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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 259 out of 8,010

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VAERS ID: 1778818 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Brain natriuretic peptide, Chest pain, Dyspnoea, Electrocardiogram normal, Exercise tolerance decreased, Full blood count, Lipids, Metabolic function test, Red blood cell sedimentation rate increased, Troponin
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: trop pending EKG normal BNP, CBC, lipid, CMP normal ESR mildly elevated for age, 19 Echo pending 14 Oct 21
CDC Split Type:

Write-up: dev chest pain, dyspnea, exercise intolerance starting 4-5 days after second shot. Symptoms progressed over the next couple weeks.


VAERS ID: 1778843 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Deafness, Ear pain
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ciprofloxacin/dexamethasone (Ciprodex)
Current Illness: none
Preexisting Conditions: none
Allergies: None
Diagnostic Lab Data: otoscope exam
CDC Split Type:

Write-up: Having pain in both ear and having some hearing loss. Still having issue


VAERS ID: 1779177 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-16
Onset:2021-09-06
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension, CAD, Diabetes Type 2, High cholestrol
Allergies: Ciprofloxacin, Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Admission to critical care hospital with COVID-19 diagnosis on admission


VAERS ID: 1779348 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-06
Onset:2021-09-06
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Blood test, Cardiac monitoring abnormal, Cardiac stress test abnormal, Catheterisation cardiac abnormal, Coronary artery stenosis, Full blood count, Myocardial ischaemia, SARS-CoV-2 test negative, Ventricular extrasystoles
SMQs:, Ventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel (Plavix) 75mg=1 tab, 1x Daily Ezetimibe (Zetia) 10mg=1 tab, 1x Daily Calcium Citrate 630mg=2 tabs, 2x Daily Metoprolol Succinate (Toprol ER) 25mg=1 tab, 1x Daily Rosuvastatin (Crestor) 40mg=1 tab, 1x Daily Olmesartan Medoxomil (
Current Illness: none
Preexisting Conditions: Cancer at age 29, treated successfully with radiation to chest Heart attack #1 at age 37, treated with quintuple bypass Heart attack #2 at age 44, untreated (silent) Heart attack #3 at age 46, treated with angioplasty plus 5 cardiac stents Hyperparathyroid hypercalcemia at age 48, diagnosed and removed parathyroid adenoma Hypoparathyroid hypocalcemia (chronic)
Allergies: none (seasonal allergies only)
Diagnostic Lab Data: Zio patch started on September 13 for one week (significant PVC) Blood tests (CBC) on September 14, 2021 Nuclear imaging stress test on September 24, 2021 (results: abnormal, large area of ischemia involving the lateral aspect of the heart) Blood tests on September 27, 2021 COVID test on September 27, 2021 (negative) Cardiac catheterization on September 29, 2021 (significant stenosis, no intervention possible)
CDC Split Type:

Write-up: Evening of September 6, 2021, patient began experiencing trigeminy PVC heart rhythm which lasted approximately 18 hours and returned occasionally over the next few days. On September 8th, patient began experiencing bigeminy PVC heart rhythm, which continued nearly non-stop for approximately one week, and slowly receded after that. Stopped metoprolol and started Coreg 3.125mg 2x Daily. After Zio patch results showing high PVC frequency, doubled Coreg to 6.25mg 2x Daily. PVC frequency significantly diminished, trigeminy and bigeminy patterns appear to have dissipated.


VAERS ID: 1779450 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-02-12
Onset:2021-09-06
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Dehydration, Malaise, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PUI''s symptoms started from 9/2/2021. She was hospitalized for a day at hospital due to dehydration. PUI''s son thinks PUI got COVID from the emergency center of hospital as she had visited the hospital due to an UTI.


VAERS ID: 1782459 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-08
Onset:2021-09-06
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: COVID 19


VAERS ID: 1782548 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-08-09
Onset:2021-09-06
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Extra dose administered, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I do not know the tests or lab results.
CDC Split Type:

Write-up: Patient developed Pericardial effusion after 3rd dose of Moderna vaccine


VAERS ID: 1783215 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-08-16
Onset:2021-09-06
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acne, COVID-19, Dyspnoea, Epicondylitis, Pneumonia, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ? Multivitamin daily ? Ibuprofen as needed
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: keflex, shellfish
Diagnostic Lab Data: Xray
CDC Split Type: vsafe

Write-up: I started breaking out with a lot of pimples, I don?t know if that?s normal or not. I?ve had tennis elbow since September. Admitted to general hospital for COVID 9/12, Discharged later that day because they pumped me full of steroids and they were able help with the breathing. Readmitted 9/18 pneumonia, same day ? still on steroid pills from the hospital & an inhaler and so they said to take all the over the counter stuff you can so you aren?t miserable. And I went to see my doctor on 10/5 and was labeled as still having pneumonia, follow up this coming Tuesday.


VAERS ID: 1783606 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Bone pain, Maternal exposure during breast feeding
SMQs:, Osteonecrosis (broad), Neonatal exposures via breast milk (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: None
Current Illness: Unknown
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client reported to RN that she developed "sensitivity in my bones" about one week after the vaccine that has not resolved. The client states she feels the sensitivity about every other day. The client states that laying down, getting up, or kneeling exacerbates her symptoms. She states that it feels similar to "when you workout after you haven''t worked out in a long time." The client states that she is 11 months postpartum and is currently breastfeeding. The client stopped taking her prenatal vitamins about 3 months ago. The client has not followed up with any medical providers regarding her symptoms. The client has no chronic conditions or medications. No known allergies.


VAERS ID: 1784849 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-01-13
Onset:2021-09-06
   Days after vaccination:236
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test positive, Asthenia, Blood creatinine increased, Blood glucose normal, COVID-19, Cough, Diarrhoea, Fatigue, Full blood count, Gait disturbance, Headache, Myalgia, Pain, SARS-CoV-2 test positive, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 80-year-old gentleman, has coronary artery disease, hypertensive heart disease, as well as diabetes mellitus. Presented to the emergency department yesterday with complaints of coughing, diarrhea, headache, myalgia, as well as fatigue. He has no energy. He wants to sleep all the time. He also has aches and pains all over the body with unsteady gait. His symptomatology has been going off and on for the last 4 days. patient underwent workup in the ER, which revealed unremarkable hemogram, although his creatinine was 2.00 with a glucose of 182.His COVID test was done also, which was positive. Antibodies positive. Admitted to COVID unit, started on decadron.


VAERS ID: 1785049 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-17
Onset:2021-09-06
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024M20A / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cardiovascular Disease, Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized due to COVID-19. Patient had cough, SOB, chest pain, and fatigue. Patient is fully vaccinated.


VAERS ID: 1785404 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-09-02
Onset:2021-09-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazole
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound confirmed blood clot (9/11/2021)
CDC Split Type:

Write-up: Blood clot formation in left calf 4 days after receiving first dose of the Covid shot. Started as pain in the left calf and progessivley got worse between Monday 9/6/2021 and Friday 9/10/2021. Went to the ER on 9/11/2021. Currently on Eliquis for 3 months. I do not have a history of any blood related issues. I have always had good blood pressure.


VAERS ID: 1785443 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-06
Onset:2021-09-06
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Rash pruritic
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DairyCare; Vit B; Allergy pill - Zyrtec
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: I had a crazy rash over my whole body - very very itchy; spots. They gave me Prednisone. That took care of it - they are mostly gone. The dermatologist has given me cream that seems to help. Not completely better yet.


VAERS ID: 1786178 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Blood test, Headache, Joint swelling, Muscular weakness, Pain in extremity, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL 75MG DAILY; LOSARTAN 25MG DAILY; LEVOTHYROXINE 25MCG DAILY; ROSUVASTATIN 20MG DAILY; FAMOTIDINE 40MG DAILY; CELECOXIB 200MG TWICE DAILY; METOPROLOL TART 12.5MG TWICE DAILY; DULOXETINE 30MG DAILY; METHOTREXATE 20MG ONCE A WEEK; F
Current Illness: SHINGLES DOWN TEMPORAL IN JUNE 2021; UPPER RIGHT QUAD PAIN ONGOING SINCE MAY CAUSE STILL UNKNOWN
Preexisting Conditions: HYPERTENSION; RA; HYPOTHYROIDISM; OA; DDD; S/P NON-ST MI 01/2021 (CAD STENT PLACED); HYPERCHOLESTEROLEMIA; CHRONIC PAIN;
Allergies: MORPHINE; INDOMETHACIN; ZOMIG; IMITREX; HONEY
Diagnostic Lab Data: PATIENT HAS HAD BLOODWORK SINCE ON 09/30/21
CDC Split Type:

Write-up: HEADACHES DAILY SINCE VACCINE (STARTED WITH FIRST) PATIENT WAS WALKING IN HOUSE AND ALMOST FELL. MUSCLES IN THIGHS FELT LIKE THEY WERE TREMBLING, NO VISIBLE TREMBLE. PATIENT WENT TO URGENT CARE BECAUSE SHE THOUGHT IT COULD BE A BLOOD CLOT. NO DOPLER WAS DONE. THE LEG IS STILL WEAK, BUT NOW THE LEFT KNEE IS SWOLLEN WITH PAIN THAT EXTENDS ENTIRE LEG. WAITING TO HAVE MRI FLUID WAS DRAW OFF KNEE. SHE HAD CORTISONE INJECTION IN KNEE


VAERS ID: 1786355 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-28
Onset:2021-09-06
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: Chest pain, need of air.


VAERS ID: 1682288 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Contusion, Delirium, Hypersomnia, Medication error, Sleep talking, Speech disorder, Tremor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: the patient was tall and muscular
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Did not have high temperature
CDC Split Type: BGJNJFOC20210909793

Write-up: BEING DELIRIOUS; STARTED TO SHAKE; SLEPT FOR TOO LONG TIME; BRUISES ON ARM (LEFT ARM WAS BLUE FROM THE ARM TO THE ELBOW); UNABLE TO TALK CLEAR; MEDICATION ERROR (ANOTHER VACCINE (MODERNA - 2 DOSSES)); HE WAS SLEEPING AND HE WAS TRYING TO TALK (IT WAS NOT UNDERSTANDABLE) IN HIS DREAM; This spontaneous report received from a consumer concerned a 26 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: the patient was tall and muscular. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, 1 total, administered at left arm on 06-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-SEP-2021, 2-3 hours after the vaccination, the patient started to shake, he was sleeping and he was trying to talk (it was not understandable) in his dream and the he was delirious. The patient was sleeping for too long time, he also had bruises and his left arm was blue from the arm to the elbow. He tried to talk, but he could not. The patient had another vaccine (Moderna - 2 dosses, but someone said to him that he had to have Johnson and Johnson too. Laboratory data included: Body temperature (NR: not provided) Did not have high temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the being delirious, slept for too long time, bruises on arm (left arm was blue from the arm to the elbow), unable to talk clear, started to shake, medication error (another vaccine (moderna - 2 dosses)) and he was sleeping and he was trying to talk (it was not understandable) in his dream was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210909793-covid-19 vaccine ad26.cov2.s- being delirious. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1682294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Therapy non-responder
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: Test Date: 20210906; Test Name: Antibody test; Result Unstructured Data: NEGATIVE
CDC Split Type: DEJNJFOC20210911429

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 50-year-old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, frequency time 1 total, administered in JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-SEP-2021, he underwent antibody test which was found to be negative (Confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) as negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192423.; Sender''s Comments: V0: 20210911429-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1686143 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD985 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative
CDC Split Type: DEJNJFOC20210912152

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer and concerned a patient of an unspecified age, sex, race and ethnic origin. The patient''s height and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: XD985 and expiry: Unknown) dose was not reported, 1 total administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-SEP-2021, the patient had performed COVID-19 antibody test and was resulted negative (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192440 This case is linked to 20210903427 (same reporter).; Sender''s Comments: V0: 20210912152-Covid-19 vaccine -Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1687792 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Hallucination, visual, Hypotension, Muscle spasms, Nausea, Symptom recurrence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (occasional); Dizziness (with syringes for instance when pt got blood tests)
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:low
CDC Split Type: GRPFIZER INC202101169203

Write-up: dizzy; dizzy; fainted; muscle spasms; hallucination dream and opening my eyes, seeing double and not recognizing what world I was in, who I was, who my husband was; nauseous; blood pressure low; This is a spontaneous report from a contactable consumer (the patient) received via the RA. A 34-years-old female patient received dose 1 of BNT162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in left arm on 06Sep2021 (Batch/Lot Number: Unknown) as a single dose (at age of 34 years) for COVID-19 immunisation. Medical history included occasional asthma, dizziness (with syringes, for instance when she got blood tests). Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient''s concomitant medications were none; the patient had not received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. A few minutes after the injection, the patient felt very dizzy and fainted. She had in the past encountered dizziness with syringes for instance when she got blood tests, but nothing of the sort ever before. Her husband who was with her informed the patient that she went into muscle spasms; her whole body hardened from arms and legs, her eyes got big and her mouth opened up wide, and then she completely blacked out, seemingly lifeless. She had no recollection of this herself. She could only recall the feeling before the black out and regaining consciousness. She took about 30sec to come to. She recalled having a type of hallucination dream and opening her eyes, seeing double and not recognizing what world she was in, who she was, who her husband was. After a short moment, she regained herself and her brain returned to normal. The head nurse attended to her and laid her down on a bed. She could not stand. She was extremely dizzy and nauseous. They took her blood pressure which was very low. The onset date of the events was 06Sep2021 at 01:00 PM. The events were reported a serious due to being life-threatening. The patient was recovering from the events. The reporter confirmed the event(s) resulted in a Doctor or other healthcare professional office/clinic visit as well as Emergency room/department or urgent care visit. Since the vaccination, the patient had not been tested for COVID-19. Follow-up activities not initiated. No consent for further follow-up obtained.


