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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 187 out of 8,753

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VAERS ID: 1849627 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Palpitations, Pharyngeal swelling, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D, ferrous sulfate
Current Illness: none
Preexisting Conditions: none
Allergies: caffeine, dust mites, polen
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 1 minute after vaccine injection throat closed, feeling difficulty breathing and swollen throat for a few hours. Palpitations for 3 hours after injection.


VAERS ID: 1850391 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-09
Onset:2021-10-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Eye pruritus, Gingival swelling, Headache, Immunodeficiency, Lip swelling, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Rash erythematous, Rash pruritic, Swollen tongue, Tongue eruption
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Opdivo 480mg IV infusion every 4 weeks, womens multi-vitamin 1 tablet daily, Glucosamine chondroitin 2 tables daily, Calcium 600mg 2 tablets daily, vitamin D 1000 i.u. 1 tablet daily, Lutein 20 mg 1 tablet daily, Vitamin E 1 tablet daily,
Current Illness: Melanoma receiving cancer treatments, osteoporosis
Preexisting Conditions: Melanoma with metastasis receiving cancer treatments, osteoporosis
Allergies: Latex- previous reaction when at dentist. Shortness of breath and wheezing.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Initial admin date 10/09/2021 symptoms were low grade temp 100 degrees F, chills, headache, body aches and right arm pain. Delayed symptoms started approximately 10/13/2021- upper lip swelling, tongue swollen with bumps, sore throat, upper gum line swollen and rash along hair line that was red and itchy including itchy eyes. Took Benadryl 25 mg tablet in the morning and evening for about a week hoping symptoms would go away, but still having swollen lip and upper gum line. Rash is now gone (today''s date 11/08/2021). Tongue still slightly swollen. Breathing okay, never had to go to emergency room.


VAERS ID: 1850744 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-25
Onset:2021-10-13
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301358A / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Cough, Tinnitus
SMQs:, Anaphylactic reaction (broad), 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: Levothyroxine, Eliquis, Metoprolol, Metformin, Simvastatin, Vitamin D2, senior man multi vitamin, Lutein, Calcium
Current Illness: n/a
Preexisting Conditions: A Fib, Hypertrophic cardiomyopathy, Pah, osteopenia, diabetic, COP, BOOP, Tracheomalacia
Allergies: Penicillin
Diagnostic Lab Data: chest x-ray blood work
CDC Split Type: vsafe

Write-up: I had ringing in both ears. I have a dry cough. These symptom since Oct 13th. They are both ongoing. I went to doctors about this. They did a chest x-ray and blood work. They gave my an inhaler for my cough.


VAERS ID: 1850924 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Interchange of vaccine products, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORVASC 10 MG TAB, ASA 81MG TAB, LIPITOR 40 MG TAB, COREG 6.25MG TAB, KLONOPIN 0.5MG TAB, PLAVIX 75 MG TAB, XALATAN 0.005% OPT SOLUTION, LISINOPRIL 20MG TAB, METFORMIN 500MG, NITROSTAT 0.4MG SL TAB, DITROPAN 5MG TAB, EFFEXOR XR 37.5MG CAPSU
Current Illness: DEPRESSION ANXIETY
Preexisting Conditions: ANXIETY, CORONARY ARTERY DISEASE, DEPRESSION, GASTROESOPHAGEAL DISEASE, HYPERLIPIDEMIA, HYPERTENSION, PEPTIC ULCER DISEASE, TYPE 2 DIABETES MELLITUS (HCC)
Allergies: NKDA
Diagnostic Lab Data: DC LISINOPRIL
CDC Split Type:

Write-up: PATIENT RECEIVED A MODERNA COVID 19 ON 01/25/2021, MODERNA COVID 19 VACCINE ON 12/30/2020 AND ON 10/12/2021 RECEIVED A PFIZER COVID 19 SHE CAME IN FOR OFFICE VISIT ON 10/25/2021 WITH COMPLAINTS STATES SHE HAS NOTICED A CHANGE IN HER BODY SINCE SHE RECEIVED 3RD COVID 19 DOSE. SHE STATES HER ARMS AND LEGS GET SWOLLEN. THE EPISODE STARTED 1 TO 4 WEEKS AGO. THE PROBLEM OCCURS CONSTANTLY ASSOCIATED SYPTOMS INCLUDE FATIGUE. PATIENT REPORTS OVERALL FEELING OF SWELLING IN HER EXTREMITIES SYPMTOMS WORSEN AS THE DAY GOES ON. SHE HAS BEEN TAKING BENADRYL AT NIGHT.


VAERS ID: 1850973 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: medrol 4mg tab naproxen 250mg Valtrex 500mg
Current Illness: none
Preexisting Conditions: asthma herpes simplex vulvovaginitis
Allergies: Tomatoes
Diagnostic Lab Data:
CDC Split Type:

Write-up: rash after administration


VAERS ID: 1851337 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-08
Onset:2021-10-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / N/A RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Biopsy lymph gland, Blood culture negative, Blood electrolytes normal, Chest X-ray normal, Decreased appetite, Differential white blood cell count normal, Discomfort, Dizziness, Fatigue, Full blood count normal, Hyperhidrosis, Lymphadenopathy, Myalgia, Nausea, Pyrexia, Thyroid function test normal, Visual impairment, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Concerta, weaning off of Klonopin, Celexa, BCP, iron, B supplement, vitamin C, vitamin D, Biotin, Magnesium Citrate.
Current Illness: Hashimoto''s, asthma, swollen lymph gland being watched.
Preexisting Conditions: Hashimoto''s, asthma, chronic depression from PTSD.
Allergies: Codine makes me sick, do not eat gluten because I have Hashimoto''s.
Diagnostic Lab Data: CBC, blood culture for bacteria and fungus, chest x-ray, thyroid panel, white blood cell differential, electrolytes. All labs normal.
CDC Split Type:

Write-up: I had the booster vaccine on October 8th. I then had a lymph node biopsy on October 13th. Within a day or two, I had extreme fatigue, excessive sweating, random fevers, muscle aches, dizziness, seeing spots, nausea, loss of appetite, weakness, general discomfort, swollen glands all over my body, especially the left side where the biopsy was. It was described to me as an "autoimmune storm". No further testing has been done. I was prescribed Meloxicam. I needed to take two to feel close to "normal". A follow up phone visit with a different doctor suggested that I try to take just one tablet, but all the symptoms returned. I did that on 11/5/2021, but had to return to taking two. I am still recovering from that on 11/8/2021. I have been to work four non-consecutive days in the past month.


VAERS ID: 1851402 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Cough, Dyspnoea, Electric shock sensation, Injected limb mobility decreased, Injection site pain, Pain in extremity, Ultrasound Doppler, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Seasonal allergies
Diagnostic Lab Data: Ultrasound of all my veins.
CDC Split Type: vsafe

Write-up: When they injected me with the shot. I felt a quick electric shock rush through my arm that went away instantly- I am still experiencing this till this day.. It happens randomly. I feel it 4 times a day and I notice more often when I am active during the day. I began to experience very bad pain injection pain at the injection site- 3 to 4 days. Around 10:30 I had trouble raising my arm above eye level. Pain in my legs. 5 days after the vaccine, I began to develop a cough; pain in my chest; trouble breathing- wheezing in the lungs.


VAERS ID: 1853252 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: Fever; Result Unstructured Data: Test Result:unknown result
CDC Split Type: USPFIZER INC202101375882

Write-up: sour arm; fatigue; fever; chill; shortness of breath; coughed; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8839), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (age at the time of vaccination was 44 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at workplace clinic. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 28Sep2021 to an unspecified stop date. Other vaccine 4 weeks included Flu shot. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (age at the time of vaccination was 44 years) as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Jan2021 (age at the time of vaccination was 44 years) as DOSE 1, SINGLE for both covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Oct2021 at 20:00, the patient experienced sour arm, fatigue, fever, chill, shortness of breath and coughed. It was reported that, in addition to the usual and most common reactions (sour arm, fatigue,) the patient started to develop a fever and chill later at night. The patient woke up with fever around 2:30 am and then started to experience shortness of breath and coughed. He took an Advil and the fever started to alleviate. Shortness of breath was also gone after about 1 to 2 hours. During the next day he still had chills and fever and tried to control them with Advil. No shortness of breath was experienced the next day. No prolonged hospitalization was reported. Therapeutic measures were taken as a result of fatigue, fever, chill, shortness of breath and coughed. On 13Oct2021, the patient underwent lab tests and procedures which included fever: unknown result. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient has not been diagnosed with COVID-19. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1853292 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Off label use, Product use issue, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (other medical history: Asthma); Blood pressure high (other medical history: high blood pressure)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101483271

Write-up: 8 days after receiving my 3rd booster Pfizer vaccine I developed a severe rash starting under my left breast area which spread to my fingers, arm, stomach, face and back.; started burning then so itchy it was unbearable; started burning then so itchy it was unbearable; other vaccine same date: Flu vaccine; Off-label use; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2590), third dose via an unspecified route of administration, administered in Arm Left on 13Oct2021 12:00 (At the age of 51 year) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and on same day patient also took influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 13Oct2021 (Batch/Lot number was not reported) to 13Oct2021, at DOSE 1, SINGLE for immunization. Medical history included hypertension (other medical history: high blood pressure), asthma (other medical history: Asthma) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 16:00 (At the age of 51 year) as dose 2 single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 16:00 (At the age of 51 year) as dose 1 single for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient experienced eight days after receiving my third booster Pfizer vaccine and developed a severe rash starting under my left breast area which spread to my fingers, arm, stomach, face and back. First started burning then so itchy it was unbearable. Had to see a doctor twice and was put on prednisone to help relieve my itching & spreading. Just started the first dose of antibiotics today seems to be helping. she knew it is the vaccine since she did nothing else out of the ordinary prior to this outbreak. The adverse event resulted in doctor or other healthcare professional office/clinic visit. While treatment received for the adverse events was Prednisone and ketoconazole. Case was considered as non-serious. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1853293 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-10
Onset:2021-10-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Loss of personal independence in daily activities, SARS-CoV-2 test, Vitreous floaters
SMQs:, Dementia (broad), Retinal disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPROPION HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD, predominantly inattentive type; Allergy to chemicals; Penicillin allergy; Seafood allergy; Shoulder injury; Stress at work
Allergies:
Diagnostic Lab Data: Test Date: 20211028; Test Name: Pcr; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101483314

Write-up: huge floaters in my right eye; it disrupted my ability to work at my job; This is a spontaneous report from a contactable consumer(patient). A 60-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA) via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:45 (Age at vaccination 60-years-old) as dose 1, single for covid-19 immunisation. Medical history includes Right shoulder injury and chronic work stress, ADHD primarily Inattentive type from unknown date to unknown if ongoing and Known allergies Penicillin, shrimp, lobster, codeine in Aspirin. Concomitant medication includes bupropion hcl (BUPROPION HCL) taken for an unspecified indication with in 2 weeks of vaccination. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 13Oct2021 at 11:00 am, patient stated that I got huge floaters in my right eye, and it disrupted my ability to work at my job. I had to go to the optometrist to get my eyes examined. Adverse event results in physician office visit. Events leads to Disability. Treatment received for the adverse event with eye exam and need for new glasses. Patient has not diagnosed with COVID-19 prior to vaccination and tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test and result was negative on 28Oct2021 Nasal Swab. Outcome of the was not recovered. Follow-up attempts completed. No further information expected.


VAERS ID: 1853672 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-09
Onset:2021-10-13
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Streptococcus test negative, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: Strep test
CDC Split Type: vsafe

Write-up: I having tightness in my throat. It feels like a tonsils stone. But nothing is showing up on the screening. These has been happening for about 3 to 4 weeks now. I was really painful around the 13th of October. Now it is just a mild pain. I went to a doctor about this. They tested my for Strep test, negative result.


VAERS ID: 1854181 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-12
Onset:2021-10-13
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Dyspnoea exertional, Interstitial lung disease, Lung opacity
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALPRAZolam, guaiFENesin, zolpidem, albuterol, asmanex, Canagliflozin Dulaglutide duloxetine furosemide insulin glargine insulin lispro meloxicam metoprolol montelukast paroxetine pravastatin spironolactone valACYclovir
Current Illness:
Preexisting Conditions: Asthma, Type 2 diabetes, hypertension, hyperlipidemia, dyslipidemia, depression, osteoarthritis, kidney disease, Hypokalemia Obesity, Class III, BMI 40-49.9 (morbid obesity)
Allergies: Ace Inhibitors, Angiotensin Receptor Blockers, Sulfa Drugs
Diagnostic Lab Data: Chest CT: Diffuse bilateral patchy peripheral interstitial airspace disease with groundglass opacities
CDC Split Type:

Write-up: 10/21 Pt to ED for complaints of increased coughing and shortness of breath with exertion. Diag w/ COVID-19 Pneumonia and hospitalized for acute hypoxic respiratory failure.


