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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: 1952338 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
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: AUPFIZER INC202101699706

Write-up: Deep vein thrombosis; Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 672448 (TGA ADR#). A 57 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Deep vein thrombosis"; PULMONARY EMBOLISM (medically significant) with onset 23Nov2021, outcome "unknown", described as "Pulmonary embolism". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Muscular weakness, Musculoskeletal stiffness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101699752

Write-up: paralysis; Lymphadenopathy; Muscular weakness; Musculoskeletal stiffness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 672639 (TGA ADR#). A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (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: PARALYSIS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "paralysis"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Lymphadenopathy"; MUSCULAR WEAKNESS (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Muscular weakness"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Musculoskeletal stiffness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953109 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; CANDESARTAN; QVAR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101712343

Write-up: Off label use; Interchange of vaccine products; Booster; painful rash; raised itchy rash; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111301530004720-HI69D. Other Case identifier: GB-MHRA-ADR 26272852. A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Patient had no symptoms associated with COVID-19. Concomitant medication(s) included: BENDROFLUMETHIAZIDE; CANDESARTAN; QVAR. Vaccination history included: COVID-19 vaccine Astrazeneca (DOSE NUMBER UNKNOWN), administration date: 24Apr2021, for COVID-19 Immunisation; COVID-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; RASH (medically significant) with onset 23Nov2021, outcome "recovering", described as "painful rash"; RASH PRURITIC (medically significant) with onset 23Nov2021, outcome "recovering", described as "raised itchy rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of rash, rash pruritic which included Loratadine, Chlorphenamine tablets and Zerobase cream. Clinical course: Rash became very sore, itchy and raised over the next few days and was only subsiding a week later. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate increased, Immunisation, Insomnia, Interchange of vaccine products, Off label use
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Medication errors (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:raised
CDC Split Type: GBPFIZER INC202101711969

Write-up: raised heart rate; Insomnia; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111301555026800-OEQXP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26273167 (MHRA). A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (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 (DOSE-1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE-2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; HEART RATE INCREASED (medically significant), outcome "not recovered", described as "raised heart rate"; INSOMNIA (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Insomnia". The patient underwent the following laboratory tests and procedures: heart rate: raised. Clinical course: Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was stated that worst night sleep ever he believe, certainly worst ever with a physical cause and the most disturbing and unexpected. Stated that raised heart rate that continued from midnight to half-past midday the following day with an accompanying feeling similar to adrenalin rushing round system for the whole of that time. The patient only got some reasonable duration sleep after 7 Am and had to stay in bed until half-past noon in order to not be completely exhausted that day. The patient would normally have been up at 7.30 that morning and had to have 10 hours sleep the following night to recover properly, when normally he would never ever have slept for more than 8 hours. The patient had never suffered from insomnia before or since that night and trying to regulate breathing that night was ineffective sleep would not come in that heightened physical state. There was no other cause that he can think of for that state that night such as having eaten a heavy meal or eaten late at night as he always careful to do neither. The patient always asleep within 5 to 10 minutes of head hitting the pillow. The patient went back to the pharmacy that administered the vaccine the day after and let them know what he had. Patient was not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. The reporter did not consider this report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea, Optic neuritis, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Vestibular disorders (broad), Ocular infections (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: AMANTADINE HYDROCHLORIDE; CARBAMAZEPINE; COVID-19 VACCINE ASTRAZENECA; FLUOXETINE; PLEGRIDY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dizziness (Major symptom was dizziness to the point of nausea caused by any head movement or touch.); Multiple sclerosis (Taking medicines for multiple sclerosis,MS diagnosis Relapsing & Remitting); Comments: Prior to my MS diagnosis (Relapsing & Remitting) my major symptom was dizziness to the point of nausea caused by any head movement or touch. Carbemazapine has almost totally eliminated this. I take Plegridy to help slow my MS progression, and Amantadine Hydrochloride to try and help my energy. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No- Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: nauseous; optic neuritis; Dizzy spells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26292376) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), OPTIC NEURITIS (optic neuritis) and DIZZINESS (Dizzy spells) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Prior to my MS diagnosis (Relapsing & Remitting) my major symptom was dizziness to the point of nausea caused by any head movement or touch. Carbemazapine has almost totally eliminated this. I take Plegridy to help slow my MS progression, and Amantadine Hydrochloride to try and help my energy. Patient has not had symptoms associated with COVID-19. The patient''s past medical history included Dizziness (Major symptom was dizziness to the point of nausea caused by any head movement or touch.) and Multiple sclerosis (Taking medicines for multiple sclerosis,MS diagnosis Relapsing & Remitting). Previously administered products included for MS: Plegridy (Plegridy to help slow MS progression); for Product used for unknown indication: Amantadine Hydrochloride (To try and help my energy.) and Carbamazepine (Carbemazapine had almost totally eliminated dizziness.). Past adverse reactions to the above products included No adverse event with Amantadine Hydrochloride, Carbamazepine and Plegridy. Concomitant products included AMANTADINE HYDROCHLORIDE for Feeling of total lack of energy, CARBAMAZEPINE and PEGINTERFERON BETA-1A (PLEGRIDY) for Multiple sclerosis, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and FLUOXETINE for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant) and OPTIC NEURITIS (optic neuritis) (seriousness criterion medically significant). On 25-Nov-2021, DIZZINESS (Dizzy spells) had resolved. At the time of the report, NAUSEA (nauseous) and OPTIC NEURITIS (optic neuritis) 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. CC: This is a regulatory case concerning a female patient of unknown age with multiple sclerosis and previous history of optic neuritis, who experienced the serious (medically significant) events nausea and dizziness. The events occurred on the same day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. Patient not had symptoms associated with COVID-19. Whenever patient moved around or just moved head would feel dizzy and nauseous, the only thing which made it stop was to stay very still. Patient have had this feeling before, in the early days before MS diagnosis, and it was what patient took Carbemazepine for. Patient had 2nd Covid jab (Astra Zeneca) and had a 15/20 minute change in my vision which was similar to when patient had Optic Neuritis earlier in MS journey. Patient had flu jab approx 6 weeks prior to the Moderna jab but don''t know its name. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age with multiple sclerosis and previous history of optic neuritis, who experienced the serious (medically significant) events nausea and dizziness. The events occurred on the same day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1953129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712267

Write-up: Painful hips; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: RA-WEBCOVID-202111301803083420-1TZGA (RA). Other Case identifier(s): RA-ADR 26273344 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr... The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization; Bnt162b2 (Dose-2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Painful hips". Clinical course: Patient did not have symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear pain; Ear swelling; Feeling hot; Flu like symptoms; Illness
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101711980

Write-up: Swollen lymph nodes; Off label use; Interchange of vaccine products; Booster; armpit is swollen; armpit is swollen and very sore; fatigued; my arm is very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111302145246890-DNPLB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26274320 (MHRA). A 38-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ill" (unspecified if ongoing); "flu like symptoms" (unspecified if ongoing); "ears swelled up to over double their size" (unspecified if ongoing); "hot to the touch" (unspecified if ongoing); "ears swelled up to over double their size and were hot to the touch and very painful." (Unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Covid-19 vaccine AstraZeneca (Dose 1, Single), for COVID-19 immunization; Covid-19 vaccine AstraZeneca (Dose 2, Single), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; SWELLING (medically significant) with onset 2021, outcome "not recovered", described as "armpit is swollen"; LYMPHADENOPATHY (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; AXILLARY PAIN (medically significant) with onset 2021, outcome "unknown", described as "armpit is swollen and very sore"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "fatigued"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "my arm is very painful". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: After the patient''s initial vaccine the patient was very ill with flu like symptoms and her ears swelled up to over double their size and were hot to the touch and very painful. After that most recent booster under the armpit was swollen and very sore, also hot to the touch. The patient had also been eaten fatigued. Moving her arm was very painful. Patient has not had symptoms associated with COVID-19. patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F83220 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101711846

Write-up: Headache; Dizziness; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; The patient received third (booster) dose of COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202112011121561190-HPXP7 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26275105 (MHRA). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: F83220) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was unsure if patient had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "The patient received third (booster) dose of COMIRNATY"; HEADACHE (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Headache"; DIZZINESS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymph node pain, Off label use
SMQs:, Medication errors (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: GBPFIZER INC202101712485

Write-up: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Agency (MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112011758460770-JHN9P (MHRA). Other Case identifier: GB-MHRA-ADR 26277342 (MHRA). A 72-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), administration date 27-Nov-2021 (Lot number: FK9413) at the age of 72 years old as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine AstraZeneca with administration date on 06-Mar-2021, and COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer) with administration date on 29-May-2021, both for COVID-19 immunization. The following information was reported: Off label use, Interchange of vaccine products and Booster, all with onset 27-Nov-2021, outcome "unknown"; burning sensation, weakness generalised, "weakness from shoulder through to lower leg/Weakness of arms/Neck muscle weakness", "weakness from shoulder through to lower leg", all with onset 27-Nov-2021, outcome "recovering"; facial paralysis and neck pain, both with onset 2021, outcome "not recovered"; chronic headaches with onset 28-Nov-2021, outcome "not recovered"; Palsy Bells, Generalized muscle aches both with onset 27-Nov-2021, outcome "not recovered"; and Slightly irritable with onset 28-Nov-2021, outcome "not recovered". The events were reported as serious per other medically important condition. The clinical course was reported as follows: The doctor prescribed Prednisolone 5mg, 5 to be taken twice a day and symptoms have not gotten worse since starting to take them on 30-Nov-2021. The patient saw his doctor again on 01-Dec-2021 to check if he was improving or getting worse. Previously, the symptoms were getting worse starting on the left side where the injection was given several hours after the injection. The weakness and a burning sensation in his left side from his shoulder through to his lower leg and was starting to move into his right side by the afternoon the day after the injection. The weakness was very slowly easing but the facial paralysis, headache, and neck pain were no better yet. The patient was told to see his doctor again on 06-Dec-2021 to monitor progress. The events "burning sensation", "weakness generalised", "weakness from shoulder through to lower leg/weakness of arms/neck muscle weakness", "weakness from shoulder through to lower leg", "facial paralysis", "chronic headaches", "neck pain", "palsy bells", "generalized muscle aches" and "slightly irritable" were evaluated at the physician office visit. Therapeutic measures were taken as a result of burning sensation, asthenia, muscular weakness, arthropathy, facial paralysis, headache, neck pain, bell''s palsy, myalgia, irritability. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This 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: 1953289 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9Y13 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712764

Write-up: Fever; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112011733383050-B4WMZ. Other Case identifier(s): GB-MHRA-ADR 26277037. A female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FK9Y13) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis). The patient''s concomitant medications were not reported. Vaccination history included: Astrazenecacovid-19vaccine (DOSE 2), administration date: 24May2021, for COVID-19 immunisation; Astrazenecacovid-19vaccine (DOSE 1), administration date: 11Mar2021, for COVID-19 immunisation. 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 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 24Nov2021, outcome "recovered" (26Nov2021), described as "Fever". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712595

Write-up: raised rash; Rash/sore rash; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112011748593600-NRJIP (RA). Other Case identifier(s): GB-MHRA-ADR 26277105 (RA). A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose-2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; RASH PAPULAR (medically significant), outcome "not recovered", described as "raised rash"; RASH (medically significant) with onset 26Nov2021, outcome "recovering", described as "Rash/sore rash". Therapeutic measures were taken as a result of rash papular, rash. Clinical course: Antihistamine and hydrocortisone cream used on sore raised rash. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953341 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy breast, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101711988

Write-up: Off label use; Interchange of vaccine products; Booster; Breast Bx; Breathlessness; 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-202112020448030780-BVDW3 (RA). Other Case identifier(s): GB-MHRA-ADR 26278735 (RA). A 62-year-old patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for Covid-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; BIOPSY BREAST (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Breast Bx"; DYSPNOEA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Breathlessness". Clinical Course: It was reported to be unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953509 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dizziness, Eye pruritus, Eye swelling, Fatigue, Headache, Hypoacusis, Influenza, Lymphadenopathy, Malaise, Muscle fatigue, Myalgia, Nausea, Oropharyngeal pain, Peripheral swelling, Pruritus, Sinus headache, Sneezing, Throat irritation, Vomiting, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: AVAMYS; BENYLIN CHESTY COUGH; CERELLE; COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; FEXOFENADINE HYDROCHLORIDE; FOSTAIR NEXTHALER; INFLUENZA VIRUS; MONTELUKAST; PARACETAMOL; PREGABALIN; SPIRIVA; VENTOLIN [SALBUTAMOL]
Current Illness: Asthmatic (inhalers of fostfair and ventolin)
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (take pregabalin); Fibromyalgia (take pregabalin); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Sore throat; Sneezing excessive; Coughing; Chronic wheezing; Asthmatic wheezing; Headache sinus; Muffled hearing in both ears; unwell; Swollen glands; Swollen eyes; Muscle fatigue; Itching eyes; Swollen arm; Itching - generalised; Dizziness; giddiness; Vomiting; Tired all the time; Headache; Nausea; Generalised muscle aches; Muscle soreness; wheezing; itchy throat; Influenza; This case was received via regulatory authority: GB-MHRA-ADR 26289346) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of WHEEZING (wheezing), THROAT IRRITATION (itchy throat), INFLUENZA (Influenza), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing excessive), COUGH (Coughing), WHEEZING (Chronic wheezing), WHEEZING (Asthmatic wheezing), SINUS HEADACHE (Headache sinus), HYPOACUSIS (Muffled hearing in both ears), MALAISE (unwell), LYMPHADENOPATHY (Swollen glands), EYE SWELLING (Swollen eyes), MUSCLE FATIGUE (Muscle fatigue), EYE PRURITUS (Itching eyes), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching - generalised), DIZZINESS (Dizziness), DIZZINESS (giddiness), VOMITING (Vomiting), FATIGUE (Tired all the time), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Generalised muscle aches) and MYALGIA (Muscle soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Endometriosis (take pregabalin), Fibromyalgia (take pregabalin) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Asthmatic (inhalers of fostfair and ventolin). Concomitant products included AMMONIUM CHLORIDE, DIPHENHYDRAMINE, MENTHOL (BENYLIN CHESTY COUGH) and PARACETAMOL for Flu symptoms, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination, FLUTICASONE FUROATE (AVAMYS), DESOGESTREL (CERELLE), COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), FEXOFENADINE HYDROCHLORIDE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE (FOSTAIR NEXTHALER), INFLUENZA VACCINE (INFLUENZA VIRUS), MONTELUKAST, PREGABALIN, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA (Influenza) (seriousness criterion medically significant). On an unknown date, the patient experienced WHEEZING (wheezing) (seriousness criterion medically significant), THROAT IRRITATION (itchy throat) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), SNEEZING (Sneezing excessive) (seriousness criterion medically significant), COUGH (Coughing) (seriousness criterion medically significant), WHEEZING (Chronic wheezing) (seriousness criterion medically significant), WHEEZING (Asthmatic wheezing) (seriousness criterion medically significant), SINUS HEADACHE (Headache sinus) (seriousness criterion medically significant), HYPOACUSIS (Muffled hearing in both ears) (seriousness criterion medically significant), MALAISE (unwell) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), EYE SWELLING (Swollen eyes) (seriousness criterion medically significant), MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), EYE PRURITUS (Itching eyes) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PRURITUS (Itching - generalised) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), DIZZINESS (giddiness) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). At the time of the report, WHEEZING (wheezing), THROAT IRRITATION (itchy throat), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing excessive), MALAISE (unwell), LYMPHADENOPATHY (Swollen glands), MUSCLE FATIGUE (Muscle fatigue), EYE PRURITUS (Itching eyes), PRURITUS (Itching - generalised), DIZZINESS (Dizziness), DIZZINESS (giddiness), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Generalised muscle aches) was resolving, INFLUENZA (Influenza), COUGH (Coughing), WHEEZING (Chronic wheezing), WHEEZING (Asthmatic wheezing), SINUS HEADACHE (Headache sinus), FATIGUE (Tired all the time) and MYALGIA (Muscle soreness) had not resolved and HYPOACUSIS (Muffled hearing in both ears), EYE SWELLING (Swollen eyes), PERIPHERAL SWELLING (Swollen arm) and VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding. COMPANY COMMENT: This is a regulatory case concerning a 51-year-old female patient with clinical history of Asthma, Endometriosis (take pregabalin), Fibromyalgia (take pregabalin) and Steroid therapy who experienced the unexpected events of WHEEZING, THROAT IRRITATION, INFLUENZA, OROPHARYNGEAL PAIN, SNEEZING, COUGH, WHEEZING, WHEEZING, SINUS HEADACHE, HYPOACUSIS, MALAISE, LYMPHADENOPATHY, EYE SWELLING, MUSCLE FATIGUE, EYE PRURITUS, PERIPHERAL SWELLING, PRURITUS, DIZZINESS, DIZZINESS, VOMITING, FATIGUE, HEADACHE, NAUSEA, MYALGIA and MYALGIA The event occurred 1days after third dose of mRNA-1273 vaccine 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.; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 51-year-old female patient with clinical history of Asthma, Endometriosis (take pregabalin), Fibromyalgia (take pregabalin) and Steroid therapy who experienced the unexpected events of WHEEZING, THROAT IRRITATION, INFLUENZA, OROPHARYNGEAL PAIN, SNEEZING, COUGH, WHEEZING, WHEEZING, SINUS HEADACHE, HYPOACUSIS, MALAISE, LYMPHADENOPATHY, EYE SWELLING, MUSCLE FATIGUE, EYE PRURITUS, PERIPHERAL SWELLING, PRURITUS, DIZZINESS, DIZZINESS, VOMITING, FATIGUE, HEADACHE, NAUSEA, MYALGIA and MYALGIA The event occurred 1days after third dose of mRNA-1273 vaccine 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: 1953655 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy (Female patient is being treated for epilepsy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202101719450

Write-up: Epileptic seizure of the grand mal type; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA. -WEB. Regulatory number: HR-HALMEDAPP-202111232332371050-KOFGH. Other Case identifier(s): HR-HALMED-300052506. A 41 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, 0.3ml, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (ongoing), notes: Female patient is being treated for epilepsy. The patient''s concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 23Nov2021, outcome "recovering", described as "Epileptic seizure of the grand mal type". Onset latency was 27 minutes. Reaction(s) / Event(s) Assessed: Grand mal epileptic fit/Source of assessment: /Method of assessment: Causality/Result of Assessment: Possible. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1953737 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31100TB / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Brain natriuretic peptide, Cardio-respiratory arrest, Coma, Hypotension, Left ventricular dysfunction, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angiodysplasia; Chronic atrial fibrillation; Hypertension pulmonary; IHD; Mitral stenosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: B-type natriuretic peptide; Result Unstructured Data: Test Result:increased by 14 times the normal value; Comments: increased by 14 times the normal value
CDC Split Type: ITPFIZER INC202101730271