VAERS ID: 1692847 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertensive urgency, Pain in extremity, Tongue haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient was fit, regularly exercised and was well before vaccination with no past medical history. There were no any other similar AEFIs reported in the facility in the past 30 days.
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: 183/119 mmHg; Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: 185/120 mmHg
CDC Split Type: ZAJNJFOC20210911884

Write-up: SEVERE HYPERTENSION ASYMPTOMATIC; HEMATOMA ON TONGUE; MINOR PAIN IN ARM; This spontaneous report received from a physician concerned an adult male with unspecified race and ethnicity. The patient''s height, and weight were not reported. As per the reporter, the patient was fit, regularly exercised and was well before the vaccination with no past medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: XE430, manufactured date: 23-Jun-2021, expiry date: UNKNOWN) dose was not reported, 1 in total administered on 05-SEP-2021 at 10:50 for prophylactic vaccination by using needle sized 23 gauge and syringe sized 2ml. Concomitant medications were not reported. On 06-SEP-2021 at 08:00 (one day after vaccination), the patient observed a swollen non tender bruise on tongue (coded as hematoma on tongue) and experienced minor pain in arm. However, on examination the patient''s blood pressure incidentally was 185/120 mmHg, and 183/119 mmHg (coded as severe hypertension asymptomatic). The cause of life threatening severe hypertension and bruise was reported as unknown. There were no any other similar adverse events following immunization (AEFIs) reported in the facility in the past 30 days. The action taken with covid-19 vaccine was not applicable. The outcome of the minor pain in arm, hematoma on tongue and severe hypertension asymptomatic was not reported. This report was serious (Life Threatening).; Sender''s Comments: V0: 20210911884-covid-19 vaccine-severe hypertension asymptomatic and hematoma on tongue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1692848 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Chest pain, Electrocardiogram, Heart rate, Hypertension, Palpitations
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no other similar adverse events following immunization reported in the facility in the past 30 days. The patient had no past medical history (including history of previous similar reaction or other allergies), concomitant medication and dates of administration (exclude those used to treat reaction), any other relevant information.
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: 160/102 mmHg; Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: 142/94 mmHg; Test Date: 20210906; Test Name: Electrocardiogram; Result Unstructured Data: Unconfirmed interpretations; Test Date: 20210906; Test Name: Heart rate; Result Unstructured Data: 88 bpm
CDC Split Type: ZAJNJFOC20210914672

Write-up: ANAPHYLAXIS; CHEST PAIN CENTRAL; HYPERTENSIVE; PALPITATION; This spontaneous report received from a physician concerned a 21 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient had no other similar adverse events following immunization reported in the facility in the past 30 days. The patient had no past medical history (including history of previous similar reaction or other allergies), concomitant medication and dates of administration (exclude those used to treat reaction), any other relevant information. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE426 expiry: UNKNOWN) dose was not reported, 1 total administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-SEP-2021 (more than 48 hours after vaccination), the patient presented with chest pain central, palpitation, dyspnea/shortness of breath and also experienced hypertensive on examination, tachycardia, on examination appears anxious, rash on chest/back and anaphylaxis. Laboratory data included: Blood pressure (NR: not provided) 160/102 mmHg, 142/94 mmHg, Electrocardiogram (NR: not provided) Unconfirmed interpretations, and Heart rate (NR: not provided) 88 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis, hypertensive, chest pain central, and palpitation was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210914672-Covid-19 vaccine ad26.cov2.s-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1699729 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Eye pain, Headache, Injection site pain, Migraine, Nausea, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (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: Medical History/Concurrent Conditions: Chills; Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: then all at once my whole body started aching; chills; I had no energy; Hurts in my eye; Aching in my arm at the site of injection; Dull Headache; Chills worsened; Aches & pains in legs; Nausea; Migraine headache; This case was received via RA (Reference number: GB-MHRA-ADR 25902690) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (then all at once my whole body started aching), CHILLS (chills), CHILLS (Chills worsened), PAIN IN EXTREMITY (Aches & pains in legs), NAUSEA (Nausea) and MIGRAINE (Migraine headache) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Headache and Chills. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced CHILLS (Chills worsened) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and MIGRAINE (Migraine headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (then all at once my whole body started aching) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), ASTHENIA (I had no energy), EYE PAIN (Hurts in my eye), INJECTION SITE PAIN (Aching in my arm at the site of injection) and HEADACHE (Dull Headache). At the time of the report, PAIN (then all at once my whole body started aching) and CHILLS (chills) was resolving, CHILLS (Chills worsened), PAIN IN EXTREMITY (Aches & pains in legs), NAUSEA (Nausea) and MIGRAINE (Migraine headache) had not resolved and ASTHENIA (I had no energy), EYE PAIN (Hurts in my eye), INJECTION SITE PAIN (Aching in my arm at the site of injection) and HEADACHE (Dull Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Concomitant medication not provided. Reported that patient was fine for about 9 hours after she initially had jab. Only aching in her arm where she had the jab and a dull headache. Then all at once patient''s whole body started aching, like been punched and kicked all over. She had no energy, a headache and lights hurt her eyes. Chills and she was tired. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1700990 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; type 2 diabetes mellitus.
Allergies:
Diagnostic Lab Data: Test Date: 09/06/2021; Test Name: blood sugar; Result Unstructured Data: Test Result: 30; Comments: at 22:45 blood testing.
CDC Split Type: AUPFIZER INC202101174983

Write-up: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 51, via an unspecified route of administration, left arm, on Sep 6, 2021, at 15:00, single dose, for COVID-19 immunization. Medical history included type 2 diabetes and asthma. Prior to vaccination, patient wasn''t diagnosed with COVID-19. Since the vaccination, patient hadn''t been tested for COVID-19. COVID-19 prior vaccination: No. COVID-19 tested post vaccination: No. Known allergy: None. The patient didn''t received other vaccine in four weeks. The patient received other medications in two weeks. On Sep 6, 2021, at 22:45, patient blood sugar went very high to 30. Treatment received included observation of blood glucose levels and blood testing. The patient admitted to hospital by ambulance. The event resulted in emergency room/department or urgent care (life-threatening illness; immediate risk of death). The event resulted in hospitalization; with outcome of recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1701590 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chills; Fatigue; Fever; Headache; Muscle ache
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shivers; fatigue; 5 celsius; muscle aches; Fever; High temperature; Chills; Headache; This case was received via The Regulatory Authority (Reference number: GB-MHRA-ADR 25900638) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), FATIGUE (fatigue), IRRITABILITY (5 celsius), PYREXIA (Fever), PYREXIA (High temperature), CHILLS (Chills) and HEADACHE (Headache) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Muscle ache, Headache, Fatigue, Chills and Fever. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), IRRITABILITY (5 celsius) (seriousness criterion medically significant) and MYALGIA (muscle aches). At the time of the report, CHILLS (shivers), FATIGUE (fatigue), IRRITABILITY (5 celsius) and MYALGIA (muscle aches) outcome was unknown and PYREXIA (Fever), PYREXIA (High temperature), CHILLS (Chills) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had Fever of 38.5 Celsius, chills, headache, muscle aches, sensitivity fatigue, shivers, all came on at around 2am in the night after the vaccine was given at 1700 the previous day. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1701598 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (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 ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stiffness; Muscle ache; Headache; Fatigue; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25902070) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), MYALGIA (Muscle ache), HEADACHE (Headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), MYALGIA (Muscle ache) and FATIGUE (Fatigue) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1701605 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Shivering; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25903699) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering) 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. Patient was not enrolled in clinical trial. No concomitant medication details was provided. No treatment medication details was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time. MA deems the event in this RA case as non serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time. MA deems the event in this RA case as non serious.


VAERS ID: 1703614 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain
SMQs:

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

Write-up: Pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25905512) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medical information were provided. No treatment information was reported. Pain started 2 hours after receiving 2nd dose the pain was located at the top of shoulder where the vaccine was administered, it was injected quite high into the shoulder rather than the deltoid muscle like 1st dose was, the pain had been so severe that had been screaming in pain and unable to move the patient''s arm outwards or raise it whatsoever. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company Comment: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.


VAERS ID: 1703618 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started, unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Headache; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25905899) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started, unsure when symptoms stopped). Concomitant products included PARACETAMOL for Frequent headaches. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and NAUSEA (Nausea) (seriousness criteria disability and medically significant). On 07-Sep-2021, NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1703621 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, Rash papular, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
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 ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: No reaction after first vaccine second vaccine swelling of arm; Swelling; Papular rash on arms; This case was received via the RA (Reference number: GB-MHRA-ADR 25906527) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (No reaction after first vaccine second vaccine swelling of arm), SWELLING (Swelling) and RASH PAPULAR (Papular rash on arms) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 20-Mar-2020. Concomitant products included CITALOPRAM from 05-May-2019 to an unknown date for Anxiety depression. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 06-Sep-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and RASH PAPULAR (Papular rash on arms) (seriousness criterion medically significant). On an unknown date, the patient experienced EPILEPSY (No reaction after first vaccine second vaccine swelling of arm) (seriousness criterion medically significant). At the time of the report, EPILEPSY (No reaction after first vaccine second vaccine swelling of arm) outcome was unknown and SWELLING (Swelling) and RASH PAPULAR (Papular rash on arms) 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) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient had No reaction after first vaccine. Patient experienced swelling of arm , heat coming from area jagged and rash around jag site for second vaccine. Patient had not tested positive for COVID-19 since having the vaccine .Patient was not enrolled in clinical trial. Patient was not pregnant, Patient was not currently breastfeeding Pharmacist confirmed a reaction, strong antihistamines was given. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority and per IME list; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority and per IME list


VAERS ID: 1703622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: General body pain; Sickness; Cold sweat; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25906484) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (General body pain), ILLNESS (Sickness), COLD SWEAT (Cold sweat) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL for Pain. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PAIN (General body pain) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PAIN (General body pain), ILLNESS (Sickness), COLD SWEAT (Cold sweat) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient had not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1703635 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstrual disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE PHOSPHATE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menstrual cramps; Menstrual cycle abnormal; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25909451) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Menstrual cramps) and MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included CODEINE PHOSPHATE for Endometriosis. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced DYSMENORRHOEA (Menstrual cramps) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Menstrual cycle abnormal) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Menstrual cramps) and MENSTRUAL DISORDER (Menstrual cycle abnormal) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication use information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1703639 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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.MOD20213

Write-up: Shivering; Vomiting; Frontal headache; Nausea; Fever; This case was received on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), HEADACHE (Frontal headache), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Frontal headache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). On 08-Sep-2021, HEADACHE (Frontal headache) had resolved. At the time of the report, VOMITING (Vomiting), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced cold sweats throughout the night post vaccination. Patient had vomiting approximately 15 hours after vaccine administration. Patient is still experiencing vomiting and nausea which is prohibiting her from completing daily tasks. Patient took Paracetamol for treating fever and has not subsided along with headache. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness criteria was assessed as per regulatory authority report. There is insufficient evidence to support seriousness from a clinical or regulatory standpoint.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness criteria was assessed as per regulatory authority report. There is insufficient evidence to support seriousness from a clinical or regulatory standpoint.