VAERS ID: 1854826 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-07
Onset:2021-10-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram normal, Gait inability, Limb discomfort, Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling, Ultrasound Doppler normal, Ultrasound scan normal, Walking aid user, Weight bearing difficulty, X-ray limb
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril , Hydrochlorothiazide Other Prescriptions
Current Illness: N/A
Preexisting Conditions: Hypertension
Allergies: Sulfa drugs
Diagnostic Lab Data: ER:10/17/2021- Memorial ER:11/03/2021- Memorial Orthopedic Center,, X-Ray 11/5/2021 X-Ray 11/5/2021
CDC Split Type: vsafe

Write-up: Three days after getting the second dose of the vaccine I had stiffness in my right leg. The stiffness got worse as the day progressed. The next day I could not put any weight on the leg and it was very swollen. My leg was painful and it progressively got worse. Ten days after the vaccine I went to the ER because I could not walk and my leg felt very heavy. There was no evidence of Blood Clot by Ultrasound. Two weeks later I had to call the Ambulance and they took me to the ER. I was in Extreme pain and they did an Ultrasound and CT scan which were normal. I went to an Orthopedic doctor two days later and they did an X-Ray. My leg is extremely swollen all over and I have been using a walker. The swelling has not gone down in any way and it is still painful. It has been over three weeks and I am now scheduled for an MRI today.


VAERS ID: 1855910 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-04
Onset:2021-10-13
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003621A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Computerised tomogram, Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atenolol Tamoxifen Vitamin D
Current Illness: none
Preexisting Conditions: Mild reactive airway disease
Allergies: none
Diagnostic Lab Data: CT scan, Ultrasound of legs
CDC Split Type:

Write-up: DVT/PE diagnosed 10/19/2021 IV Heparin, oral Eliquis 5mg twice daily for 6 months


VAERS ID: 1856782 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Dizziness, Dyspnoea, Fatigue, Headache, Malaise, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular 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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN; LISINOPRIL; ZOLOFT; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arthritis; COPD
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: covid test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101458313

Write-up: Hospitalized overnight for severe shortness of breath along with a COPD attack; Hospitalized overnight for severe shortness of breath along with a COPD attack; feel unwell; headaches; very tired; some dizziness & weakness; some dizziness & weakness; This is a spontaneous report from a Contactable Consumer (patient). This 82-year-old female patient received the third dose of BNT162B2 (Lot number unknown) at arm left at single dose for COVID-19 immunisation on 12Oct2021 at 10:15. Relevant history included AFib (Atrial fibrillation), COPD (Chronic obstructive pulmonary disease) and Arthritis. The patient had allergy with Lovastatin. Concomitant drug included warfarin, lisinopril, sertraline hydrochloride (ZOLOFT) and simvastatin. The patient previously received the first dose of BNT162B2 at arm left for COVID-19 immunisation on 03Feb2021 at 10:30 am, the second dose of BNT162B2 at arm left for COVID-19 immunisation on 24Feb2021 at 8:30 am, both for COVID-19 immunisation. No other vaccine was received in four weeks. The patient felt unwell, headaches, very tired, some dizziness & weakness since 13Oct2021 at 11:00 AM. The patient hospitalized overnight for severe shortness of breath along with a COPD attack. The patient still had some shortness of breath at the reporting time. AEs resulted in Emergency room/department or urgent care and Hospitalization (1 day). Outcome of events was not resolved. Treatment therapy included Oxygen & Breathing treatments.The patient had covid test (Nasal Swab) on 14Oct2021 with negative result. The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.


VAERS ID: 1857567 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-04
Onset:2021-10-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fibrin D dimer, Full blood count, Metabolic function test, Pericarditis, SARS-CoV-2 test negative, Troponin
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: CBC - unremarkable CMP - unremarkable D-Dimer - within normal limits Troponin - within normal limits COVID-19 - negative EKG - sinus rhythm CXR
CDC Split Type:

Write-up: The patient developed chest pain and some shortness of breath on 10/13/2021. He was seen in the and discharge with instructions to follow up with Cardiology, Dr. Appointment with Dr. on 10/15 diagnosed with pericarditis. Dr. recommended Motrin for treatment.


VAERS ID: 1858022 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-01
Onset:2021-10-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040D21A / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Condition aggravated, Dizziness, Dyspnoea, Fatigue, General physical health deterioration, Headache, Injection site mass, Injection site pain, Insomnia, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Protonix, multi-vitamin, flaxseed, fish oil, CoQ10
Current Illness: None
Preexisting Conditions: Barrett''s Esophagus
Allergies: Dilaudid
Diagnostic Lab Data: Chest x-ray, blood work, EKG, oxygen and others may have been administered at the hospital. I am unsure of the actual date but I believe it was approximately October 13, 2021.
CDC Split Type:

Write-up: From the 2nd vaccine, I still have a sore spot and a lump where the vaccination was administered, I am having problems breathing, chest pain on the left side, fatigue all of the time, problems sleeping, sleepiness during the day (I thought this was because of my problems with sleeping), pounding headache EVERYDAY since the 1st vaccine, daily joint pain, but mostly in my hips and shoulders, dizziness and issues with medical or physical exertion.


VAERS ID: 1858201 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-08
Onset:2021-10-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arrhythmia, Cardiac disorder, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Fear, Heart rate increased, Palpitations, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 10/18/21-Primary doctor appt, EKG 10/25/21-ER for another EKG 10/26/21-Cardiologist for another EKG 10/26/21-10/28/21-48 hour halter monitor 11/4/21-Echocardiogram
CDC Split Type:

Write-up: Heart issues...rapid and strong beating...occasional light headed...I went to the ER because I almost fainted twice at work. Now have a cardiologist. Have had 3 EKG''s, just had a 48 hour halter and an echocardiogram. I am feeling better than I initially did, but it was 3 weeks and 1 day from the 2 dose that I started feeling better. I''m still very winded, still have heart palpitations/feels like it beats out of sync. But it is better. I''m not back to normal. Scared to do cardio activity, but I am walking.


VAERS ID: 1858483 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D Zinc NAC Omega 3 Magnesium Citrate Probiotic
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Within 24 hours I had severe headache and arm soreness. I started having localized tingling and numbness throughout body. It is felt like as if something is crawling under my skin. It itches slightly and then continuously moves to other localized spots all over the body. It has been persistent. I have continued to only feel this more after the 2nd dose through out hands, feet and face more. After the 2nd dose I am experience some joint pain in feet/ face and increases tingling in extremities and face.


VAERS ID: 1858756 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-30
Onset:2021-10-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Computerised tomogram thorax abnormal, Dizziness, Dyspnoea, Fibrin D dimer increased, Peripheral swelling, Troponin increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: INCREASED D-DIMER CT OF CHEST POSITIVE FOR PE ELEVATED TROPONIN
CDC Split Type:

Write-up: 2 WEEKS AFTER BALANCE/DIZZINESS COMPLAINTS, 3-4 WEEKS AFTER SHORTNESS OF BREATH, BLIATERAL LOWER LEG SWELLING


VAERS ID: 1858979 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-07
Onset:2021-10-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 3 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Pt received pfizer booster on 10/7/21. Pt called hospital call center injection site is red, swollen, sore, and itches from covid and flu vaccinations last week. Pt has used ice packs but no relief. Pt was scheduled for urgent care visit that same day. Pt was prescribe loratadine 10mg PO qAM and hydroxyzine 25mg PO QHS PRN for itching.


VAERS ID: 1860464 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2020-09-14
Onset:2021-10-13
   Days after vaccination:394
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Catheterisation cardiac, Echocardiogram, Troponin
SMQs:, Other ischaemic heart disease (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALBUTEROL [SALBUTAMOL]; LACTAID FAST ACT; IBUPROFEN; PREDNISONE; SERTRALINE; VITAMIN D3; FISH OIL; ASCORBIC ACID
Current Illness: Allergy to animal dander (CAT AND DOG DANDER); Allergy to nuts (Walnuts); Amblyopia (LEFT EYE); Asthma; Eczema (BILATERAL UPPER ARMS); Environmental allergy; Lactose intolerant; Lyme disease; Nephrolithiasis (RIGHT SIDE)
Preexisting Conditions: Medical History/Concurrent Conditions: Arthroscopy L knee; Cartilage injury (TORN CARTILAGE RIGHT SHOULDER); Dislocated knee (left); Shoulder arthroscopy (RIGHT); Vasectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Coronary catheterization; Result Unstructured Data: unremarkable, without significant coronary artery disease; Test Date: 20211014; Test Name: echo; Result Unstructured Data: unremarkable, without significant coronary artery disease; Test Date: 20211014; Test Name: Troponin; Result Unstructured Data: elevated; Test Date: 202110; Test Name: Troponin; Result Unstructured Data: came down after started on carvedilol
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: CARDIAC CHEST PAIN; This approximately 42 -year-old, Male subject was participating in a Study and experienced the medically significant serious adverse event of special interest of cardiac chest pain. The subject''s medical history, as provided by the investigator, included dislocated left knee, environmental allergies, torn cartilage right shoulder, lactose intolerant, vasectomy, left eye amblyopia, allergy to cat and dog dander, allergy to walnuts, asthma, eczema - bilateral upper arms, nephrolithiasis right side, Lyme disease, left knee arthroscopic surgery, and right shoulder arthroscopic surgery. Concomitant medications included salbutamol, tilactase, ibuprofen, prednisone, sertraline, colecalciferol, fish oil, and ascorbic acid. The subject was randomized to receive blinded intramuscular mRNA-1273 for SARS-CoV-2 vaccination and was unblinded on 12 Feb 2021. The subject received the first dose of mRNA-1273 on 14 Sep 2020, the second dose on 12 Oct 2020, and a booster dose on 12 Oct 2021. The subject''s last dose of mRNA-1273 prior to event onset was on 12 Oct 2021. On 13 Oct 2021, the subject experienced cardiac chest pain. The subject reported developing a low-grade fever, myalgias, and chest pain that awoke him from sleep around midnight. The chest pain was described as sharp, constant, non-exertional, and worse when lying down on his left side. He denied shortness of breath or dyspnea on exertion. It was noted that the subject had no history of coronary artery disease. On 14 Oct 2021, the pain got worse and the subject went to the emergency room. He was admitted to the hospital on the same day. His troponin was elevated. An echocardiogram and coronary catheterization were performed, both reported as unremarkable without significant coronary artery disease. After being treated with carvedilol, troponin levels came down. On 17 Oct 2021, the subject was discharged from the hospital. The subject reported feeling better with minimal mild, intermittent chest pressure. The subject reported a diagnosis of non-ST elevation myocardial infarction and denied being diagnosed with myocarditis or pericarditis. The subject was scheduled to follow-up with his primary care provider and cardiology. A cardiac magnetic resonance imaging scan was scheduled for the end of November. Action taken with study drug in response to the event was not applicable, as the subject had already received all scheduled doses. The event, cardiac chest pain, was reported as resolving with sequelae (still had aches from time to time; subject stated he felt pain when exercising). The investigator assessed the event, cardiac chest pain, as related to study drug (per the investigator, as symptoms started the day after receiving the booster dose) and not related to study procedure. Follow-up received on 26 Oct 2021 and 02 Nov 2021 included updated event outcome, event term (previously chest pain), and concomitant medication details. On 26 Oct 2021, the safety database was searched for events similar to Chest Pain using the following search criteria: PT: Chest pain cardiac, Myocarditis and Troponin increased. 1257 cases were retrieved from PM and CT settings, excluding the index case; out of 1257, one was a CT case. 1208 cases were retrieved with PT: Myocarditis and 48 cases were retrieved with PT: Troponin increased. The CT case (MOD-2021-273925) reported an event with PT: Troponin increased. As of 26 Oct 2021, for mRNA-1273, 2 similar events were retrieved, including the current index case. One case reporting event Troponin increased was previously submitted as Safety Reports (MOD-2021-273925). There were 0 of subtotal cases unrelated cases were non- Safety Reports (expected and related or unexpected and unrelated or expected and unrelated to the IMP) reporting the following events: Chest pain cardiac (0), Myocarditis (0), Troponin increased (0). The case previously reported as (MOD-2021-273925) concerns a 70-year-old, female subject with relevant medical history of dyslipidemia, hypertension, type II diabetes, cardiac stress test positive about 20 years ago, overweight and sinus bradycardia who experienced dizziness and elevated troponin. The events occurred 29 days after receiving single booster shot dose of mRNA-1273.211. At the time of the events ECG revealed known sinus bradycardia and echocardiogram revealed borderline concentric left ventricular hypertrophy. Both events resolved within two days. The event elevated troponin was assessed as related to mRNA-1273.211 in agreement with the Investigator. The event dizziness was assessed as unrelated to mRNA-1273.211 in agreement with the Investigator. The index case concerns a 42 -year-old, male subject with a medical history relevant for asthma and Lyme disease, and NO history of CAD. Other medical history included dislocated left knee, environmental allergies, torn cartilage right shoulder, lactose intolerance, vasectomy, left eye amblyopia, eczema, and nephrolithiasis. The subject experienced chest pain on the day following the booster dose; the subject had received the first dose of mRNA-1273 1 year 1 month prior to the event and the second dose, 1 year prior to the event. The event chest pain developed in the context low-grade fever and myalgia. The chest pain was sharp, constant, non-exertional, and worsened lying down on the left side. The subject went to the ER and his troponin was noted to be elevated, echocardiogram and coronary catheterization were unremarkable. The subject was treated with carvedilol, and his troponin levels decreased. A final diagnosis was not provided but per the subject''s recollection it was NSTEMI versus myocarditis or pericarditis; medical records are pending. The outcome of the event chest pain was unknown. The event was considered related to the study vaccine in agreement with the Investigator based on close temporal association. In the index case the chest pain happened one day following the booster injection, which favors causal association. There was no history of CAD and no SOB, and the subject had accompanying symptoms of fever and myalgia. No final diagnosis was provided but differential diagnoses included NSTEMI vs myocarditis/pericarditis. In all 3 conditions, troponin could be elevated, accompanying symptoms of fever and myalgia as well as subject''s age and lack of history of CAD with unremarkable coronary catheterization, are more in favor of possible myocarditis/pericarditis. Final diagnosis is to be confirmed once medical records are received. Based on review of available data, and temporal association, the Sponsor cannot rule out a possible cause and effect relationship between administration of mRNA-1273 and the occurrence of Chest pain. After review of the clinical details and investigator comments pertaining to this adverse event, and based upon experience to date, the Sponsor does not believe that changes to the conduct of this clinical trial are warranted. The Company will continue to monitor these and other serious adverse events reported in association with the RA and will communicate any relevant changes to the protocol, Informed Consent Form, Investigator''s Brochure, and/or Core Safety Information.; Reporter''s Comments: This case concerns a 42 -year-old, male subject with a medical history of dislocated left knee, environmental allergies, torn cartilage right shoulder, lactose intolerant, vasectomy, left eye amblyopia, allergy to cat and dog dander, allergy to walnuts, asthma, eczema - bilateral upper arms, nephrolithiasis right side, Lyme disease, left knee arthroscopic surgery, and right shoulder arthroscopic surgery who experienced the unexpected event of special interest of cardiac chest pain. The event occurred 1 year 1 month after the first dose of mRNA-1273, 1 year after the second dose and the following day of the booster dose. The subject reported a diagnosis of non-ST elevation myocardial infarction and denied being diagnosed with myocarditis or pericarditis. Action taken with study drug in response to the event, dechallenge and rechallenge were not applicable as the subject had already received all scheduled doses. The outcome of the event chest pain was reported as resolving with sequelae . The event was considered related to the study vaccine in agreement with the Investigator based on close temporal association. Additional information, including final diagnosis ,has been requested.