Write-up: severe left ventricular dysfunction; Coma; CARDIORESPIRATORY ARREST; DESATURATION; progressive hypotension; ASTHENIA; This is a spontaneous report received from a contactable Physician from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-815999. A 79 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: 31100TB) as dose 3 (booster), 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Hypertension pulmonary" (unknown if ongoing); "IHD" (unknown if ongoing); "Chronic atrial fibrillation" (unknown if ongoing); "Type 2 diabetes mellitus" (unknown if ongoing); "Angiodysplasia" (unknown if ongoing); "Mitral stenosis" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (2nd dose; LOT: FA4597), administration date: 25May2021, for COVID-19 immunisation, reaction(s): "No adverse reaction"; Comirnaty (1st dose), administration date: 04May2021, for COVID-19 immunisation, reaction(s): "No adverse reaction". The following information was reported: ASTHENIA (life threatening) with onset 23Nov2021, outcome "not recovered", described as "ASTHENIA"; CARDIO-RESPIRATORY ARREST (life threatening) with onset 23Nov2021 12:50, outcome "not recovered", described as "CARDIORESPIRATORY ARREST"; OXYGEN SATURATION DECREASED (life threatening) with onset 23Nov2021, outcome "not recovered", described as "DESATURATION"; LEFT VENTRICULAR DYSFUNCTION (life threatening) with onset 23Nov2021 18:39, outcome "unknown", described as "severe left ventricular dysfunction"; COMA (life threatening) with onset 23Nov2021 18:39, outcome "unknown", described as "Coma"; HYPOTENSION (life threatening) with onset 23Nov2021, outcome "unknown", described as "progressive hypotension ". The events "asthenia", "cardiorespiratory arrest", "desaturation", "severe left ventricular dysfunction", "coma" and "progressive hypotension " were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: increased by 14 times the normal value, notes: increased by 14 times the normal value. Therapeutic measures were taken as a result of asthenia, cardio-respiratory arrest, oxygen saturation decreased, left ventricular dysfunction, coma. Clinical course: The patient arrives in the emergency room on 23Nov2021 at 12.50 am accompanied by Advanced Rescue Unit intubated post cardiac arrest and Pulseless electrical activity. During the preliminary examinations in the emergency room he manifests progressive hypotension and a new episode of Pulseless electrical activity. at 18:39 post anoxic coma in cardiac arrest secondary to Pulseless electrical activity, severe left ventricular dysfunction. Currently hospitalized in coronary intensive care unit. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Coma, Headache, Hypertensive crisis, Intraventricular haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TEGRETOL; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Allergy to plants; Arteriovenous malformation; Epilepsy; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:pressure peak at 200
CDC Split Type: ITPFIZER INC202101734273

Write-up: fourth degree coma; intraventricular hemorrhage; brown vomit; operated on AVM (arteriovenous malformation) erupted due to a pressure peak at 200; severe headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: -MINISAL02-816285 (MINISAL02). A 51 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 12Nov2021 (Lot number: 1F1008A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to cats" (unspecified if ongoing); "Allergy to ragweed" (unspecified if ongoing); "Mild hypertension" (unspecified if ongoing); "Epileptic due to right parietal AVM" (unspecified if ongoing); "right parietal AVM" (unspecified if ongoing). Concomitant medications included: TEGRETOL taken for epilepsy; LISINOPRIL taken for hypertension. The following information was reported: VOMITING (hospitalization, life threatening) with onset 23Nov2021, outcome "not recovered", described as "brown vomit"; HYPERTENSIVE CRISIS (hospitalization, life threatening) with onset 23Nov2021, outcome "not recovered", described as "operated on AVM (arteriovenous malformation) erupted due to a pressure peak at 200"; HEADACHE (hospitalization, life threatening) with onset 23Nov2021, outcome "not recovered", described as "severe headache"; COMA (hospitalization, life threatening), outcome "not recovered", described as "fourth degree coma"; INTRAVENTRICULAR HAEMORRHAGE (hospitalization, life threatening), outcome "not recovered", described as "intraventricular hemorrhage". Actions taken (To date hospitalized in resuscitation with fourth degree coma following right parietal AVM (arteriovenous malformation) intraventricular hemorrhage) - Impact on quality of life (10/10). Still in a coma.The patient underwent the following laboratory tests and procedures: blood pressure measurement: pressure peak at 200. Reporter Comment: Allergy to cats and ragweed Epileptic due to right parietal AVM for years Mild hypertension. Pfizer. The Lady is being treated with tegretol CR 400 (1.5 tablets in the morning and 1.5 tablets in the evening for years) and in the last year with lisinopril one-third only in the evening due to mild hypertension. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Allergy to cats and ragweed Epileptic due to right parietal AVM for years Mild hypertension. Pfizer. The Lady is being treated with tegretol CR 400 (1.5 tablets in the morning and 1.5 tablets in the evening for years) and in the last year with lisinopril one-third only in the evening due to mild hypertension.


VAERS ID: 1953870 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:120/100 mmHg; Comments: 11:23
CDC Split Type: PHPFIZER INC202101712636

Write-up: ELEVATED BP (120/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121303 (RA). A 16 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: PCB0002) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 11:23, outcome "recovered" (23Nov2021), described as "ELEVATED BP (120/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 120/100 mmHg, notes: 11:23. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953875 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:170/80 mmHg; Comments: 10:42
CDC Split Type: PHPFIZER INC202101712665

Write-up: ELEVATED BP (170/80); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121309. A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: PCB0002) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 10:42, outcome "recovered" (23Nov2021 10:42), described as "ELEVATED BP (170/80)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 170/80 mmHg, notes: 10:42. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953878 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:140/100 mmHg; Comments: 14:07
CDC Split Type: PHPFIZER INC202101712934

Write-up: Elevated BP (140/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121432 (RA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: PCB0002) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 14:07, outcome "recovered" (23Nov2021), described as "Elevated BP (140/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 140/100 mmHg, notes: 14:07. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953880 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-11-23
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/90 mmHg; Comments: 11:23
CDC Split Type: PHPFIZER INC202101712946

Write-up: "ELEVATED BP (160/90); This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121344 (RA). A 13-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Oct2021 (Lot number: PCB0002) at the age of 13 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 11:23, outcome "recovered" (23Nov2021, unspecified time), described as ""ELEVATED BP (160/90)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 160/90 mmHg, notes: 11:23. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953881 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-11-23
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:176/110 mmHg; Comments: 11:00
CDC Split Type: PHPFIZER INC202101712957

Write-up: ELEVATED BP (176/110); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121405 (RA). A 50 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Oct2021 (Lot number: PCB0002) at the age of 50 years as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: Blood Pressure Increased (medically significant) with onset 23Nov2021 11:00, outcome "recovered" (23Nov2021), described as "Elevated BP (176/110)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 176/110 mmHg, notes: 11:00. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953882 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/120 mmHg; Comments: 11:30
CDC Split Type: PHPFIZER INC202101712959

Write-up: ELEVATED BP (180/120); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121414 (RA). A 30 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: PCB0002) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 11:30, outcome "recovered" (23Nov2021), described as "ELEVATED BP (180/120)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 180/120 mmHg, notes: 11:30. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953883 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:140/100 mmHg; Comments: 14:31
CDC Split Type: PHPFIZER INC202101712962

Write-up: Elevated BP (140/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121434 (RA). A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: PCB0002) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021 14:31, outcome "recovered" (23Nov2021), described as "Elevated BP (140/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 140/100 mmHg, notes: 14:31. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953889 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Capillary nail refill test, Capillary nail refill test abnormal, Cold sweat, Dizziness, Heart rate, Hyperhidrosis, Hypotension, Oxygen saturation, Pulse abnormal, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:60/40 mmHg; Comments: 01:02; Test Date: 20211123; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20211123; Test Name: capillary refill; Result Unstructured Data: Test Result:$g 2 seconds; Comments: delayed capillary refill time.; Test Date: 20211123; Test Name: Heart rate; Result Unstructured Data: Test Result:72 beats per minute; Test Date: 20211123; Test Name: Oxygen saturation; Test Result: 74 %; Test Date: 20211123; Test Name: Respiratory rate; Result Unstructured Data: Test Result:17; Comments: cycles per minute
CDC Split Type: PHPFIZER INC202101713125

Write-up: Patient suddenly felt dizzy; Diaphoretic; Cold and Clammy to touched; Low blood pressure/60/40 mmHg; Delayed capillary refill time; Body temperature 35.7 Centigrade; Weak pulses upon palpation; This is a spontaneous report received from a contactable Physician from Regulatory Authority. Regulatory number: PH-PHFDA-300121517 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: 32025BD) at the age of 14 years as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPOTENSION (medically significant) with onset 23Nov2021 01:02, outcome "recovered" (23Nov2021 03:15), described as "Low blood pressure/60/40 mmHg"; CAPILLARY NAIL REFILL TEST ABNORMAL (medically significant) with onset 23Nov2021, outcome "unknown", described as "Delayed capillary refill time"; DIZZINESS (non-serious) with onset 23Nov2021 01:02, outcome "recovered" (23Nov2021 03:15), described as "Patient suddenly felt dizzy"; HYPERHIDROSIS (non-serious) with onset 23Nov2021 01:02, outcome "recovered" (23Nov2021 03:15), described as "Diaphoretic"; COLD SWEAT (non-serious) with onset 23Nov2021 01:02, outcome "recovered" (23Nov2021 03:15), described as "Cold and Clammy to touched"; PULSE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Weak pulses upon palpation"; BODY TEMPERATURE DECREASED (non-serious) with onset 23Nov2021, outcome "unknown", described as "Body temperature 35.7 Centigrade". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 60/40 mmHg, notes: 01:02; body temperature: (23Nov2021) 35.7 Centigrade; capillary nail refill test: (23Nov2021) $g 2 seconds, notes: delayed capillary refill time; heart rate: (23Nov2021) 72 beats per minute; oxygen saturation: (23Nov2021) 74 %; respiratory rate: (23Nov2021) 17, notes: cycles per minute. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953892 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101713142

Write-up: DIZZINESS, THEN LOSS OF CONSCIOUSNESS; DIZZINESS, THEN LOSS OF CONSCIOUSNESS; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121482 (RA). A 15-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY, solution for injection), dose number unknown, intramuscular, administration date 23Nov2021 (Lot number: 32025BD) (at the vaccination age of 15 years old) as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Nov2021 13:17, outcome "recovered" (23Nov2021 13:45), DIZZINESS (non-serious) with onset 23Nov2021 13:17, outcome "unknown" (also reported as '' Event stop date for dizziness: 23-NOV-2021 13:45'') and all described as "DIZZINESS, THEN LOSS OF CONSCIOUSNESS". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953911 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/90 mmHg; Comments: PRE-VACCINATION; Test Date: 20211123; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: POST VACCINATION
CDC Split Type: PHPFIZER INC202101713327

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121820. A 64 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: 32025BD) at the age of 64 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Nov2021, outcome "recovered" (25Nov2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) 140/90 mmHg, notes: PRE-VACCINATION; (23Nov2021) 160/100 mmHg, notes: POST VACCINATION. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953921 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320218D / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Rash, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101713446

Write-up: Fatigue; Skin rash; Numbness; Injection site soreness; Body weakness; This is a spontaneous report from a contactable Other HCP from Regulatory Authority. Regulatory number: PH-PHFDA-300121991 (RA). A 17-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: 320218D) at the age of 17 years as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: fatigue (hospitalization) with onset 23Nov2021, outcome "recovering", described as "fatigue"; rash (hospitalization) with onset 23Nov2021, outcome "recovering", described as "skin rash"; hypoaesthesia (hospitalization) with onset 23Nov2021, outcome "recovering", described as "numbness"; vaccination site pain (hospitalization) with onset 23Nov2021, outcome "recovering", described as "injection site soreness"; asthenia (non-serious), outcome "unknown", described as "body weakness". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954026 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Deep vein thrombosis
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: TWMODERNATX, INC.MOD20214

Write-up: DVT; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and CHILLS (Chills) in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DVT) and CHILLS (Chills) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Other product was prescribed with Cravit 750mg st IVD for antibiotic treatment. Patient was received Moderna vaccine on 23-NOV-2021 then developed fever for 3 days. On 26-NOV-2021 patient was visited the emergency department for treatment and lab test revealed no leukocytosis (WBC, 8910), CRP increased (13.186mg/dl), elevated D -Dimer ($g10000ng/mL(FEU)). Abdominal CT showed thrombosis from left iliacvein to femoral vein with additional Clexane6000IU/ 60mg/0.6mL 1 amp sc. Patient had a history of heart disease and had lived in the center two years and after received the Moderna vaccine on 23-NOV-2021 the patient developed fever for 3 days and was assisted to visit Hospital for treatment by the Care Center and then patient was admitted to the general ward for hospitalization. Patient was currently under nursing care and was informed with VICP application issues. Company Comment - This case concerns a 89 year old female patient with medical history of heart disease, who experienced the serious (medically significant) unexpected events of deep vein thrombosis and chills. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient''s medical history of heart disease remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 89 year old female patient with medical history of heart disease, who experienced the serious (medically significant) unexpected events of deep vein thrombosis and chills. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient''s medical history of heart disease remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1954443 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Fall, Headache, Hypoaesthesia, Hypotension, Loss of consciousness, Oxygen saturation decreased, Presyncope, Seizure, Vaccination site hypoaesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101712965

Write-up: hypotension; low O2 saturation; felt numbness on his injection site; Blacked out; Seizure; Numbness; Near fainting; patient fell on the floor from his chair; had jerky-like movements; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121452 (RA). A 17-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 14:13 (Lot number: 32025BD) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was reported that the patient was being monitored post vaccination, 5 minutes after, Patient felt numbness on his injection site (VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 23Nov2021 14:18, outcome "unknown") and he said he felt numbness all throughout his body (HYPOAESTHESIA (medically significant) with onset 23Nov2021 14:18, outcome "recovered" (23Nov2021 14:55), described as "Numbness") and blacked out (LOSS OF CONSCIOUSNESS (medically significant) with onset 23Nov2021 14:18, outcome "recovered"). Patient fell on the floor from his chair (FALL (non-serious) with onset 23Nov2021, outcome "unknown") and had jerky-like movements for 1-2 seconds (DYSKINESIA (non-serious) with onset 23Nov2021, outcome "unknown"). Patient was transported to AEFI area. placed on Trendelenburg position, Paracetamol was given due to headache (HEADACHE (non-serious) with onset 23Nov2021, outcome "unknown"). Vital signs taken every 15 minutes initially reveal hypotension (HYPOTENSION (non-serious) with onset 23Nov2021 14:28, outcome "unknown") and low o2 saturation (OXYGEN SATURATION DECREASED (non-serious) with onset 23Nov2021 14:28, outcome "unknown"). Patient recovered in a short while and no oxygenation was needed. Patient was referred to hospital as per advice by doctor on duty for further management. Patient was transported and accompanied and companions (Family members). It was also reported that the patient experienced SEIZURE (medically significant) with onset 23Nov2021 14:18, outcome "recovered" (23Nov2021 14:55), described as "Seizure" and PRESYNCOPE (non-serious) with onset 23Nov2021 14:18, outcome "recovered" (23Nov2021 14:55), described as "Near fainting". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-11-23
   Days after vaccination:249
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 PCR virus test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101724850

Write-up: vaccination failure; COVID-19 confirmed by positive COVID-19 test (sypmtoms: flu like symptoms, no smell, no taste, muscle pain, joint pain, sinusitis, fatigue); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Nov2021, outcome "unknown", described as "vaccination failure"; COVID-19 (medically significant) with onset 23Nov2021, outcome "unknown", described as "COVID-19 confirmed by positive COVID-19 test (sypmtoms: flu like symptoms, no smell, no taste, muscle pain, joint pain, sinusitis, fatigue)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954696 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-11-23
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101725017

Write-up: flu like; drug ineffective; covid positive pcr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 45-year-old male patient received bnt162b2 (COMIRNATY), administration date May2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and administration date May2021 (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 23Nov2021, outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant) with onset 23Nov2021, outcome "unknown", described as "covid positive pcr"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (23Nov2021) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956431 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101721501

Write-up: Off label use; interchange of vaccine products; Booster; Headache; Lethargy; achiness in joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-ADR 26275108. A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FH4751) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose: 01), for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose: 02), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 23Nov2021, outcome "recovering", described as "Headache"; LETHARGY (medically significant) with onset 23Nov2021, outcome "recovering", described as "Lethargy"; ARTHRALGIA (medically significant) with onset 23Nov2021, outcome "recovering", described as "achiness in joints". Clinical course: It was reported that my wife, had the same vaccine at the same time as me. She has also had headaches, some achiness in joints and has felt very lethargic ever since last Tuesday. This has eased a bit but she is still not feeling fully fit and totally energetic. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956454 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary mass, Breast swelling, Illness, Muscle fatigue, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEIN; ETORICOXIB; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swelling arm, armpit swelling and breast. Sickness, muscle fatigue; Swelling arm, armpit swelling and breast. Sickness, muscle fatigue; Swelling arm, armpit swelling and breast. Sickness, muscle fatigue; Swelling arm, armpit swelling and breast. Sickness, muscle fatigue; Swelling arm, armpit swelling and breast. Sickness, muscle fatigue; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26262589) on 05-Dec-2021 and was forwarded to Moderna on 05-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), AXILLARY MASS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), BREAST SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), ILLNESS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) and MUSCLE FATIGUE (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included CODEINE PHOSPHATE (CODEIN), ETORICOXIB and PARACETAMOL for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 23-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) (seriousness criterion medically significant), AXILLARY MASS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) (seriousness criterion medically significant), BREAST SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) (seriousness criterion medically significant), ILLNESS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) (seriousness criterion medically significant) and MUSCLE FATIGUE (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), AXILLARY MASS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), BREAST SWELLING (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue), ILLNESS (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) and MUSCLE FATIGUE (Swelling arm, armpit swelling and breast. Sickness, muscle fatigue) had not resolved. No treatment information was reported. Company Comment: This is a case of Inappropriate route of vaccination for this 36-year-old, female subject with no relevant medical history, who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Peripheral swelling (swelling arm), Axillary mass, Breast swelling, Illness, and Muscle Fatigue. The events occurred on the same day after the third dose of mRNA 1273 Vaccine which was administered parenterally. No diagnostic test done nor treatment medication given was mentioned. Rechallenge was not applicable as no additional dose is expected to be given. At the time of the report, the outcome of the events was Not Recovered/Not Resolved. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report. Swelling arm, armpit swelling and breast. Sickness, muscle fatigue. This is still ongoing.; Sender''s Comments: This is a case of Inappropriate route of vaccination for this 36-year-old, female subject with no relevant medical history, who experienced the serious (seriousness criterion= Other medically important condition) unexpected events of Peripheral swelling (swelling arm), Axillary mass, Breast swelling, Illness, and Muscle Fatigue. The events occurred on the same day after the third dose of mRNA 1273 Vaccine which was administered parenterally. No diagnostic test done nor treatment medication given was mentioned. Rechallenge was not applicable as no additional dose is expected to be given. At the time of the report, the outcome of the events was Not Recovered/Not Resolved. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.