VAERS ID: 1707917 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic (Amoxicillin allergy)
Preexisting Conditions: Medical History/Concurrent Conditions: Rash
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Dizziness; Fatigue extreme; Heart racing; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25911306) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PALPITATIONS (Heart racing), CHILLS (Chills), FATIGUE (Fatigue extreme) and DIZZINESS (Dizziness) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The patient''s past medical history included Rash. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin allergy). On 06-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Fatigue extreme) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 07-Sep-2021, PALPITATIONS (Heart racing) and CHILLS (Chills) had resolved. On 08-Sep-2021, PYREXIA (Fever) was resolving. At the time of the report, FATIGUE (Fatigue extreme) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information were reported. Patient was not having symptoms associated to COVID-19. Patient did not have COVID-19 test. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the unexpected events of pyrexia, chills, fatigue, dizziness, and palpitations. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown since no information about the dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority; Sender''s Comments: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the unexpected events of pyrexia, chills, fatigue, dizziness, and palpitations. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown since no information about the dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority


VAERS ID: 1707928 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylphenidate
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: Positive.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Myocarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25912437) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) and CHEST PAIN (Chest pain) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included METHYLPHENIDATE for an unknown indication. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving and CHEST PAIN (Chest pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. 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. On an unknown date patient undergone Troponin test, where troponin was increased to 49- and 48. On an unknown date patient undergone ECG which was Normal. Reporter stated that the pain was resolved and Troponin was improving 2 days later. Company comment: This case concerns a 27-year-old, male patient with no previous relevant medical history, who experienced the expected event of myocarditis and the unexpected event of chest pain. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was not applicable since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old, male patient with no previous relevant medical history, who experienced the expected event of myocarditis and the unexpected event of chest pain. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was not applicable since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1707930 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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.MOD20213

Write-up: Irregular menstrual cycle; Bleeding menstrual heavy; Menstrual flooding; Menstrual flow excessive; Menstrual cycle abnormal; This case was received via Regulatory Authority (Reference number: 25912750) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of menstruation irregular, heavy menstrual bleeding and menstrual disorder in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular menstrual cycle) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Menstrual cycle abnormal) (seriousness criterion medically significant). At the time of the report, MENSTRUATION IRREGULAR (Irregular menstrual cycle), HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy), HEAVY MENSTRUAL BLEEDING (Menstrual flooding), HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) and MENSTRUAL DISORDER (Menstrual cycle abnormal) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected event of irregular menstrual cycle, Bleeding menstrual heavy, Menstrual flooding, Menstrual flow excessive and Menstrual cycle abnormal. The events occurred 6 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected event of irregular menstrual cycle, Bleeding menstrual heavy, Menstrual flooding, Menstrual flow excessive and Menstrual cycle abnormal. The events occurred 6 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1707932 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Nausea, Palpitations, SARS-CoV-2 test, Skin warm, Sweating fever
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALIN; TRAMADOL
Current Illness: Chronic fatigue; Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Cryptogenic organising pneumonia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sweating fever; Nausea; Heart racing; Skin warm; Tiredness; Headache; Armpit pain; Heart pounding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25914451) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever), NAUSEA (Nausea), PALPITATIONS (Heart racing), SKIN WARM (Skin warm), FATIGUE (Tiredness), HEADACHE (Headache), AXILLARY PAIN (Armpit pain) and PALPITATIONS (Heart pounding) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Cryptogenic organising pneumonia in September 2019. Concurrent medical conditions included Chronic fatigue, Fibromyalgia and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included PREGABALIN from 01-Jun-2010 to an unknown date and TRAMADOL from 01-Jun-2010 to an unknown date for Herniated disc. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On 08-Sep-2021, SWEATING FEVER (Sweating fever), NAUSEA (Nausea), PALPITATIONS (Heart racing) and AXILLARY PAIN (Armpit pain) was resolving, SKIN WARM (Skin warm) and PALPITATIONS (Heart pounding) had resolved, FATIGUE (Tiredness) had not resolved. At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported Company Comment: This case concerns a 52-year-old, female patient with relevant medical history of cryptogenic pneumonia, chronic fatigue, fibromyalgia and immunodeficiency, who experienced the unexpected events of sweating fever, nausea, palpitations, skin warm, fatigue, headache and axillary pain. The events occurred approximately 2 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The underlying medical history of cryptogenic pneumonia, chronic fatigue, fibromyalgia and immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 52-year-old, female patient with relevant medical history of cryptogenic pneumonia, chronic fatigue, fibromyalgia and immunodeficiency, who experienced the unexpected events of sweating fever, nausea, palpitations, skin warm, fatigue, headache and axillary pain. The events occurred approximately 2 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The underlying medical history of cryptogenic pneumonia, chronic fatigue, fibromyalgia and immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1708165 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-06
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Inappropriate schedule of product administration, Muscle strength abnormal, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Medication errors (narrow), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLCHICINE A
Current Illness: Pericarditis (Hospitalised and operated last year. Only had an episode two weeks after my first dose since my o)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101182907

Write-up: Dose 2: 22Aug2021 / Dose 1: 15Jun2021; I feel that I have the Guillain Barre syndrome; I have less sensitivity in my hands and legs; weird pickling feeling all across my body but essentially on legs arms hands and face; less strength in my hands; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FD7204), via an unspecified route of administration, administered in arm left on 22Aug2021 as dose 2, single (at the age of 23-years-old) for covid-19 immunization. Medical history included ongoing chronic pericarditis (hospitalised and operated last year) and COVID-19. Concomitant medication included colchicine (COLCHICINE A) taken for pericarditis. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EY0579), via an unspecified route of administration on 15Jun2021 as dose 1, single for covid-19 immunization and experienced pericarditis. The did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID since vaccination. On 06Sep2021, the patient felt that he had Guillain Barre syndrome. Also had less sensitivity in hands and legs, weird pickling feeling all across body but essentially on legs arms hands and face. No paralysis but less strength in hands. Symptoms started 3 days. The patient was not hospitalized for the events. The patient did not receive any treatment for the event Guillain Barre syndrome. The outcome of the events was not recovered. No follow-up attempts were needed. No further information was expected.


VAERS ID: 1709938 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Itching
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168215

Write-up: Severe itching; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109061556079810-8JHOD with Safety Report Unique Identifier of GB-MHRA-ADR 25901128. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Sep2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included itching and clinical trial participant. On 01Sep2021, the patient underwent COVID-19 virus test and the result was negative. The patient had no symptoms associated with COVID-19. Concomitant medications were not reported. On 06Sep2021, the patient received the second dose of vaccine in the morning, 1 hour after vaccination he experienced itching which was reported as serious for being medically significant. It was reported as the patient body was having a severe itching problem and he didn''t know what to do now and asked for any prescription. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event severe itching was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1709949 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site erythema, Lymphadenopathy, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling of face; Fever; Swollen lymph nodes; Headache; Injection site redness; Tiredness; Swelling arm; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25911698) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), INJECTION SITE ERYTHEMA (Injection site redness), FATIGUE (Tiredness), PERIPHERAL SWELLING (Swelling arm), PAIN IN EXTREMITY (Painful arm), SWELLING FACE (Swelling of face), PYREXIA (Fever) and LYMPHADENOPATHY (Swollen lymph nodes) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced SWELLING FACE (Swelling of face) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), INJECTION SITE ERYTHEMA (Injection site redness), FATIGUE (Tiredness), PERIPHERAL SWELLING (Swelling arm) and SWELLING FACE (Swelling of face) had not resolved, PAIN IN EXTREMITY (Painful arm) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. no concomitant and treatment details reported. Company Comment: This case concerns a 28-year-old, female subject who experienced the expected events of headache, fatigue, pain in extremity, injection site erythema, lymphadenopathy, and fever, and unexpected event of peripheral swelling. Th patient''s medical history was not provided. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was not applicable, as the patient had completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of the vaccine in not affected by this report; Sender''s Comments: This case concerns a 28-year-old, female subject who experienced the expected events of headache, fatigue, pain in extremity, injection site erythema, lymphadenopathy, and fever, and unexpected event of peripheral swelling. Th patient''s medical history was not provided. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was not applicable, as the patient had completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of the vaccine in not affected by this report


VAERS ID: 1709968 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Allergic rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25918091) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: PENICILLIN NOS. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash) (seriousness criterion medically significant). At the time of the report, DERMATITIS ALLERGIC (Allergic rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced lumpy rash appeared all over skin (mainly arms, thighs, stomach, back, armpits). Patient took antihistamines for that. Went down within half hour, this has happened random times of the day it would come up in rash and go back down again multiple times within that day. No concomitant medications were provided. Company comment: This case concerns a 19-year-old, female patient with previous relevant medical history of penicillin allergy, who experienced the unexpected event of Dermatitis allergic. The event occurred 4 days after the second dose of Moderna COVID-19 VACCINE. The rechallenge was not applicable since only information about the second dose was disclosed. The medical history of penicillin allergy remains a confounder. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 VACCINE is not affected by this report. Event is assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.; Sender''s Comments: This case concerns a 19-year-old, female patient with previous relevant medical history of penicillin allergy, who experienced the unexpected event of Dermatitis allergic. The event occurred 4 days after the second dose of Moderna COVID-19 VACCINE. The rechallenge was not applicable since only information about the second dose was disclosed. The medical history of penicillin allergy remains a confounder. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 VACCINE is not affected by this report. Event is assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.


VAERS ID: 1714498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21E10-05 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: CHJNJFOC20210930900

Write-up: LACK OF EFFICACY; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21e10-05, expiry: Unknown) dose was not reported, 1 total administered on left deltoid on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-Sep-2021, the patient stated he was tested Covid-19 positive. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (confirmed covid-19 infection and lack of efficacy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lack of efficacy, and the outcome of confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.; Sender''s Comments: V0. 20210930900-covid-19 vaccine ad26.cov2.s-Lack of efficacy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1716034 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: OMEPRAZOLE; PREDNISOLONE
Current Illness: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Coughing; Sore throat; Stiff neck; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25917469) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 07-Sep-2021 and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included PREDNISOLONE from 19-Sep-2019 to an unknown date for Uveitis, OMEPRAZOLE for an unknown indication. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion medically significant). At the time of the report, COUGH (Coughing) and OROPHARYNGEAL PAIN (Sore throat) had not resolved, MUSCULOSKELETAL STIFFNESS (Stiff neck) was resolving and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected events of Coughing, Sore throat, stiff neck, and fever. The event fever occurred on the same day after the second dose of Spikevax. The events Coughing, Sore throat and stiff neck occurred one day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected events of Coughing, Sore throat, stiff neck, and fever. The event fever occurred on the same day after the second dose of Spikevax. The events Coughing, Sore throat and stiff neck occurred one day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1716045 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Dysgeusia, Pain in extremity, Tinnitus
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Taste bitter-salty; Tinnitus; Feeling of total lack of energy; Decreased appetite; Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25923765) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste bitter-salty), TINNITUS (Tinnitus), ASTHENIA (Feeling of total lack of energy), DECREASED APPETITE (Decreased appetite) and PAIN IN EXTREMITY (Pain in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced DYSGEUSIA (Taste bitter-salty) (seriousness criterion medically significant), TINNITUS (Tinnitus) (seriousness criterion medically significant), ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant) and DECREASED APPETITE (Decreased appetite) (seriousness criterion medically significant). On 07-Sep-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 09-Sep-2021, TINNITUS (Tinnitus) and ASTHENIA (Feeling of total lack of energy) had resolved. On 10-Sep-2021, DECREASED APPETITE (Decreased appetite) had resolved. At the time of the report, DYSGEUSIA (Taste bitter-salty) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications on use were not provided. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. This case concerns a 58-year-old, female subject with no relevant medical history, who experienced the unexpected events of dysgeusia, tinnitus, asthenia, decreased appetite and pain in extremity. The event pain in extremity occurred on the same day of administration of the second dose; the events dysgeusia, tinnitus, asthenia and decreased appetite occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.; Sender''s Comments: This case concerns a 58-year-old, female subject with no relevant medical history, who experienced the unexpected events of dysgeusia, tinnitus, asthenia, decreased appetite and pain in extremity. The event pain in extremity occurred on the same day of administration of the second dose; the events dysgeusia, tinnitus, asthenia and decreased appetite occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.