VAERS ID: 1860490 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-06-05
Onset:2021-10-13
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Maternal exposure during pregnancy, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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: N/A
Current Illness: N/A
Preexisting Conditions: eczema
Allergies: advil shellfish
Diagnostic Lab Data: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND BETA HCG Patient is recovering from physical and emotional trauma. Will continue to follow
CDC Split Type:

Write-up: positive UPT on 9/20/21 LMP July 2021 patient experienced vaginal bleeding consistent with miscarriage on 10/13/21-10/18/21


VAERS ID: 1860505 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-01
Onset:2021-10-13
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Blood glucose normal, Blood pressure decreased, Chest pain, Dizziness, Epistaxis, Fatigue, Feeding disorder, Hyperhidrosis, Influenza virus test negative, Migraine, Muscle spasms, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative, Tonsillar hypertrophy
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Local Urgent Care 10/21. Tested for Strep throat. Negative. Pharmacy 10/21. Tested for Flu and Covid. Negative on both. Local Urgent Care 10/29. Tested for Strep and inflammation of tonsils.
CDC Split Type:

Write-up: Got the second dose at 3pm 10/13. Around 12am 10/14 my temperature spiked and I couldn''t get warm. I felt faint and dizzy. I did an Blood oxygen reading and it read 73% on three measurements. I did a blood sugar test and it read 68. My Blood pressure also dropped to dangerous levels but I did not have the strength to record the numbers by that time. From 10/14 to 10/22 I had registered fevers ranging from 101.8 to 104.1 alongside not being able to eat due to pain in my stomach and chest. Back at 10/12 my weight was 315 pounds, and by this time I was 285 pounds. On 10/23 I suffered from a crippling migraine for 36 hours. My joints ached and my muscles cramped endlessly. On 10/24 my migraine broke at 11:45am. When I blew my nose I saw what looked like Blood clots in the tissue. I couldn''t walk 10 feet without crippling exhaustion and profusely sweating, as well as swelling tonsils. And that continued from 10/24 until 11/3. From 11/3 to 11/11 I have slowly been getting my strength back.


VAERS ID: 1860787 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-10-06
Onset:2021-10-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Crepitations, Fatigue, Inflammation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine, elderberry, tumeric, multi-vitamin (pure encapsulation)
Current Illness: No
Preexisting Conditions: Asthma, recovered from BII (Explant 12/16/2020)
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Muscle, joint pain, inflammation, exhaustion, lower back pain (constant), bones in back and neck crack with deep breaths.


VAERS ID: 1861605 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Unknown  
Location: Kentucky  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthma, Blepharospasm, Injected limb mobility decreased, Lymphadenopathy, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Dystonia (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Modeena
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe, persistent eyelid twitching. Asthma attacks and hives, swollen lymph nodes, loss of full function in arm of injection


VAERS ID: 1862528 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Heart rate increased, Injection site pain, Insomnia, Migraine, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: Hepatitis B (1999) and flu vaccine (2008)
Other Medications: multivitamins
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: NKA - I got jaundice after the Hepatitis B vaccine (1999) and difficulty breathing after the flu vaccine (2008)
Diagnostic Lab Data:
CDC Split Type:

Write-up: As soon as the injection occurred, I had intense pain not just at the injection site but throughout my left arm. I also felt that my pulse was very fast. This continued through the next week. The next day, I had a migraine in the evening and could not sleep. Earlier in the day, I started to have incredible dizziness and weakness. On the 3rd day in the afternoon, I became so nauseous when standing outside, that I wasn''t able to go back into the house on my own. I was dizzy and weak. These symptoms kept coming in waves. I also still felt the adrenaline-type rush. I was so weak that I had to rest. These symptoms continued for a total of a week and a half.


VAERS ID: 1863800 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Rash, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient came to pharmacy on 11-10-2021 to receive Dose 2 of Moderna. Upon reviewing her screening form, the patient told me she had a rash about 4 hours after getting her first dose on 10-13-2021. The rash was on her legs and described as being pin-point in nature and very itchy. At the time, she tried taking Benadryl for several days but it wasn''t helping. Patient states she kept itching the area, causing it to turn red in appearance and caused some spots to bruise. On 10-18-2021, she went to her Dr and was prescribed oral hydroxyzine tablets which helped her itching and the rash eventually disappeared.


VAERS ID: 1863846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.


VAERS ID: 1863929 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / OT

Administered by: Work       Purchased by: ?
Symptoms: Chills, Diarrhoea, Immunisation, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101379938

Write-up: Chills.; Nausea; Diarrhea; muscle aches; Booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old male patient received bnt162b2 (Comirnaty, Solution for injection) via intramuscular, administered in arm left on 13Oct2021 12:30 (Lot Number: FF8839) (at the age of 35-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included known allergies: Sulfa Drugs from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient had previously received the second dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 04Feb2021 (Lot Number: FL3247) (at the age of 35-years-old) as dose 2, single and first dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 15Jan2021 (Lot Number: EL3247) (at the age of 35-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Oct2021 12:30, had administered booster. On 13Oct2021 16:30, the patient experienced nausea, diarrhea, muscle aches, chills. The patient did not received treatment for the events. The outcome of the events was recovering at the time of report. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1788941 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0586 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3529 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Cold sweat, Feeling abnormal, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: shivers, body pain, and fever after the thirteen day of application, I started feeling bad at night and had a lot of leg pain with cold sweating.


VAERS ID: 1793937 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045D21A / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cold sweat, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Migraine , cold sweats , nausea , back pain


VAERS ID: 1800170 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: UAJNJFOC20211031034

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 29 year old female. 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: 205A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient got COVID (confirmed covid-19 infection) and worried that the vaccine could not be real/lack of efficacy (confirmed clinical vaccination failure). The patient tested positive for PCR (COVID-19 Polymerase chain reaction) test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000197763.; Sender''s Comments: V0: 20211031034-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination 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: 1802780 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dysgeusia, Headache, Mass, Nausea, Tinnitus, Vulvovaginal pain
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Noninfectious diarrhoea (narrow), Sexual dysfunction (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:
CDC Split Type:

Write-up: Metallic taste in mouth, headaches, buzzing in ears, stomach cramps, diorrhea, nausea, vaginal pain - hard painful lump has grown two days later after vaccine inside vagina.


VAERS ID: 1802883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Chest pain, Fibrin D dimer, Fibrin D dimer increased, Platelet count, Platelet count decreased, Pulmonary thrombosis, SARS-CoV-2 test
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism (on treatment); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown; Comments: Were anti-PF4 antibodies identified?: "Unknown"; Test Name: D-dimer; Result Unstructured Data: Test Result:Slightly raised; Test Date: 20211013; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Comments: Was the D-dimer greater than 4000?: "Unknown"; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown x10 9/l; Comments: Was the platelet count less than 150 x 10 9/L?: "Unknown"; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373918

Write-up: possible blood clot in the lung; D-dimer levels are slightly raised; low platelet counts / Platelet count less than 150 x 10 9/L: unknown; Acute chest pain/Chest pain; This is a spontaneous report from a contactable healthcare professional received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110132019295110-WEZY6, Safety Report Unique Identifier GB-MHRA-ADR 26073645. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 05Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included hypothyroidism (on treatment), immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response and i), and non-smoker. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced acute chest pain/chest pain on 13Oct2021. Clinical course reported: on treatment for possible blood clot in the lung. Blood test: D-dimer levels were slightly raised. Acute chest pain continued even with painkillers. Reaction was related to possible blood clots or low platelet counts. CT scan due this week. Specific details of the event: random acute chest pain 1 week post COVID booster, diagnosed in accident & emergency (A&E) on 13Oct2021. Platelet count less than 150 x 10 9/L: unknown; D-dimer greater than 4000 (measured on 13Oct2021): unknown; and anti-PF4 antibodies identified: unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the event acute chest pain/chest pain was recovering; and for other events was unknown. Regulatory authority assessed the events as serious: life-threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1802884 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Hyperhidrosis, Migraine, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Bedirect study)
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1, High temperature
CDC Split Type: GBPFIZER INC202101380532

Write-up: High temperature; Feeling hot; Sweating; Migraine; Feeling cold; continuous Shivering; 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-202110140430466210-RELUL with Safety Report Unique Identifier GB-MHRA-ADR 26077718. A 25-years-old non pregnant female patient received bnt162b2 (COMIRNATY, solution for injection; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 13Oct2021 (at the age of 25-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included suspected COVID-19 from 13Oct2021 which is ongoing and clinical trial participant (bedirect study). Concomitant medication included influenza vaccine inact split (INFLUENZA VACCINE INACT SPLIT) taken for an unspecified indication on 13Oct2021. The patient previously received first dose of (COMIRNATY, solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 17Jan2021 as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (COMIRNATY, solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on 04Apr2021 as a single dose for COVID-19 immunisation. The patient did not had COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of this report. On 13Oct2021, the patient experienced feeling cold, shivering and migraine. On 14Oct2021, the patient experienced high temperature. feeling hot and sweating. On the same day, the patient underwent body temperature test, and the result was 38.1 (unspecified units). The clinical course was reported as follows: the patient came home (also reported around 11:30 PM), after having had the vaccine (also reported at 12:00 PM) and high temperature around 04:00 AM (14Oct2021) woke up feeling hot and sweating, temperature was 38.1 (unspecified units); her migraine was worse than before and she took paracetamol. The patient was not tested positive for COVID-19 since having the vaccine. The patient received treatment for the event high temperature and migraine. The patient underwent lab tests and procedures which included body temperature resulted 38.1 on 14Oct2021. The clinical outcome of feeling cold was resolved on an unknown date in Oct2021; while that of continuous shivering, high temperature, feeling hot and sweating were resolving and that of migraine 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. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101400107 Same patient, different events/doses


VAERS ID: 1803732 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-10-13
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Haemorrhage subcutaneous
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.1 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Internal bleeding spot; This case was received (Reference number: 2021TJP107543) on 13-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This case, reported by a physician, was received. adverse reaction reporting site (TASK0022250), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21129332). Internal bleeding spot was assessed as serious by the MAH. On 15-Sep-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 13-Oct-2021, the patient received the 2nd dose of this vaccine. During follow-up, internal bleeding developed in the forearm, which was different side of the vaccinated left arm. Internal bleeding spot was observed. The patient visited a clinic soon. The patient was not diagnosed with urticaria, etc. The patient went home. The outcome of internal bleeding spot was unknown. 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: Not reported.; Sender''s Comments: This is a regulatory authority case concerning a 48-year-old female patient with no relevant medical history reported, who experienced serious unexpected event of Haemorrhage subcutaneous. The event occurred the same day after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1806845 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Nausea, Pyrexia, SARS-CoV-2 test, 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), 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: 20211013; Test Name: Body temperature; Result Unstructured Data: Test Result:HIgh; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393218

Write-up: nausea; headache; high temperature; Vomiting; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151311109020-GTIA5. Safety Report Unique Identifier GB-MHRA-ADR 26082330. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Oct2021 (Batch/Lot Number: FF8288) at the age of as 12-year-old as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Nothing to note Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Within three hours of the vaccination on 13Oct2021, she reported headache, nausea and had a high temperature. Within 5 hours she was vomiting. She was continuing to vomit at least 6 times a day and night. The case was reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the events vomiting was not recovered, and the outcome of the other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1807119 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20211037813

Write-up: ITCH BURNING; GENERALISED RASH; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, LV-SAM-2021106741) on 20-OCT-2021 and concerned a 39 year old female of unknown race and ethnicity. The patient''s weight was 60 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5775 expiry: UNKNOWN) 0.5 ml, one total, administered on 12-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced itch burning and generalised rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itch burning, and generalised rash. This report was serious (Other Medically Important Condition).