VAERS ID: 1956489 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-11-23
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30003607 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Numbness; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26248578) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30003607) for an unknown indication. The patient''s past medical history included Clinical trial participant. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 15-Dec-2020 to an unknown date for an unknown indication. On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter. Patient did not had symptoms associated with COVID-19, not had a COVID-19 test, Patient was not currently breastfeeding. Company comment: This is a regulatory authority case concerning a 38-year-old female patient with no relevant medical history, who experienced unexpected event of hypoesthesia. The event occurred 22 days after the third 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 38-year-old female patient with no relevant medical history, who experienced unexpected event of hypoesthesia. The events occurred 22 days after the third 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: 1956764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Intestinal ischaemia, Malpositioned teeth, Platelet count, SARS-CoV-2 test
SMQs:, Ischaemic colitis (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT; Surgery; Vena cava filter insertion
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: Test Result:361; Test Name: platelet count; Result Unstructured Data: Test Result:227; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101722400

Write-up: Malpositioned teeth; Bowel ischaemia; Booster; This is a spontaneous report received from a contactable reporter (pharmacist) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112030841434380-YH5OO. Other Case identifiers: GB-MHRA-ADR 26285349. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing); "DVT" (unspecified if ongoing); "IVC filter in situ" (unspecified if ongoing). Concomitant medications included: AMLODIPINE taken for hypertension; RIVAROXABAN taken for deep vein thrombosis. Past drug history included: Heparin. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, disability, life threatening) with onset 23Nov2021, outcome "unknown", described as "Booster"; MALPOSITIONED TEETH (hospitalization, disability, life threatening), outcome "unknown", described as "Malpositioned teeth "; INTESTINAL ISCHAEMIA (hospitalization, disability, life threatening) with onset 24Nov2021, outcome "recovering", described as "Bowel ischaemia". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test; platelet count: 361; platelet count (150-450): 227. Therapeutic measures were taken as a result of intestinal ischaemia. Clinical source: bowel ischaemia requiring surgery and stoma formation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This reported relate to possible blood clots or low platelet counts. Unknown if the D-dimer is $g4000. Unknown if anti-PF4 antibodies were identified. The patient had no any previous reactions to medications, especially heparin or anticoagulants. No confirmed or suspected autoimmune or inflammatory disease, including vasculitis. No history of, or current, malignancy. Unknown if the patient currently smoke. No history of, or concurrent, intracranial malignancy. No concurrent or recent intracranial infections. No recent surgical or medical interventions to the central nervous system (including lumbar puncture). No recent trauma/head injury. Prev DVT, IVC filter in situ, on rivaroxaban 20mg OD normally. Ischaemic gut through this requiring surgery. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956921 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Illness, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

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

Write-up: Swelling; Sickness; Tiredness; This case was received (Reference number: GB-MHRA-ADR 26288565) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ILLNESS (Sickness) and FATIGUE (Tiredness) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 24-Nov-2021, ILLNESS (Sickness) had resolved. On 30-Nov-2021, FATIGUE (Tiredness) had resolved. At the time of the report, SWELLING (Swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. CC: This is a regulatory case concerning a 51-year-old female patient with no reported medical history, who experienced the serious (medically significant) events swelling, illness and fatigue. The events occurred on the same day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. Patient has not had symptoms associated with COVID-19 and patient was not currently breastfeeding . Patient has not tested positive for COVID-19 since having the vaccine. Patient last menstrual period date was 01-FEB-2020 The treatment information were unknown; Sender''s Comments: This is a regulatory case concerning a 51-year-old female patient with no reported medical history, who experienced the serious (medically significant) events swelling, illness and fatigue. The events occurred on the same day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957009 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: sweating; tiredness; shivering; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26292619) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FATIGUE (tiredness), CHILLS (shivering) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 22-Nov-2021 to an unknown date for an unknown indication. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), FATIGUE (tiredness) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 24-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, HYPERHIDROSIS (sweating), FATIGUE (tiredness) and CHILLS (shivering) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication details was provided. Company comment: This case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of vomiting, hyperhidrosis, fatigue, and chills. The events started one day after the booster dose of mRNA-1273. The source document reports that the patient received two doses of the mRNA-1273 booster, though it is unclear if the patient received an overdose. Concomitant administration of the influenza vaccine is a confounder. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of vomiting, hyperhidrosis, fatigue, and chills. The events started one day after the booster dose of mRNA-1273. The source document reports that the patient received two doses of the mRNA-1273 booster, though it is unclear if the patient received an overdose. Concomitant administration of the influenza vaccine is a confounder. 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: 1957087 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthritis reactive, Myocarditis, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Ocular infections (broad), Arthritis (narrow), 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? 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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768910

Write-up: myocarditis; vomiting; Reactive arthritis; High temperature; Stomach pain; 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-202112092253091910-PLQ5S (MHRA). Other Case identifier(s): GB-MHRA-ADR 26314808 (MHRA). A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 13 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: MYOCARDITIS (disability, medically significant), outcome "not recovered", described as "myocarditis"; VOMITING (disability, medically significant), outcome "not recovered", described as "vomiting"; ARTHRITIS REACTIVE (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Reactive arthritis"; PYREXIA (disability, medically significant) with onset 23Nov2021, outcome "recovering", described as "High temperature"; ABDOMINAL PAIN UPPER (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Stomach pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient was not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No 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: 1957219 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005887 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hallucination, auditory, Headache, Hypothermia, Pyrexia, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...; This case was received via regulatory authority (Reference number: IT-MINISAL02-814367) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOTHERMIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...), VISUAL IMPAIRMENT (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...), PYREXIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...), HEADACHE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...), HALLUCINATION, AUDITORY (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) and FATIGUE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005887) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: SPIKEVAX on 25-Oct-2021. Past adverse reactions to the above products included No adverse reaction with SPIKEVAX. On 22-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced HYPOTHERMIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant), VISUAL IMPAIRMENT (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant), PYREXIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant), HEADACHE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant) and FATIGUE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision...) (seriousness criterion medically significant). At the time of the report, HYPOTHERMIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..), VISUAL IMPAIRMENT (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..), PYREXIA (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..), HEADACHE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..), HALLUCINATION, AUDITORY (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..) and FATIGUE (About 12 hours after the administration of Moderna drug (Mrna Covid vaccine), which occurred at approximately 14,21 on 22 nov 2021, marked hypothermia (34.8), auditory hallucinations, low vision..) was resolving. 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 information was provided. No treatment medication was provided. Company comment: This is a regulatory case concerning a 46-year-old male patient with no medical history reported who experienced the unexpected and serious events of hypothermia, visual impairment, pyrexia, headache, hallucination, auditory and fatigue. The events occurred the following day a first dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Significant follow-up received on 10-DEC-2021: contains historical drug information.; Sender''s Comments: This is a regulatory case concerning a 46-year-old male patient with no medical history reported who experienced the unexpected and serious events of hypothermia, visual impairment, pyrexia, headache, hallucination, auditory and fatigue. The events occurred the following day a first dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957232 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Haematochezia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101716001

Write-up: diarrhea with red blood in the stool; diarrhea with red blood in the stool; abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-814986. A 36 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: 1F1005A) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Dust allergy" (unknown if ongoing); "Allergy to animal" (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), DIARRHOEA (non-serious) all with onset 23Nov2021, outcome "unknown" and all described as "diarrhea with red blood in the stool"; ABDOMINAL PAIN (non-serious) with onset 23Nov2021, outcome "unknown", described as "abdominal pain". The attending physician has been informed of this reaction and can be contacted to doctor. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1957266 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bone pain, Chills, Immunisation, Loss of personal independence in daily activities, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: fever; Result Unstructured Data: Test Result:39.1 Centigrade
CDC Split Type: ITPFIZER INC202101717650

Write-up: unable to go to work for two days; fainting; Shivers; Vomiting; Fever 39.1 C; bone pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-815559 (MINISAL02). A 48 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (dose 2 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 24Nov2021, outcome "recovering", described as "fainting"; CHILLS (non-serious) with onset 24Nov2021, outcome "recovering", described as "Shivers"; VOMITING (non-serious) with onset 24Nov2021, outcome "recovering", described as "Vomiting"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovering", described as "Fever 39.1 C"; BONE PAIN (non-serious) with onset 24Nov2021, outcome "recovering", described as "bone pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "unable to go to work for two days". The patient underwent the following laboratory tests and procedures: body temperature: (24Nov2021) 39.1 Centigrade. Clinical course: Impact on quality of life (10/10). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957324 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8562 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Dyspnoea, Exercise tolerance decreased, Multisystem inflammatory syndrome, Oxygen consumption decreased, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Intubation; Organising pneumonia; Pneumonia bacterial; Reintubate; Tracheostomy; Tracheostomy closure
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 20211113; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: before vaccination; Test Date: 20211124; Test Name: CT; Result Unstructured Data: Test Result:Lung field change could not be confirmed; Test Date: 20211123; Test Name: Oxygen demand worse; Result Unstructured Data: Test Result:Oxygen demand worse; Test Date: 20211124; Test Name: SPO2; Result Unstructured Data: Test Result:under 90 %; Test Date: 20211124; Test Name: SPO2; Result Unstructured Data: Test Result:decreased until 85 %
CDC Split Type: JPPFIZER INC202101760906

Write-up: pyrexia of 38s degrees Celsius; SPO2 under until 90/SPO2 (2 L) decreased until 85%; Dyspnoea; Oxygen demand worse; Exercise tolerance decreased; MIS (Multisystem Inflammatory Syndrome); This is a spontaneous report from a contactable physician received from the regulatory authority (PMDA). Regulatory authority report number is v21132304 A 70 year and 9-month old male patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 13Nov2021 (the day of vaccination), (Lot number: FK8562, Expiration Date: 30Apr2022) at the age of 70 years via an unspecified route of administration as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19 severe pneumonia", start date: 03Aug2021 (unspecified if ongoing); "Intubation", start date: 16Aug2021 (unspecified if ongoing); "Pneumonia bacterial", start date: 27Aug2021 (unspecified if ongoing); "Reintubate", start date: 27Aug2021 (unspecified if ongoing); "Tracheostomy", start date: 03Sep2021 (unspecified if ongoing); "Tracheostomy closure", start date: 01Oct2021 (unspecified if ongoing); "Organising pneumonia" (unspecified if ongoing). The patient''s concomitant medications were not reported. Body temperature before vaccination was 37.2 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that the patient was recovered from COVID-19 severe pneumonia. (Onset on 03Aug2021, need oxygen and got hospitalization on 14Aug2021, breathing status worsened and got Intubation on 16Aug2021, extubated on 20Aug2021, reintubate due to Pneumonia bacterial on 27Aug2021, Tracheostomy was performed on 03Sep2021, Tracheostomy closure was performed on 01Oct2021. Rehabilitation and transformed hospital on 07Oct2021.) The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (medically significant) with onset 23Nov2021, described as "MIS (Multisystem Inflammatory Syndrome)"; DYSPNOEA (non-serious) with onset 24Nov2021, described as "Dyspnoea"; OXYGEN CONSUMPTION DECREASED (non-serious) with onset 23Nov2021, described as "Oxygen demand worse"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 23Nov2021, described as "Exercise tolerance decreased"; PYREXIA (non-serious), described as "pyrexia of 38s degrees Celsius"; OXYGEN SATURATION DECREASED (non-serious) with onset 24Nov2021, described as "SPO2 under until 90/SPO2 (2 L) decreased until 85%". The course of the event was as follows: On 23Nov2021 (10 days after the vaccination), the patient experienced Oxygen demand worse, Exercise tolerance decreased. Even though there was Sequelae of Organising pneumonia, after that, no SPO2 decreased and the patient could walk for 180 meter due to rehabilitation, Exercise tolerance improved. On 13Nov2021, the patient got vaccinated, even though pyrexia of 38s degrees Celsius continued for 10 days after that, the rehabilitation was well. But from 24Nov2021, Dyspnoea appeared, because there was SPO2 under 90 when had rest, Oxygen administration began. SPO2 (2 L) decreased until 85% when the patient inhaled 2L oxygen and walked for 60 meters, Exercise tolerance decreased obviously. Lung field change could not be confirmed when CT performed only. After that, there was recovered tendency of Exercise tolerance, but now, on 07Dec2021 (24 days after vaccination), SPO2 decreased still existed when the patient walked for 180 meters. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 38s; (13Nov2021) 37.2 Centigrade, notes: before vaccination; computerised tomogram: (24Nov2021) lung field change could not be confirmed; oxygen consumption decreased: (23Nov2021) oxygen demand worse; oxygen saturation: (24Nov2021) under 90; (24Nov2021) decreased until 85. On 07Dec2021 (24 days after vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was rehabilitation was stopped due to pyrexia after vaccination. The reporting physician commented as follows: For person who need Artificial respiration management due to COVID-19 infection, case that oxygen needed after COVID-19 vaccination. For case that MIS (Multisystem Inflammatory Syndrome) onset after COVID-19 infected, the benefits of vaccination were not clear, the possibility of harmfulness was high for this case. So the second vaccination was stopped. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1957356 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Pain, SARS-CoV-2 test
SMQs:, Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness: Asthma (Suffer with asthma, take blue and brown inhalers)
Preexisting Conditions: Medical History/Concurrent Conditions: Hysterectomy (Anaphylactic to hard shelled seafood Had a full hysterectomy at age 40)
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; Chest pain - cardiac; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26298262) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Chest pain - cardiac) and PAIN (pain) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Hysterectomy (Anaphylactic to hard shelled seafood Had a full hysterectomy at age 40). Concurrent medical conditions included Asthma (Suffer with asthma, take blue and brown inhalers). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 30-Oct-2021 to an unknown date for Influenza immunisation. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ANGINA PECTORIS (Chest pain - cardiac) (seriousness criterion hospitalization). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion hospitalization). On 27-Nov-2021, ANGINA PECTORIS (Chest pain - cardiac) had resolved. At the time of the report, PAIN (pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No -Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment medication was not reported. Patient was relaxed at home sewing, when excruciating pain came into my chest, heart region. It went into back directly behind heart. The more Patient breathed the more painful it got, so compensated by trying to breathe more shallow, however this then caused patient to hyperventilate. The pain increased and my breathing continued to get worse. Patient called 111 and an ambulance was immediately despatched. Pain was so intense in that region patient was having a heart attack. Paramedics did an ECG and checked my oxygen levels, all of which were ok. Was taken to hospital for further checks. Xray and bloods all came back negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. CC: This is a regulatory case concerning a 54-year-old female patient with asthma and previos anaphylactic reaction to sea food, who experienced the serious unexpected event chest pain, the next following day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca and Tozineram). . Patient experienced sudden chest pain, in "heart region", and difficulty breathing. Was transferred to the hospital: oxygen levels, x-ray and blood work showed no abnormalities. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 54-year-old female patient with asthma and previos anaphylactic reaction to sea food, who experienced the serious unexpected event chest pain, the next following day after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca and Tozineram). . Patient experienced sudden chest pain, in "heart region", and difficulty breathing. Was transferred to the hospital: oxygen levels, x-ray and blood work showed no abnormalities. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-11-23
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20211234114

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, LT-SMCA-6862N] concerned a 41 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, dose series in number 1, 1 total, administered on 20-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-NOV-2021, the patient experienced vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1957633 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Sexual dysfunction (broad)