VAERS ID: 1716798 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAM; DIHYDROCODEINE; VENLAFAXINE; VENLAFAXINE HYDROCHLORIDE SUN PHARMACEUTICAL; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Preterm premature rupture of membranes; Sciatica (Chronic sciatica (disorder))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176212

Write-up: pericarditis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-TPP15891357C7313691YC1630916466105. A 26-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 06Sep2021 (at the age of 26-year-old) as Dose Number Unknown, Single for covid-19 immunization. Medical history included preterm premature rupture of membranes on an unknown date (Spontaneous vertex delivery findings unknown) and sciatica from an unknown date (Chronic disorder). Concomitant medications included diazepam (DIAZEPAM) taken for an unspecified indication from 22Jun2021 to 06Jul2021, dihydrocodeine (DIHYDROCODEINE) taken for an unspecified indication from 09Jul2021 to an unspecified stop date, venlafaxine (VENLAFAXINE) taken for an unspecified indication from 27Aug2021 to an unspecified stop date, venlafaxine hydrochloride (VENLAFAXINE HYDROCHLORIDE SUN PHARMACEUTICAL) taken for an unspecified indication from 25Jun2021 to 23Jul2021, zolpidem (ZOLPIDEM) taken for an unspecified indication from 27Aug2021 to an unspecified stop date. On 06 Sep2021, the patient experienced pericarditis. The outcome of the event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716799 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAM; MIRTAZAPINE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Chronic thrombocytopenia; Haemochromatosis (Haemochromatosis for 25+ years.); Ill-defined disorder
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: Test Result:low platelet count
CDC Split Type: GBPFIZER INC202101168580

Write-up: Thrombocytopenia; Has chronic thrombocytopenia which has worsened since having vaccine; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-TPP24474885C7332734YC1630928038348, Safety Report Unique Identifier GB-MHRA-ADR 25899908. An 84-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Sep2021 (at the age of 84-year-old) as dose number unknown, single for covid-19 immunization. Medical history included haemochromatosis for 25+ years, ill-defined disorder, anxiety, chronic thrombocytopenia. Concomitant medication(s) included diazepam taken for ill-defined disorder, anxiety from 13Dec2018 to an unspecified stop date; mirtazapine taken for ill-defined disorder, anxiety from 16Aug2021 to an unspecified stop date; propranolol taken for ill-defined disorder from 13Apr2021 to an unspecified stop date. Recently started mirtazapine 7.5-15mg nocte due to anxiety. The patient experienced thrombocytopenia on 06Sep2021. It was reported that the patient had chronic thrombocytopenia which had worsened since having vaccine. Under care of haemotologist (name) but had been unable to have venesection due to low platelet count. Outcome of the event was not recovered. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101161024

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202109060423539700-I02ZX, Safety Report Unique Identifier GB-MHRA-ADR 25897601. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Sep2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration received for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes (lymphadenopathy) (medically significant) on 06Sep2021 with outcome of not recovered. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No causality was provided for lymphadenopathy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716957 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: CODEINE SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain (Taking pain relief regularly)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168432

Write-up: bruising; Bruising of face; This is a spontaneous report from a contactable consumer, this report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109060924437340-T1YK3 and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25898784. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Sep2021 as dose number unknown, single for COVID-19 immunisation. Medical history included pain from an unknown date and unknown if ongoing Taking pain relief regularly. Concomitant medication included codeine sulfate taken for headache, start and stop date were not reported. The patient previously took naproxen. The patient experienced bruising on an unspecified date; bruising of face on 06Sep2021. The event was reported as medically significant. Bruising feeling without physical signs on side of face left side hurts without touching Patient is not enrolled in clinical trial. The outcome of event bruising was unknown, whereas the event bruising of face was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1716991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Capillary leak syndrome, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Capillary leak syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168495

Write-up: incredibly heavy period; menstrual cup leakage; Menstrual flooding; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202109061600580090-ZKBCA. Safety Report Unique Identifier GB-MHRA-ADR 25901135. A 42-year-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech covid-19 vaccine, Formulation:Solution for injection,Batch/lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included capillary leak syndrome from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline taken for anxiety, start and stop date were not reported. The patient has not tested positive for covid-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient has not had symptoms associated with covid-19 and not had a covid-19 test.The patient was not currently breastfeeding. On an unspecified date patient experienced incredibly heavy period, menstrual cup leakage.On 06Sep2021, the patient experienced menstrual flooding. The outcome of the event menstrual flooding was recovering while the outcome of the events incredibly heavy period, menstrual cup leakage was unknown Note: patient reported she had Incredibly heavy period, unlike anything prior. Filling menstrual cup in an hour. Leaked through 2 sets of trousers. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary fibrosis, Pulmonary pain, Renal pain
SMQs:, Interstitial lung disease (narrow), 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: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally.))
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Eczema; Lung fibrosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168384

Write-up: Aching lungs; Lung pain; Kidney pain; This is a spontaneous report from a contactable consumer (patient), received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061711523030-OUFSQ. Safety Report Unique Identifier is GB-MHRA-ADR 25901560. A 26-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as 2nd single dose, for COVID-19 immunisation. Medical history included lung fibrosis, eczema, asthma, and ongoing regular steroid therapy (e.g. orally or rectally). The patient''s concomitant medications were not specified. Past drug history included salbutamol taken when required. The patient had not had symptoms associated with COVID-19, had not had a COVID-19 test, was not pregnant or breastfeeding, had not tested positive for COVID-19 since having the vaccine, and was not enrolled in a clinical trial. The patient stated she was experiencing aching lungs and kidneys. Due to the pain, the patient took paracetamol that did not help, however warm compress and having a warm bath did help. The reported events were lung fibrosis with unknown onset date, pulmonary pain with onset date 06Sep2021, and kidney pain with onset date 06Sep2021. The patient was recovering from lung fibrosis, but had not recovered from lung and kidney pain. The case was reported as serious due to important medical condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Muscular weakness, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168561

Write-up: Armpit pain; Shoulder pain; Neck pain; Hands weakness of; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109061740409680-8CMOO. Safety Report Unique Identifier GB-MHRA-ADR 25901802. A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 04Sep2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included pain from an unknown date. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. On 06Sep2021, the patient experienced armpit pain, shoulder pain, neck pain, hands weakness of. It was stated that pain does not radiate from vaccination site. Is worst in armpit and feels like tight pinching. No position is comfortable, and pain does not subside with painkillers. Grip strength was weakened, and knuckles feel sore. Therapeutic measures were taken as a result of AEs. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chest pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101168413

Write-up: Tightness in chest; Chest pain; Joint pain; Fever chills; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061951070000-BYBUP and Safety Report Unique Identifier is GB-MHRA-ADR 25903099. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087) via an unspecified route of administration, on 05Sep2021, at single dose, for COVID-19 immunisation. Relevant medical history chest pain from an unknown date and COVID-19. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced tightness in chest. On 06Sep2021, the patient developed chest pain, joint pain and fever chills. The adverse events were described as "chest pain: tightness in chest, sharp pain in chest, pain worsens during deep breathing". No treatment received at time of this report. The patient did not recover from chest pain and joint pain. He recovered from fever chills on 06Sep2021, while clinical outcome of tightness in chest was unknown. Relevant laboratory test included COVID-19 virus test positive on 26Jun2021. Post the vaccination, the patient has not been tested for COVID-19. Patient is not enrolled in clinical trial. The adverse events were assessed as serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-09-06
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Tinnitus, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Visual disturbance
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101168218

Write-up: visual disturbance; ringing in ears/tinnitus; high temperature; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109062027056590-GWPFT with Safety Report Unique Identifier of GB-MHRA-ADR 25902950. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Feb2021, as a single dose for COVID-19 immunisation. Medical history included visual disturbance. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and not breastfeeding at the time of this report. Patient was not enrolled in clinical trial. Concomitant medications were not reported. On 06Sep2021, the patient experienced high temperature and visual disturbance. On 06Sep2021, the patient experienced ringing in ears/tinnitus. Patient felt well until the reporting date when started with a high temperature, visual disturbance and ringing in ears. Events ringing in ears/tinnitus and visual disturbance were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events visual disturbance and ringing in ears was resolving; tinnitus was not resolved and that of high temperature was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1717033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Diarrhoea, Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill; Breathing difficult; COVID-19 (hospitalised with covid); Hospitalisation (hospitalisation due to respiratory viruses); Suspected COVID-19; Unwell
Allergies:
Diagnostic Lab Data: Test Date: 20201224; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101176125

Write-up: unwell; Tremor; Fever; Nausea; Diarrhea; Bone pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109070957270710-CH1TB.Safety Report Unique Identifier GB-MHRA-ADR 25905747. A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 05Sep2021 (Batch/Lot number was not reported), as single dose for COVID-19 immunisation. The patient''s medical history included suspected COVID-19 (from 23Dec2020 to 09Jun2021), hospitalisation (hospitalisation due to respiratory viruses), malaise, dyspnoea, COVID-19 (hospitalised with COVID), oral contraception (from an unknown date and unknown if ongoing). Concomitant medication(s) included desogestrel (CERELLE) taken for oral contraception, (start and stop date were not reported). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization with reaction unwell. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. On an unspecified date, the patient experinced unwell. On 06Sep2021, the patient experienced tremor, fever, nausea, diarrhea and bone pain. All the events were serous (Medically significant). It was reported that usually become unwell after vaccines, was hospitalised with COVID, have had history of breathing difficulties/hospitalization due to respiratory viruses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Dec2020 Yes - Positive COVID-19 test. The outcome of the event unwell was unknown and the events fever, nausea, bone pain was recovering. The outcome of the events diarrhea was recovered on an unspecified date in 2021 and tremor was recovered on 07Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717035 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Hypoaesthesia oral, Illness, Muscle spasms, Pain in extremity, Palpitations, Paraesthesia, Presyncope, Respiration abnormal, SARS-CoV-2 test, Tremor, Vision blurred, Visual impairment
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101176234

Write-up: This is a spontaneous report from a contactable consumer or other non-HCP, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109071028587430-FNGM8; safety report unique identifier: GB-MHRA-ADR: 25905860). A 16-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 4, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has no symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The patient experienced difficulty breathing, sickness, shaking and blurred vision on an unspecified date, numb mouth, cramp in hand, palpitations, hand pain, pins and needles occurred in arms, hands and legs - caused hands to not be able to move, nor could he pick anything up - struggled to walk, near fainting, abnormal breathing and abnormal vision. He decided to go to the hospital as he could not move his hands on several occasions for approximately 15 minutes at a time. This lasted all day on Sep 6, 2021. All the events assessed medically significant. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: No-Negative COVID-19 test on unspecified date. The outcome of difficulty breathing, sickness, shaking, blurred vision: not recovered; numb mouth, cramp in hand, palpitations, hand pain: recovering; the outcome of pins and needles, near fainting, abnormal breathing recovered on Sep 6, 2021; and abnormal vision recovered on Sep 7, 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1717041 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101176237

Write-up: Vomiting; Nausea; Headache; Tiredness; Feeling hot and cold; Shivering; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071105021580-EE8UB, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25906124. A 20-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 06Sep2021 (Batch/Lot Number: FE1510) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 08Aug2021 to 12Aug2021. The patient''s concomitant medications were not reported. The patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. On 06Sep2021, the patient experienced nausea, headache, tiredness, feeling hot and cold, shivering. On 07Sep2021, the patient experienced vomiting. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021 Yes - Positive COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. The Patient was not enrolled in clinical trial. The outcome of the events nausea, headache, tiredness, feeling hot and cold, shivering not recovered and event vomiting was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101176167

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071150343300-LTLCU. Safety Report Unique Identifier GB-MHRA-ADR 25906275. A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant. The patient was not currently breastfeeding. The patient historical vaccine included bnt162b2 (COMIRNATY) on an unspecified date as dose 1, single for COVID-19 immunization. On 06Sep2021 the patient experienced armpit pain. On 25Jul2021 the patient underwent lab tests and procedures which included COVID-19 virus test was positive covid-19 test. The patient not had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The event was reported as eventually medically significant. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717061 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176185

Write-up: Spasms/arm spasm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071651038290-9AWSW, Safety Report Unique Identifier GB-MHRA-ADR 25907631. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced arm spasm on an unspecified date, spasms on 06Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Outcome of the event arm spasm was unknown, spasms was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1717069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101176272

Write-up: Head cold; Cold; Swollen glands; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is -MHRA-WEBCOVID-202109080258361680-6G8HX. Safety Report Unique Identifier -MHRA-ADR 25909833. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 06Sep2021 the patient experienced cold, swollen glands, and headache, on 07Sep2021 patient had head cold. The patient underwent lab tests and procedures which included sars-cov-2 test was no-negative COVID-19 test on. The patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of event was not recovered yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ASPIRIN (E.C.); BISOPROLOL; CANDESARTAN; LEVOTHYROXINE; MESALAZINE; OMEPRAZOLE; SEEBRI BREEZHALER; SYMBICORT; VENTOLIN ACCUHALER
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191742