VAERS ID: 1807753 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Pain, Rash pruritic
SMQs:, Anaphylactic reaction (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin/keflex
Diagnostic Lab Data: None, ever tried getting an appointment.
CDC Split Type:

Write-up: Body aches, chest heaviness, rash with itching


VAERS ID: 1808807 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-10-13
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 093D21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Cellulitis, Diarrhoea, Dizziness, Dry eye, Erythema, Fatigue, Feeling hot, Headache, Hypoaesthesia, Joint stiffness, Joint swelling, Myalgia, Nausea, Peripheral swelling, Urinary retention, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: METFORMIN; ASPIRIN 81; OZEMPIC; PRAVASTATIN; SOLIFENACIN 1A PHARMA
Current Illness: Allergy to metals (Iron); Allergy to nuts ((walnut, hazelnut).); Allergy to plants (Pine tree); Diabetes mellitus; Drug allergy (Allergy to Codeine); Penicillin allergy; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20213

Write-up: cellulitis; Inability to void as before; Abdominal cramping; Diarrhea; Swelling and burning of the joints; Dizziness; Blurred vision; Worsening dry eye; Joint stiffness; Numbness; Generalized body ache/muscle pain especially around the hand and legs; Headache; Nausea; Fatigue; Swelling and burning of the joints; Her right hand was swollen; Hot to touch; Red; This spontaneous case was reported by a pharmacist and describes the occurrence of CELLULITIS (cellulitis) and URINARY RETENTION (Inability to void as before) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 093D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to Codeine), Allergy to plants (Pine tree), Allergy to metals (Iron), Allergy to nuts ((walnut, hazelnut).), Stroke since 2011 and Diabetes mellitus. Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN 81), SEMAGLUTIDE (OZEMPIC), PRAVASTATIN and SOLIFENACIN SUCCINATE (SOLIFENACIN 1A PHARMA) for an unknown indication. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced PERIPHERAL SWELLING (Her right hand was swollen), FEELING HOT (Hot to touch) and ERYTHEMA (Red). On an unknown date, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), URINARY RETENTION (Inability to void as before) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Diarrhea), JOINT SWELLING (Swelling and burning of the joints), DIZZINESS (Dizziness), VISION BLURRED (Blurred vision), DRY EYE (Worsening dry eye), JOINT STIFFNESS (Joint stiffness), HYPOAESTHESIA (Numbness), MYALGIA (Generalized body ache/muscle pain especially around the hand and legs), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Swelling and burning of the joints). The patient was treated with CEFALEXIN (CEPHALEXIN AMEL) (oral) in October 2021 for Adverse event, at a dose of 500 milligram four times per day. At the time of the report, CELLULITIS (cellulitis), URINARY RETENTION (Inability to void as before), ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Diarrhea), JOINT SWELLING (Swelling and burning of the joints), DIZZINESS (Dizziness), VISION BLURRED (Blurred vision), DRY EYE (Worsening dry eye), JOINT STIFFNESS (Joint stiffness), PERIPHERAL SWELLING (Her right hand was swollen), FEELING HOT (Hot to touch), ERYTHEMA (Red), HYPOAESTHESIA (Numbness), MYALGIA (Generalized body ache/muscle pain especially around the hand and legs), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Swelling and burning of the joints) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment: This case concerns a 61-year-old female with relevant medical history of Diabetes Mellitus, who experienced the unexpected events of Cellulitis and Urinary Retention. The events occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Diabetes Melllitus remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old female with relevant medical history of Diabetes Mellitus, who experienced the unexpected events of Cellulitis and Urinary Retention. The events occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Diabetes Melllitus remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1809597 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-10-13
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills
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: Shivers; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26077560) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivers) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications and treatment drug were not provided. It was reported that patient developed intense shivering, muscle cramping, shaking and chattering teeth so hard that she had to stick towel in mouth to prevent damage. Hot water bottle and blanket helped this subside slightly. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and Patient was not currently breastfeeding. Company Comment: This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the serious event of chills. Chills is unexpected as it is retained as serious per the source document Authority reporting. The event occurred on the same day after the second dose of Spikevax. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the serious event of chills. Chills is unexpected as it is retained as serious per the source document Authority reporting. The event occurred on the same day after the second dose of Spikevax. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1809607 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Freezing phenomenon, Insomnia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: 20211002; 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: Freezing phenomenon; Stomach ache; Appetite lost; Dizziness; Acute diarrhea; Sleep loss; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26078605) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (Freezing phenomenon), ABDOMINAL PAIN UPPER (Stomach ache), DECREASED APPETITE (Appetite lost), DIARRHOEA (Acute diarrhea), INSOMNIA (Sleep loss) and DIZZINESS (Dizziness) in a 45-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced DIARRHOEA (Acute diarrhea) (seriousness criterion medically significant) and INSOMNIA (Sleep loss) (seriousness criterion medically significant). On 14-Oct-2021, the patient experienced FREEZING PHENOMENON (Freezing phenomenon) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, FREEZING PHENOMENON (Freezing phenomenon), ABDOMINAL PAIN UPPER (Stomach ache), DECREASED APPETITE (Appetite lost), DIARRHOEA (Acute diarrhea), INSOMNIA (Sleep loss) and DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment medications was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 45 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Diarrhoea, Dizziness, Freezing phenomenon, Abdominal pain upper, Insomnia and Decreased appetite. The events occurred approximately 1 to 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 45 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Diarrhoea, Dizziness, Freezing phenomenon, Abdominal pain upper, Insomnia and Decreased appetite. The events occurred approximately 1 to 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1809609 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hiccups
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: Clinical trial participant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Intractable hiccups; This case was received (Reference number: GB-MHRA-ADR 26078904) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HICCUPS (Intractable hiccups) in a 71-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Clinical trial participant. On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced HICCUPS (Intractable hiccups) (seriousness criterion medically significant). At the time of the report, HICCUPS (Intractable hiccups) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant history was not reported. The treatment history was not provided. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for covid-19. since having the vaccine clinical trial participant study details: covid survey - every month give a swab and blood. Company comment: This case concerns a 71-year-old, female patient who is a clinical trial participant with no other relevant medical history, who experienced the unexpected event of hiccups. The events occurred on the same day after the third dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the other doses was disclosed. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 71-year-old, female patient who is a clinical trial participant with no other relevant medical history, who experienced the unexpected event of hiccups. The events occurred on the same day after the third dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the other doses was disclosed. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1809612 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Retinal vein occlusion, SARS-CoV-2 test, Visual field defect
SMQs:, Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Retinal disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA.
Current Illness: Hypertension; Multiple myeloma; Neoplasm malignant (Patient has history of, or current, malignancy); Non-smoker; Type 2 diabetes mellitus
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: possible branch retinal artery occlusion; Visual field defect; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26079300) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RETINAL VEIN OCCLUSION (possible branch retinal artery occlusion) and VISUAL FIELD DEFECT (Visual field defect) in a 65-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple myeloma since 2006, Hypertension, Neoplasm malignant (Patient has history of, or current, malignancy), Non-smoker and Type 2 diabetes mellitus. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced VISUAL FIELD DEFECT (Visual field defect) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced RETINAL VEIN OCCLUSION (possible branch retinal artery occlusion) (seriousness criteria medically significant and life threatening). At the time of the report, RETINAL VEIN OCCLUSION (possible branch retinal artery occlusion) outcome was unknown and VISUAL FIELD DEFECT (Visual field defect) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient''s medical history include blood clot in base of penis. On 14-Oct-2021, laboratory investigations included visual field test, other examinations include IOPs, pupils and fundus exam. On an unknown date, the patient experienced sudden loss of vision in lower nasal left visual field. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - This case concerns a 65 year-old, male with medical history of multiple myeloma, diabetes type 2 and hypertension, who experienced the serious, unexpected events of retinal vein occlusion and visual field deffect. Interchange of vaccine product was also reported. Time to onset from vaccination was not reported. The rechallenge is unknown since dose number related to this case is unknown. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting. Sender''s Comments: This case concerns a 65 year-old, male with medical history of multiple myeloma, diabetes type 2 and hypertension, who experienced the serious, unexpected events of retinal vein occlusion and visual field deffect. Interchange of vaccine product was also reported. Time to onset from vaccination was not reported. The rechallenge is unknown since dose number related to this case is unknown. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1809900 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Nausea, Pericarditis, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Blood test; Result Unstructured Data: Increased cardiac enzymes.; Test Date: 20211015; Test Name: Electrocardiogram; Result Unstructured Data: Increased cardiac enzymes.; Test Date: 20211015; Test Name: Ultrasound scan; Result Unstructured Data: No pericardial effusion.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Chest pain; Queasy; Suspected acute myocarditis; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP109040) on 16-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This case, initially reported to the regulatory authority by a (pharmacist), was received via the regulatory authority (Ref, v21130015). The patient had a history of epilepsy and was taking levetiracetam. On an unknown date, the patient received the 1st dose of this vaccine. On 12-Oct-2021, the patient received the 2nd dose of this vaccine. On 13-Oct-2021, chest pain and queasy developed. On 15-Oct-2021, in the morning, the patient was raced to a hospital with a pain scale of 10/10. No pericardial effusion was confirmed by ultrasound. Electrocardiogram and blood test showed increased cardiac enzymes, and acute pericarditis was suspected. The patient was hospitalized. The outcome of chest pain, queasy, and suspected myocarditis was unknown. 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: Not reported. 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 19-year old, male subject with no medical history, who experienced the serious expected event of Pericarditis(AESI) and non-serious unexpected events of Chest pain and Nausea. The events, which resulted in hospitalization, occurred 1 day after the second dose of MODERNA COVID-19 VACCINE. Rechallenge is not applicable as no information about adverse events, which appeared after the first dose and resolved before the second dose, is available. The patient''s age and gender remain as confounders. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report.


VAERS ID: 1816593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Nausea, Off label use, Paraesthesia oral, Rash, SARS-CoV-2 test, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; METHOTREXATE; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis)
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380509

Write-up: Tingling tongue/ tongue began to tingle and later lips; previously received COVID-19 VACCINE ASTRAZENECA/initial Pfizer dose; previously received COVID-19 VACCINE ASTRAZENECA/initial Pfizer dose; Nausea; overnight skin discolouration/ Overnight, rash on torso front had coalesced (like an angry sunburn) and spread down arms to wrists and over upper thighs; Skin rash on torso front + back and flexure left arm (Jabbed arm) developed within a few hours; 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-202110141547340840-FCIQO with Safety Report Unique Identifier GB-MHRA-ADR 26079393. A 68-year-old female patient received initial Pfizer dose BNT162b2 (COMIRNATY; Lot Number: UNKNOWN, initial Pfizer dose) via an unspecified route of administration in left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and asthma. The patient was taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis). The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 27Sep2021, the patient underwent COVID-19 virus test and the result negative. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) taken for rheumatoid arthritis; fluticasone propionate/salmeterol xinafoate (SERETIDE) taken for asthma; and folic acid (MANUFACTURER UNKNOWN) taken for unspecified indications, taken from an unknown date and unknown if ongoing; and influenza vaccine (INFLUENZA VIRUS VACCINE) on 12Oct2021 for immunization. The patient previously received gold injection (MANUFACTURER UNKNOWN) and experienced anaphylactic reaction necessitating hospital admission. The patient previously received COVID-19 VACCINE ASTRAZENECA via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced nausea; overnight skin discolouration and skin rash. On 13Oct2021, the patient had tingling in tongue and later in lips. The events nausea, skin discolouration, skin rash; tingling in tongue and later in lips were reported as serious for being medically significant. The clinical course was reported as follows: The patient had skin rash on torso front, back and flexure left arm (jabbed arm) which developed within a few hours. Over the counter (OTC) chlorphenamine maleate (PIRITON) tablet was taken at approximately 20:30 and another one approximately at 16:40. Overnight the rash on torso front had coalesced (like an angry sunburn) and spread down arms to wrists and over upper thighs. Another chlorphenamine maleate was taken approximately at 10:30. On 13Oct2021, the patient tongue began to tingle and later on lips. The patient was prescribed a 3 days course (30mg, 20mg, 10mg) of prednisolone (MANUFACTURER UNKNONWN). The patient was advised to continue chlorphenamine maleate until the rash settled. The patient was not tested positive for COVID-19 since having the vaccine. No relevant investigations or tests were conducted. The clinical outcome of the events nausea and overnight skin discolouration/ overnight, rash on torso front had coalesced (like an angry sunburn) and spread down arms to wrists and over upper thighs was resolved on an unknown date in 2021. The clinical outcome of the event tongue began to tingle and later lips was resolved on 14Oct2021, after the duration of 1 day. The clinical outcome of the event skin rash on torso front, back and flexure left arm was resolving 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: 1816834 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005891 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Presyncope, Tonic convulsion
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion; Vagal reaction (Vasovagal reflex)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Depressed level of consciousness; Tonic convulsion; Vasovagal reflex; This case was received (Reference number: JP-TAKEDA-2021TJP109036) on 16-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This case was received (Ref, v21129477). Depressed level of consciousness and tonic convulsion were assessed as serious. The patient had the past medical history of convulsion (suspected epilepsy) during infancy and vagal reflex. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 13-Oct-2021, at 10:30, the patient received the 1st dose of this vaccine. At 10:40, vasovagal reflex developed. At 10:45, the patient was found lying limply on a chair during follow-up. JCS was 3-300. Tonic convulsion was observed for about 3 seconds after calls and pain stimulation. Thereafter, the patient recovered consciousness to JCS-1 but had queasy. Afterwards, the symptoms were resolving. The outcome of vasovagal reflex, depressed level of consciousness, and tonic convulsion 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 27 year-old male patient with the medical history of Convulsion and Vagal reflex, who experienced the unexpected serious events of Depressed level of consciousness and Tonic convulsion. These events occurred on the same day as the patient received the first dose of COVID 19 Vaccine Moderna. Both events were reported as resolving. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of COVID 19 Vaccine Moderna is not affected by this report.