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

Write-up: Paresthesia (touch, pain, cold and hot sensation); Numbness of limbs; Weakness of limbs; Facial palsy; This regulatory authority case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Paresthesia (touch, pain, cold and hot sensation)), HYPOAESTHESIA (Numbness of limbs), MUSCULAR WEAKNESS (Weakness of limbs) and FACIAL PARALYSIS (Facial palsy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced PARAESTHESIA (Paresthesia (touch, pain, cold and hot sensation)) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness of limbs) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Facial palsy) (seriousness criterion hospitalization). At the time of the report, PARAESTHESIA (Paresthesia (touch, pain, cold and hot sensation)), HYPOAESTHESIA (Numbness of limbs), MUSCULAR WEAKNESS (Weakness of limbs) and FACIAL PARALYSIS (Facial palsy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs were reported. No treatment information was reported. On 19 NOV 2021 patient had received the first dose of Moderna COVID-19 Vaccine. On 23 NOV 2021 patient came to the Emergency Department of hospital, and the chief complaint was numbness in the left face and numbness in the left upper limb for several days, and mild numbness in the left lower limb. He was admitted to out hospital for observation and treatment. The follow-up care was as follows. On 01 DEC 2021 we contacted the patient, who had been discharged from hospital on 29 NOV 2021. At present, his right face developed hemiplegia and his right eye could not be completely closed. He was followed up by the Outpatient Department and under rehabilitation at Rehabilitation Department. He was offered vicp application health education. Company comment: This case concerns a 44-year-old female patient, with no reported medical history, who experienced the unexpected serious events of PARAESTHESIA, HYPOAESTHESIA, MUSCULAR WEAKNESS and the expected serious event of FACIAL PARALYSIS. The events occurred approximately 4 days after the administration of the first dose of mRNA-1273 vaccine. Patient was hospitalized for approximately 7 days. At present, his right face developed hemiplegia and his right eye could not be completely closed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient, with no reported medical history, who experienced the unexpected serious events of PARAESTHESIA, HYPOAESTHESIA, MUSCULAR WEAKNESS and the expected serious event of FACIAL PARALYSIS. The events occurred approximately 4 days after the administration of the first dose of mRNA-1273 vaccine. Patient was hospitalized for approximately 7 days. At present, his right face developed hemiplegia and his right eye could not be completely closed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957646 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Pruritus; Skin rashes (non-injection site); This regulatory authority case was reported by an other health care professional and describes the occurrence of PRURITUS (Pruritus) and RASH (Skin rashes (non-injection site)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PRURITUS (Pruritus) (seriousness criterion hospitalization) and RASH (Skin rashes (non-injection site)) (seriousness criterion hospitalization). At the time of the report, PRURITUS (Pruritus) and RASH (Skin rashes (non-injection site)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information include Acetaminophen and Allegra 60 mg Company Comment: This case concerns a 54-year-old, female patient with no medical history, who experienced the unexpected events of Pruritus and Rash. The events occurred approximately 9 days after a dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of report the outcome of the events was not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 54-year-old, female patient with no medical history, who experienced the unexpected events of Pruritus and Rash. The events occurred approximately 9 days after a dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of report the outcome of the events was not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1957671 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-03
Onset:2021-11-23
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cognitive disorder
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life 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: Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Cognitive impairment of the brain; This regulatory authority case was reported by an other health care professional and describes the occurrence of COGNITIVE DISORDER (Cognitive impairment of the brain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Blood pressure high. On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced COGNITIVE DISORDER (Cognitive impairment of the brain) (seriousness criterion hospitalization). At the time of the report, COGNITIVE DISORDER (Cognitive impairment of the brain) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medication was provided. On 03 Oct 2021, patient administered 2nd dose of the Moderna vaccine and on 13 Oct 2021, the patient started to forget to turn off taps. On 20 Oct 2021, the patient often got time mixed up, bathed a few times a day, washed clothes repeatedly, and did not know how to wear clothes and socks. On 06 Nov 2021, the patient registered for neurology outpatient at hospital and was scheduled for magnetic resonance imaging but the report required 1 week. Therefore, the patient went to the emergency department of hospital on 06 Nov 2021. The computed tomography report was normal and the patient returned home. The patient''s condition worsened on 11 Nov 2021 and he registered at the neurology outpatient of hospital and was scheduled for magnetic resonance imaging. The patient developed urinary incontinence on 12 Nov 2021 and immediately went to the emergency department of hospital on 13 Nov 2021. It was reported that the patient was hospitalized until 19 Nov 2021 and was not discharged. Currently, blood test report showed that red blood cell, white blood cell, and platelet counts were normal and relevant examinations were being performed. The patient called a regulatory authority for notification. This case concerns a 77-year-old, male patient, with no relevant medical history, who experienced the serious, unexpected event of cognitive disorder. The patient started to have symptoms 10 days after the second dose of mRNA 1273 vaccine when he forgot to turn off the taps, then 17 days after the vaccine the patient often got time mixed up, bathed a few times a day, washed clothes repeatedly, and did not know how to wear clothes and socks. The patient consulted a neurology department outpatient clinic and was advised to have a MRI, but because of the long wait, the patient instead visited the emergency department 34 days after the vaccine. A computed tomography was done, it was normal and patient went home. Patient again consulted the neurology clinic, and was scheduled for MRI. However prior to the MRI, patient developed urinary incontinence 40 days after the vaccine and was admitted to the hospital the next day. Blood works showed normal RBC, WBC and platelets, other examinations performed were not provided and as of receipt of report, patient is still admitted. The patient''s age remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 77-year-old, male patient, with no relevant medical history, who experienced the serious, unexpected event of cognitive disorder. The patient started to have symptoms 10 days after the second dose of mRNA 1273 vaccine when he forgot to turn off the taps, then 17 days after the vaccine the patient often got time mixed up, bathed a few times a day, washed clothes repeatedly, and did not know how to wear clothes and socks. The patient consulted a neurology department outpatient clinic and was advised to have a MRI, but because of the long wait, the patient instead visited the emergency department 34 days after the vaccine. A computed tomography was done, it was normal and patient went home. Patient again consulted the neurology clinic, and was scheduled for MRI. However prior to the MRI, patient developed urinary incontinence 40 days after the vaccine and was admitted to the hospital the next day. Blood works showed normal RBC, WBC and platelets, other examinations performed were not provided and as of receipt of report, patient is still admitted. The patient''s age remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1957689 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 072F21A-1101207 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Hyperhidrosis, Nausea, Pyrexia
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), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Chills; Fever; Nausea; Excessive sweating; Dizziness, chest tightness, shortness of breath; Dizziness, chest tightness, shortness of breath; Dizziness, chest tightness, shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HYPERHIDROSIS (Excessive sweating), DIZZINESS (Dizziness, chest tightness, shortness of breath), CHEST DISCOMFORT (Dizziness, chest tightness, shortness of breath) and DYSPNOEA (Dizziness, chest tightness, shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072F21A-1101207-CDC) for an unknown indication. Concurrent medical conditions included Seafood allergy. On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), HYPERHIDROSIS (Excessive sweating) (seriousness criterion hospitalization), DIZZINESS (Dizziness, chest tightness, shortness of breath) (seriousness criterion hospitalization), CHEST DISCOMFORT (Dizziness, chest tightness, shortness of breath) (seriousness criterion hospitalization) and DYSPNOEA (Dizziness, chest tightness, shortness of breath) (seriousness criterion hospitalization). At the time of the report, CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HYPERHIDROSIS (Excessive sweating), DIZZINESS (Dizziness, chest tightness, shortness of breath), CHEST DISCOMFORT (Dizziness, chest tightness, shortness of breath) and DYSPNOEA (Dizziness, chest tightness, shortness of breath) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient received the first dose of COVID-19 Moderna vaccine on 22 Jul 2021 and complained that he developed pain on the site of administration. The patient received the second dose of COVID-19 Moderna vaccine at 11:00 am on 23 Nov 2021 (despite SBP of 200mmHg measured by the clinic, he received the vaccine). At about 12 noon, the patient developed dizziness, chest tightness, wheezing, and nausea. The patient received acetaminophen first at noon, received acetaminophen again at 4:00 pm, and received acetaminophen again at 11:00 pm. On 24 Nov 2021, at 1-2 am in the morning, the patient developed high fever and chills without receiving medication again. On 25 Nov 2021, at 5-6 in the morning the patient visited the emergency department of the hospital, and was diagnosed with hypertension and hydronephrosis. On 26 Nov 2021, the patient was hospitalized and continued treatment. As the physician could not rule out the cause of the vaccine, ADR was reported. Company Comment: This case concerns a 54-year-old female subject, with no relevant medical history, who experienced the unexpected and serious events of Chills, Pyrexia, Nausea, Hyperhidrosis, Dizziness, Chest discomfort, and Dyspnoea. Hypertension and Hydronephrosis were also events experienced by de patient, and that lead to hospitalization. The events occurred the same day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 54-year-old female subject, with no relevant medical history, who experienced the unexpected and serious events of Chills, Pyrexia, Nausea, Hyperhidrosis, Dizziness, Chest discomfort, and Dyspnoea. Hypertension and Hydronephrosis were also events experienced by de patient, and that lead to hospitalization. The events occurred the same day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1958119 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Pain, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 202111; Test Name: Body temperature; Result Unstructured Data: Approximately 40 degrees Celsius.
CDC Split Type: CZJNJFOC20211235652

Write-up: PANTALGIA; PAINFUL ARM; VOMITING; FEVER; JOINT PAIN; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, CZ-CZSUKL-21012689] concerned a 25 year old female of unspecified race and ethnicity. The patient''s weight was 60 kilograms, and height was 160 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total administered on 23-NOV-2021 for covid-19 vaccination (dose number in series 1). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On NOV-2021, Laboratory data included: Body temperature (NR: not provided) approximately 40 degrees Celsius. On 23-NOV-2021, the patient experienced pantalgia, painful arm, vomiting, fever, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pantalgia, vomiting, fever, and joint pain on 25-NOV-2021, and painful arm on 27-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1959971 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Heart rate, Heart rate increased, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:220; Test Name: heart rate; Result Unstructured Data: Test Result:normal
CDC Split Type: FIPFIZER INC202101729159

Write-up: Arrhythmia; Heart rate increased; seizure; This is a spontaneous report received from a contactable Consumer (patient) from the Regulatory Authority-WEB. Regulatory number: FI-FIMEA-20217281. A 25-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administration date Nov2021 (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: ARRHYTHMIA (life threatening) with onset 23Nov2021, outcome "recovering", described as "Arrhythmia"; HEART RATE INCREASED (life threatening) with onset 23Nov2021, outcome "recovering", described as "Heart rate increased"; SEIZURE (life threatening) with onset 23Nov2021, outcome "unknown", described as "seizure". The patient underwent the following laboratory tests and procedures: heart rate: 220; normal. Therapeutic measures were taken as a result of arrhythmia, heart rate increased including cardioversion. The course of the events was reported as follows: Very severe arrhythmia seizure, ambulance called. The cause of arrhythmia is unclear, the first vaccination received 3 weeks ago and I do not dare to take the second vaccination anymore. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1959976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0004 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Atrial fibrillation, Blood pressure measurement, Coma scale, Electrocardiogram, Glycosylated haemoglobin, Heart rate, Immunisation, Ischaemic stroke, Low density lipoprotein, Magnetic resonance imaging, Magnetic resonance imaging head, NIH stroke scale, Neurological examination, Oxygen saturation
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiovascular disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: cerebral CT angiogram with study of the supra-aortic trunks; Result Unstructured Data: Test Result:finding stenosis at 70% on the right and 50% on th; Comments: finding stenosis at 70% on the right and 50% on the left; Test Date: 20211124; Test Name: hypertensive surge; Result Unstructured Data: Test Result:209/93; Comments: hypertensive crisis; Test Date: 20211124; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20211124; Test Name: ECG; Result Unstructured Data: Test Result:not found a trace in paroxysmal atrial fibrillatio; Comments: not found a trace in paroxysmal atrial fibrillation; Test Date: 20211124; Test Name: HbA1c; Test Result: 5.8 %; Test Date: 20211124; Test Name: pulse; Result Unstructured Data: Test Result:68; Test Date: 20211124; Test Name: LDLc cholesterol; Result Unstructured Data: Test Result:2.13 x10 9/l; Test Date: 20211124; Test Name: MRI; Result Unstructured Data: Test Result:found a trace in paroxysmal atrial fibrillation; Comments: found a trace in paroxysmal atrial fibrillation; Test Date: 20211124; Test Name: cerebral MRI; Result Unstructured Data: Test Result:finding several infarcts on the right carotid terr; Comments: finding several infarcts on the right carotid territory; Test Date: 20211124; Test Name: neurological examination; Result Unstructured Data: Test Result:Strictly normal neurological examination without a; Comments: Strictly normal neurological examination without any neurological deficit; Test Date: 20211124; Test Name: neurological examination; Result Unstructured Data: Test Result:found weakness of the left upper limb, dysarthria; Comments: On arrival : found weakness of the left upper limb, dysarthria and left facial deviation.; Test Date: 20211125; Test Name: NIHSS; Result Unstructured Data: Test Result:5; Test Date: 20211124; Test Name: saturation; Test Result: 97 %; Comments: AA (ambient air)
CDC Split Type: FRPFIZER INC202101762510

Write-up: Ischemic stroke; Paroxysmal atrial fibrillation; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-AN20214635. A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Nov2021 (Lot number: PCA0004) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "cardiovascular history" (unspecified if ongoing). Concomitant medication(s) included: LERCANIDIPINE. Vaccination history included: Covid-19 vaccine (Dose 1, Lot: unknown, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Lot: unknown, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ISCHAEMIC STROKE (hospitalization, life threatening) with onset 24Nov2021, outcome "recovering", described as "Ischemic stroke"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 24Nov2021, outcome "recovered" (24Nov2021), described as "Paroxysmal atrial fibrillation"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster". The patient was hospitalized for ischaemic stroke, atrial fibrillation (start date: 24Nov2021). The patient underwent the following laboratory tests and procedures: angiogram: (24Nov2021) finding stenosis at 70% on the right and 50% on th, notes: finding stenosis at 70% on the right and 50% on the left; blood pressure measurement: (24Nov2021) 209/93, notes: hypertensive crisis; coma scale: (24Nov2021) 15; electrocardiogram: (24Nov2021) not found a trace in paroxysmal atrial fibrillatio, notes: not found a trace in paroxysmal atrial fibrillation; glycosylated haemoglobin: (24Nov2021) 5.8 %; heart rate: (24Nov2021) 68; low density lipoprotein: (24Nov2021) 2.13 x10 9/l; magnetic resonance imaging: (24Nov2021) found a trace in paroxysmal atrial fibrillation, notes: found a trace in paroxysmal atrial fibrillation; magnetic resonance imaging head: (24Nov2021) finding several infarcts on the right carotid terr, notes: finding several infarcts on the right carotid territory; neurological examination: (24Nov2021) strictly normal neurological examination without a, notes: Strictly normal neurological examination without any neurological deficit; (24Nov2021) found weakness of the left upper limb, dysarthria, notes: On arrival : found weakness of the left upper limb, dysarthria and left facial deviation; nih stroke scale: (25Nov2021) 5; oxygen saturation: (24Nov2021) 97 %, notes: AA (ambient air). Therapeutic measures were taken as a result of ischaemic stroke, atrial fibrillation. Additional information: On the morning of 24Nov the patient presented with a sudden onset left brachio-facial deficit for which he was urgently hospitalized. Physical examination: No longer had speech disorders, facial paralysis was almost invisible and then disappeared. Trictly normal neurological examination without any neurological deficit. Treatment and evolution: On arrival the patient had correct constants, a neurological examination found weakness of the left upper limb, dysarthria and left facial deviation. The scope carried out during the MRI found a trace in paroxysmal atrial fibrillation, but not found on the ECG subsequently taken in the box. Initiation of treatment with KARDEGIC 160mg + atorvastatin 80mg. The patient was then transferred to intensive care for the continuation of the management in particular of the carotid artery. 25Nov2021: Pending endarterectomy. 03Dec2021: Right carotid endarterectomy by eversion. Conclusion: Patient with a history of cardiovascular disease who presents with a stroke the day after the third dose of COMIRNATY vaccine. Notion of paroxysmal AF over the period. Atheromatous patient, endarterectomy performed. Summary: Patient with a cardiovascular history who presents with a stroke the day after the third dose of COMIRNATY vaccine.


VAERS ID: 1960056 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8713 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Headache, Malaise, Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pruritus
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; CANDESARTAN CILEXETIL; CETIRIZINE HYDROCHLORIDE; LOSEC [OMEPRAZOLE]; MOMETASONE FUROATE
Current Illness: Allergy (all year.); Drug hypersensitivity (sensitive to many things including medications)
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever (all year)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 100
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Pain in arm; Unwell; Terrible pain in every joint, every movement agony; Fever; General body pain; Headache; Nausea; Vaccination site bleeding; Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.; Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.; Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26281169) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.), ARTHRALGIA (Terrible pain in every joint, every movement agony), PYREXIA (Fever), PAIN (General body pain), HEADACHE (Headache), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), MALAISE (Unwell), VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding), VACCINATION SITE BRUISING (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) and VACCINATION SITE PRURITUS (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) in a 67-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for Ill-defined disorder. Co-suspect product included non-company product TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for COVID-19 vaccination. The patient''s past medical history included Hay fever (all year). Concurrent medical conditions included Allergy (all year.) and Drug hypersensitivity (sensitive to many things including medications). Concomitant products included BISOPROLOL FUMARATE, CANDESARTAN CILEXETIL, CETIRIZINE HYDROCHLORIDE, OMEPRAZOLE (LOSEC [OMEPRAZOLE]) and MOMETASONE FUROATE for an unknown indication. On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) at an unspecified dose. On an unknown date, received dose of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) dosage was changed to at an unspecified dose. On 23-Nov-2021, the patient experienced PARAESTHESIA ORAL (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding) (seriousness criterion medically significant), VACCINATION SITE BRUISING (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ARTHRALGIA (Terrible pain in every joint, every movement agony) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant) and MALAISE (Unwell) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 24-Nov-2021, PARAESTHESIA ORAL (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) had resolved with sequelae. On 25-Nov-2021, ARTHRALGIA (Terrible pain in every joint, every movement agony) had resolved. At the time of the report, PYREXIA (Fever), PAIN (General body pain), HEADACHE (Headache), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), MALAISE (Unwell) and VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding) outcome was unknown and VACCINATION SITE BRUISING (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) and VACCINATION SITE PRURITUS (Upper Lips Tingle, itchy arm, still itchy after 1week. Bruised arm from injection.) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100. mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) dosing remained unchanged. No treatment medications were provided. Patient stated she had no reaction for Pfizer vaccine Company Comment: This RA case concerns a 67 year old female with relevant medical history of Hay fever, allergy , drug hypersensitivity, vaccinated initially with two doses of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) , who experienced Serious ( medically significant ) , unexpected events of headache, vaccination site hemorrhage, nausea, paresthesia oral , vaccination site brusing , vaccination site pruritus which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The day after the vaccination with the 3rd dose she experienced Serious ( medically significant ) , Unexpected events of Arthralgia , pyrexia , pain, malaise , pain in extremity . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 67 year old female with relevant medical history of Hay fever, allergy , drug hypersensitivity, vaccinated initially with two doses of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) , who experienced Serious ( medically significant ) , unexpected events of headache, vaccination site hemorrhage, nausea, paresthesia oral , vaccination site brusing , vaccination site pruritus which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The day after the vaccination with the 3rd dose she experienced Serious ( medically significant ) , Unexpected events of Arthralgia , pyrexia , pain, malaise , pain in extremity . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1960079 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain, Chest pain, Chills, Cough, Ear pain, Fatigue, Headache, Myalgia, Pain, Pain in extremity, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: pain; Swollen arm; Headache; Breast pain; Sore feet; Muscle ache; Chest ache; Earache; Cough; Shivering; Tiredness; This case was received via European Medicines Agency (Reference number: GB-MHRA-ADR 26247489) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Tiredness), BREAST PAIN (Breast pain), CHILLS (Shivering), PAIN IN EXTREMITY (Sore feet), MYALGIA (Muscle ache), CHEST PAIN (Chest ache), EAR PAIN (Earache), COUGH (Cough), PAIN (pain) and PERIPHERAL SWELLING (Swollen arm) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Asthma (Have poorly controlled asthma). On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant) and COUGH (Cough) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BREAST PAIN (Breast pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore feet) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHEST PAIN (Chest ache) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Tiredness), PAIN IN EXTREMITY (Sore feet), MYALGIA (Muscle ache), CHEST PAIN (Chest ache), COUGH (Cough), PAIN (pain) and PERIPHERAL SWELLING (Swollen arm) had not resolved, BREAST PAIN (Breast pain) and EAR PAIN (Earache) was resolving and CHILLS (Shivering) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Company comment: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of HEADACHE, FATIGUE, PAIN IN EXTREMITY, MYALGIA, CHEST PAIN, COUGH, PAIN, PERIPHERAL SWELLING, EAR PAIN, BREAST PAIN and CHILLS. The events FATIGUE, COUGH, EAR PAIN and CHILLS occurred on the same day of the third dose of the mRNA-1273 vaccine, and the events HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY, MYALGIA, CHEST PAIN, PERIPHERAL SWELLING and BREAST PAIN occurred on the following day of the third dose of the mRNA-1273 vaccine. And the event PAIN occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown by Regulatory Authority, it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of HEADACHE, FATIGUE, PAIN IN EXTREMITY, MYALGIA, CHEST PAIN, COUGH, PAIN, PERIPHERAL SWELLING, EAR PAIN, BREAST PAIN and CHILLS. The events FATIGUE, COUGH, EAR PAIN and CHILLS occurred on the same day of the third dose of the mRNA-1273 vaccine, and the events HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY, MYALGIA, CHEST PAIN, PERIPHERAL SWELLING and BREAST PAIN occurred on the following day of the third dose of the mRNA-1273 vaccine. And the event PAIN occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown by Regulatory Authority, it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1960206 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Feeling hot, Malaise, Pallor, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Fit and healthy.
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101732158