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; COVID-19 pneumonia; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109101217364010-8OMH1. Safety Report Unique Identifier GB-MHRA-ADR 25923746. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on an unspecified date as dose 2, single; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included suspected COVID-19 patient from 03Sep2021 and ongoing. Concomitant medications included allopurinol, acetylsalicylic acid (ASPIRIN (E.C.), bisoprolol, candesartan, levothyroxine, mesalazine, omeprazole, glycopyrronium bromide (SEEBRI BREEZHALER), budesonide, formoterol fumarate (SYMBICORT) and salbutamol sulfate (VENTOLIN ACCUHALER); all for an unspecified indication, start and stop date were not reported. The patient had two doses of the Pfizer BionTech covid vaccine, dates unclear, but tested positive via PCR on 06Sep2021. She is currently being treated for Covid-pneumonitis (2021) as an inpatient in hospital. The events were serious hospitalization, medically significant, life threatening. The outcome of Covid-pneumonia was not recovered; for other event was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717404 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect dosage administered, Underdose, Vaccination site thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101160790

Write-up: Vaccination site thrombosis; Vaccine Underdose; Vaccine Underdose; This is a spontaneous report from a contactable nurse received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 17-year-old non-pregnant female patient received BNT162B2 (Pfizer; Solution for injection; Batch/Lot Number: FF9942; Expiration Date: 30Nov2021), via intramuscular route, administered in left arm on 06Sep2021 at 16:00 (at the age of 17-year-old) as dose 1, 0.1 ml single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Since the vaccination, the patient had not been tested for COVID-19. On 06Sep2021 at 16:00 (the same time of the vaccination), the patient experienced vaccination site thrombosis and vaccine underdose. The details of the reaction were reported as follow: The 25G needle (0.3ml) was inserted into the upper left arm and when 0.1ml had been entered, the resistance of syringe inner barrel was strong and the drug solution could not be entered anymore, so the needle was pulled out once. It might be a problem with the needle, so the needle (25G) was changed and inserted it again. The syringe inner barrel was pushed for injecting the drug solution, but there was also a resistance to inject and the needle was pulled out again. When checking the needle, there was a thrombus on the top of the needle, and vaccination was discontinued. The outcome of vaccination site thrombosis was recovered without treatment. The reporter classified vaccination site thrombosis as non-serious. Sender''s Comments: Based on temporal association and available information the reported vaccination site thrombosis is assessed as related to BNT162B2. Case will be reassessed if additional information is received. 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, Investigators, as appropriate.


VAERS ID: 1717433 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Drug hypersensitivity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/76 mmHg; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101169561

Write-up: Urticaria; Allergic reaction due to vaccination; This is a spontaneous report from a contactable physician received from the Regulatory AUTHORITy (RA). Regulatory authority report number is v21126037. A 27-years-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 06Sep2021 16:30 (Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) age at vaccination of 27-years-old, as 0.3ml single for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing (allergy to Tempura powder). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines in the past two weeks. The patient experienced urticaria on 06Sep2021 16:40 (10 minutes after the vaccination) and allergic reaction due to vaccination on 06Sep2021. The patient had not been sick or had a fever in the past month. The patient did not feel sick on the vaccination day. The patient did not have convulsions (seizures). The course of the event was as follows: Body temperature on 06Sep2021 (before vaccination) was 36.8 degrees Centigrade. After receiving the vaccination about 10 minutes later, urticaria appeared. Blood pressure was 110/76 mmHg, no dyspnoea. Drip included: saline 100 l (as reported), Solu-Cortef 100mg 1A, POLARAMINE 5mg 1A, Tagamet 200mg 1A. After receiving the drip, the patient was recovering. On 06Sep2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the events as non-serious and related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that the patient had allergic reaction to COMIRNATY. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1717439 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure diastolic, Blood pressure systolic, Blood pressure systolic decreased, Feeling abnormal, Heart rate, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:80 mmHg; Test Date: 20210906; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:106 mmHg; Test Date: 20210906; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:120 mmHg; Test Date: 20210906; Test Name: HR; Result Unstructured Data: Test Result:69; Test Date: 20210906; Test Name: SpO2; Test Result: 96 %; Comments: (room air); Test Date: 20210906; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101169674

Write-up: SpO2 96% (room air)/ oxygen saturation slightly decreased; BP 106/80 mmHg; Anaphylaxis; sweaty/ a lot of sweating; feeling poorly; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). Regulatory authority report number is i21103547. A 15-year-old male patient received of BNT162b2 (Pfizer, Solution for injection) intramuscular injection in the central part of left deltoid, on 06Sep2021 at 16:00 (Lot number FG0978, Expiration date 30Nov2021), at the age of 15 years old, as first single dose at 0.3 mL, for COVID-19 immunization. The patient did not have any primary disease or complications. The patient did not have any relevant medical history. The patient did not have any history of past side effects. The patient did not drink alcohol or smoked and did not have any allergies. The patient was not taking any concomitant drug. On 06Sep2021 (the same day of the vaccination), starting from approximately 16:05, the patient started being sweaty and feeling poorly. At 16:10, the patient reported to the physician. SpO2 was 96% (room air) considered slightly decreased, blood pressure (BP) was 106/80 mmHg, and heart rate (HR) was 69. Anaphylaxis was suspected, and adrenaline 0.3 mL was injected intramuscular to the left upper arm. After that, the symptoms improved quickly with systolic BP at about 120 mmHg, and SpO2 at 98%. After 30-minutes observation, the patient was permitted to go home. As for the second dose of BNT162b2, this was canceled. The patient was going to receive an antibody level evaluation 3 months after the 1st vaccination. The patient was considered recovered from the suspected anaphylactic reaction and its symptoms on 06Sep2021 (the same day of the vaccination). The reporting physician classified the event(s) as non-serious and did not provide any causality assessment. There was no other possible cause of the event such as any other diseases. Reporting physician comment: It was said the frequency of anaphylaxis due to BNT162b2 was several out of 1 million vaccination. However, it was considered to happen even in a small venue like this facility where only about 2000 vaccination was received, and adrenaline, steroid, antihistamine, and oxygen administration were prepared. It was so lucky the preparation worked, and the patient recovered when the symptoms were still very mild. The patient was a very young male, and to judge anaphylaxis from vasovagal reaction was not easy. But, based on blood pressure and oxygen saturation slightly decreased, adrenaline administration was judged as necessary. In this case, the patient did not claim of allergy to pollinosis, food or drug. The symptoms were very mild, so it was not a confirmed diagnose of anaphylaxis, and minor symptoms of respiratory and cardiovascular were suspected. Although it was not sure to match Brighton classification level 3, if the symptoms became serious, this facility was mostly probably not able to treat the patient, so the treatment was prioritized. As to future issues to be examined, currently the third booster vaccination was already on discussion. So, in the future, if this patient was to receive vaccination, how to decide whether the patient can receive or not? (AstraZeneca cannot be received below 40 years old. Nova Bucks would be authorized in this year?) Should PEG allergy confirmation diagnose be added to conditions? Information provision like these would be very helpful to the explanation to patients.


VAERS ID: 1717449 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Heart rate, Oxygen saturation, Seizure
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:70s mmHg; Comments: 15 minutes after the vaccination; Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60 mmHg; Comments: at 18:45; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210906; Test Name: pulse; Result Unstructured Data: Test Result:58 per minute; Comments: regular 15 minutes after the vaccination; Test Date: 20210906; Test Name: SpO2; Test Result: 99 %; Comments: room air 15 minutes after the vaccination
CDC Split Type: JPPFIZER INC202101170774

Write-up: Anaphylaxis; convulsion symptoms, which was likely diaphragm convulsion; Blood pressure 70s mmHg; chills; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21126046. This is the first of two reports and concerns events occurred after the second dose of BNT162B2. A 37-year and 0-month-old female patient received the second dose of bnt162b2 (COMIRNATY, solution for injection, lot number FF3620, expiration date 30Nov2021) via an unspecified route of administration on 06Sep2021 at 18:15 (the day of vaccination, at the age of 37-years-old), as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiration date not provided) on an unspecified date for COVID-19 immunisation and experienced tingling mouth, suspected as allergy symptom. Body temperature before vaccination, on 06Sep2021, was 36.1 degrees Centigrade. On 06Sep2021 at 18:30 (15 minutes after the vaccination), the patient experienced anaphylaxis, convulsion symptoms, which was likely diaphragm convulsion, blood pressure 70s mmHg and chills. On 09Sep2021 (reported as 09Jun2021), the patient was admitted to the hospital. The course of the event was as follows: 15 minutes after the vaccination, the patient experienced convulsion symptoms, which was likely diaphragm convulsion. Blood pressure 70s mmHg, pulse rate 58 per minute, regular, SpO2 (oxygen saturation) 99% (room air). After that the patient experienced chills. Consciousness clear. At 18:38, EPIPEN was administrated. At 18:45, blood pressure went back to 100/60 mmHg. The patient was transferred to hospital for observation. The outcome of the events was reported as unknown. The reporting physician classified the event as serious (hospitalized from 09Jun2021 as reported) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101183814 same patient/drug,different events/dose


VAERS ID: 1717484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Fall, Presyncope, Wound
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fall; Wound; Bruise of head; Vagal reflex; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP087676) on 07-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This case was reported by a physician via a medical representative. On 06-Sep-2021, the patient received the 1st dose of this vaccine. About 10 minutes after the vaccination, vagal reflex developed. The patient fell from a chair and was urgently transported to hospital due to bruise of head. Because there was wound, it was sutured, and there was no problem in the CT image. Thereafter, the patient returned home because the symptoms were resolving. The outcome of fall, wound, bruise of head, and vagal reflex was reported as resolving. Follow-up investigation will be made Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a male patient with unknown age with relevant medical history of epilepsy, who experienced the unexpected event of fall, wound, contusion and presyncope. The events fall, wound, contusion and presyncope occurred 10 minutes after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the first dose of mRNA-1273 vaccine. The events were considered not related to the product per the reporter''s assessment. The medical history of epilepsy remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1717489 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005289 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad)

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

Write-up: Hyperventilation syndrome; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP090256) on 07-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the RA (Ref, v21126000). On an unknown date, body temperature before the vaccination: 35.8 degrees Celsius. On 06-Sep-2021, at 14:00, the patient received the 1st dose of the vaccine. Several minutes later, dyspnea developed. The patient was emergently transported and was diagnosed with hyperventilation syndrome. Subsequently, respiration and circulation were stabilized. No skin rash developed. The symptom subsided spontaneously and resolved. The outcome of hyperventilation syndrome was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event might be a psychogenic reaction associated with the administration of the vaccine.; Sender''s Comments: This case concerns a 19year-old, female patient with no relevant medical history who experienced the unexpected event of hyperventilation. The event occurred on the same day after the first dose of mRNA 1273 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The reporter assessed the event as related to the product. The benefit-risk relationship of vaccine in not affected by this report.


VAERS ID: 1717494 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Bradycardia, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: At 14:26; Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: At 15:00; Test Date: 20210906; Test Name: Pulse; Result Unstructured Data: At 14:26 pulse (P9 47); Test Date: 20210906; Test Name: Pulse; Result Unstructured Data: At 15:00; Test Date: 20210906; Test Name: percutaneous oxygen saturation (SpO2); Test Result: 99 %; Result Unstructured Data: At 14:26; Test Date: 20210906; Test Name: percutaneous oxygen saturation (SpO2); Test Result: 99 %; Result Unstructured Data: At 15:00
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Bradycardia; Vagal reflex; This case was received via Pharmaceuticals (Reference number: 2021TJP092049) on 08-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. The license partner had received the report from A (Reference number: v21126940). This case, initially reported to the Agency (A) by a physician, was received via the A (Ref, v21126940). Bradycardia was assessed as serious. On an unknown date, body temperature before vaccination: 36.2 degrees Celsius. On 06-Sep-2021, at 14:12, the patient received the 1st dose of this vaccine. At 14:26, the patient experienced poorly feeling after the vaccination. Blood pressure (BP) 78/45, pulse (P9 47, percutaneous oxygen saturation (SpO2) 99%, level of consciousness was clear, and no findings of the skin. Just in case, oxygen administration (3L) was started. Between 14:26 and 15:00, vagal reflex was suspected because of bradycardia and decreased blood pressure, and the patient was followed up. At 15:00, BP 96/65, P 64, and SpO2 99%. The patient was able to drink water by him/herself and the symptoms improved, so the patient went home. In addition, the patient was instructed to lie in bed to get the 2nd vaccination from the beginning. The outcome of bradycardia and vagal reflex was reported as recovered. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. The event seemed to be a vagal reflex from the situation. The event was causally related to the conduct of vaccination, but not to the vaccine. Follow-up investigation will be made.; Sender''s Comments: This case concerns a 23 year old female patient with no relevant medical history, who experienced the unexpected event of bradycardia and presyncope. The events occurred 14 minutes after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The events are considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1717495 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Bradycardia; Vagal reflex; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP092051) on 08-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This case, initially reported by a physician, was received via the regulatory authority (Ref, v21126942). Bradycardia was assessed as serious by the regulatory authority. On an unknown date, body temperature before the vaccination: 35.9 degrees Celsius. On 06-Sep-2021, at 14:56, the patient received the 1st dose of this vaccine. At 15:00, the patient felt poor after the vaccination. Blood pressure (BP): 79/50, pulse (P): 43, and percutaneous oxygen saturation (SpO2): 99%. The patient was awake and alert, and there were no skin findings. As bradycardia and decreased blood pressure developed, vagal reflex was suspected, and the patient was followed up. At 15:15, BP: 91/55, P: 47, and SpO2: 99%. At 15:30, BP: 87/68, P: 49, and SpO2: 99%. The patient was able to drink water by him/herself, and the symptoms were resolving, so the patient returned home. The patient was instructed to receive the 2nd vaccination in bed from the beginning. The outcome of bradycardia and vagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event is considered vagal reflex from the situation. This event is causally related to the conduct of vaccination with this vaccine, but not to this vaccine. Sender''s comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 23-year-old, female patient with no relevant medical history, who experienced the unexpected event of bradycardia. The event occurred on the same day, right after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The event was considered related to the act of vaccination but unrelated to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as reported (case).