VAERS ID: 1817462 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest discomfort, Chills, Foetal hypokinesia, Headache, Hyperhidrosis, Influenza like illness, Maternal exposure during pregnancy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Arthritis (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20211216)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: flu like symptoms; Maternal exposure during pregnancy; Tight chest; High temperature; Shivers; Drenching sweats; Back ache; Muscle pain; Headache; Fetal movements decreased; Joint pain; This case was received via RA (Reference number: GB-MHRA-ADR 26081680) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (High temperature), CHILLS (Shivers), HYPERHIDROSIS (Drenching sweats), ARTHRALGIA (Joint pain), BACK PAIN (Back ache), MYALGIA (Muscle pain), HEADACHE (Headache), FOETAL HYPOKINESIA (Fetal movements decreased), CHEST DISCOMFORT (Tight chest) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Estimated due date: 20211216). Concomitant products included FOLIC ACID for Folic acid supplementation. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 16-Dec-2021. On 13-Oct-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 14-Oct-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), HYPERHIDROSIS (Drenching sweats) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). 14-Oct-2021, the patient experienced FOETAL HYPOKINESIA (Fetal movements decreased) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (High temperature), CHILLS (Shivers), HYPERHIDROSIS (Drenching sweats), ARTHRALGIA (Joint pain), BACK PAIN (Back ache), MYALGIA (Muscle pain) and HEADACHE (Headache) was resolving, FOETAL HYPOKINESIA (Fetal movements decreased) had resolved, CHEST DISCOMFORT (Tight chest) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. This was really severe flu like symptoms that lasted for 2 nights and 2 days. The patient didn''t feel the baby move for several hours and was really distressed, the patient could barely lift the body to turn in bed, at the same time couldn''t lay still because of the pain in the joints and back. The patient had to peel cold wet clothes off the body throughout the night and had to dry the bedding with a hairdryer, it was really bad. The patient wasn''t told that this could happen at any point and was just advised to have the vaccine. It was a really scary experience. Most of the symptoms were easing but the patient had been left with a tight chest. This case of maternal exposure during pregnancy concerns a 31-year-old female patient, who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS, PYREXIA, CHILLS, HYPERHIDROSIS, ARTHRALGIA, BACK PAIN, MYALGIA, HEADACHE, FOETAL HYPOKINESIA and CHEST DISCOMFORT. The events occurred approximately 1 day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. This case was linked to MOD-2021-356712 (Patient Link).; Sender''s Comments: This case of maternal exposure during pregnancy concerns a 31-year-old female patient, who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS, PYREXIA, CHILLS, HYPERHIDROSIS, ARTHRALGIA, BACK PAIN, MYALGIA, HEADACHE, FOETAL HYPOKINESIA and CHEST DISCOMFORT. The events occurred approximately 1 day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1817463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Muscle fatigue, Myalgia, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: High temperature; Vomiting; Headache; Muscle ache; Dizziness; Muscle fatigue; Shivering; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26085498) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MUSCLE FATIGUE (Muscle fatigue), CHILLS (Shivering), PYREXIA (High temperature), VOMITING (Vomiting), HEADACHE (Headache) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness) and MUSCLE FATIGUE (Muscle fatigue) was resolving and CHILLS (Shivering), PYREXIA (High temperature), VOMITING (Vomiting), HEADACHE (Headache) and MYALGIA (Muscle ache) had 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. Concomitant Medication information was not provided by reporter. Treatment Medication information was not provided by reporter. Patient had not symptoms associated with COVID-19. Company Comment: This case concerns a female patient of unknown age, with no relevant medical history, who experienced the unexpected events of Dizziness , Muscle fatigue, Chills, Pyrexia, Vomiting, Headache, Myalgia. The events occurred approximately on the same day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a female patient of unknown age, with no relevant medical history, who experienced the unexpected events of Dizziness , Muscle fatigue, Chills, Pyrexia, Vomiting, Headache, Myalgia. The events occurred approximately on the same day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1819366 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101373901

Write-up: off label use; Faint; Drug use in unapproved population; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110131316384680-XVYIF. Safety Report Unique Identifier GB-MHRA-ADR-26071134. A 1-hours-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FJ5782), dose 1 via an unspecified route of administration on 13Oct2021 (Age at time of vaccination 1-hours-old) as DOSE 1,SINGLE for covid-19 immunization. The patient medical history, concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 13Oct2021 The patient experienced faint, drug use in unapproved population. The outcome of event faint was resolving and other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1819369 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101374015

Write-up: hearing loss; dizzy; Vomited; This is a spontaneous report from a contactable Other Healthcare Professional. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110131412028540-MTJT6, Safety Report Unique Identifier GB-MHRA-ADR 26071648. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number FF8288), via an unspecified route of administration on 13Oct2021 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The report does not relate to possible blood clots or low platelet counts. On an unspecified date, the patient experienced hearing loss, dizzy. On 13Oct2021, the patient vomited. The patient felt dizzy and some hearing loss for a few minutes and made a full recovery. The outcome of the events hearing loss and dizzy were recovered on an unspecified date and the event vomited on 13Oct2021 was recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819373 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Headache, Malaise, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101374072

Write-up: headache; raised rash/raised rash on trunk, tighs and arms; feeling heat; generally unwell; Skin rash; This is a spontaneous report from a contactable other HCP received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110131450419410-MNZNX, Safety Report Unique Identifier GB-MHRA-ADR 26071837. A 12-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: FG3712; Expiration Date: Nov2021) via an unspecified route of administration, administered on 13Oct2021 (at the age of 12-years-old) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not had symptoms associated with COVID-19. Not had a COVID-19 test and had no illnesses known. It was reported that on 13Oct2021 within 10 minutes of vaccination the patient experienced feeling heat behind right ear with pain and within 15 minutes developed raised rash on trunk, thighs and arms and also complained of headache, skin rash and feeling generally unwell. The patient further reported that went to emergency ambulance and IM piriton given by paramedic on arrival and admitted to hospital. The patient was hospitalized and received treatment for the events. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was unknown at the time of report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness
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: GBPFIZER INC202101374057

Write-up: Sickness/Being sick; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202110131728525010-LM8YA, Safety Report Unique Identifier GB-MHRA-ADR 26073463. A 14-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection), via an unspecified route of administration on 12Oct2021 as DOSE 1, SINGLE for COVID-19 immunization. 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. The patient experienced sickness/being sick (medically significant) on 13Oct2021. Being sick. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The 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: 1819383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / UNK - / -

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 Date: 20211004; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101374026

Write-up: Period pains; Heavy periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110131808318810-I9CXF. Safety Report Unique Identifier is GB-MHRA-ADR 26073506. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FG6431), via an unspecified route of administration on 04Oct2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. On 13Oct2021, the patient experienced period pains and heavy periods. The patient underwent sars-cov-2 test resulted in negative on 04Oct2021. She never had period pains like this, and her period is so heavy with large clots in it. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not re-solved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1819384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test (13Oct2021 at 08:40 Undertook lateral flow test, negative result, kit number LWP39606764)
CDC Split Type: GBPFIZER INC202101373889

Write-up: Vomiting; Opening of bowel; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110131817496510-NQF1D, Safety Report Unique Identifier GB-MHRA-ADR 26073537. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,Lot number was not reported), via an unspecified route of administration as Dose 3 (Booster), Single on 11Oct2021 at 14:20 for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medication included received single dose of influenza vaccine (INFLUENZA VIRUS) on 28Sep2021 for immunization. The patient has not had symptoms associated with COVID-19. Historical vaccine included patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number and expiration date were not reported), via an unspecified route of administration on 11Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 as Dose 2, Single for COVID-19 immunization. It was reported that, patient received Covid-19 booster on 11Oct2021 at 14:20 at (withheld). No problem with the injection. On 13Oct2021 at 01:00, patient experienced prolonged vomiting and opening of bowel. On 13Oct2021 at 08:40, undertook lateral flow test, negative result, kit number LWP39606764. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The case was assessed as serious- Other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No-Negative COVID-19 test) on 13Oct2021 at 08:40. The outcome of the event vomiting was resolved on 13Oct2021 while the outcome of the event opening of bowel was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1819426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Hyperhidrosis, Immunisation, Pain, Pain in extremity, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:80/41 mmHg; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373883

Write-up: pain in arm; sweaty; dizzy; blood pressure decreased to 80/41; Booster; Ache/Pain; Syncope vasovagal; This is a spontaneous report from a contactable consumer(Patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110132035405180-DP9X9, safety report unique identifier is GB-MHRA-ADR 26073820. A 44-year-old female patient received BNT162B2 (Pfizer BioNTech covid-19 vaccine), dose 3 via an unspecified route of administration on 13Oct2021 as Dose 3 (booster), Single for COVID-19 immunization. Medical history included clinical trial participant from an unknown date and unknown if ongoing. Concomitant medication(s) included desogestrel (cerazette) taken for contraception, start and stop date were not reported; influenza vaccine (influenza virus) taken for an unspecified indication from 01Oct2021 to an unspecified stop date. Patient was fit and well. Patient has not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was a clinical trial participant. Study details: SIREN. On an unspecified date patient experienced pain in arm, sweaty, on 13Oct2021 ache, pain, syncope vasovagal, blood pressure decreased, booster. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on No - Negative COVID-19 test, blood pressure measurement: 80/41 mmhg. The outcome of syncope vasovagal was recovered on an unspecified date, pain in arm, sweaty, ache, pain, blood pressure decreased to 80/41 was not recovered, booster was unknown. clinical course: Patient had waited 15mins in the clinic at work (healthcare professional) as advised, felt fine. Walked back to her department. Sat outside talking to a colleague, stood up to walk back to her office, felt dizzy so sat down, then became sweaty and increasingly dizzier so lay down. Colleague was with her and a met call was put out. BP did not read first two tries then was 80/41. Moved to a trolley and into recovery for obs. Patient reportedly did not react like this with first two vaccines. He also had usual ache and pain in arm this evening. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1819434 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Immunisation, Muscle spasms, Myalgia, Nausea, Off label use, Pyrexia, SARS-CoV-2 test, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Ectopic heartbeats (occasional ectopic heart beats)
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3; Test Date: 20210101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101380510

Write-up: Muscle spasm/ Muscle spasms in R hand; Muscle pain/ muscle ache; Vomiting; Pyrexia/Pyrexia of 38.3; Weakness; Dose 3b; Dose 3b; nausea; Tachycardia; 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-202110150643568220-ZDBSZ with Safety Report Unique Identifier of GB-MHRA-ADR 26080722. A 46-year-old female patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 13Oct2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional ectopic heartbeats and COVID-19 which was confirmed by the positive COVID-19 test on 01Jan2021. The patient was not pregnant and was not breastfeeding at the time of this report. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On 13Oct2021, 1 hour after the vaccination, the patient experienced tachycardia continued intermittently 24 hours and 10 hours after the vaccination the patient experienced vomiting. On the same day, the patient also experienced muscle pain/muscle ache, nausea, pyrexia/pyrexia of 38.3, weakness. On 14Oct2021, the patient experienced muscle spasms/ muscle spasms in R hand. All the events were reported as serious for being medically significant. The clinical course was reported as follows: Pyrexia of 38.3, took paracetamol & Ibuprofen (MANUFACTURER UNKNOWN). Therapeutic measures were taken for tachycardia which included propranolol (MANUFACTURER UNKNOWN). It was also reported that the patient had no headaches. The patient had not been tested positive for COVID-19 since the vaccination. The clinical outcome of the events vomiting, nausea, pyrexia/pyrexia of 38.3 and muscle pain/muscle ache was recovered on 14Oct2021, after the duration of 24 hours and the event muscle spasm recovered on 14Oct2021 while that of the event weakness was recovered on 15Oct2021, after the duration of 2 days (also reported for over 24hrs). The clinical outcome of the event tachycardia was recovering (also reported with stop date as 14Oct2021) 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: 1819758 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-10-13
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Language disorder, Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: Loss of consciousness; Breakdown of conversation; Light-headedness; Queasy; This case was received via the RA (Reference number: 2021TJP111488) on 14-Oct-2021 and was forwarded to Moderna on 26-Oct-2021. This case, reported by a pharmacist, was received by Takeda via Modernas adverse reaction reporting site (TASK0022271). Loss of consciousness was assessed as serious by the MAH. On 07-Sep-2021, at 14:57, the patient received the 1st dose of the vaccine. On 13-Oct-2021, at 15:06, the patient received the 2nd dose of the vaccine. After the vaccination, the patient experienced breakdown of conversation, light-headedness, queasy, and loss of consciousness. The patient was seated in a wheelchair before noticing it. At 15:24, the symptoms improved and was confirmed as resolved. The outcome of breakdown of conversation, light-headedness, queasy, and loss of consciousness was reported as resolved. Follow-up was not possible due to lack of cooperation from the reporter. 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 19-year-old, female patient with no medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the second dose of Moderna COVID-19 Vaccine. After the vaccination, the patient experienced breakdown of conversation, light-headedness, queasy, and loss of consciousness. The patient was seated in a wheelchair before noticing it. The rechallenge was not applicable as event occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in source document.


