POLYP (non-serious) with onset 30Nov2021, outcome "unknown", described as "small maxillary sinus polyps"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown", described as "trigeminal somatosensory evoked potentials: mild to moderate affection of the right trigeminal nerve with neuralgia-like pain symptoms". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; computerised tomogram: (26Nov2021) no evidence of an acute intracranial pathology; computerised tomogram head: (unspecified date) normal; magnetic resonance imaging: (30Nov2021) native, essentially age-appropriate cerebrum, notes: Secondary finding of small maxillary sinus polyps on the left side; neurological examination: (unspecified date) unknown results. Therapeutic measures were not taken as a result of trigeminal neuralgia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025968 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVK4 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest discomfort, Dizziness, Dyspnoea, Erythema, Myoclonus, Pruritus, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Allergy to plants (plaintain allergy); Grass allergy; House dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101875019

Write-up: Day after: whole body itchy; Day after: asthma symptoms: tightness, shortness of breath; Day after: whole body itchy, red skin; Day after:asthma symptoms: tightness, shortness of breath; After 20 minutes: severe myoclonus, cardiac arrhythmias; After 20 minutes: severe myoclonus, cardiac arrhythmias; Immediately: tachycardia, dizziness; Immediately: tachycardia, dizziness; 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-CADR2021209781 (RA). Other Case identifier(s): DE-CADRPEI-2021209781 (RA Webportal), DE-PEI-202100261786 (RA). A 45 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: SCVK4) at the age of 45 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Grasses" (unspecified if ongoing); "plantain" (unspecified if ongoing), notes: plaintain allergy; "house dust" (unspecified if ongoing); "Allergic asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset 25Nov2021, outcome "recovering", MYOCLONUS (non-serious) with onset 25Nov2021, outcome "unknown" and all described as "After 20 minutes: severe myoclonus, cardiac arrhythmias"; DIZZINESS (non-serious), TACHYCARDIA (non-serious) all with onset 25Nov2021, outcome "unknown" and all described as "Immediately: tachycardia, dizziness"; PRURITUS (non-serious) with onset 26Nov2021, outcome "unknown", described as "Day after: whole body itchy"; DYSPNOEA (non-serious) with onset 26Nov2021, outcome "unknown", described as "Day after: asthma symptoms: tightness, shortness of breath"; ERYTHEMA (non-serious) with onset 26Nov2021, outcome "unknown", described as "Day after: whole body itchy, red skin"; CHEST DISCOMFORT (non-serious) with onset 26Nov2021, outcome "unknown", described as "Day after:asthma symptoms: tightness, shortness of breath". SENDER COMMENT: Are you or the person concerned known of any allergies? If yes, which? Grasses, plantain, house dust Information on risk factors or previous illnesses Allergic asthma No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Superficial vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicose vein
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer female NOS
Allergies:
Diagnostic Lab Data: Test Name: duplex sonography; Result Unstructured Data: Test Result:confirmed thrombosis
CDC Split Type: DEPFIZER INC202101865377

Write-up: Superficial venous thrombosis of leg; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from The Regulatory WEB. Regulatory number: DE-PEI-CADR2021223993 (PEI). Other Case identifier(s): DE-CADRPEI-2021223993 (PEI Webportal), DE-PEI-202100278173 (PEI). A 55 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Breast cancer female NOS" (unknown if ongoing); "Varicose vein" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; SUPERFICIAL VEIN THROMBOSIS (medically significant) with onset 30Nov2021, outcome "recovering", described as "Superficial venous thrombosis of leg". This report was serious - other. The patient underwent the following laboratory tests and procedures: ultrasound doppler: confirmed thrombosis. Result of Assessment: Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026135 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Gait disturbance, Immunisation, Pain, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypoglycaemia (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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrosis lung
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Date: 20211129; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Date: 20211129; Test Name: Electrocardiography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101874291

Write-up: Booster; Embolism pulmonary; breathless; acute side pain; walking became impossible; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-LM20214086. A 75 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; rivaroxaban (XARELTO) (Batch/Lot number: unknown). Relevant medical history included: "Fibrosis lung" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Embolism pulmonary"; DYSPNOEA (medically significant) with onset 25Nov2021, outcome "unknown", described as "breathless"; PAIN (medically significant) with onset 25Nov2021, outcome "unknown", described as "acute side pain"; GAIT DISTURBANCE (medically significant) with onset 25Nov2021, outcome "unknown", described as "walking became impossible". The event "breathless" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (29Nov2021) unknown results; (29Nov2021) unknown results; electrocardiogram: (29Nov2021) unknown results. Therapeutic measures were taken as a result of pulmonary embolism, dyspnoea, pain, gait disturbance. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026331 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Limb injury, Mobility decreased, Off label use, Pain in extremity, SARS-CoV-2 test, Sleep disorder
SMQs:, Parkinson-like events (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877614