VAERS ID: 1720618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyphaema
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ophthalmic migraine; Tachycardia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210937454

Write-up: HYPHAEMA; This spontaneous report received from a physician via a Regulatory Authority (FR-AFSSAPS-NT20213949) was received on 20-SEP-2021 and concerned a 71 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: tachycardia, and ophthalmic migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total administered on 26-AUG-2021 for sars-cov-2 vaccination. Drug start period was 12 days. The batch number was not reported. Per procedure, no follow -up will be requested for this case. No concomitant medications were reported. On 06-SEP-2021, the patient experienced hyphaema. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 26-AUG-2021. The patient recovered from hyphaema. This report was serious (Other Medically Important Condition).


VAERS ID: 1720658 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176053

Write-up: chest pains; Extremely sore arm; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-EYC 00259957, Safety Report Unique Identifier GB-MHRA-ADR 25902093. A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via parenteral route of administration on 06Sep2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced extremely sore arm, nausea, extreme fatigue and chest pains. The clinical outcome of the events extremely sore arm, nausea, extreme fatigue and chest pains was not resolved at the time of this report. The events extremely sore arm, nausea, extreme fatigue and chest pains were reported as serious for being medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168301

Write-up: Chest pain/sharp pain in the middle of her chest/dull ache/stabbing pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202109062301174340-TIROZ, Safety Report Unique Identifier is GB-MHRA-ADR 25903697. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Sep2021 (Lot/batch number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included pain and depression, both from an unknown date and unknown if ongoing. Concomitant medications included sertraline taken for depression, start and stop date were not reported. The patient experienced chest pain/sharp pain in the middle of her chest/dull ache/stabbing pain on 06Sep2021. The event was assessed as serious (disability, medically significant). The outcome of the event was unknown. The clinical course was reported as follows: patient was standing and suddenly got a sharp pain in the middle of her chest getting worse when she breathed in it dulled down after 5 minutes and had stayed as a dull ache/stabbing pain since. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720760 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Inappropriate schedule of product administration, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176207

Write-up: Fever; Abdominal pain; Dose 1: 04Jul2021 Dose 2: 06Sep2021 Inappropriate schedule of vaccination administered; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071459361390-H9XNU. Safety Report Unique Identifier GB-MHRA-ADR 25907014. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 06Sep2021 (Age at vaccination 22 years) as dose 2, single for covid-19 immunisation. Medical history included steroid therapy from an unknown date and unknown if ongoing Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on 04Jul2021 as dose 1, single for covid-19 immunisation and experienced no adverse reaction. On 06Sep2021, the patient experienced fever; abdominal pain and dose 1: 04jul2021 dose 2: 06sep2021 inappropriate schedule of vaccination administered. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Palpitations, Pericarditis, Poor quality sleep
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; DICLOFENAC SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Knee injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101175993

Write-up: Pericarditis; Chest pain; Palpitations; Light-headed; Poor sleep; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109080616245940-4AHZL with Safety Report Unique Identifier GB-MHRA-ADR 25910213. A 44-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380), via an unspecified route of administration on 04Sep2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal and knee injury. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included amlodipine for blood pressure abnormal and diclofenac sodium for knee injury from 24Mar2021. On 06Sep2021, 2 days after the vaccination, the patient experienced chest pain, palpitations, light-headed, poor sleep and pericarditis; all events were reported as serious for being medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events chest pain, palpitations, light-headed, poor sleep and pericarditis was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720772 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Headache, Myalgia, Off label use, Pain, Product use issue, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182322

Write-up: Joint ache; Stomach pain; Head pain; Diarrhea; Muscle pain; Entire body hurt; Off label use; Drug used in unapproved population; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109080648252860-5OBHJ with Safety Report Unique Identifier of GB-MHRA-ADR 25911169. A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3380, Expiry date: unknown, at the age of 37 years), dose 2 via an unspecified route of administration on 06Sep2021 as dose 2, single for covid-19 immunisation. Medical history included breast feeding; also reported that, the patient was fit and healthy with no medical conditions or problems. There were no concomitant medications. The patient had no symptoms associated with COVID-19. It was unsure whether the patient was enrolled in clinical trial. On 07Sep2021, the patient experienced joint ache, stomach pain, head pain, diarrhoea, muscle pain and entire body hurt. The events joint ache, stomach pain, head pain, diarrhoea, muscle pain were reported as serious for being medically significant. The clinical course was reported as follows: The morning following the vaccine, the patient entire body hurt when she woke. The patient had muscle pain, bad stomach pain, joint ache, and severe head pain. It was reported that the patient had many vaccinations in life and never had any side effects. It was also reported patient didn''t think she ever felt bad as the morning after the second dose of the vaccine. Although it was short term but severe. The patient underwent lab tests and procedures which included sars-cov-2 test: negative covid-19 test on 21Aug2021. The outcome of the events head pain, diarrhoea and muscle pain were resolved on 08Sep2021 after the duration of 1 day; while that of joint ache, stomach pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101196680 Mother/Baby case


VAERS ID: 1720780 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Thyroid pain
SMQs:, Hypothyroidism (broad), Hyperthyroidism (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101182444

Write-up: Inappropriate schedule of vaccine administered; Thyroid pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109081202530680-CXI8D, and Safety Report Unique Identifier GB-MHRA-ADR 25911497. A 29-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 06Sep2021 (at the age of 29-years-old) (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Historical vaccine included first dose of BNT162B2 on 09Jun2021 for covid-19 immunisation. On 06Sep2021 the patient experienced thyroid pain and inappropriate schedule of vaccine administered on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of event thyroid pain was not recovered whereas other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Hyperhidrosis, Influenza like illness, Malaise, Myalgia, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
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 INC202101182406

Write-up: feeling sick; Taste loss; Muscle ache; flu like symptoms; Sweating; Nose congestion; Sore throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109082347493170-V027Y, Safety Report Unique Identifier GB-MHRA-ADR 25915268. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 06Sep2021 as dose 2, single for COVID-19 immunization (Age at vaccination not specified patient age). The patient''s medical history included suspected covid-19 from 06Sep2021 and ongoing. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) for COVID-19 immunization. On 06Sep2021 the patient came down with cold/flu like symptoms, nose congestion, sore throat, Sweating. The next day on 07Sep2021 they had not improved at all and on an unspecified date she was feeling sick enough to stay home and had muscle ache. On 08Sep2021 she had taste loss. She started to feel worse, and by the time evening came she was unable to taste even the strongest things such as jalapenos or mouthwash. She was work in an environment where she tests regularly, and the people interact with were either vaccinated or have a negative pcr test. She had 0 symptoms or positive results before the 2nd dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on an unspecified date, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of all events was not recovered yet. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720835 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190665

Write-up: Vertigo; This is a spontaneous report from a contactable consumer. This report was received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091653480250-K5MBV. Safety Report Unique Identifier GB-MHRA-ADR 25919039. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 02Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, single on an unspecified date for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced vertigo on 06Sep2021. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test): negative (No - Negative COVID-19 test). The event was reported as serious as medically significant. The outcome of the event was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1720922 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea, Inappropriate schedule of product administration, Nightmare, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101197434

Write-up: Inappropriate schedule of vaccine administered; Nightmares; periods have not returned to normal; Light periods; with thinner blood; This is a spontaneous report from a contactable consumer (patient). This is the second of 2 reports. The first report is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109081212135420-BPO2Y, Safety Report Unique Identifier GB-MHRA-ADR 25911652. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), dose 2 via an unspecified route of administration on 06Sep2021 (at the age of 36 years old) as DOSE 2, SINGLE for covid-19 immunization. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Historical vaccine was taken for first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Jul2021 as DOSE 1, SINGLE for COVID-19 immunization and patient experienced prolonged periods/periods have not returned to normal, nightmares, sleeplessness/weeks of disrupted sleep and light periods. On an unspecified date in 2021, the patient experienced nightmares, periods have not returned to normal, light periods and with thinner blood. It was stated that nightmares after both vaccines - first time for one week. Weeks of disrupted sleep after first vaccine. Periods have not returned to normal, having been the same all her life. They were now lighter, with thinner blood. Patient has not tested positive for COVID-19 since having the vaccine. The events were serious (medically significant). The patient underwent lab tests and procedures which included covid-19 virus test negative on unspecified date. Outcome of the events was not recovered. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101182319 Same patient, different events/doses


VAERS ID: 1721153 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Feeling abnormal, Heart rate, Pallor
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: 20210906; Test Name: BP; Result Unstructured Data: Test Result:114/63 mmHg; Comments: Before vaccination; Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:100/73 mmHg; Comments: 13:42; Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:108/70 mmHg; Comments: 13:44; Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:106/66 mmHg; Comments: 13:52; Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:115/61 mmHg; Comments: 14:30; Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:over 90 mmHg; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210906; Test Name: P; Result Unstructured Data: Test Result:96; Comments: times/minute Before vaccination; Test Date: 20210906; Test Name: P; Result Unstructured Data: Test Result:89; Comments: times/minute 13:42; Test Date: 20210906; Test Name: P; Result Unstructured Data: Test Result:73; Comments: times/minute 13:44; Test Date: 20210906; Test Name: P; Result Unstructured Data: Test Result:68; Comments: times/minute 13:52; Test Date: 20210906; Test Name: P; Result Unstructured Data: Test Result:62; Comments: times/minute 14:30
CDC Split Type: JPPFIZER INC202101164558

Write-up: Anaphylaxis; dyspnoea; pallor facial; feels poorly; This is a spontaneous report from a contactable physician (vaccinator) received from the Regulatory Authority. Regulatory authority report number is v21126054. The patient was a 49-year and 8-month-old (age at vaccination) male. Body temperature before vaccination was 36.6 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Sep2021 at 13:27 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date/time was reported as 06Sep2021 at 13:42. On 06Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 13:20, before vaccination, 114/63 mmHg, P (pulse rate) 96 times/minute. Then the patient received vaccination. At 13:42, 15 minutes after the vaccination, the patient claimed feels poorly, BP 100/73 mmHg, P 89 times/minute. The patient rested on bed. Based on dyspnoea and pallor facial, the patient was treated as anaphylaxis. At 13:42, Adrenaline for injection 0.1% syringe 0.3 ml was injected via intramuscular to the outside center part of the left thigh. At 13:44, 108/70 mmHg, P 73 times/minute. At 13:52, 106/66 mmHg, P 68 times/minute, feels poorly improved. At 14:30, 115/61 mmHg, P 62 times/minute. Feels poorly continued improving. Then the patient went home. The reporting physician (vaccinator) classified the events as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the events such as any other diseases. The reporting physician (vaccinator) commented as follows: Systolic blood pressure was 100/73 mmHg (15 minutes after the vaccination), then over 90 mmHg. But based on dyspnoea and pallor facial, anaphylaxis was considered, and adrenaline was administrated. Outcome of the events was recovered on 06Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1721156 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Depressed level of consciousness, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101164727

Write-up: Consciousness decreased/Depressed level of consciousness; vomiting; cold sweat; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126034. The patient was a 12-year-old male (age at vaccination). Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Sep2021 at 17:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FF9944, Expiration date: 30Nov2021) via an unspecified route of administration as a single dose (at the age of 12-years-old) for COVID-19 immunization. The onset date of event was reported as 06Sep2021 at 17:10 (10 minutes after the vaccination). The course of the event was as follows: On 06Sep2021 at 17:00, the patient received vaccine, 10 minutes after the vaccination, the patient experienced Consciousness decreased, cold sweat and vomiting once. A drip infusion was performed, after that the symptoms recovered then the patient went home. On 06Sep2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The reporting physician commented as follows: Due to Depressed level of consciousness and vomiting, considered as Brighton level 3. Follow up attempts are completed. Further information is not expected.; Reporter''s Comments: Due to Depressed level of consciousness and vomiting, considered as Brighton level 3.