Write-up: Tachycardia; Feeling sick; Feeling hot; Pale skin; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112032137109140-PDNP1. Other Case identifier(s): GB-MHRA-ADR 26288330. A male patient received BNT162b2 (COMIRNATY), on 23Nov2021 (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history, the patient was fit and healthy. The patient''s concomitant medications were not reported. The patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, was not enrolled in a clinical trial. The patient experienced feeling sick, feeling hot, and pale skin from 23Nov2021, and tachycardia from 24Nov2021. The patient attended A&E for ECG on an unspecified date in Nov2021. The patient recovered from tachycardia, feeling hot, and pale skin on 26Nov2021, and was recovering from feeling sick. The case was reporting as serious due to medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960235 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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; Test Result: Negative
CDC Split Type: GBPFIZER INC202101731973

Write-up: Muscle pain; 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-202112040913326360-8HYMD. Other Case identifier(s): GB-MHRA-ADR 26288615. A female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, lot number unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Muscle pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ALOR96 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Dry mouth, Immunisation, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101731591

Write-up: Swollen neck glands; The patient received third (booster) dose; dry mouth; Dehydration; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112041754024320-OUPLZ (RA). Other Case identifier(s): GB-MHRA-ADR 26289178 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: Alor96) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date was 22Nov2021. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "The patient received third (booster) dose"; DRY MOUTH (medically significant) with onset 2021, outcome "not recovered", described as "dry mouth"; LYMPHADENOPATHY (medically significant) with onset 24Nov2021, outcome "recovered" (30Nov2021), described as "Swollen neck glands"; DEHYDRATION (medically significant) with onset 2021, outcome "unknown", described as "Dehydration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient did not test positive for COVID-19 since having the vaccine Clinical course: 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: 1960358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INDAPAMIDE; IRBESARTAN; LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101732168

Write-up: headache; Swollen lymph nodes; Migraine type headaches; Chills; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable Consumer or other non HCP from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112051243118840-GGDQB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26291050 (MHRA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medications included: INDAPAMIDE taken for hypertension; IRBESARTAN taken for hypertension; LEVOTHYROXINE taken for hypothyroidism; METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "unknown", described as "headache"; LYMPHADENOPATHY (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; MIGRAINE (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Migraine type headaches"; CHILLS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of headache as sumatriptan was prescribed on 03Dec2021. Clinical course: Patient has not had symptoms associated with COVID-19. Blood test arranged. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960485 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Influenza like illness, Loss of consciousness, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Feverish; Sweating; Flu like symptoms; Giddiness; Fever; Loss of consciousness; Fatigue; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26296020) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Giddiness), PYREXIA (Fever), LOSS OF CONSCIOUSNESS (Loss of consciousness), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS (Giddiness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). On 23-Nov-2021, DIZZINESS (Giddiness), PYREXIA (Fever) and LOSS OF CONSCIOUSNESS (Loss of consciousness) had resolved. On 25-Nov-2021, NAUSEA (Nausea) had resolved. On 26-Nov-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PYREXIA (Feverish), HYPERHIDROSIS (Sweating) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication include Paracetamol. It was reported that patient had flu like symptoms and fatigue 21 hours after the vaccine. Slept for 3 hours , got up, giddy, feverish, then sweating so much it was running off the chin, collapsed on bed, unable to move for 3hrs, drifting in and out of consciousness. Patient was unable to move to get paracetamol initially then take paracetamol after 3 hours. Next day she had extreme fatigue, total loss of appetite and joint pains. Fatigue continued next day also but appetite improved slightly. Unsure if patient has had symptoms associated with COVID-19 but not had any heart related inflammation. Company comment: This case concerns a 62-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of dizziness, pyrexia(two events), loss of consciousness, fatigue, nausea, hyperhidrosis and influenza like illness. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the patient had flu like symptoms and fatigue 21 hours after the vaccine. Patient slept for 3 hours, got up, giddy, feverish, then sweating so much it was running off the chin, collapsed on bed, unable to move for 3hrs, drifting in and out of consciousness. Patient was unable to move to get paracetamol initially then took paracetamol after 3 hours. Next day she had extreme fatigue, total loss of appetite and joint pains. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 62-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of dizziness, pyrexia(two events), loss of consciousness, fatigue, nausea, hyperhidrosis and influenza like illness. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the patient had flu like symptoms and fatigue 21 hours after the vaccine. Patient slept for 3 hours, got up, giddy, feverish, then sweating so much it was running off the chin, collapsed on bed, unable to move for 3hrs, drifting in and out of consciousness. Patient was unable to move to get paracetamol initially then took paracetamol after 3 hours. Next day she had extreme fatigue, total loss of appetite and joint pains. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1960632 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: Allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Near fainting; Shoulder pain; This case was received via Regulatory authority-RA (Reference number: GB-MHRA-ADR 26299448) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRESYNCOPE (Near fainting) and ARTHRALGIA (Shoulder pain) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Previously administered products included for Product used for unknown indication: ASPIRIN. Past adverse reactions to the above products included Allergy with ASPIRIN. Concurrent medical conditions included Allergy. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 23-Nov-2021, PRESYNCOPE (Near fainting) had resolved. On 05-Dec-2021, ARTHRALGIA (Shoulder pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant drug details not provided. Patient did not have an adverse reaction to a vaccine before. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Shoulder pain came on suddenly at approximately at 6 a.m. on day after vaccination. Pain was quite severe and treated with paracetamol. Pain decreased over following 4 days but dull ache continued until 5 December. When patient tried to get out of bed on the morning after vaccination (approximately at 7 a.m.), felt extremely faint and had to lie down to avoid passing out. Patient tried repeatedly to get up but the same thing happened each time. This passed at approximately 1 p.m.. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Arthralgia and Presyncope. The events, which were medically significant, occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Arthralgia and Presyncope. The events, which were medically significant, occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1960754 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006321 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, Ischaemia, Skin burning sensation
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Noninfectious encephalopathy/delirium (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: LISINOPRIL; ALPRAZOLAM; TIKLID; ZARELIS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia; one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia; one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia; This case was received via regulatory authority (Reference number: IT-MINISAL02-815260) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ISCHAEMIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia), AMNESIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) and SKIN BURNING SENSATION (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006321) for COVID-19 vaccination. Concomitant products included LISINOPRIL, ALPRAZOLAM, TICLOPIDINE HYDROCHLORIDE (TIKLID) and VENLAFAXINE HYDROCHLORIDE (ZARELIS) for an unknown indication. On 23-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced ISCHAEMIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) (seriousness criterion disability), AMNESIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) (seriousness criterion disability) and SKIN BURNING SENSATION (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) (seriousness criterion disability). At the time of the report, ISCHAEMIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia), AMNESIA (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) and SKIN BURNING SENSATION (one hour after the third dose of Moderna vaccine, I had memory loss. Night and morning burns all over the body, ischemia) had not resolved. Treatment details not provided. Company comment: This is a regulatory case concerns a 73-year-old, male patient with medical history of angina pectoris, who experienced the unexpected, serious (Disabling) events of amnesia, skin burning sensation and ischaemia. The patient experienced one hour after the third dose of mRNA-1273 vaccine memory loss, night and morning burns all over his body and ischemia. The rechallenge was not applicable, as no additional dose information was disclosed. Memory impairment is listed for concomitant alprazolam. The medical history of angina pectoris remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.; Reporter''s Comments: No particular pathology. I suffer from angina pectoris occasionally; Sender''s Comments: This is a regulatory case concerns a 73-year-old, male patient with medical history of angina pectoris, who experienced the unexpected, serious (Disabling) events of amnesia, skin burning sensation and ischaemia. The patient experienced one hour after the third dose of mRNA-1273 vaccine memory loss, night and morning burns all over his body and ischemia. The rechallenge was not applicable, as no additional dose information was disclosed. Memory impairment is listed for concomitant alprazolam. The medical history of angina pectoris remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.


VAERS ID: 1960775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 3 LA / 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: ITPFIZER INC202101730441

Write-up: booster; OTHER, DEEP VEIN THROMBOSIS; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-816624 (RA). A 60 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Nov2021 11:51 (Lot number: FG6273, Expiration Date: 28Feb2022) 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), outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 23Nov2021, outcome "unknown", described as "OTHER, DEEP VEIN THROMBOSIS". No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Inoculation site: DELTOID LEFT


VAERS ID: 1960785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Oropharyngeal pain, Pruritus, Rhinitis, Tracheitis, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Fruit allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101774192

Write-up: severe headache; Every now and then I feel that I begin to tremble all over my body; Itchy nose, throat, ears; acute rhinitis; tracheitis; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-818521 Regulatory Authority. A 46 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Nov2021 11:10 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "pollen allergy" (unspecified if ongoing); "allergy to nuts" (unspecified if ongoing); "allergy to fruits" (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. The following information was reported: PRURITUS (life threatening) with onset 23Nov2021 09:00, outcome "recovering", described as "Itchy nose, throat, ears"; RHINITIS (life threatening) with onset 23Nov2021 09:00, outcome "recovering", described as "acute rhinitis"; TRACHEITIS (life threatening) with onset 23Nov2021 09:00, outcome "recovering", described as "tracheitis"; OROPHARYNGEAL PAIN (life threatening) with onset 23Nov2021 09:00, outcome "recovering", described as "Sore throat"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; TREMOR (non-serious), outcome "unknown", described as "Every now and then I feel that I begin to tremble all over my body". The events "itchy nose, throat, ears", "acute rhinitis", "tracheitis", "sore throat", "severe headache" and "every now and then i feel that i begin to tremble all over my body" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, rhinitis, tracheitis, oropharyngeal pain, headache, tremor. Clinical information: Actions taken (I took cortisone and went to the emergency room). Senders comment: Regulatory Authority: requests for further information Reporter Comment: I''ve been to the Emergency room; I developed allergic rhinitis, tracheitis and severe headache. Every now and then I feel that I begin to tremble all over my body, my nose is often blocked and when I blow my nose there is blood on my handkerchief. - Influenza vaccination was not carried out - Concomitant conditions: Allergies - Allergies: Fruit, nuts, pollen - Reaction time: 09:00 - Agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: I''ve been to the Emergency room; I developed allergic rhinitis, tracheitis and severe headache. Every now and then I feel that I begin to tremble all over my body, my nose is often blocked and when I blow my nose there is blood on my handkerchief. - Influenza vaccination was not carried out - Concomitant conditions: Allergies - Allergies: Fruit, nuts, pollen - Reaction time: 09:00 - Agency


VAERS ID: 1960817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6272 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Pharyngeal paraesthesia, Throat irritation
SMQs:, Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BELLOZAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fruit allergy (Kiwi allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUPFIZER INC202101730903

Write-up: Throat irritation; tingling in the throat; Allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Physician) from the the regulatory authority. Regulatory number: LU-ALMPS-202103195 (RA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 11:49 (Lot number: FG6272) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Kiwi allergy. Concomitant medication(s) included: BELLOZAL taken for allergy prophylaxis, start date: Nov2021, stop date: Nov2021. The following information was reported: THROAT IRRITATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Throat irritation"; PHARYNGEAL PARAESTHESIA (medically significant) with onset 23Nov2021, outcome "unknown", described as "tingling in the throat"; HYPERSENSITIVITY (medically significant) with onset 23Nov2021, outcome "unknown", described as "Allergic reaction". During the 15 minutes of monitoring, the patient had no particular reaction. However, 30 minutes later, the patient experienced the allergic reaction with tingling in the throat, pharyngeal irritation. Therapeutic measures were taken as a result of the events and it included MEDROL. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960840 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Dyspnoea, Electrocardiogram, Hyperhidrosis, Lip swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: ECG; Result Unstructured Data: Test Result:results not reported; Comments: at least an EKG has been made in the emergency room; but the results were not reported
CDC Split Type: NLPFIZER INC202101734001

Write-up: Apnea: approx. 5 minutes after the vaccination, the patient was gasping for breath; Ran purple red when gasping for breath; When gasping for breath, first the lower lip and then the upper lip began to swell; sweated profusely; This is a spontaneous report received from a contactable reporter (Physician) from the Agency Regulatory Authority-WEB. Regulatory number: NL-LRB-00717926 Agency Regulatory Authority. This is the second of two reports. A 28-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FG6273) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Historical vaccine includes: Biontech/pfizer vaccin (comirnaty), start date: 26Oct2021, stop date: 26Oct2021, for covid-19 immunisation, reaction(s): "tendency to faint" Notes: Dose 1 (also reported as presyncope) and " Shortness of breath " notes: Dose 1. It was reported that the patient experienced Apnea: approx. 5 minutes after the vaccination, the patient was gasping for breath (DYSPNOEA (life threatening) with onset 23Nov2021, outcome "unknown"). It was added about 5 minutes after the vaccination, the patient was gasping for breath, turned purple (also reported as Ran purple red when gasping for breath; CYANOSIS (life threatening) with onset 23Nov2021, outcome "unknown") and sweated profusely (HYPERHIDROSIS (life threatening) with onset 23Nov2021, outcome "unknown"). When gasping for breath, first the lower lip and then the upper lip began to swell (LIP SWELLING (life threatening) with onset 23Nov2021 (also reported 6 minutes after start), outcome "unknown"). The patient underwent the following laboratory tests and procedures: electrocardiogram: (23Nov2021) results not reported (at least an EKG has been made in the emergency room; but the results were not reported). The events were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dyspnoea, cyanosis, lip swelling, hyperhidrosis which includes Epipen and Tavegil. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101746345 same patient, same vaccine, different dose and events


VAERS ID: 1961047 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (1PPD since 18 yr of age)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Myocarditis; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Smoker (1PPD since 18 yr of age) since 2010. On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 24-Nov-2021, Initially, patient noticed breathlessness during working which was not relieved with rest, as before. No associated chest pain was mentioned. Gradually, he noticed he could not lie flat to sleep and has to sit up after about 10 minutes. No obvious limbs swelling was noted. He mentioned about reduced urine amount with increased yellow color in recent one week. No loss of appetite or abdominal pain was mentioned. No fever in recent days. He complained of cough without sputum, especially at night in recent few days. patient had history of Moderna Vaccination(1st dose) on 11/20; and breathlessness had occurred before vaccination. He seeked advice at local clinic where suspected cardia problem and was referred to CMUH for further evaluation. On arrival to ER, CXR showed diffuse bilateral infiltrates and cardiomegaly. Mild elevation of TropI and NT-proBNP was noted. Acute pulmonary edema was noted and NTG, Lasix was used. CT aorta: no pulmonary embolism or aortic dissection. The patient was admitted to CCU for intensive care, with suspected myocarditis and acute pulmonary edema since 11/24.On 30-Nov afternoon, a cardiac catheterization will be arranged to find out the cause. Patient height: 176 cm, weight: 101 kg and BMI 32.6 Lab data: CXR showed diffuse bilateral infiltrates and cardiomegaly. Mild elevation of TropI and NT-proBNP was noted. Acute pulmonary edema was noted and NTG, Lasix was used. CT aorta: no pulmonary embolism or aortic dissection. Company Comment This case concerns a 29 year old male, smoker (1PPD since 18 yrs old) no reported chronic disease, who experienced serious expected event of myocarditis. Three (3) days after the first dose of mRNA 1273, patient started to feel dyspnea at work, orthopnea, decreased urine output and non-productive cough hence he went to the hospital. On arrival to the Emergency room, CXR showed diffuse bilateral infiltrates and cardiomegaly, there was mild elevation of Trop I and NT-proBNP was noted. Acute pulmonary edema was noted and patient was given diuretics and NTG. CT aorta showed no pulmonary embolism or aortic dissection. The patient was admitted to CCU, with suspected myocarditis and acute pulmonary edema 4 days after the vaccine. Patient will undergo a cardiac catheterization to find out the cause of the event. Patient''s history of chronic smoking remains a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29 year old male, smoker (1PPD since 18 yrs old) no reported chronic disease, who experienced serious expected event of myocarditis. Three (3) days after the first dose of mRNA 1273, patient started to feel dyspnea at work, orthopnea, decreased urine output and non-productive cough hence he went to the hospital. On arrival to the Emergency room, CXR showed diffuse bilateral infiltrates and cardiomegaly, there was mild elevation of Trop I and NT-proBNP was noted. Acute pulmonary edema was noted and patient was given diuretics and NTG. CT aorta showed no pulmonary embolism or aortic dissection. The patient was admitted to CCU, with suspected myocarditis and acute pulmonary edema 4 days after the vaccine. Patient will undergo a cardiac catheterization to find out the cause of the event. Patient''s history of chronic smoking remains a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1962586 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46671 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Ear pain, Fatigue, Headache, Influenza like illness, Myalgia, Pain in extremity, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; EVOREL CONTI; LANSOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Flu like symptoms; Exhaustion; Pain in arm; Earache; Muscle pain; Fever; Headache; Arthralgia; This case was received Reference number: GB-MHRA-ADR 26288578) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Arthralgia), EAR PAIN (Earache), FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. Concomitant products included LANSOPRAZOLE from 03-Jan-2011 to an unknown date for Acid reflux (esophageal), ESTRADIOL, NORETHISTERONE ACETATE (EVOREL CONTI) for Hysterectomy, AMITRIPTYLINE for Pain relief. On 09-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. In 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 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and ARTHRALGIA (Arthralgia) (seriousness criteria disability and medically significant). On 25-Nov-2021, the patient experienced EAR PAIN (Earache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criteria disability and medically significant), FATIGUE (Exhaustion) (seriousness criteria disability and medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criteria disability and medically significant). On 25-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain) and ARTHRALGIA (Arthralgia) was resolving, HEADACHE (Headache) and EAR PAIN (Earache) had not resolved and FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. No treatment information was provided. Patient experienced extreme exhaustion, pain in arm, flu like symptoms some of which were still with her 11 days after jab. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 50-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, EAR PAIN, FATIGUE, PAIN IN EXTREMITY, INFLUENZA LIKE ILLNESS, MYALGIA, PYREXIA and ARTHRALGIA. The events HEADACHE, MYALGIA, PYREXIA and ARTHRALGIA occurred on the same day the third dose of the mRNA-1273 vaccine. The event EAR PAIN occurred two days after the third dose of the mRNA-1273. The events FATIGUE, PAIN IN EXTREMITY and INFLUENZA LIKE ILLNESS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, EAR PAIN, FATIGUE, PAIN IN EXTREMITY, INFLUENZA LIKE ILLNESS, MYALGIA, PYREXIA and ARTHRALGIA. The events HEADACHE, MYALGIA, PYREXIA and ARTHRALGIA occurred on the same day the third dose of the mRNA-1273 vaccine. The event EAR PAIN occurred two days after the third dose of the mRNA-1273. The events FATIGUE, PAIN IN EXTREMITY and INFLUENZA LIKE ILLNESS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1962721 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-11-23
   Days after vaccination:259
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46672 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20201108; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; General body pain; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26311448) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (General body pain) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for COVID-19 vaccination. No medical history was reported. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 05-Oct-2021 to an unknown date for Flu prevention. On 09-Mar-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2021, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (General body pain) (seriousness criterion medically significant). On 24-Nov-2021, HEADACHE (Headache) and PAIN (General body pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 57-year-old male patient, with no medical history reported, who experienced the serious unexpected events of headache and pain after third dose of mRNA-1273. The events occurred two days after vaccination. It was reported that the patient was previously vaccinated with two doses of ASTRAZENECA COVID-19 VACCINE. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 57-year-old male patient, with no medical history reported, who experienced the serious unexpected events of headache and pain after third dose of mRNA-1273. The events occurred two days after vaccination. It was reported that the patient was previously vaccinated with two doses of ASTRAZENECA COVID-19 VACCINE. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1962886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-18
Onset:2021-11-23
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood test, Body temperature, C-reactive protein, Chest X-ray, Chest pain, Chills, Computerised tomogram, Cough, Dyspnoea, Euphoric mood, Fatigue, Fibrin D dimer, Heart rate, Heart rate increased, Nasopharyngitis, Pain in extremity, Polymerase chain reaction, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (On 14th December 2020)
Preexisting Conditions: Comments: Covid positive in December 2020,Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: Chest X-ray; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: CT scan; Result Unstructured Data: (Test Result:showed clots in both lower lobes of each lung.,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: (Test Result:raised,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: Fibrin D dimer; Result Unstructured Data: (Test Result:increased,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: PCR; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201217; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Yes - Positive COVID-19 test,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202125