Write-up: reduced mobility; sleep disturbance; arm pain; Arm injury; Off label use; Booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory agency. Regulatory number: GB-MHRA-WEBCOVID-202112281142545990-M59MW. Other Case identifier(s): GB-MHRA-ADR 26402725. A 57 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 25Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; MOBILITY DECREASED (disability), outcome "not recovered", described as "reduced mobility"; SLEEP DISORDER (disability), outcome "not recovered", described as "sleep disturbance"; LIMB INJURY (disability) with onset 27Nov2021, outcome "not recovered", described as "Arm injury"; PAIN IN EXTREMITY (disability), outcome "not recovered", described as "arm pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: On going arm pain. Sharp pain with certain movements. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026506 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
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: pain; Pain in arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26407697) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain) and PAIN IN EXTREMITY (Pain in arm) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-Dec-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain) and PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient''s last menstrual period was on 18-NOV-2021. The patient had no known medical problems. Patient did not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient had pain in arm since getting the booster on the 25-Nov-2021. On 08-Dec, patient received flu vaccine in the same arm. The pain had remained in arm but now feels worse and patient''s shoulder was really painful all movement in that arm was painful but to lift arm up or forward was getting more and more painful. Patient had no swelling or redness in the injection site. The booster injection itself was painful and felt different to the first two vaccines. No treatment medication was provided. Company comment: This case concerns a 42-year-old female patient with no medical history, who experienced serious unexpected events of Pain and Pain in extremity. The event of Pain in extremity occurred during the same day, after the administration of the mRNA-1273 vaccine (as third dose, booster). As per case description, the patient had pain in the arm since getting the mRNA-1273 vaccine. However, two weeks later the patient also received flu vaccine in the same arm and the pain in the arm remained and it got worsened. At the time of this report, the events were ongoing. he rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. 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.; Sender''s Comments: This case concerns a 42-year-old female patient with no medical history, who experienced serious unexpected events of Pain and Pain in extremity. The event of Pain in extremity occurred during the same day, after the administration of the mRNA-1273 vaccine (as third dose, booster). As per case description, the patient had pain in the arm since getting the mRNA-1273 vaccine. However, two weeks later the patient also received flu vaccine in the same arm and the pain in the arm remained and it got worsened. At the time of this report, the events were ongoing. he rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. 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.


VAERS ID: 2026991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-11-25
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: PTPFIZER INC202200005974

Write-up: Vaccination failure; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1592. A 15 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Sep2021 (Lot number: FG6273) as dose 2, 0.3 ml single and intramuscular, administration date 24Aug2021 (Lot number: FE4728) 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: VACCINATION FAILURE (medically significant) with onset 25Nov2021, outcome "recovered" (03Dec2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 25Nov2021, outcome "recovered" (03Dec2021), described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive. Reporter Comment: Other information - Female patient, 15 years old. Positive COVID19 test on 25Nov2021 after risky contact. Symptoms (onset 25Nov): dry cough, odynophagia, myalgia and nasal congestion. Cure criteria on 03Dec, already asymptomatic. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information - Female patient, 15 years old. Positive COVID19 test on 25Nov2021 after risky contact. Symptoms (onset 25Nov): dry cough, odynophagia, myalgia and nasal congestion. Cure criteria on 03Dec, already asymptomatic.


VAERS ID: 2027040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Discomfort, Inflammation
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101876318

Write-up: CHEST TIGHTNESS; CHEST PAIN; DISCOMFORT; body inflammation; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014339 Agency Regulatory Authority. Other Case identifier(s): TW-Fosun-2021FOS007160 Regulatory Authority. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014339. A 19-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 16-Nov-2021 via intramuscular for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced chest tightness, chest pain, discomfort on 25-Nov-2021. On 16-Nov-2021, the patient received 2nd dose of BNT vaccine. On 25-Nov-2021, the patient experienced chest tightness, chest pain. Due to the immortality of the symptoms, the patient went to hospital for emergency treatment. At 22:35, the patient was given Sodium Chloride (Isotonic) 0.9% 500ml bit drop and acetamol inj 1g needle treatment. At 23:23, the patient was discomfort, so the hospital gave Bokey E.M 100mg and Magnesium Oxide 250mg oral drugs for testing. According to the follow up on 30-Nov-2021, the physician table said that the vaccine caused the body inflammation, which currently recovered, no discomfort. The patient still needed to rest and supplemental more moisture, expressed understanding by the patient. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. On an unknown date, the outcomes of the events were recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Reporter''s and company''s (BIONTECH) assessment of causal relationship for COMIRNATY with the events Chest tightness, Chest pain, Discomfort was reported as possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech.


VAERS ID: 2029269 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FCTN4 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Immunisation, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (6 years ago); Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101881763

Write-up: Booster; Severe pain in thigh (with tissue warming); Warming of tissue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 111954 (Biontech). A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FCTN4) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thrombosis", start date: 1979 (unspecified if ongoing); "several vein surgeries on both legs" (unspecified if ongoing), notes: 6 years ago. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single, Batch/Lot number- EW8904), administration date: 05May2021, for COVID-19 immunisation; Comirnaty (Dose 2, single, Batch/Lot number- EX8679), administration date: 21May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (hospitalization) with onset 2021, outcome "recovered" (2021), described as "Severe pain in thigh (with tissue warming)"; FEELING HOT (hospitalization) with onset 2021, outcome "recovered" (2021), described as "Warming of tissue". The patient was hospitalized for immunisation, pain in extremity, feeling hot (start date: 2021). Therapeutic measures were taken as a result of pain in extremity. Patient was suspected of having thrombosis but thrombosis could no longer be detected in the hospital - husband (biologist) is sure it was. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER_INC-202101881764 same reporter/product, different patient


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