VAERS ID: 1819983 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-10-13
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

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

Write-up: Peripheral nerve disorder; Numbness in hands and feet; Lightheadedness; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP111528) on 14-Oct-2021 and was forwarded to Moderna on 26-Oct-2021. This case, initially reported to Takeda by a pharmacist, was received via Moderna''s adverse reaction reporting site (TASK0022268). Peripheral nerve disorder was assessed as serious by the MAH. On 07-Sep-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: unknown. On 13-Oct-2021, at 12:30, the patient received the 2nd dose of this vaccine. Peripheral nerve disorder, numbness in hands and feet, and lightheadedness developed. Thereafter, the symptoms improved with follow-up. The symptoms resolved. The outcome of peripheral nerve disorder, numbness in hands and feet, and lightheadedness was reported as resolved. Follow-up was not possible due to lack of cooperation from the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 19 year old female patient with no relevant medical history, who experienced the unexpected event of neuropathy peripheral. The event occurred on the same date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1822350 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211051287

Write-up: FLU SYMPTOMS; RESPIRATORY DISTRESS; This spontaneous report received from a consumer via a Regulatory Authority (DE-PEI-CADR2021190472) on 25-OCT-2021 and concerned a 21 year old female. The patient''s weight was 65 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 13-OCT-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-OCT-2021, the patient experienced flu symptoms (very very strong head and limb pain. Fever, chills, tiredness) and respiratory distress (labored breathing). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from respiratory distress on 14-OCT-2021, and was recovering from flu symptoms. This report was serious (Other Medically Important Condition).


VAERS ID: 1822660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Flushing, Muscle tightness, SARS-CoV-2 test, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373960

Write-up: flushed; intermittent jerking; tensing of muscles; Unresponsive to stimuli; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110131302290000-WFDUC, Safety Report Unique Identifier GB-MHRA-ADR 26071090. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 13Oct2021 (Batch/Lot Number: FF8288) as DOSE 1, SINGLE 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 an clinical trial participant. The patient experienced unresponsive to stimuli (medically significant) on 13Oct2021. The patient experienced flushed, intermittent jerking and tensing of muscles on an unspecified date. It was reported that ambulance was called. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of unresponsive to stimuli was recovering and other events was unknown. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No". Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "ambulance called". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1822669 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8 222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Lethargy, Nausea
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: URSODEOXYCHOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Primary biliary cholangitis
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101373944

Write-up: lethargy; tiredness; Temperature; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110131838513590-MPEBS, Safety Report Unique Identifier is GB-MHRA-ADR 26073625. A 71-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8 222), dose 3 via an unspecified route of administration on 12Oct2021 (at the age of 71-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included primary biliary cholangitis from an unknown date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included ursodeoxycholic acid taken for primary biliary cholangitis, start and stop date were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced lethargy, tiredness and temperature. On 13Oct2021, the patient experienced nausea. The patient underwent lab tests and procedures which included body temperature: unknown on an unknown date. Events were considered as serious (medically significant). Outcome of the event nausea was recovering. Outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822672 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Dizziness, Labyrinthitis, Nausea, SARS-CoV-2 test, Somnolence, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (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:
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 INC202101374144

Write-up: nauseous; 08:30am became dizzy; room spinning; groggy; unable to focus; Labyrinthitis; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This is a report received from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110131931001050-PJPAC, Safety Report Unique Identifier (GB-MHRA-ADR 26073572). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ff8288), via an unspecified route of administration on 12Oct2021 at 05:30 as DOSE 3 (Booster), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient had experienced nauseous, at 08:30 became dizzy, room spinning, groggy, unable to focus and labyrinthitis on 13Oct2021. It was reported that groggy was resolved after 4 hours but remained all day. The events (nauseous, at 08:30 became dizzy, room spinning, groggy, labyrinthitis) were reported as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date No - Negative COVID-19 test. The outcome of nauseous, at 08:30 became dizzy, room spinning, groggy was not recovered. Outcome of labyrinthitis was recovered on 13Oct2021. Outcome of unable to focus was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822720 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Intermenstrual bleeding, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (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: GBMODERNATX, INC.MOD20213

Write-up: Intermenstrual bleeding; Generalised muscle aches; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26087329) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Intermenstrual bleeding), MYALGIA (Generalised muscle aches) and FATIGUE (Fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 16-Oct-2021, the patient experienced INTERMENSTRUAL BLEEDING (Intermenstrual bleeding) (seriousness criterion medically significant). On 14-Oct-2021, MYALGIA (Generalised muscle aches) had resolved. On 16-Oct-2021, FATIGUE (Fatigue) had resolved. At the time of the report, INTERMENSTRUAL BLEEDING (Intermenstrual bleeding) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. 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 has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected events of Intermenstrual bleeding, Myalgia and Fatigue. The events of Myalgia and Fatigue are unexpected as they are retained as serious per the RA source document. The events occurred approximately 1-4 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected events of Intermenstrual bleeding, Myalgia and Fatigue. The events of Myalgia and Fatigue are unexpected as they are retained as serious per the RA source document. The events occurred approximately 1-4 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1822741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Blood pressure measurement, Blood test, Cardiac arrest, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Emphysema, Fibrin D dimer, Immunisation, Inferior vena cava dilatation, International normalised ratio, Nodule, Off label use, Platelet count, Platelet factor 4, Prothrombin time, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol addiction; Depression; Smoker
Allergies:
Diagnostic Lab Data: Test Name: Activated Partial Thromboplastin Clotting Time; Result Unstructured Data: Test Result:31.3; Test Name: Fibrinogen; Result Unstructured Data: Test Result:5.19; Test Name: BP; Result Unstructured Data: Test Result:124/86; Test Name: Blood film findings; Result Unstructured Data: Test Result:elongated rec cells; Test Date: 20211019; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:confirms bilateral pulmonary embolism; Comments: with multiple small emboli consistent with moderate thrombus volume.; Test Name: ECG; Result Unstructured Data: Test Result:suggestive of pulmonary embolus; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was $g4000; Test Date: 20211018; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Unknown; Test Date: 20211019; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:$g20000; Test Name: IVC; Result Unstructured Data: Test Result:increased right heart pressure; Test Date: 20211019; Test Name: INR; Result Unstructured Data: Test Result:1.1; Test Name: indeterminate nodule; Result Unstructured Data: Test Result:9.1 mm; Comments: in the posterior segment of the right upper lobe.; Test Date: 20141122; Test Name: platelet count measured; Result Unstructured Data: Test Result:250; Test Date: 20211018; Test Name: platelet count measured; Result Unstructured Data: Test Result:353; Comments: the lowest platelet count after vaccine; Test Name: Platelet factor 4; Result Unstructured Data: Test Result:Anti-PF4 antibodies were not identified; Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: PT; Result Unstructured Data: Test Result:14.9
CDC Split Type: GBPFIZER INC202101417987

Write-up: Cardiac arrest; breathless; Centrilobular emphysema; Pulmonary embolus/pulmonary embolism; dose 3 (booster), single for covid-19 immunisation; dose 3 (booster), single for covid-19 immunisation; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110191542200780-R4V9I, Safety Report Unique Identifier GB-MHRA-ADR 26093173. A 77-year-old female patient received bnt162b2 (COMIRNATY) dose 3 via an unspecified route of administration on 13Oct2021 (Lot Number: FF8288) as dose 3 (booster), single for covid-19 immunisation. Medical history included depression, previous alcohol excess, previous alcohol dependence. Generally frail with no limits to activities of daily living Smokes. No known history of lung disease, but emphysematous changes on CTPA, Patient has not had symptoms associated with COVID-19. No regular Medications. No known medication allergies. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included influenza vaccine inact sag 3v (FLUAD) taken for influenza immunisation on 13Oct2021. The patient previously took heparin. The patient experienced pulmonary embolus on 18Oct2021, pulmonary embolism on an unspecified date. The patient collapsed at home, appeared breathless and unresponsive; reportedly well prior to this. Cardiac arrest with paramedics - down time of 15 minutes - return of circulation by time of arrival to hospital. Intubated and ventilated on arrival. ECG and blood gases suggestive of pulmonary embolus. D-Dimer $g20000; BP 124/86; commenced on treatment dose low molecular weight heparin. CTPA 19Oct2021 confirms bilateral pulmonary embolism with multiple small emboli consistent with moderate thrombus volume. Mild reflux of contrast is evident in the IVC suggestive of increased right heart pressure. Centrilobular emphysema and an indeterminate nodule measuring 9.1 mm in the posterior segment of the right upper lobe. Guarded prognosis. The report was related to possible blood clots or low platelet counts. No relate to possible myocarditis or pericarditis. CT pulmonary angiogram was conducted. Bilateral Pulmonary Embolism was this diagnosed with CT-pulmonary angiogram on 19Oct2021. The platelet count was not lower than 150 A- 109/L. The platelet count was measured on 18Oct2021 and D-dimer on 18Oct2021. No previous reactions to medications, especially heparin or anticoagulants. No known history of VTE. The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The lowest platelet count after vaccine (usual normal range 150-450) was 353. The last platelet count before vaccine (usual normal range 150-450) was 250 on 22Nov2014. The patient was not reviewed by a hematologist. No haemorrhage identified. No history of, or concurrent, intracranial malignancy. No concurrent or recent intracranial infections. No recent surgical or medical interventions to the central nervous system (including lumbar puncture). No recent trauma/head injury. PT: 14.9 Activated Partial Thromboplastin Clotting Time (aPTT): 31.3. Fibrinogen: 5.19. Blood film findings: elongated rec cells. D-dimer was $g4000. Anti-PF4 antibodies were not identified. INR 1.1 and COVID-19 virus test negative on 19Oct2021. The outcome of event pulmonary embolus on 18Oct2021 was not recovered and other events was unknown. Events were considered as serious as life-threatening and medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDUM; BETAMETHASONE VALERATE; COVID-19 VACCINE ASTRAZENECA; ESTRIOL; IBUPROFEN; INFLUENZA VIRUS; METFORMIN; NITROFURANTOIN; PARACETAMOL; RAMIPRIL
Current Illness: Blood pressure; Diabetes; Eczema; Pain; Vaginal dryness
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132110GBR006958

Write-up: Giddiness; Information has been received from the Agency (GB-MHRA-WEBCOVID-202110221537298720-W1T3K) on 24-OCT-2021. This spontaneous report originating from Regulatory authority as received from a consumer referring to a 74-year-old female patient. Information regarding the patient''s concurrent conditions or medical history was not provided. Concomitant therapies included bendroflumethiazid, betamethasone valerate, covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), estriol, ibuprofen, influenza vaccine (INFLUENZA VIRUS), metformin, nitrofurantoin, paracetamol and ramipril. On an unspecified date, the patient was vaccinated with Hepatitis Virus A vaccine (manufacturer unknown) (dose, strength, route of administration, indication and lot number were not reported). On 13-OCT-2021, the patient was vaccinated with tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose "3b" (strength, route of administration, indication and lot number were not reported). On 13-OCT-2021, the patient experienced sudden severe giddiness that resulted in falling to the ground with no loss of consciousness. Giddiness disappeared almost straight away. The event occurred 1.5 hours after booster vaccine given. Reported to GP (general practitioner), when blood pressure (BP) was 150/90 (unit not reported), usually 1 approx 130/75. ECG (electrocardiogram) performed five days later, pronounced all clear. A shocking event never before experienced. Now afraid to drive or lock a WC (water closet) door. Needed to know if others had experienced this. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Reaction, does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No" The action taken for tozinameran (PFIZER BIONTECH COVID-19 VACCINE) and Hepatitis Virus A vaccine (manufacturer unknown) was reported as unknown with unknown rechallenge. The reporter did not provide a causality assessment between the reported event and vaccination with tozinameran (PFIZER BIONTECH COVID-19 VACCINE) and Hepatitis Virus A vaccine (manufacturer unknown). The agency reported the event giddiness to medically significant.