Write-up: d dimmer elevated; sudden chest pain; Arthralgia; dry cough; fatigue; Nasopharyngitis; Pain in extremity; Dyspnoea; Heart rate increased; Pyrexia; Chills; Pulmonary embolus; This case received by Company via RA on 17th December 2021 This case was reported by a consumer via regulatory authority and described the occurrence of pulmonary embolus in a 37-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) (batch number FF8288, expiry date unknown) for prophylaxis. Previously administered products included COVID-19 MRNA VACCINE BIONTECH (1st dose received on 27th January 2021 with batch number EL0739) and COVID-19 MRNA VACCINE BIONTECH (2nd dose received on 16th March 2021 with batch number ER1749). Concurrent medical conditions included suspected covid-19 (On 14th December 2020). Additional patient notes included Covid positive in December 2020,Patient is not pregnant,Patient is not currently breastfeeding. On 18th October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (unknown) and the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 23rd November 2021, 36 days after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pulmonary embolus (serious criteria hospitalization, medically significant, life threatening and other: Serious as per reporter). In 2021, the patient experienced high feeling (serious criteria hospitalization, life threatening and other: Serious as per reporter), chest pain (serious criteria hospitalization, life threatening and other: Serious as per reporter), joint pain (serious criteria hospitalization, life threatening and other: Serious as per reporter), dry cough (serious criteria hospitalization, life threatening and other: Serious as per reporter), fatigue (serious criteria hospitalization, life threatening and other: Serious as per reporter), cold symptoms (serious criteria hospitalization, life threatening and other: Serious as per reporter), pain in arm (serious criteria hospitalization, life threatening and other: Serious as per reporter), shortness of breath (serious criteria hospitalization, life threatening and other: Serious as per reporter), heart rate high (serious criteria hospitalization, life threatening and other: Serious as per reporter), high temperature (serious criteria hospitalization, life threatening and other: Serious as per reporter) and shivering (serious criteria hospitalization, life threatening and other: Serious as per reporter). The patient was treated with medication unknown (Blood Thinner) and rivaroxaban. On an unknown date, the outcome of the pulmonary embolus was recovering/resolving and the outcome of the high feeling, chest pain, joint pain, dry cough and fatigue were not recovered/not resolved and the outcome of the cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering were unknown. It was unknown if the reporter considered the pulmonary embolus, high feeling, chest pain, joint pain, dry cough, fatigue, cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering to be related to Influenza vaccine Quadrivalent 2021-2022 season. Additional details were reported as follows: The age at vaccination was unknown. In 2021, the patient had COVID-19 virus test with result Negative COVID-19 test, Fibrin D dimer with result increased, C-reactive protein with result raised, CT scan showed clots in both lower lobes of each lung and Chest, X-ray and blood test with no result, body temperature and heart rate with result high and Polymerase chain reaction with result negative. On 17th December 2020, the Covid 19 test was performed with Positive COVID-19 test. The time to onset for the events high feeling, chest pain, joint pain, dry cough, fatigue, cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering was less than 2 months with respect to Influenza vaccine Quadrivalent 2021-2022 season and BIONTECH COVID-19 MRNA VACCINE. It was unknown if the reporter considered the pulmonary embolus, high feeling, chest pain, joint pain, dry cough, fatigue, cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering to be related to BIONTECH COVID-19 MRNA VACCINE . The concomitant BIONTECH COVID-19 MRNA VACCINE was captured as historical as per reported dates. The patient was hospitalized for the events pulmonary embolus, high feeling, chest pain, joint pain, dry cough, fatigue, cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering. Initial information received from consumer via regulatory authority on 17th December 2021: pulmonary embolus, high feeling, chest pain, joint pain, dry cough, fatigue, cold symptoms, pain in arm, shortness of breath, heart rate high, high temperature and shivering Case narrative : Sudden chest pain, cold symptoms. Negative PCR. Week later left side pain in arm, shoulder, ribs, shortness of breath, unable to take full breaths. Pain on moving, coughing. Dry cough. High heart rate and temperature. Fatigue, shivers. D dimmer elevated, CPR raised. CT scan showed clots in both lower lobes of each lung.Hospital treatment and now taking blood thinning medication, Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial, Reaction, Does your report relate to possible inflammation of the heart (myocarditis or pericarditis) If yes, we will ask you some additional questions at the end of this report: "No" FU received 14.12.2021, Good evening, Thank you for your email requesting further information relating to my recent diagnosis of bilateral pulmonary emboli. I am still currently off work, recovering, physically and emotionally, not something I expected at my age. The information below i have answered in the order the questions were asked. 1 Pfizer 27/1/21 batch number EL0739, 16/3/21 batch number ER1749, 18/10/21 batch number FF8288, 2 no adverse reactions , 3 No previous issues, 4 No previous clots affecting any part of my body, 5.None, 6. No,7 No, 8. None, 9.No, 10. Not previous to this event. Currently on rivaroxaban 15mg twice daily then 20mg once daily after the initial 3 weeks , 11. No, 12. Flu jab 18/10/21 (straight after booster jab) , 13. No, 14. Treatment I received - d dimmer blood test from gp, which was raised.GP arranged for me to visit the same day emergency care department. Here they performed covid test, flu tests, chest X-ray, bloods and ct scan with dye through my veins. Sent home with medication to thin the blood. No further treatment so far still recovering ,15. No, 16. My GP of Telephone number. I was treated at by a


VAERS ID: 1964551 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-11-23
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Audiogram, Deafness, Magnetic resonance imaging, Specialist consultation
SMQs:, Hearing impairment (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: 2019; Test Name: audiometry; Result Unstructured Data: Test Result:left ear with normal hearing; Test Date: 20211126; Test Name: audiometry; Result Unstructured Data: Test Result:hearing loss observed in the right ear; Comments: confirmed the loss with several audiometries, including 26Nov2021, the loss is in all frequencies and an average loss of about 50 dB, the Left Ear remains with normal hearing, as in the audiometry of the year 2019; Test Name: RMN; Result Unstructured Data: Test Result:unknown results; Test Name: seen by ENT; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ESPFIZER INC202101729897

Write-up: Hearing loss; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: ES-AEMPS-1062132 (regulatory authority). A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Jun2021 (Lot number: FC3098, Expiration Date: 30Sep2021) 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: DEAFNESS (medically significant) with onset 23Nov2021 (as reported), outcome "not recovered", described as "Hearing loss". The patient underwent the following laboratory tests and procedures: audiogram: (2019) left ear with normal hearing; (26Nov2021) hearing loss observed in the right ear, notes: confirmed the loss with several audiometries, including 26Nov2021, the loss is in all frequencies and an average loss of about 50 dB, the Left Ear remains with normal hearing, as in the audiometry of the year 2019; magnetic resonance imaging: (unspecified date) unknown results; specialist consultation: (unspecified date) unknown results. Clinical course: Hearing loss is observed in right ear. five days after the first dose of vaccine, seen by ear nose throat doctor (ENT), performed magnetic resonance imaging (MRI), the loss confirmed with several audiometries, including 26Nov2021, the loss is in all frequencies and an average loss of about 50 dB, the left ear remains with normal hearing, as in the audiometry of the year 2019.


VAERS ID: 1964727 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-11-23
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension arterial; Sleep apnoea syndromes
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20214

Write-up: Failure of vaccination; This case was received via regulatory authority (Reference number: FR-AFSSAPS-LL20217888) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of VACCINATION FAILURE (Failure of vaccination) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial, Sleep apnoea syndromes and Dyslipidaemia. On 12-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION FAILURE (Failure of vaccination) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (Failure of vaccination) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications and concomitant medications were not reported. The dose of the Spikevax was reported as 2 milliliter. Company Comment: This regulatory case concerns a 74-year-old, male patient with relevant medical history of Hypertension, who experienced vaccination failure. The event, which resulted in hospitalization, occurred 21 days after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details were provided. The event had not resolved at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient''s age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 74-year-old, male patient with relevant medical history of Hypertension, who experienced vaccination failure. The event, which resulted in hospitalization, occurred 21 days after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details were provided. The event had not resolved at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient''s age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1964835 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Immunisation, Influenza like illness, Lymphadenopathy, Pyrexia, Synovial cyst
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: FRPFIZER INC202101734170

Write-up: Axillary adenopathy; Influenza like illness; ganglion apparition at the level of the right aisle; fever at 38.5 �C; headaches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-PO20215608 (RA). A 51 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 23Nov2021 (Lot number: J07BX03) 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: Comirnaty (dose 2, single, lot: EJ6788), administration date: 26Jan2021, for covid-19 immunisation, reaction(s): "Influenza like illness"; Comirnaty (dose 1, single), for covid-19 immunisation. The following information was reported: Immunisation (medically significant) with onset 23Nov2021, outcome "unknown", described as "booster"; Lymphadenopathy (medically significant) with onset 24Nov2021, outcome "recovering", described as "Axillary adenopathy"; Influenza Like Illness (medically significant) with onset 24Nov2021, outcome "recovering", described as "Influenza like illness"; Synovial Cyst (non-serious) with onset 24Nov2021, outcome "recovering", described as "ganglion apparition at the level of the right aisle"; Pyrexia (non-serious) with onset 24Nov2021, outcome "recovering", described as "fever at 38.5 �C"; Headache (non-serious) with onset 24Nov2021, outcome "recovering", described as "headaches". The patient underwent the following laboratory tests and procedures: body temperature: (24Nov2021) 38.5 Centigrade. Course of events: On 24Nov2021, ganglion apparition at the level of the right aisle as well as a flu-like syndrome (fever at 38.5 � C; headaches; strobatures (as reported)) undergoing a 48h work stop. On 26Nov2021: Regression of symptoms in progress. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Costochondritis, Dyspnoea, Fatigue, Headache, Immunisation, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis collagenous; Immunodeficiency (condition which reduces the immune response (e.g. immunodeficiency)); Microvascular angina
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739294

Write-up: Costal chondritis; Palpitations; Fatigue; Headache; Dose number 3; Chest pain; Shortness of breath; Racing heart (tachycardia); This is a spontaneous report from a contactable reporter (consumer or other non-HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112031001209850-RQVD4 (RA). Other Case identifier: GB-MHRA-ADR 26286025 (RA). A 59-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Microvascular angina" (unspecified if ongoing); "Colitis collagenous" (unspecified if ongoing) and "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g., immunodeficiency). The patient had no symptoms associated with COVID-19. Concomitant medications were not reported. The patient previously received the first and second dose of bnt162b2 (BNT162b2; Lot number: UNKNOWN); both via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Dose number 3"; COSTOCHONDRITIS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Costal chondritis"; PALPITATIONS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Palpitations"; FATIGUE (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Fatigue"; HEADACHE (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Headache"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (medically significant) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)". Clinical course: On an unknown date in 2021, the patient experienced chest pain, shortness of breath, racing heart (tachycardia); on 24Nov2021, one day after the vaccination, the patient experienced costal chondritis, palpitations, fatigue and headache; all the events were reported as serious for being medically significant. On 29Nov2021, the patient underwent COVID-19 virus test and the result was negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965064 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute lymphoblastic leukaemia (treated at age 3-6); Echocardiogram (every 5 years to monitor that this hasn''''t affected my heart health)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739412

Write-up: discomfort; Chest pain; possible inflammation of the heart (pericarditis); possible inflammation of the heart (myocarditis); Shortness of breath/little breathless; Racing heart (tachycardia); Chest discomfort; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter (consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112031334219820-4TBD9 (RA). Other Case identifier: GB-MHRA-ADR 26286994 (RA). A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FK9413) at the age of 26 years as dose 3, single for COVID-19 immunisation. Relevant medical history included: "Acute lymphocytic leukaemia" (unspecified if ongoing), notes: treated at age 3-6; "Echocardiogram" (unspecified if ongoing), notes: every 5 years to monitor that this hasn''''t affected my heart health. The patient''s concomitant medications were not reported. Past drug history included: Daunorubicin for Acute lymphocytic leukaemia. Vaccination history included: Covid-19 vaccine (DOSE 1, BATCH/LOT NUMBER: UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, BATCH/LOT NUMBER: UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "booster"; DISCOMFORT (medically significant), outcome "recovering", described as "discomfort"; CHEST DISCOMFORT (medically significant) with onset 23Nov2021, outcome "recovered" (26Nov2021), described as "Chest discomfort"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant) with onset 23Nov2021, outcome "recovered" (24Nov2021), described as "Shortness of breath/little breathless"; TACHYCARDIA (medically significant) with onset 23Nov2021, outcome "recovered" (24Nov2021), described as "Racing heart (tachycardia)"; PERICARDITIS (medically significant), outcome "unknown", described as "possible inflammation of the heart (pericarditis)"; MYOCARDITIS (medically significant), outcome "unknown", described as "possible inflammation of the heart (myocarditis)". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test. Clinical course: In the evening of his booster vaccine (23rd), patient felt a little breathless and his heart rate was higher than it should be from about 9pm until he went to sleep at 3am. He had some discomfort in his chest, around the area of his heart, from about 11pm. His condition was the same upon waking the next day (24th) but his heart rate was back to normal and didn''t feel breathless at all by that evening. The discomfort in his chest continued until sometime on the 26th. This report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. No any imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). Patient has a history of treatment for Acute Lymphoblastic Leukaemia age 3-6. Have subsequently been released from follow up care. He received Daunorubicin as part of his treatment and has an echocardiogram every 5 years to monitor that this hasn''t affected his heart health. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, Paraesthesia, Pruritus, SARS-CoV-2 test, Skin temperature
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101731710

Write-up: Paraesthesia; Skin temperature; Itchy skin; Diarrhea; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable consumer from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112040759531410-89JDC. Other Case identifier(s): GB-MHRA-ADR 26288541. A 56-year-old male patient received BNT162B2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 05Oct2020 (unspecified if ongoing), notes: unsure when symptoms stopped. Patient is not enrolled in clinical trial. Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date 23Nov2021. Vaccination history included: COVID-19 VACCINE (dose 2, primary immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 VACCINE (dose 1, primary immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; SKIN TEMPERATURE (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Skin temperature"; PARAESTHESIA (medically significant) with onset 02Dec2021, outcome "not recovered", described as "Paraesthesia"; DIARRHOEA (medically significant) with onset 29Nov2021, outcome "not recovered", described as "Diarrhea"; PRURITUS (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Itchy skin". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Cough, Dyspnoea, Electrocardiogram, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Rhinorrhoea, SARS-CoV-2 test, Suspected COVID-19, 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), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 2021; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result: Unknown results; Test Date: 20211203; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101739287

Write-up: Suspected COVID-19; Breath shortness; Chest pain; Runny nose; Cough; Off label use; Interchange of vaccine products; Booster; myocarditis; Fatigue/unusual tiredness; Racing heart (tachycardia); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112042217168620-RDQBM, Other Case identifier(s) GB-MHRA-ADR 26289428. A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported OFF LABEL USE (medically significant) with onset 23Nov2021, outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome unknown; IMMUNISATION (medically significant) with onset 23Nov2021, outcome unknown; MYOCARDITIS (medically significant) with onset 2021, outcome unknown; SUSPECTED COVID-19 (medically significant) with onset 24Nov2021, outcome unknown; DYSPNOEA (medically significant) with onset 24Nov2021, outcome not recovered; CHEST PAIN (medically significant) with onset 24Nov2021, outcome not recovered; RHINORRHOEA (medically significant) with onset 24Nov2021, outcome not recovered; COUGH (medically significant) with onset 24Nov2021, outcome not recovered; FATIGUE (medically significant) with onset 2021, outcome unknown; TACHYCARDIA (medically significant) with onset 2021, outcome unknown. The events myocarditis, breath shortness, chest pain, runny nose, cough, fatigue/unusual tiredness, and racing heart (tachycardia) were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; electrocardiogram: (2021) unknown results; sars-cov-2 test (03Dec2021) no - negative covid-19 test. Therapeutic measures were not taken as a result of myocarditis, dyspnoea, chest pain, rhinorrhoea, cough, fatigue, tachycardia. Patient was not enrolled in clinical trial. The symptoms did not lead to a hospital stay. No diagnosis was made by a medical professional. No treatment given because of your symptoms. The patient went to emergency, did blood tests and an electrocardiogram (ECG), waited about 10 hours but they any doctor talked to her. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731841