VAERS ID: 1721159 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101165006

Write-up: Loss of consciousness; Vasovagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126011. A 40-year and 2-month-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Sep2021 14:00 (Batch/Lot Number: FG0978; Expiration Date: 30Nov2021) (at the age of 40-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had no relevant medical history and no concomitant medications. On 06Sep2021 at 14:03 (3 minutes after the vaccination), the patient experienced Vasovagal reflex and loss of consciousness. The course of the event was as follows: Shortly after receiving the vaccination, the patient lost consciousness in the waiting room. The patient regained consciousness while being transferred to the bed in a wheelchair. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. On 06Sep2021 (the day of the vaccination), the outcome of the events was recovered.


VAERS ID: 1721179 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Hyperventilation, Hypoaesthesia, Paraesthesia oral, Presyncope, Tremor, Vagus nerve disorder
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (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: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101170088

Write-up: Anaphylaxis; vagus nerve reflex; Hyperpnoea/Hyperventilation; Tingling mouth; Tremulousness; Numbness of peripheral limbs; Vasovagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126040. This is the second of two reports. This report concerns events occurred after the second dose of BNT162B2. A 37-year-old female patient received the second dose of bnt162b2 (COMIRNATY, solution for injection, lot number FF3620, expiration date 30Nov2021) via an unspecified route of administration on 06Sep2021 at 18:19 (the day of vaccination, at the age of 37-years-old), at dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no family history. 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: the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced tingling mouth. Body temperature before vaccination, on 06Sep2021, was 36.1 degrees Centigrade. On 06Sep2021 at 18:30 (11 minutes after the vaccination), the patient experienced vasovagal reflex, tingling mouth, hyperpnoea/hyperventilation, tremulousness, numbness of peripheral limbs, vagus nerve reflex and anaphylaxis. The course of the event was as follows: there was a feeling of tingling mouth in the beginning, blood pressure was difficult to measure, anaphylaxis was suspected, and EPIPEN was used. When visiting the hospital, there were no significant findings in the skin, breathing, digestive organs, circulation, etc., and just in case, antihistamines and steroid was administered, the symptoms became recovering naturally, and returned home. On 06Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was hyperpnoea. The reporting physician commented as follows: there was impressions of numbness of peripheral limbs by vagus nerve reflex and hyperventilation. Considered as a drug nonspecific symptom.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101221921 Same reporter/patient/product; different doses/AEs


VAERS ID: 1721180 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101170764

Write-up: Thrombosis; induration was found on the front of the patient''s thigh/ thumb-sized induration; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 49-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number unknown) via an unspecified route of administration on 06Sep2021 (the day of vaccination, at the age of 49-years-old) at dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced thrombosis. On 06Sep2021 (the day of vaccination), after returned home, induration was found on the front of the patient''s thigh. On 07Sep2021 (1 day after vaccination), the patient visited a hospital, it was confirmed to be thumb-sized induration. The events were found after using the product. The outcome of events was unknown. The seriousness and causality of events were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Thrombosis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1721223 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005289 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Pharmaceuticals (Reference number: 2021TJP092436 ) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, reported by a physician, was received by via Moderna''s adverse reaction reporting site (TASK0021594), and reported to the Agency (A) by a physician, was received via the A (Ref, v21126216). On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 06-Sep-2021, at 11:05, the patient received the 1st dose of this vaccine. At 11:21, the patient complained of strange sensation of pharynx. There was no respiratory discomfort. SpO2 was 99%. The patient was aware of palpitations. At 11:23, BP: 132/82, P: 84 beats/min, and there was no rash. At 11:25, antihistamines were taken. At 11:35, BP: 124/80, and P: 82 beats/min. There was no respiratory discomfort, but strange sensation of pharynx persisted. Pharyngeal oedema and hoarseness developed. At 11:40, adrenaline 0.5 mg was injected intramuscularly. SpO2: 99%, P: 82 beats/min (R), and there were no palpitations. An emergency call was made. At 11:44, the ambulance arrived. The patient was diagnosed with anaphylaxis after transport. The patient was hospitalized for 24 hours of follow-up. On 08-Sep-2021, it was confirmed that the symptoms resolved. The outcome of anaphylaxis was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company comment- This case concerns a 31 year old female patient with no relevant medical history, who experienced the expected event of anaphylactic reaction. The event occurred 16 minutes after the first dose of Moderna COVID-19 vaccine . The rechallenge was not applicable. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This case concerns a 31 year old female patient with no relevant medical history, who experienced the expected event of anaphylactic reaction. The event occurred 16 minutes after the first dose of Moderna COVID-19 vaccine . The rechallenge was not applicable. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1722115 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Heart rate increased, Hyperhidrosis, Palpitations, Scrotal pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Pulse rapid; Result Unstructured Data: High.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: each time; shakiness; Sweating; Chest pain; Fatigue/tired; Palpitations; This case was received via the RA (Reference number: GB-MHRA-ADR 25931298) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SCROTAL PAIN, TREMOR, CHEST PAIN, FATIGUE, PALPITATIONS, and HYPERHIDROSIS in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021 at 2:00 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PALPITATIONS (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced CHEST PAIN (seriousness criterion medically significant) and FATIGUE (seriousness criterion medically significant). On an unknown date, the patient experienced SCROTAL PAIN (seriousness criterion medically significant), TREMOR (seriousness criterion medically significant), and HYPERHIDROSIS (seriousness criterion medically significant). At the time of the report, SCROTAL PAIN and TREMOR outcome was unknown and CHEST PAIN, FATIGUE, PALPITATIONS, and HYPERHIDROSIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Heart rate increased, high. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Patient got episodes, in which he could no longer remain upright, occurred on Tuesday at 1pm, Wednesday to Saturday from 3-5 pm, and Sunday from 10-11pm. The trend line was encouraging. Each time, the solution was to lie down for 1-2 hours. On Friday Patient went to Clinic. The thing that helped most was that they had a spare cot available on which patient could lie down. The patient had foggy feeling in head. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 32 year-old, male subject, with no medical relevant history, who experienced the unexpected events of Scrotal pain, Tremor, Chest pain, Fatigue, Palpitations, Hyperhidrosis. The events occurred approximately 1 day after the second dose of Spikevax. The re-challenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1723323 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Limb discomfort
SMQs:, Dementia (broad), Arthritis (broad)

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

Write-up: Extreme pain in my knees. Bending down causes the feeling that they were about to explode due to the pressure. Taking pain killers to manage the pain. Ive been more tired than usual with brain fog.


VAERS ID: 1724429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Breast swelling, Breast tenderness, Lymph node pain, Lymphadenopathy, Malaise, Pain
SMQs:, Angioedema (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: SERTRALINE HYDROCHLORIDE; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101182409

Write-up: Swollen lymph nodes - breast/underarm; Lymph nodes enlarged; Lymph node pain; side of breast swelling, very painful and tender; as pain is so bad; Feel like going to Accident; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-EYC 00259975. Safety Report Unique Identifier GB-MHRA-ADR 25905498. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: FE8087), via parenteral route on 05Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 Immunization. The patient medical history was not reported. The patient concomitant medications included sertraline hydrochloride and colecalciferol (VITAMIN D): both taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph nodes - breast/underarm, lymph nodes enlarged, lymph node pain on 06Sep2021, side of breast swelling, very painful and tender and as pain is so bad on an unspecified date in 2021. Reaction description: Swollen lymph nodes underarm and side of breast swelling, very painful and tender. Seek Advice Details: Felt like going to Accident and Emergency (A&E) as pain was so bad - could not ignore the pain. The case was assessed as serious (medically significant). The outcome of the events swollen lymph nodes - breast/underarm, lymph nodes enlarged and lymph node pain was not resolved, whereas events side of breast swelling, very painful and tender, feel like going to accident and as pain is so bad was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstrual disorder
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: MIRENA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168343

Write-up: bleeding; Menstrual flow altered; Bleeding menstrual heavy; This is a spontaneous report from a contactable consumer. This report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109060918343970-TQIM3. Safety Report Unique Identifier GB-MHRA-ADR 25898747. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Aug2021 with unspecified Batch/Lot number as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). The patient experienced bleeding on an unspecified date. On 06Sep2021, the patient had menstrual flow altered and bleeding menstrual heavy. The outcome of the events was not recovered. The patient had the mirena coil fitted and usually have some light bleeding around the time of her period. She had been experiencing abnormally heavy bleeding at a time when her period would not be expected. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724511 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168351

Write-up: Fainting; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061811488600-0FSGP, Safety Report Unique Identifier number is GB-MHRA-ADR 25902121. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 06Sep2021 (at the age of 25 years old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. The patient experienced fainting on 06Sep2021. The event was reported as non-serious. The clinical course was reported as follows: 5 minutes post vaccination, patient fainted. Patient regained full consciousness immediately after. Patient laid on the floor with legs elevated. After 10 minutes, patient sat up and left 5 minutes after with friend feeling okay. 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 blood clots or low platelet counts. The outcome of the event was recovered on 06Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Lymph node pain, Pain, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101176020

Write-up: strong headache; extreme fatigue; pain; Lymph node pain; Armpit pain; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109070844153360-1ZUCS, Safety Report Unique Identifier of GB-MHRA-ADR 25905527. A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8087) via an unspecified route of administration, on 04Sep2021, as dose 1, single, for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications were not reported. The patient previously received valsartan (MANUFACTURER UNKNOWN), paroxetine (MANUFACTURER UNKNOWN) and levothyroxine sodium (EUTIROXIN) all on unknown dates for unspecified indications. On 05Sep2021, the patient underwent a COVID-19 virus test and the result was negative. On 06Sep2021, around 48 hours after vaccination, the patient was awakened in the night with pain. On the same day, the patient experienced pain in armpit even when motionless and lymph node pain. On the same day night, the patient experienced a strong headache and extreme fatigue; all the events were reported as serious for being medically significant. It was also reported that pain had not subsided but the patient had become used to it and took paracetamol (PANADOL) to relieve it which didn''t really work. The clinical outcome of the event extreme fatigue was recovered on an unknown date in Sep2021 while that of the events armpit pain and lymph node pain was not recovered. The clinical outcome of the events strong headache and pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Sweating fever
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FRAGMIN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Broken ankle
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176031

Write-up: Tiredness/ Fatigue; Nausea/ nauseous; Headache; Sweating fever; moments of being intensely warm; Hot sweats; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109071157333410-WKTTN, Safety Report Unique Identifier GB-MHRA-ADR 25906489. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Sep2021 as a single dose for COVID-19 immunisation. Medical history included broken ankle. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. Concomitant medications included dalteparin sodium (FRAGMIN) from 03Sep2021 to 05Sep2021 for broken ankle; and paracetamol from 03Sep2021 for broken ankle. On 06Sep2021, the patient experienced nausea, headache, sweating fever, moments of being intensely warm with hot sweats. on 07Sep2021, the patient experienced fatigue; all reported as serious for being medically significant. The clinical course was reported as follows: The main symptoms the patient had since the 2nd jab was constant nausea and tiredness. The day after she also had moments of being intensely warm, with hot sweats, and headaches which had lasted for the first 24 hours but had eased off at that time. She was currently on the day 2 after the jab and she was still feeling very fatigued and nauseous. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event (headache) was recovered on 07Sep2021, after a duration of 1 day; event (sweating fever) was recovering; events (moments of being intensely warm and hot sweats) was unknown; while that of the event fatigue and nausea was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dysgeusia, Eye disorder, Eye swelling, Lip erythema, Lip pain, Lip swelling, Pain in extremity, Rash, SARS-CoV-2 test, Sensitive skin, Swelling face, Tongue disorder, Tongue movement disturbance, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176056