VAERS ID: 1822781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic (novamix insulin for diabetes, taking it from 2010 diabetic since 1997)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101373887

Write-up: Felt faint; Coldness; Sore feet; This is a non-interventional study report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-YCVM-202110131234439750-G4PW5, Safety Report Unique Identifier GB-MHRA-ADR 26071004. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF8222), dose 3 via an unspecified route of administration on 12Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included suspected covid-19 from 13Oct2021 and ongoing, diabetic from 1997 to an unknown date (novamix insulin for diabetes, taking it from 2010 diabetic since 1997). The patient''s concomitant medications were not reported. Not had a COVID-19 test. On 13Oct2021, patient experienced felt faint, coldness, sore feet. Patient was not enrolled in clinical trial. The clinical outcome of events was recovering. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events - dizziness, feeling cold, pain in extremity and the suspect drug "BNT162B2" cannot be completely 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: 1824965 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20211051678

Write-up: Headache; Nausea; Fever; Malaise; Sweating increased; Abdominal pain; Shivering; This spontaneous report received from a consumer via a Regulatory Authority (BE-FAMHP-DHH-N2021-107846) on 25-OCT-2021 and concerned a 46 year old male of unknown 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, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered on 13-OCT-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-OCT-2021, the patient experienced headache, nausea, fever, malaise, sweating increased, abdominal pain, shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, fever, malaise, sweating increased, abdominal pain and shivering was not reported. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: "Treatment - No Evolution of the ADR - ADR description - Wednesday evening vaccinated. During the night developed fever. Headache as well. Thursday to Friday night sweated a lot. Friday afternoon I felt better. Today Saturday around midday experienced abdominal pain until now"


VAERS ID: 1825886 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIPROFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Spice allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101380973

Write-up: felt like her heart was going to explode/ feeling of pressure around her heart; swelling on the left side of her chest/lung area; This is a spontaneous report from a contactable consumer (patient) received via the RA. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 13Oct2021 at 09:15 (Batch/Lot Number: FF2595) (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was pharmacy/drugstore. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Medical history included mint/menthol allergy. Concomitant medication included ciprofloxacin for an unspecified indication from 01Oct2021 to an unspecified stop date. The patient received Ciprofloxacin within 2 weeks of vaccination on 01Oct2021 at 500mg 1 tab b.i.d (twice a day) x 7 days. The patient previously took morphine and experienced allergy. On 13Oct2021 at 10:00, within 30 - 45 minutes after injection, the patient started to experience pressure and swelling on the left side of her chest/lung area. It radiated from the center of the body outward towards the left. It felt like her heart was going to explode. Within a couple hours, the side effect did subside, but it is now day 3 after the injection and the patient was still having some feeling of pressure around her heart. There was no treatment received. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1826403 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (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 Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101380626

Write-up: Vomiting; Abdominal pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110140121152790-1BGFJ.Safety Report Unique Identifier GB-MHRA-ADR 26077701. A 17-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF8288), via an unspecified route of administration on 13Oct2021 as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination: 17-year-old) for covid-19 immunisation. Medical history included suspected covid-19 from 15Aug2021 to 25Aug2021.The patient''s concomitant medications were not reported. On 13Oct2021, The patient experienced vomiting and abdominal pain. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Yes - Positive COVID-19 test. Still waiting for Emergency number callbacks. Patient was not enrolled in clinical trial. The outcome of the all reported events (vomiting and abdominal pain) was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826407 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response); Threadworms
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380647

Write-up: Swollen arm; Head pain; 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-202110140637467150-KTRJC, Safety Report Unique Identifier is GB-MHRA-ADR 26077734. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/ Lot Number: Not known) via an unspecified route of administration on 13Oct2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. Medical history included constipation, immunodeficiency, (has an illness or condition, not listed above, which reduces the immune response e.g. immunodeficiency) and threadworms. Concomitant medication was not reported. Patient was not enrolled in clinical trial. Unsure if patient had had symptoms associated with COVID-19. Not had a COVID-19 test. On 13Oct2021, patient experienced head pain. On 14Oct2021 (after 1 day of vaccination), patient experienced swollen arm. All events were reported as medically significant. The 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: 1826408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-09
Onset:2021-10-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380655

Write-up: heavy period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110140654204550-68K3P, Safety Report Unique Identifier GB-MHRA-ADR 26077736. A 42-year-old non pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Oct2021 as dose 3 (booster), 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 is not pregnant,Patient is not currently breastfeeding. The patient previously took thyroxine. The patient experienced heavy period (medically significant) on 13Oct2021. Unusual heavy period. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The 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: 1826412 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache, Hyperhidrosis, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (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 INC202101380627

Write-up: Muscle ache; Shivers; Headache; Sweating; Joint ache; Weakness; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110140808597220-M5IIF, Safety Report Unique Identifier GB-MHRA-ADR 26077816. A 62-year-old male patient received third/booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 12Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On 13Oct2021 the patient experienced muscle ache, shivers, headache, sweating, joint ache, weakness, tiredness. The onset of reactions was within 24 hours of having the booster vaccine. Headache was the first to subside, though it still hasn''t resolved yet, nearly 48 hours after the jab. The other reactions are still very evident. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The outcome of the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826416 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GG8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Feeling abnormal, Oxygen saturation, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular 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: Medical History/Concurrent Conditions: Blackout spell; Wheeze (as a child. Last affected a year or two ago.)
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:Fine; Test Name: Blood oxygen level; Result Unstructured Data: Test Result:could not be raised above about 92/93 %; Test Name: Blood oxygen level; Result Unstructured Data: Test Result:Fine %; Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101380835

Write-up: Shaky limbs; room swam when he stood up; Breathlessness; Dizziness; This is a spontaneous report from a contactable consumer (parent). This is a report received This is a spontaneous report from a contactable consumer (parent). This is a report received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110140910407080-2IIKJ. Safety Report Unique Identifier GB-MHRA-ADR 26078595. This consumer reported for a 14-years-old male patient (son) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, dose 1 via an unspecified route of administration on 11Oct2021 (Batch/Lot Number: GG8288) as dose 1, single for COVID-19 immunisation. Medical history included wheeze (last affected a year or two ago) and blackout spell. The patient''s concomitant medications were not reported. On an unknown date, the patient experienced shaky limbs, room swam when he stood up, on 13Oct2021, experienced breathlessness and dizziness. The patient underwent lab tests and procedures which included blood pressure measurement, which was fine, oxygen saturation was could not be raised above about 92/93%, oxygen saturation was fine and COVID-19 virus test was negative on 13Oct2021. The clinical course included Some wheezing spells in A&E to stabilise when inhaler did not work (nebuliser needed). Once had to stay overnight because blood oxygen level could not be raised above about 92/93%. Patient has not had symptoms associated with COVID-19. Sudden difficulty with breathing. The reporter son was sitting at the computer, no reason to have problems breathing. Used inhaler as had asthma when younger. Inhaler did not have much effect. Shaky limbs. Room swam when he stood up. Continued to find breathing difficult. Rang 111. Doctor called back after maybe 1.5 hours. Advised to go to A&E. Went, taken, BP and blood oxygen fine. Returned home, went to sleep. Breathlessness remains this morning but not as bad. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the events shaky limbs, room swam when he stood up was recovered and for other events it was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1826432 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Feeling cold, Headache, Hot flush, Nausea, Pain, Rhinorrhoea, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380753

Write-up: UTI; Nausea; Hot flushes; Coldness; Headache; Runny nose; Cough; Ache; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110141156041290-P1VGA, safety report unique identifier is GB-MHRA-ADR 26078830. A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 13Oct2021 (at the age of 19-years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced hot flushes on 13Oct2021, coldness on 13Oct2021, UTI on 14Oct2021, headache on 13Oct2021, runny nose on 13Oct2021, cough on 13Oct2021, ache on 13Oct2021, tiredness on 13Oct2021, nausea on 14Oct2021. The patient not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient was not pregnant. The patient was not currently breastfeeding. Patient is not enrolled in clinical trial. The events were reported eventually medically significant. The outcome of the events was recovering for Tiredness, Ache, Headache, and not recovered for Nausea, Cough, Runny nose, UTI, Coldness, Hot flushes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826491 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure, Tonic convulsion, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380680

Write-up: tonic clonic seizure; Tonic seizure; vomited; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110141343268080-1HJLO, Safety Report Unique Identifier GB-MHRA-ADR 26079053. A 54-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection), dose 3 via an unspecified route of administration on 12Oct2021 (Lot Number: FJ5782) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took valproate sodium (EPILIM) and topiramate for tonic clonic epilepsy. On an unknown date, the patient experienced tonic clonic seizure and on 13Oct2021, experienced tonic seizure and vomited. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding. The clinical case narrative included, the patient had vaccine on 12Oct2021, on 13Oct2021 vomited., suffered tonic clonic seizure in the night. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible blood clots or low platelet counts. The outcome of the events tonic clonic seizure, vomited was unknown and for the event tonic seizure it was resolved on 14Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826519 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211009; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380883

Write-up: Nauseous; Flu-like aching; Headache dull; Dizzy spells; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110141723346410-GGGUW, Safety Report Unique Identifier GB-MHRA-ADR 26079580. A 79-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ff8222), dose 3 via an unspecified route of administration on 13Oct2021 (at age of 79-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medications were not reported. On 13Oct2021, the patient experienced nauseous, flu-like aching, headache dull, dizzy spells. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative (no - negative covid-19 test) on 09Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1826527 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380892

Write-up: sudden heavy period bleed; Chest pain; Excessive menstruation; Vaginal bleeding; Heavy periods; Numerous clotted blood from heavy periods; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110141912340130-ZALJ5, Safety Report Unique Identifier GB-MHRA-ADR 26079767. A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8222), dose 3 via an unspecified route of administration on 13Oct2021 (at the age of 31 years) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient previously received historical vaccine which included dose 1 of BNT162b2 on an unspecified date in Nov2020 and dose 2 of BNT162b2 on an unspecified date in Jan2021 for covid-19 immunization. On 13Oct2021, the patient experienced sudden heavy period bleed, excessive menstruation, vaginal bleeding, heavy periods, menstrual disorder. Patient also experienced chest pain on 14Oct2021. Clinical course: Sudden heavy period bleed, occurring after receiving Pfizer Booster. Normal period recently finished 4 days ago and heavy period bleed restarting immediately after covid-19 Pfizer injection. Bleeding was heavy and with lots of clotted blood (numerous clotted blood from heavy periods). Relevant investigations or tests conducted: None. Events were considered serious (medically significant). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826539 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, Swelling, Vaccination site mass, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101380947

Write-up: arm started to ache 22 hours after vaccine; followed by 4cm hard lump on upper arm increasingly worse; Swelling; Off label use; booster; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110142217148980-PGFRP, Safety Report Unique Identifier GB-MHRA-ADR 26079889. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, age at the vaccination: 74-year-old) on 13Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included steroid therapy (taking regular steroid treatment (e.g. orally or rectally)). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient previously received first and second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced swelling on 14Oct2021. The patient experienced arm started to ache 22 hours after vaccine, followed by 4cm hard lump on upper arm increasingly worse on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of swelling was not recovered, arm started to ache 22 hours after vaccine was recovering. The clinical outcome of followed by 4cm hard lump on upper arm increasingly worse was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1826647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-10-13
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 antibody test; Test Result: Positive ; Comments: in Country; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: in Country
CDC Split Type: HKPFIZER INC202101441180

Write-up: CONFIRMED CASE OF COVID-19; CONFIRMED CASE OF COVID-19; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority; number: not applicable), based on information received by Pfizer from BioNtech SE (manufacturer control number HK-Fosun-2021FOS004252), license party for bnt162b2 (COMIRNATY). As of 0:00 am, 16-Oct-2021, DH announced that three additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 3 cases that confirmed COVID-19 after Comirnaty vaccination. A 48-year-old male patient started to receive two doses of bnt162b2 (COMIRNATY, Solution for injection), dose 1 unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 unspecified route of administration on 09Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history, concomitant medication(s) and past product were not reported. On 06-Aug-2021 in Country, the patient''s blood specimen tested positive for anti-spike protein antibody. His symptom onset was on 13-Oct-2021. On 14-Oct-2021, the patient arrived at Country from the Country by flight. On an unknown date, the patient tested positive. The patient was confirmed as COVID-19 with mutant strain of L452R(13-Oct-2021). The adverse event Confirmed case of COVID-19 was considered as Important Medical Event. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive on 06Aug2021 in Country, sars-cov-2 test positive on an unspecified date in Country. At the time of the report, the clinical outcome of the events was unknown. The primary reporter causality assessment for the between COMIRNATY and Confirmed case of COVID-19 was possible whereas, per company (BioNTech SE), it was possible. Initial report was received on 17-Oct-2021. This is one of three reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS004250 (master case), 2021FOS004251 and 2021FOS004252. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101441181 same reporter/drug/event, different patient;HK-PFIZER INC-202101441179 same reporter/drug/event, different patient