Write-up: developed shingles; Dose 1 and Dose 2: Non-Pfizer manufacturer; and Dose 3: Pfizer Covid vaccine; Dose 1 and Dose 2: Non-Pfizer manufacturer; and Dose 3: Pfizer Covid vaccine; dose number 3; persistent and incredibly painful headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112051958439530-W65PK (MHRA). Other Case identifier(s): GB-MHRA-ADR 26292837 (MHRA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: Non-Pfizer manufacturer; and Dose 3: Pfizer Covid vaccine"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "dose number 3"; HEADACHE (medically significant) with onset 2021, outcome "not recovered", described as "persistent and incredibly painful headache"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "sore arm"; HERPES ZOSTER (medically significant) with onset 24Nov2021, outcome "not recovered", described as "developed shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) 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: 1965510 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Depressed mood, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101751681

Write-up: Depressed mood; Nauseous; Painful arm; Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose number 3; Armpit pain; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112072009475810-3GG6U (RA). Other Case identifier: GB-MHRA-ADR 26300802 (RA). A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient was not breastfeeding at the time of this report. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Dose number 3"; AXILLARY PAIN (medically significant) with onset 23Nov2021, outcome "recovered" (26Nov2021), described as "Armpit pain"; NAUSEA (medically significant) with onset 24Nov2021, outcome "recovered" (30Nov2021), described as "Nauseous"; PAIN IN EXTREMITY (medically significant) with onset 24Nov2021, outcome "recovered" (28Nov2021), described as "Painful arm"; DEPRESSED MOOD (medically significant) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "Depressed mood". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965841 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Hypothermia, Pain, SARS-CoV-2 test
SMQs:, Accidents and injuries (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: CORTISONE
Current Illness:
Preexisting Conditions: Comments: No reported medical history.
Allergies:
Diagnostic Lab Data: Test Date: 20211122; 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; Chills; Hypothermia; Ache; Fatigue; This case was received via regulatory authority on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering), CHILLS (Chills), HYPOTHERMIA (Hypothermia), PAIN (Ache) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No reported medical history. Concomitant products included CORTISONE from 08-Nov-2021 to an unknown date for Plantar fasciitis, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Mar-2021 to an unknown date, INFLUENZA VACCINE (INFLUENZA VIRUS) from 09-Nov-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), HYPOTHERMIA (Hypothermia) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). On 23-Nov-2021, HYPOTHERMIA (Hypothermia) had resolved. On 24-Nov-2021, CHILLS (Chills), PAIN (Ache) and FATIGUE (Fatigue) had resolved. At the time of the report, CHILLS (shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient has not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding The patient didn''t sleep well the night after the booster jab and her arm ached for around 3 days. Around 16-17 hours after the jab, she began shivering uncontrollably and felt suddenly extremely faint. The patient''s hands were ice cold and temperature dropped to 34.7 degrees. It was very frightening. She managed to regulate temperature by wrapping herself tightly in a blanket with a hot water bottle. It took about 2 hours for the shivering to subside and for temperature to get back to a more normal level. Then the patient slept most of the rest of the day and night. 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 50-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of chills, hypothermia, pain, and fatigue. The events started 16-17 hours after the booster dose of mRNA-1273. The patient reports that she began shivering uncontrollably and that her temperature was around 34.7�C. She was later able to regulate her temperature with blankets and a hot water bottle. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of chills, hypothermia, pain, and fatigue. The events started 16-17 hours after the booster dose of mRNA-1273. The patient reports that she began shivering uncontrollably and that her temperature was around 34.7�C. She was later able to regulate her temperature with blankets and a hot water bottle. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1965858 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201006; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26317378) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 19-Nov-2021 to an unknown date for Influenza. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 26-Nov-2021, PAIN IN EXTREMITY (Painful arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2020, 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. This is a regulatory case concerning a 62-year-old female patient with no reported relevant medical history, who experienced the serious unexpected per reported severity event of Pain in extremity. The event occurred on the next day after the third dose of mRNA-1273 vaccine administration. The event was assessed as serious by the Regulatory Authority. The event was considered as related, per temporal association with the product administration. The patient was given an Influenza vaccine 4 days prior to mRNA-1273 vaccination and may be considered as a co-suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 62-year-old female patient with no reported relevant medical history, who experienced the serious unexpected per reported severity event of Pain in extremity. The event occurred on the next day after the third dose of mRNA-1273 vaccine administration. The event was assessed as serious by the Regulatory Authority. The event was considered as related, per temporal association with the product administration. The patient was given an Influenza vaccine 4 days prior to mRNA-1273 vaccination and may be considered as a co-suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1965990 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Result Unstructured Data: Result: NEGATIVE
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Appearance of cough, fever and dyspnoea; Appearance of cough, fever and dyspnoea; Appearance of cough, fever and dyspnoea; This case was received via regulatory authority (Reference number: IT-MINISAL02-815402) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of COUGH (Appearance of cough, fever and dyspnoea), DYSPNOEA (Appearance of cough, fever and dyspnoea) and PYREXIA (Appearance of cough, fever and dyspnoea) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Nov-2021, the patient experienced COUGH (Appearance of cough, fever and dyspnoea) (seriousness criterion hospitalization), DYSPNOEA (Appearance of cough, fever and dyspnoea) (seriousness criterion hospitalization) and PYREXIA (Appearance of cough, fever and dyspnoea) (seriousness criterion hospitalization). At the time of the report, COUGH (Appearance of cough, fever and dyspnoea), DYSPNOEA (Appearance of cough, fever and dyspnoea) and PYREXIA (Appearance of cough, fever and dyspnoea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, SARS-CoV-2 test: negative (Negative) Result: NEGATIVE. 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 information provided No treatment medication information provided Company Comment : This case concerns a 91-year-old patient of an unknown gender with no medical history, who experienced the serious unexpected events of Cough, Dyspnoea and Pyrexia. The events occurred on an unknown day after the dose of mRNA-1273 vaccine. (Date of vaccination and dose sequence not provided). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 91-year-old patient of an unknown gender with no medical history, who experienced the serious unexpected events of Cough, Dyspnoea and Pyrexia. The events occurred on an unknown day after the dose of mRNA-1273 vaccine. (Date of vaccination and dose sequence not provided). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1965999 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214024 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Sense of fainting, headache, heart pain; Sense of fainting, headache, heart pain; Sense of fainting, headache, heart pain; This case was received via regulatory authority (Reference number: IT-MINISAL02-815663) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Sense of fainting, headache, heart pain), CHEST PAIN (Sense of fainting, headache, heart pain) and HEADACHE (Sense of fainting, headache, heart pain) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214024) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto''s thyroiditis. On 23-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS (Sense of fainting, headache, heart pain) (seriousness criterion medically significant), CHEST PAIN (Sense of fainting, headache, heart pain) (seriousness criterion medically significant) and HEADACHE (Sense of fainting, headache, heart pain) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Sense of fainting, headache, heart pain), CHEST PAIN (Sense of fainting, headache, heart pain) and HEADACHE (Sense of fainting, headache, heart pain) had not resolved. No concomitant medication provided. No treatment information mentioned. Company comment: This is a regulatory authority case concerning a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of dizziness (sense of fainting), headache and chest pain (heart pain). The events dizziness (sense of fainting), headache and chest pain (heart pain) occurred the same day with the first dose of mRNA-1273 vaccine administration. No reported treatment medication. The events were reported as on going from the last observation. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of dizziness (sense of fainting), headache and chest pain (heart pain). The events dizziness (sense of fainting), headache and chest pain (heart pain) occurred the same day with the first dose of mRNA-1273 vaccine administration. No reported treatment medication. The events were reported as on going from the last observation. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1966250 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PTKWFA6HLZGHTIU / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Fatigue, Headache, Immunisation, Malaise, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: Sars-CoV-2 PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20211127; Test Name: Sars-CoV-2 rapid test; Result Unstructured Data: Test Result:Positive
CDC Split Type: NLPFIZER INC202101754658

Write-up: Nasopharyngitis; Throat pain; Headache; Fatigue; Positive selftest covid-19; vaccination failure; Chills; Malaise; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: NL-LRB-00720883. Other Case identifier(s): NL-LRB-00724852. A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: PTKWFA6HLZGHTIU4WJTU42#C) as dose 3 (booster), 0.3 ml single, administration date 11Feb2021 (Batch/Lot number: unknown) as dose 2, 0.3 ml single and administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "booster"; COVID-19 (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Positive selftest covid-19"; VACCINATION FAILURE (medically significant) with onset 24Nov2021, outcome "unknown", described as "vaccination failure"; NASOPHARYNGITIS (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Nasopharyngitis"; OROPHARYNGEAL PAIN (non-serious) with onset 25Nov2021, outcome "recovering", described as "Throat pain"; CHILLS (non-serious) with onset 24Nov2021, outcome "recovered" (26Nov2021), described as "Chills"; MALAISE (non-serious) with onset 24Nov2021, outcome "recovering", described as "Malaise"; HEADACHE (non-serious) with onset 25Nov2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 24Nov2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (27Nov2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3219 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ecchymosis, Immunisation, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amenorrhea
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101730952

Write-up: ECCHYMOSIS; POSTMENOPAUSAL BLEEDING; Booster; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority-WEB. Regulatory number: NO-NOMAADVRE-FHI-2021-U8py5j (NOMA). Other Case identifier: NO-NOMAADVRE-E2B_00062971 (NOMA). A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Nov2021 08:50 (Lot number: FH3219) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "amenorrhea", start date: 2020 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, lot no. EJ6795), administration date: 20Jan2021, for COVID-19 immunization; Comirnaty (dose 2, lot no. EJ6789), administration date: 10Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; ECCHYMOSIS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "ECCHYMOSIS"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 24Nov2021, outcome "not recovered", described as "POSTMENOPAUSAL BLEEDING". The patient reported that, "She never gets bruises otherwise, and have had amenorrhea for over a year before the event." Reporter Comment: Ecchymosis right arm and left thigh. Reporter''s qualification: Nurse. 01Dec2021 RELIS: additional information received. The following fields have been updated: event description. The Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Ecchymosis right arm and left thigh. Reporter''s qualification: Nurse. 01Dec2021 RELIS: additional information received. The following fields have been updated: event description.


VAERS ID: 1966410 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101734070

Write-up: Presyncope; This is a spontaneous report received from a contactable reporter (physician) from the regulatory authority-WEB. Regulatory number: PT-INFARMED-F202111-1900 (regulatory authority). A 21 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: 1F1014A) at the age of 21 years as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRESYNCOPE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Presyncope". Therapeutic measures were taken as a result of presyncope. Additional information: The adverse reaction (ARD) arose after the only administration of the suspect drug, about 5 minutes after administration. The drug was of single administration. There is no suspected interaction between medications. As a treatment of ADR, no medication was used, however, the notifier mentions that the patient was placed in a decubitus position and did not lose his senses, having improved in the next half hour. There is no concomitant medication. Additional data: The suspect medicine is an additional monitoring medicine. Sent request for additional information to the reporter to complete the missing data. The reporter also states that there are no comorbidities, no history of allergies or ADRs prior to other vaccines or other drugs. Evolution of ADR: Unknown Reporter''s Comment: Concomitant Medication-No Medication Error Occurred?-No Other information-User was vaccinated in the vaccination center and after 5 minutes while in recovery began with decreased vision, dizziness, heat in the head, not even losing senses. It improved about half an hour later and was discharged. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred?-No Other information-User was vaccinated in the vaccination center and after 5 minutes while in recovery began with decreased vision, dizziness, heat in the head, not even losing senses. It improved about half an hour later and was discharged.


VAERS ID: 1966472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8372 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Echocardiogram, Electrocardiogram, Myocarditis, N-terminal prohormone brain natriuretic peptide, Platelet count, Troponin, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Test Result: Negative ; Test Name: CRP; Result Unstructured Data: Test Result:15; Test Name: Echocardiography; Result Unstructured Data: Test Result:In notes; Comments: ST segment elevations, without arrhythmia. Also showed 6-7 mm localized effusion; Test Date: 20211125; Test Name: ECG; Result Unstructured Data: Test Result:abormal patterns; Test Name: pro BNP; Result Unstructured Data: Test Result:355; Test Name: platelet concentration; Result Unstructured Data: Test Result:247; Test Name: troponin; Result Unstructured Data: Test Result:7500; Test Name: troponin; Result Unstructured Data: Test Result:4400; Test Name: troponin; Result Unstructured Data: Test Result:2100; Test Name: troponin; Result Unstructured Data: Test Result:1100; Test Name: troponin; Result Unstructured Data: Test Result:140; Test Name: troponin; Result Unstructured Data: Test Result:43; Test Name: leukocyte concentration; Result Unstructured Data: Test Result:6.1
CDC Split Type: SEPFIZER INC202101730931

Write-up: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-095222 (RA). Other Case identifier(s): SE-VISMA-1638179357879 (RA). A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: Fj8372) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing); "Asthma" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 23Nov2021, outcome "recovering", described as "Myocarditis". The patient was hospitalized for myocarditis (start date: 25Nov2021, discharge date: 30Nov2021, hospitalization duration: 5 day(s)). The man also got fever and chest pain after the vaccination. The physician has also mentioned that he did not have COVID-19. He came first to healthcare centre on 25Nov2021 and was referred to emergency clinic due to abnormal ECG patterns. Echocardiography showed ST segment elevations, but he did not have arrhythmia. His proBNP was 355, CRP 15, leukocyte concentration 6.1 and platelet concentration 247. His troponin levels were 7500, 4400, 2100, 1100, 140 and finally declined to 43. Echocardiography also showed 6-7 mm localized effusion. The man is going to be discharged on 30Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1967059 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-11-23
   Days after vaccination:260
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46669 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; PROPRANOLOL HCL; IMIPRAMINE; LEVOTHYROXINE
Current Illness: Anxiety; Depression; High cholesterol; Mitral valve disease (MILD MITRAL VALVE REGUGITATION.); Thyroid function abnormal (UNDERACTIVE THYROID)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200912; Test Name: COVID-19 virus test; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: High temperature; Headache; Shivers; Muscle ache; This case was received (Reference number: GB-MHRA-ADR 24908031) on 16-Dec-2021 and was forwarded to Moderna on 16-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), HEADACHE (Headache), CHILLS (Shivers) and MYALGIA (Muscle ache) in a 59-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. Concurrent medical conditions included Thyroid function abnormal (UNDERACTIVE THYROID), Mitral valve disease (MILD MITRAL VALVE REGUGITATION.), High cholesterol, Depression and Anxiety. Concomitant products included ATORVASTATIN for High cholesterol, IMIPRAMINE for Stress, PROPRANOLOL HCL from 02-Jan-1998 to an unknown date and LEVOTHYROXINE from 02-Jan-2010 to an unknown date for an unknown indication. On 08-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 06-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 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature), HEADACHE (Headache), CHILLS (Shivers) and MYALGIA (Muscle ache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2020, SARS-CoV-2 test: negetive No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Patient experienced ill at the first night of vaccination patient had VERY BAD HEADACHE ON RIGHT SIDE, HIGH TEMPERATURE ,SHIVERS and MUSCLE PAINS LASTED FOR ABOUT 5 DAYS AFTER BOOSTER dose. Indication for LEVOTHYROXINE was UNDERACTIVE THYROID.; Sender''s Comments: This case concerns a 59-year-old female patient, with medical history of thyroid function abnormal, mitral valve disease, high cholesterol, depression, and anxiety, who experienced the serious (medically significant) expected event of pyrexia, headache, chills and myalgia. The events occurred on the same day after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. However, patient took the 1st and 2nd doses of COVID-19 VACCINE ASTRAZENECA. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1968256 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dysarthria, Loss of consciousness, Movement disorder, Muscle strain, Muscle twitching, Myalgia, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: AUPFIZER INC202101740319

Write-up: Loss of consciousness; Arthralgia; Dysarthria; Movement disorder; Muscle strain; Muscle twitching; Myalgia; Paraesthesia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 674172 Regulatory Authority. A 38-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Loss of consciousness"; ARTHRALGIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Arthralgia"; DYSARTHRIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Dysarthria"; MOVEMENT DISORDER (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Movement disorder"; MUSCLE STRAIN (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Muscle strain"; MUSCLE TWITCHING (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Muscle twitching"; MYALGIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Myalgia"; PARAESTHESIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Paraesthesia". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram T wave inversion, Hypoaesthesia, Myocarditis, Paraesthesia, Sinus rhythm
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Electrocardiogram T wave inversion; Result Unstructured Data: Test Result:T wave inversion
CDC Split Type: AUPFIZER INC202101740756

Write-up: Myocarditis; Electrocardiogram T wave inversion; Chest pain; Hypoaesthesia; Paraesthesia; Sinus rhythm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 675851 Regulatory Authority. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Myocarditis"; ELECTROCARDIOGRAM T WAVE INVERSION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Electrocardiogram T wave inversion"; CHEST PAIN (non-serious) with onset 23Nov2021, outcome "unknown", described as "Chest pain"; HYPOAESTHESIA (non-serious) with onset 23Nov2021, outcome "unknown", described as "Hypoaesthesia"; PARAESTHESIA (non-serious) with onset 23Nov2021, outcome "unknown", described as "Paraesthesia"; SINUS RHYTHM (non-serious) with onset 23Nov2021, outcome "unknown", described as "Sinus rhythm". The patient underwent the following laboratory tests and procedures: electrocardiogram t wave inversion: (23Nov2021) t wave inversion. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968317 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101740765

Write-up: Cerebrovascular accident; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 675728 Regulatory Authority. A 58 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 and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 23Nov2021, outcome "recovering", described as "Cerebrovascular accident". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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: AUPFIZER INC202101740964

Write-up: Seizure; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 676810 Regulatory Authority. A 15 year-old female patient received bnt162b2 (COMIRNATY) (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: SEIZURE (medically significant) with onset 23Nov2021, outcome "recovered", described as "Seizure"; TACHYCARDIA (non-serious) with onset 23Nov2021, outcome "recovered", described as "Tachycardia". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1969136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-11-23
   Days after vaccination:203
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral haemorrhage, Hemiparesis
SMQs:, Haemorrhage terms (excl laboratory terms) (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? 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 INC202101742800

Write-up: Speech loss; Hemiparesis; Cerebral bleeding; 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-CADR2021209333 (RA). Other Case identifier(s): DE-CADRPEI-2021209333 (RA Webportal), DE-PEI-202100260615 (RA). A 88 year-old male patient received bnt162b2 (COMIRNATY), administration date 04May2021 (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 (1st dose, manufacturer unknown), for covid-19 immunization. The following information was reported: APHASIA (hospitalization) with onset 23Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "Speech loss"; HEMIPARESIS (hospitalization) with onset 23Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "Hemiparesis"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 23Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "Cerebral bleeding". Relatedness of drug to events assessed by RA was: D (unclassifiable). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1969236 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Pericarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101762002

Write-up: Influenza; Fever; Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DK-DKMA-WBS-0092035 (DKMA). A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: Asked But Unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient reports that he has no other health issues. The following information was reported: INFLUENZA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Influenza"; PYREXIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Fever"; PERICARDITIS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Pericarditis". Therapeutic measures were taken as a result of influenza, pyrexia, pericarditis. The patient was treated with unspecified medications due to the ADRs. No medical procedure was reported. There is no information regarding test results. The ADRs were by the Medicines Agency assessed medically significant due to the ADR Pericarditis being on the IME list. No follow-up attempts are possible. No further information is expected. Batch/LOT number cannot be obtained.