Write-up: Left side of the face under the eye was swelling up and was very sensitive; Left side of the face under the eye was swelling up and was very sensitive; Eye swelling; eye swelling and was very sensitive; Neck rash; Tongue weak; The right side of lip was swelling non-specific; The right side of lip was hurting; The right side of lip was red; taste metal in throat and palate; tongue felt very weird; Pain in the arm was unreal; feeling weak; shaking; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority). Regulatory authority report number is GB-MHRA-WEBCOVID-202109071413214280-EMAAX with Safety Report Unique Identifier of GB-MHRA-ADR 25906895. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8087) via an unspecified route of administration on 06Sep2021, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications included drospirenone, ethinylestradiol (YASMIN) from 09May2005 unknown if ongoing for contraception. On 30Aug2021, the patient underwent COVID-19 virus test and the result was negative. On 06Sep2021, the patient experienced shaking, taste metal in throat and palate, tongue felt very weird, pain in the arm was unreal and feeling weak. On 07Sep2021, the patient experienced Left side of the face under the eye was swelling up and was very sensitive (sensitive skin), eye swelling and was very sensitive, neck rash, tongue weak, the right side of lip was swelling non-specific, hurting and red. Events facial swelling, shaking, eye swelling, neck rash, lips swelling non-specific and tongue weak were reported as serious for being medically significant. The clinical course was reported as follows: The patient took the vaccine and starting shaking feeling weak. Pain in the arm was unreal and she could taste metal in her throat, palate and tongue felt very weird. The following day, 07Sep2021, the patient noticed that her left side of the face under the eye was swelling up and was very sensitive. The right side of her lip was swollen, red and hurting. The patient had visited pharmacist as the result of events. The clinical outcome of the events eye swelling, neck rash, the right side of lip was swelling non-specific and tongue weak was recovering. The clinical outcome of the events left side of the face under the eye was swelling up and was very sensitive, eye was very sensitive, shaking, taste metal in throat and palate, tongue felt very weird, pain in the arm was unreal, feeling weak, the right side of lip was hurting and red was unknown at the time of report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724549 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Lymph node pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182389

Write-up: Lymph node pain; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109080849234140-EYXCB with Safety Report Unique Identifier GB-MHRA-ADR 25910619. A 34-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration on 06Sep2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. On 06Sep2021, the patient experienced chest pain; on 07Sep2021, the patient experienced lymph node pain; both the events were reported as serious for being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No-negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event chest pain was resolving while the outcome of the event lymph node pain was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-06
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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 INC202101190545

Write-up: Painful periods; Heavy periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202109090924329660-RQDH8, Safety Report Unique Identifier GB-MHRA-ADR 25916728. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant and was not breastfeeding at the time of report. The patient had no symptoms associated with COVID-19. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient was not enrolled in clinical trial. On 06Sep2021, the patient experienced painful and heavy periods; both reported as serious for being medically significant. The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of painful and heavy periods was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724596 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Lymph node pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190719

Write-up: Dizziness; Nauseous; Headache dull; Lymph node pain; First vaccination date: 21Jun2021 and second vaccination date: 06Sep2021; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109090930120920-JBB0C, Safety Report Unique Identifier GB-MHRA-ADR 25916776. A 28-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2153), via an unspecified route of administration on 06Sep2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergic to penicillin. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FA1027), via an unspecified route of administration on 21Jun2021 as dose 1, single for covid-19 immunization. On 07Sep2021 the patient had lymph node pain, on 09Sep2021 the patient experienced dizziness, nauseous and headache dull. The reporter considered the events as serious (medically significant). Patient was not enrolled in clinical trial. The outcome of events lymph node pain, dizziness, nauseous and headache dull was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Anxiety, Chills, Discomfort, Dyspepsia, Fatigue, Headache, Hyperhidrosis, Hypersomnia, Myalgia, Night sweats, Pain, Poor quality sleep, Pyrexia, SARS-CoV-2 test, Somnolence, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; FOSTAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma late onset; Contraception; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191606

Write-up: sweaty; chills; vomiting; discomfort; night sweats; restless sleep; Heartburn; Impending doom; Slept a lot; Headache; Fever; Fatigue; Muscle ache; Lucid dreams; bed early felt drowsy; restless ache legs (not painful but discomfort level significant, distracted from sleep); This is a spontaneous report from a contactable consumer (the patient). This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109110803174990-H4GOU and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25927679. A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ff2153), via an unspecified route of administration, on 06Sep2021, as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected COVID-19 unsure when symptoms started and unsure when symptoms stopped, contraception and asthma late onset. Concomitant medications included desogestrel (CERAZETTE) taken for contraception from 01Nov2019 and beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma late onset from 23Feb2021. The patient experienced sweaty, chills, vomiting, discomfort, night sweats, restless sleep, Heartburn on an unspecified date, headache, fever, fatigue, Muscle ache, lucid dreams, bed early felt drowsy, restless ache legs on 06Sep2021, slept a lot on 07Sep2021 and impending doom on 08Sep2021. Patient stated that, 5 days in, this is the illest I''ve ever felt. Worse than Covid was for me. Head/face ache on day 1/2 similar to concussion following a riding accident. First night, 8 hours post vaccine, bed early felt drowsy, restless sleep, woken by bizarre hot feeling inside arms, lucid dreams, night sweats, fever, restless ache legs (not painful but discomfort level significant, distracted from sleep). Slept on floor downstairs due to discomfort. Following day, headache, a hey limbs, hot sweaty, chills, slept. Couldn''t watch TV or read. Day 2, not as bad, headache and fatigued, but not as hot, able to watch TV. Slept a lot. Struggled to concentrate. Day 3-4, Easily fatigued, few hours concentration then needing to sleep. headache and muscle aches subsided for the most part. Teary and overly emotional, felt like I would be OK not to wake up. Day 4, first day no nap, fell asleep by 8pm, less than 12 hours awake. Day 5: woken up with headache, not as severe as first days. Slight muscle aches. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test COVID-19 virus test: positive on an unspecified date (Yes - Positive COVID-19 test) and patient did lateral flow home Covid test day 4 -negative. Patient was not enrolled in clinical trial. Patient taken paracetamol for headache from 07Sep2021. Event lucid dreams was recovered on 07Sep2021, event fever was recovered on 08Sep2021, event impending doom was recovered on 09Sep2021, events headache and muscle ache was recovering, outcome of the events sweaty, chills, vomiting, discomfort, Night sweats, Sleep restless, Heartburn, Fatigue was not recovered and outcome of the events restless ache legs, bed early felt drowsy, slept a lot was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724739 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Heart rate, Hypotension, Illness, Myalgia, Oxygen saturation, Presyncope, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:Results Unknown; Test Name: pulse check; Result Unstructured Data: Test Result:unknown results; Test Name: O2 check; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191521

Write-up: Low blood pressure; Dizziness; Near fainting; Sickness; Fatigue; Muscle ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109112106249450-GXHW2. Safety Report Unique Identifier GB-MHRA-ADR 25928706. A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Lot number: FF2153 and Expiration date: unknown), via an unspecified route of administration on 06Sep2021 (at the age of 28-years-old) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date (Unsure when symptoms started, unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient experienced low blood pressure, dizziness, fatigue, sickness, near fainting and muscle ache on 06Sep2021. Initially started around 10 mins after vaccine, spent 3 plus hours in the waiting area with a doctor checking blood pressure multiple times. Most events resolved after 24 hours. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical tria l. The patient underwent lab tests and procedures which included blood pressure: results unknown on 06Sep2021, sars-cov-2 test: yes - positive covid-19 test on an unspecified date, pulse/o2 check: unknown results on an unspecified date. Outcome of event dizziness recovered on 06Sep2021, events fatigue, sickness, near fainting, low blood pressure recovered on 07Sep2021, and event muscle ache recovered on 09Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724782 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Menstruation irregular, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; LORATADINE; PARACETAMOL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Asthma; Joint pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190576

Write-up: Headache; Irregular menstruation; Muscle ache; This is a solicited report from the RA Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202109051259360510-PR2TS. Safety Report Unique Identifier [GB-MHRA-ADR 25918882]. A 16-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3380), via an unspecified route of administration on 06Sep2021 as dose number unknown, single (at the age of 16 years old) for COVID-19 immunization. The patient medical history included arthralgia, hypersensitivity, and asthma. The concomitant medications included ibuprofen (IBUPROFEN) taken for arthralgia, start and stop date were not reported, loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported, paracetamol (PARACETAMOL) taken for arthralgia, start and stop date were not reported and salbutamol (SALBUTAMOL) taken for asthma, start and stop date were not reported. On 06Sep2021 the patient experienced muscle ache, on 07Sep2021 she had headache, and same day on 07Sep2021 she had irregular menstruation. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Outcome of muscle ache recovered on 09Sep2021, headache and irregular menstruation was not recovered. No follow-up attempts are needed. No further information is expected. 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; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the events Myalgia, headache and menstruation irregular 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.


VAERS ID: 1724794 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Exposure via breast milk, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Neonatal exposures via breast milk (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196680

Write-up: Maternal exposure during breast feeding; Off label use; Drug used in unapproved population; This is a spontaneous report from a contactable consumer (parent). This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109080648252860-5OBHJ with Safety Report Unique Identifier of GB-MHRA-ADR 25911169. A neonate of unknown age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot Number: FE3380) via an unspecified route of administration on 06Sep2021 (via 37-year-old female mother) as DOSE 2, SINGLE for COVID-19 immunization. Medical history of mother included breast feeding; also reported that, the mother was fit and healthy with no medical conditions or problems. The mother was not pregnant at the time of this report. The mother had no symptoms associated with COVID-19. The mother did not receive any concomitant medications. On an unspecified date, the patient maternal exposure during breast feeding. The morning following the vaccine, the mother''s entire body hurt when she woke. The mother had muscle pain, bad stomach pain, joint ache and severe head pain. It was reported that the mother had many vaccinations in life and never had any side effects. It was also reported mother didn''t think she ever felt bad as the morning after the second dose of the vaccine. Although it was short term but severe. On 21Aug2021, the mother underwent COVID-19 virus test and the result was negative. It was unsure whether the mother was enrolled in clinical trial. Seriousness for event maternal exposure during breast feeding was reported as medically significant. No follow-up attempts are needed. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101182322 Mother/Baby case


VAERS ID: 1724884 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Depressed level of consciousness, Feeling abnormal, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), 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: BOSULIF
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Leukaemia; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101162804

Write-up: it became dull in the patient''s mind; numbness; fuzzy head; no strength; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration on 06Sep2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included leukemia, diabetes mellitus, and schizophrenia, all from unknown dates and unknown if ongoing. Concomitant medications included bosutinib (BOSULIF) from an unknown date for chronic myeloid leukemia. On 06Sep2021 at about 16:00 the patient received the first dose of BNT162B2. From the night there was numbness, fuzzy head, and no strength. The patient reported not being tired but was dull in the mind. The clinical outcomes of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724888 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Erythema, Feeling abnormal, Heart rate, Heart rate increased, Lacrimation increased, Oxygen saturation, Respiratory rate, Respiratory rate increased, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:164/120 mmHg; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210906; Test Name: heart rate; Result Unstructured Data: Test Result:166; Test Date: 20210906; Test Name: heart rate; Result Unstructured Data: Test Result:113; Comments: 15:30; Test Date: 20210906; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:98%; Test Date: 20210906; Test Name: Respiratory Rate; Result Unstructured Data: Test Result:30; Test Date: 20210906; Test Name: Respiratory Rate; Result Unstructured Data: Test Result:16; Comments: 15:30
CDC Split Type: JPPFIZER INC202101164203

Write-up: Anaphylaxis; Blood pressure was 164/120 mmHg; dyspnoea; Feeling strange in the tongue; Lacrimation Mildly; redness on the front chest and two upper limbs; Heart rate was 166/min; RR was 30/min; Tremor finger; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126035. The patient was a 49-year and 7-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient family history was unknown. On the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was reported that on 16Aug the first dose of COMIRNATY (the day of vaccination). On 06Sep2021 at 14:13 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was reported as on 06Sep2021 at 14:18 (as reported) (the day of vaccination). The course of the event was as follows: The patient complained of dyspnoea and feeling strange in the tongue. Judged as lacrimation mildly, redness on the front chest and two upper limbs. HR was 166/min, RR was 30/min. BP was 164/120, Oxygen saturation was 98%. Diagnosed with anaphylaxis, the physician prescribed Bosmin 0.3mg by muscle injection and Bosmin 0.3mg by inhalation. Breathing cleaning. Celestamine 2T was prescribed by orally. Symptoms of dyspnea and redness had quickly recovered. At 15:30, HR was 113/min, RR was 16/min. There was still a feeling strange on the front chest and have the symptom of tremor finger. The patient was taken by ambulance to another hospital. The reporting physician classified the event as serious (location of the transfer hospital was unknown) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was judged with Anaphylaxis, Brighton classification level 2-3. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


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