VAERS ID: 1969388 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Headache, Nausea, Pain, Pain in extremity, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Redness; Shaking; Headache; Generalised aching; Nausea; Tiredness; Pain in extremity; This case was received (Reference number: GB-MHRA-ADR 26310876) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), TREMOR (Shaking), HEADACHE (Headache), PAIN (Generalised aching), NAUSEA (Nausea), FATIGUE (Tiredness) and PAIN IN EXTREMITY (Pain in extremity) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 immunisation. Previously administered products included for COVID-19 vaccination: SARS-COV-2 VACCINE and SARS-COV-2 VACCINE. Past adverse reactions to the above products included No adverse effect with SARS-COV-2 VACCINE and SARS-COV-2 VACCINE. Concomitant products included LANSOPRAZOLE (LANSOPRAZOL) and ASPIRIN for an unknown indication. On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 23-Nov-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN (Generalised aching) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion medically significant). On 23-Nov-2021, TREMOR (Shaking) had resolved. On 05-Dec-2021, ERYTHEMA (Redness) and PAIN IN EXTREMITY (Pain in extremity) had resolved with sequelae. On 07-Dec-2021, HEADACHE (Headache), PAIN (Generalised aching), NAUSEA (Nausea) and FATIGUE (Tiredness) had resolved. Treatment information was not provided. The concomitant medication was reported as diet supplement. Company comment. This regulatory authority case concerns a 65-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of erythema, tremor, pain, headache, nausea, fatigue, and pain in extremity. The events headache, nausea, and fatigue are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, it is not reported if the previous vaccines were mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.; Sender''s Comments: This regulatory authority case concerns a 65-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of erythema, tremor, pain, headache, nausea, fatigue, and pain in extremity. The events headache, nausea, and fatigue are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, it is not reported if the previous vaccines were mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.


VAERS ID: 1969451 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Blood test, Chest X-ray, Chest pain, Diarrhoea, Dyspnoea, Electrocardiogram, Headache, Libido decreased, Musculoskeletal stiffness, Palpitations, Paraesthesia, Respiratory rate decreased, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: No medical history
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20211201; Test Name: Blood pressure; Result Unstructured Data: Test Result:185/80; Comments: at hospital; Test Date: 20211202; Test Name: Blood pressure; Result Unstructured Data: Test Result:123/88; Test Date: 20211203; Test Name: Blood pressure; Result Unstructured Data: Test Result:185/110; Test Date: 20211204; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/81; Test Date: 20211205; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/84; Test Date: 20211206; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/85; Test Date: 20211201; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/91; Test Date: 20211201; Test Name: Blood pressure; Result Unstructured Data: Test Result:143/87; Test Date: 20211202; Test Name: Blood pressure; Result Unstructured Data: Test Result:149/88; Test Date: 20211203; Test Name: Blood pressure; Result Unstructured Data: Test Result:147/79; Test Date: 20211203; Test Name: Blood pressure; Result Unstructured Data: Test Result:185/110; Test Date: 20211204; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/81; Test Date: 20211205; Test Name: Blood pressure; Result Unstructured Data: Test Result:139/83; Test Date: 20211206; Test Name: Blood pressure; Result Unstructured Data: Test Result:151/86; Test Date: 20211127; Test Name: Blood test; Result Unstructured Data: Test Result:show nothing; Test Date: 20211201; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Comments: showing all ok; Test Date: 20211127; Test Name: Chest X-ray; Result Unstructured Data: Test Result:show nothing; Test Date: 20211201; Test Name: ECG; Result Unstructured Data: Test Result:showing all ok; Test Date: 20211201; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative pcr result from hospital; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20211202; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative lateral flow test.
CDC Split Type: GBPFIZER INC202101738968

Write-up: Tingling; toes and fingers started to go stiff; Very strange feeling in stomach while brushing teeth - crampy/ churning feeling; Diarrhea; Blood pressure 185/110; Chest pain/slight weight on chest; Headache; heart palpitations/heart beating in his throat/heart beating in his ears; Shortness of breath; Breathing slowed; Racing heart (tachycardia); Libido decreased; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112061704589040-XBA2V (MHRA). Other Case identifier: GB-MHRA-ADR 26297386 (MHRA). A 36-year-old male patient received BNT162B2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK0596; also reported as FK9413) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications were not reported. The following information was reported: LIBIDO DECREASED (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "Libido decreased"; PARAESTHESIA (hospitalization, medically significant) with onset 03Dec2021, outcome "recovered" (Dec2021), described as "Tingling"; DIARRHOEA (hospitalization, medically significant) with onset 28Nov2021, outcome "recovered" (02Dec2021), described as "Diarrhea"; BLOOD PRESSURE INCREASED (hospitalization, medically significant) with onset 27Nov2021, outcome "recovered" (2021), described as "Blood pressure 185/110"; HEADACHE (hospitalization, medically significant) with onset 26Nov2021, outcome "recovered" (2021), described as "Headache"; RESPIRATORY RATE DECREASED (hospitalization, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Breathing slowed"; CHEST PAIN (hospitalization, medically significant) with onset 27Nov2021, outcome "unknown", described as "Chest pain/slight weight on chest"; DYSPNOEA (hospitalization, medically significant) with onset 23Nov2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "heart palpitations/heart beating in his throat/heart beating in his ears"; TACHYCARDIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)"; ABDOMINAL DISCOMFORT (hospitalization, medically significant) with onset 02Dec2021, outcome "recovered" (02Dec2021), described as "Very strange feeling in stomach while brushing teeth - crampy/ churning feeling"; MUSCULOSKELETAL STIFFNESS (hospitalization, medically significant) with onset 03Dec2021, outcome "recovered" (03Dec2021), described as "toes and fingers started to go stiff". The patient was hospitalized for libido decreased, paraesthesia, diarrhoea, blood pressure increased, headache, respiratory rate decreased, chest pain, dyspnoea, palpitations, tachycardia, abdominal discomfort, musculoskeletal stiffness (start date: 2021). The events "libido decreased", "tingling", "diarrhea", "blood pressure 185/110", "headache", "breathing slowed", "chest pain/slight weight on chest", "shortness of breath", "heart palpitations/heart beating in his throat/heart beating in his ears", "racing heart (tachycardia)", "very strange feeling in stomach while brushing teeth - crampy/ churning feeling" and "toes and fingers started to go stiff" were evaluated at the physician office visit. The patient had 3 visits to hospital. The clinical course was reported as follows: The patient had slight shortness of breath on 23Nov2021/24Nov2021, and shortness of breath happening more often, slight heart palpitations on 25Nov2021, shortness of breath all day, slight heart palpitations, and headache, on 26Nov2021. On 27Nov2021, he still had shortness of breath all day, slight weight on chest, and slight heart palpitations, so went to hospital, underwent blood tests and chest X-ray which showed nothing, but blood pressure was high, and was told to see GP (general physician) if it did not stop. On 28 or 29Nov2021, again shortness of breath all day, slight weight on chest, diarrhoea, heart palpitations in bed while laying down. On 30Nov2021, shortness of breath all day, slight weight on chest, diarrhoea, and heart palpitations in bed while laying down, so he booked appointment to see GP (general physician), and was told to keep 7 days diary of blood pressure. On 01Dec2021, shortness of breath all day, slight weight on chest, diarrhoea, headache and heart palpitations in bed while laying down, and heart beating in his throat and lasted longer, so he called to 111, who booked to be seen at hospital and in 20 mins blood pressure was at 185/80 at hospital, however blood test, and ECG results were all ok (blood pressure during the day was 132/91 and 143/87). On 02Dec2021, shortness of breath all day, slight weight on chest, diarrhoea stopped, negative lateral flow test and very strange feeling in stomach while brushing teeth, crampy/churning feeling lasted may be 2 to 3 minutes, heart palpitations worsened than previous night, heart beating in his ears, could see heart beating in chest and again negative lateral flow in evening, (blood pressure during the day was123/88 and149/88). On 03Dec2021, shortness of breath all day, slight weight on chest, and again booked drive through PCR, called on 999, and around 15:00 taken to hospital, blood pressure was 185/110, tingling finger tips, after arriving at hospital tried to stand to pass urine, but experienced full body tingling so lay back down and tingling slowed, toes and fingers started to go stiff, moved to elbows and kneed and completely stiffed, fingers in different position to what he could feel/see, full body tingling including inside mouth, because of that he was feeling very scary, and it was lasted for 20 minutes. The nurse sprayed something under his tongue which slowly stopped what was happening and given sodium chloride through drip then the patient felt better. The first night without heart palpitations, and blood pressure during the day was 147/79 and 185/110. On 04Dec2021, shortness of breath all the day, slight weight on chest and headache from around 18:00, no heart palpitations, and blood pressure during the day was 144/81 and 133/81. On 05Dec2021, shortness of breath all day, slight weight on chest, no heart palpitations, and blood pressure during the day was 144/84 and 139/83. On 06Dec2021, shortness of breath all day, slight weight on chest, headache from around 18:00, no heart palpitations, and blood pressure during the day was 144/85 and 151/86. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The report was related to possible inflammation of the heart (myocarditis or pericarditis). Therapeutic measures were taken as a result of breathing slowed, shortness of breath, heart palpitations/heart beating in my throat/heart beating in my ears, headache, blood pressure 185/110, chest pain/slight weight on chest, diarrhea, racing heart (tachycardia), tingling/tingling fingertips/full-body tingling/full body tingling including inside mouth, libido decreased and very strange feeling in stomach while brushing teeth - crampy/ churning feeling and included treatment with sodium chloride through drip. Therapeutic measures were taken as a result of libido decreased, paraesthesia, diarrhoea, blood pressure increased, headache, respiratory rate decreased, chest pain, dyspnoea, palpitations, tachycardia, abdominal discomfort, musculoskeletal stiffness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969510 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Decreased interest, Dizziness, Eye movement disorder, Feeling of body temperature change, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vertigo
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Ocular motility disorders (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: FLUOXETINE; LEVOTHYROXINE; OMEPRAZOLE
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 INC202101758765

Write-up: eyes were not keeping up with my head movements; off balance; lacked any energy or enthusiasm for anything including food; lacked any energy or enthusiasm for anything including food; Dizziness; Feeling hot and cold; Off label use; Interchange of vaccine products; Booster; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112081509329570-ICONT (RA). Other Case identifier(s): GB-MHRA-ADR 26308488 (RA). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FH4751) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; INFLUVAC taken for immunisation, administration date 02Oct2021; LEVOTHYROXINE; OMEPRAZOLE. 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 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; VERTIGO (medically significant) with onset 23Nov2021, outcome "unknown", described as "vertigo"; DIZZINESS (medically significant) with onset 24Nov2021, outcome "recovering", described as "Dizziness"; FEELING OF BODY TEMPERATURE CHANGE (medically significant) with onset 23Nov2021, outcome "recovered" (28Nov2021), described as "Feeling hot and cold"; EYE MOVEMENT DISORDER (medically significant), outcome "unknown", described as "eyes were not keeping up with my head movements"; BALANCE DISORDER (medically significant), outcome "unknown", described as "off balance"; ASTHENIA (medically significant), DECREASED INTEREST (medically significant), outcome "unknown" and all described as "lacked any energy or enthusiasm for anything including food". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. "I just felt my eyes were not keeping up with my head movements and was off balance. A vertigo like feeling the evening of the booster. I could not get warm and had multiple layers on. Lacked any energy or enthusiasm for anything including food." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969636 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Dizziness postural
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

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

Write-up: dizziness; unsteadiness; Positional dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26320060) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and DIZZINESS POSTURAL (Positional dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS POSTURAL (Positional dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant) and BALANCE DISORDER (unsteadiness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizziness) and BALANCE DISORDER (unsteadiness) was resolving and DIZZINESS POSTURAL (Positional dizziness) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient firstly had felt muzziness or detachment and the next day, laying down on back turning head to one side everything started to spin and when tried to get up to seated had to put both hands on the floor to stabilise and prevent from falling, the floor was spinning and couldn''t move for a few seconds. Patient was teaching a Pilates class at the time which had to immediately stop, dizziness was brought on by tipping head back and round felt general unsteadiness for the last 2 weeks, it was gradually lessening , but it was so sudden. Patient was exceptionally tired so it impacted significantly on work as an exercise instructor. Company comment: This is a regulatory authority case concerning a 66-year-old female patient with no medical history reported, who experienced dizziness, balance disorder and dizziness postural. The event dizziness postural occurred 2 days after the third dose of mRNA-1273 vaccine. The events dizziness and balance disorder occurred on an unknown date. 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 66-year-old female patient with no medical history reported, who experienced dizziness, balance disorder and dizziness postural. The event dizziness postural occurred 2 days after the third dose of mRNA-1273 vaccine. The events dizziness and balance disorder occurred on an unknown date. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1969891 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: headache; fever; shivering; Feverish; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26317430) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (shivering) and PYREXIA (Feverish) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 25-Nov-2021, PYREXIA (Feverish) had resolved. At the time of the report, HEADACHE (headache), PYREXIA (fever) and CHILLS (shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported No treatment medication were reported Company comment: This case concerns a 53-year-old male patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, PYREXIA, CHILLS and PYREXIA. The event PYREXIA occurred on the same day of the third dose of mRNA-1273 vaccine. The events HEADACHE, PYREXIA and CHILLS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, however, could be not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This case concerns a 53-year-old male patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, PYREXIA, CHILLS and PYREXIA. The event PYREXIA occurred on the same day of the third dose of mRNA-1273 vaccine. The events HEADACHE, PYREXIA and CHILLS occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, however, could be not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 1969908 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL19393 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: DONEPEZIL; OMEPRAZOLE; SEEBRI BREEZHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Dementia with Lewy bodies
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101706143

Write-up: BOOSTER; vomited; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority for a sponsored program. A 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FL19393) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lewy body Dementia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Dementia" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS VACCINE taken for immunisation, administration date 30Nov2020; DONEPEZIL taken for dementia, start date: 15Dec2020; OMEPRAZOLE; SEEBRI BREEZHALER taken for chronic obstructive pulmonary disease. Vaccination history included: Bnt162b2 (first dose, lot number: EL0739), administration date: 23Jan2021, for COVID-19 vaccination; Bnt162b2 (Dose 2, Batch/lot number: ER1749), administration date: 17Apr2021, for COVID-19 vaccination, reaction(s): "Neck cramps". The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "BOOSTER"; VOMITING (medically significant) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "vomited". Additional information: The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Follow-up (12Dec2021): This is a follow up spontaneous report from a contactable consumer Via Regulatory Authority. Updated information: Event verbatim Vomited.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021437777 Same Patient, Same product, different dose and different Event.


VAERS ID: 1969989 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dry throat, Immunisation, Vital signs measurement
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Uncontrolled hypertension (not adequately controlled)
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: BP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211123; Test Name: Vital signs measurement; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: IEPFIZER INC202101762059

Write-up: Booster; SLIGHT DRYNESS IN THROAT; This is a spontaneous report received from a contactable Other HCP from the Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087243 (HPRA). Other Case identifier: IE-HPRA-CVARR2021112422829 (HPRA). A 60-year-old male patient received BNT162B2 (COMIRNATY), administration date 23Nov2021 (Lot number: FH8469) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Uncontrolled hypertension" (unspecified if ongoing), notes: not adequately controlled. Concomitant medication included: RAMIPRIL. Vaccination history included: COVID-19 vaccine (DOSE 1 and DOSE 2, Manufacturer unknown), for COVID-19 immunization, reaction: "no problems". The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; DRY THROAT (medically significant) with onset 23Nov2021 , outcome "recovered" (Nov2021), described as "SLIGHT DRYNESS IN THROAT". The events "booster" and "slight dryness in throat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) unknown results; vital signs measurement: (23Nov2021) unknown results. Clinical course: 20 minutes following the administration of the third dose of COMIRNATY, on 23Nov2021 the patient felt a slight dryness in the throat, persisting for 6 hours. It was noted that the patient was not very anxious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Pain in extremity, Tinnitus
SMQs:, Hearing impairment (narrow), 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: MICROLITE [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101762074

Write-up: TINNITUS IN RIGHT EAR; FATIGUE / FALLING WITH TIREDNESS; Booster; SORE ARM; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory authority. A 22 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 14:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Contraception" (unspecified if ongoing). Concomitant medication(s) included: MICROLITE [ETHINYLESTRADIOL;LEVONORGESTREL] taken for contraception, start date: 13Aug2021. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 Immunization; Covid-19 vaccine (dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Nov2021 14:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 23Nov2021, outcome "not recovered", described as "SORE ARM"; FATIGUE (medically significant) with onset 23Nov2021 20:00, outcome "recovered", described as "FATIGUE / FALLING WITH TIREDNESS"; TINNITUS (medically significant) with onset 24Nov2021, outcome "recovered" (24Nov2021), described as "TINNITUS IN RIGHT EAR". Therapeutic measures were taken as a result of pain in extremity. Clinical course: initial report received by the Regulatory authority on 24Nov2021 from a healthcare provider, reporting on behalf of herself. This report concerned a 22-year-old female who experienced fatigue, tinnitus and pain in extremity following vaccination with Comirnaty for COVID-19 immunisation. Concomitant medication included Microlite. Information regarding the patient''s medical history/concurrent conditions were not provided in the report. At approximately 2 pm on 23Nov2021, the patient was vaccinated with the booster dose of Comirnaty (batch number: not available). On 23Nov2021, the patient experienced fatigue and a sore arm. The patient outlined that by 8 pm she was falling with tiredness, then she went to sleep. The patient took paracetamol for pain. On 24Nov2021, the patient experienced tinnitus in the right ear, which started when she woke and wore off throughout the day. The duration of the reactions was reported as follows: fatigue lasted 3 hours, tinnitus lasted 12 hours, and sore arm was ongoing at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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