VAERS ID: 1826684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Endometriosis (TREATMENT FOR ENDOMETRIOSIS AND IBS); Irritable bowel syndrome (TREATMENT FOR ENDOMETRIOSIS AND IBS); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380913

Write-up: Diarrhea; Headache; Stomach pain; Myalgia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110141505358550-2NIKT. Safety Report Unique Identifier GB-MHRA-ADR 26079199. A 32-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Oct2021 (Batch/Lot Number: FJ5782) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included endometriosis and irritable bowel syndrome from an unknown date and unknown if ongoing, suspected covid-19 from an unknown date and unknown if ongoing, unsure when symptoms started and unsure when symptoms stopped. Patient received treatment for endometriosis and irritable bowel syndrome. Not had a COVID-19 test. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 06Oct2021 to an unspecified stop date. The patient experienced myalgia on 13Oct2021, diarrhea on 14Oct2021, headache and stomach pain on 13Oct2021. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826809 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Laryngeal discomfort, Vital signs measurement
SMQs:, Anaphylactic reaction (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; Fruit allergy; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: vital signs; Result Unstructured Data: Test Result:No abnormality
CDC Split Type: JPPFIZER INC202101376282

Write-up: Pharyngolaryngeal strange sensation of; dry cough; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21129356. A 44-year-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: FJ7489, Expiration date: 31Jan2022), via an unspecified route of administration on 13Oct2021 at 16:05 (the day of vaccination, at the age of 44-years) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history included severe allergic symptoms (such as anaphylaxis) from medications or foods: shellfish, mushroom, fruits and fish. The patient concomitant medications were not reported. On 13Oct2021 at 16:35 (30 minutes after the vaccination), the patient experienced Pharyngolaryngeal strange sensation of and dry cough. The course of the event was as follows: 30 minutes after the vaccination, symptoms above occurred. POLARAMINE 2mg orally taken and Solu-Medrol 125mg IV drip was given but no improvement. No abnormality with vital signs. From then, since the possibility of developing into laryngeal oedema could not be denied, the patient was transferred by ambulance. Pre vaccination Screening Questionnaire for COVID-19 vaccine: This was the first time for the patient to receive COVID-19 vaccine. It was the city, town, or village where the paint currently resided the same as the city, town, or village stated on the coupon. The patient had read the "Instructions for the COVID-19 vaccine" and understood the effects and adverse side effects. The patient fell into one of the target groups that have a higher priority for this vaccine (Worker at a senior citizen etc.). The patient did not currently suffer from any kind of illness and receiving treatment or medication. The patient did not have a fever or gotten sick in the last month. No part of the patient''s body that are not feeling well today. The patient did not ever have a convulsion. The patient had experience severe allergic symptoms (such as anaphylaxis) from medications or foods: shellfish, mushroom, fruits and fish. The patient did not ever be sick after receiving a vaccine. There is no possibility that the patient was currently pregnant (for example, the patient''s period is later than expected) Or breastfeeding. The patient did not have any vaccines within the last two weeks. The patient had questions about the vaccine today. In light of the results of the questions above and examination, today''s vaccine was possible. After receiving a medical examination and explanation from a doctor and understanding the effects and side effects of the vaccine, the patient wished to receive this vaccine. Vaccination date was 13Oct2021 and Inoculation amount was 0.3 ml. Therapeutic measures were taken as a result of event Pharyngolaryngeal strange sensation with POLARAMINE 2mg orally taken and Solu-Medrol 125mg IV drip was given. On 13Oct2021 (the day of the vaccination), the outcome of the events was not recovered. The reporting physician classified the event as serious (medically significant) and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases was not reported.


VAERS ID: 1826848 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, Dyspnoea, Feeling hot, Nasopharyngitis, Nocturnal dyspnoea
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101382892

Write-up: On 14Oct, at around 01:00, the patient presented with sudden sensation of dyspnoea during asleep; Dyspnoea; Cold symptoms; hoarseness; Feeling hot of body; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21129450. A 64-year and 2-month-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) age at vaccination of 64-years-old, as single dose,for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Oct2021 at 21:00 (6 days 21 hours after the vaccination), the patient experienced cold symptoms, hoarseness, feeling hot of body, dyspnea. The course of the event was as follows: On 13Oct2021, at around 21:00, the patient complained of common cold symptoms and hoarseness. Feeling hot of body was present. On 14Oct2021, at around 01:00, the patient presented with sudden sensation of dyspnea during asleep. The outcome of the events was not provided. The reporting physician classified the event as serious (Hospitalized from 14Oct2021) and assessed the causality between the event and the vaccines as Unassessable. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up


VAERS ID: 1826901 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Electrocardiogram, Laboratory test, Loss of consciousness, Malaise, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: Blood pressure systolic; Result Unstructured Data: 9.5 mmHg; Test Date: 20211013; Test Name: Lab test; Result Unstructured Data: normal; Test Date: 20211013; Test Name: ECG; Result Unstructured Data: without particularity
CDC Split Type: LUJNJFOC20211055104

Write-up: LOSS OF CONSCIOUSNESS; VAGAL REACTION; MALAISE; This spontaneous report received from a physician via a Regulatory authority (EVHUMAN Vaccines, LU-ALMPS-202103098) on 27-OCT-2021 and concerned a 30 year old female of unspecified race and ethnic origin. The patient''s weight was 55 kilograms, and height was 156 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 13-OCT-2021 for covid-19 immunisation. No concomitant medications were reported. On 13-OCT-2021, the patient experienced loss of consciousness, vagal reaction, malaise and was hospitalized (date unspecified). Laboratory data included: Blood pressure systolic (NR: not provided) 9.5 mmHg, ECG (NR: not provided) without particularity, and Lab test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, vagal reaction, and malaise. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1828079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Extensive swelling of vaccinated limb, Fatigue, Headache, Housebound, Myalgia, Neuralgia, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Extensive swelling of the arm; Neuralgia in all muscles; and weakness.; Extensive swelling of the arm with burning sensation. Very painful; Impossible to leave my house.; Extensive swelling of the arm with burning sensation. Very painful.; Muscle pain; Headache; Chills; Fatigue; Fever; Joint pain; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-107799) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), NEURALGIA (Neuralgia in all muscles), ASTHENIA (and weakness.), PERIPHERAL SWELLING (Extensive swelling of the arm with burning sensation. Very painful), HOUSEBOUND (Impossible to leave my house.), BURNING SENSATION (Extensive swelling of the arm with burning sensation. Very painful.), MYALGIA (Muscle pain), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. No Medical History information was reported. On 12-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm) (seriousness criterion disability), NEURALGIA (Neuralgia in all muscles) (seriousness criterion disability), ASTHENIA (and weakness.) (seriousness criterion disability), PERIPHERAL SWELLING (Extensive swelling of the arm with burning sensation. Very painful) (seriousness criterion disability), HOUSEBOUND (Impossible to leave my house.) (seriousness criterion disability), BURNING SENSATION (Extensive swelling of the arm with burning sensation. Very painful.) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), FATIGUE (Fatigue) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability) and ARTHRALGIA (Joint pain) (seriousness criterion disability). At the time of the report, EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), NEURALGIA (Neuralgia in all muscles), ASTHENIA (and weakness.), PERIPHERAL SWELLING (Extensive swelling of the arm with burning sensation. Very painful), HOUSEBOUND (Impossible to leave my house.), BURNING SENSATION (Extensive swelling of the arm with burning sensation. Very painful.), MYALGIA (Muscle pain), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) was resolving. No concomitant medications were reported No treatment medications were reported. Patient had a fever of 38.4 degree. Company Comment: This case concerns an elderly female with no relevant medical history reported, who experienced the serious unexpected events of Extensive swelling of vaccinated limb, Neuralgia, Asthenia, Peripheral swelling, Housebound, Burning sensation and serious unexpected per reported severity events of Myalgia, Headache, Chills, Fatigue, Pyrexia, Arthralgia. The events occurred 2 days after the unspecified dose of Spikevax administration. The rechallenge was not applicable since information on the other dose and doses sequence order was not provided. The events were assessed by the reporting RA as serious per disability criterion; however, there was no clinical evidence provided to justify long term incapacity and the outcome at the time of report was Recovering/Resolving. The medical history was not reported, however, the elderly patient''s age considered as a confounder. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 25-OCT-2021 included event verbatim and reporter''s comments.; Reporter''s Comments: Treatment - Non Evolution of the ADR - In the process of improving ADR description - Severe headaches Fever up to 38.4? Neuralgia in all muscles and weakness. Impossible to leave my house. Extensive swelling of the arm with burning sensation. Very painful Information on the temporal relationship (ADR) - It is not over. The signs are improving, but the arm worries me a lot. Sender''s Comments: This case concerns an elderly female with no relevant medical history reported, who experienced the serious unexpected events of Extensive swelling of vaccinated limb, Neuralgia, Asthenia, Peripheral swelling, Housebound, Burning sensation and serious unexpected per reported severity events of Myalgia, Headache, Chills, Fatigue, Pyrexia, Arthralgia. The events occurred 2 days after the unspecified dose of Spikevax administration. The rechallenge was not applicable since information on the other dose and doses sequence order was not provided. The events were assessed by the reporting RA as serious per disability criterion; however, there was no clinical evidence provided to justify long term incapacity and the outcome at the time of report was Recovering/Resolving. The medical history was not reported, however, the elderly patient''s age considered as a confounder. The benefit-risk relationship is not affected by this report.


VAERS ID: 1828160 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Oligodipsia, 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days; After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days; After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days; After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days; This case was received via the Regulatory Agency (Reference number: IT-MINISAL02-799842) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days), OLIGODIPSIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days), PYREXIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) and VOMITING (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. No Medical History information was reported. On 12-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 13-Oct-2021, the patient experienced DECREASED APPETITE (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) (seriousness criterion disability), OLIGODIPSIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) (seriousness criterion disability), PYREXIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) (seriousness criterion disability) and VOMITING (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) (seriousness criterion disability). At the time of the report, DECREASED APPETITE (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days), OLIGODIPSIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days), PYREXIA (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) and VOMITING (After 12 hours from the vaccination, upon awakening Ihad fever, loss of appetite, adipsia, vomiting that persisted for several days) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case concerns a 37-year-old female patient with no relevant medical history, who experienced the serious unexpected events of decreased appetite, oligodipsia, pyrexia and vomiting. The events occurred next day after the receiving the mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The re-challenge was not applicable as there is no clear information regarding the vaccine doses. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 25-Oct-21 include translated verbatim, Reporter''s comments.; Sender''s Comments: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the serious unexpected events of decreased appetite, oligodipsia, pyrexia and vomiting. The events occurred next day after the receiving the mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The re-challenge was not applicable as there is no clear information regarding the vaccine doses. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1828373 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Guillain-Barre syndrome, Headache
SMQs:, Peripheral neuropathy (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211056084

Write-up: NUMBNESS AND WEAKNESS; DIARRHEA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority: PH-PHFDA-300113593] concerned a 78 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 13-OCT-2021 at 12:30 hours, the patient experienced numbness and weakness (Guillain Barre syndrome), diarrhea and headache and was hospitalized (unspecified date and days). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness and weakness (Guillain Barre syndrome), diarrhea, and headache. This report was serious (Disability Or Permanent Damage and Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20211056084 - covid-19 vaccine ad26.cov2.s ? Numbness and weakness (Guillain-Barre Syndrome), Diarrhea, Headache This event(s) is labeled per regulatory authority and is therefore considered potentially related.


VAERS ID: 1829820 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
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: ESMODERNATX, INC.MOD20213

Write-up: Macroscopic hematuria; This case was received via regulatory authority (Reference number: ES-AEMPS-1028278) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of HAEMATURIA (Macroscopic hematuria) in a 56-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced HAEMATURIA (Macroscopic hematuria) (seriousness criterion medically significant). At the time of the report, HAEMATURIA (Macroscopic hematuria) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Very limited information regarding this event has been provided at this time.- Company Comment: This case concerns a 56 year old male patient with no relevant medical history,who experienced the serious unexpected event of Haematuria.The event occurred on the same day after third dose of Spikevax . The rechallenge was not applicable.The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 26-Oct-2021 included suspect drug dosage regimen information and event verbatim were translated.; Sender''s Comments: This case concerns a 56 year old male patient with no relevant medical history,who experienced the serious unexpected event of Haematuria.The event occurred on the same day after third dose of Spikevax . The rechallenge was not applicable.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1829951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (uncontrolled); Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: PCR Sars Cov2; Test Result: Positive
CDC Split Type: FRPFIZER INC202101437429

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NT20214822. A 78-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and intramuscular on 17Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included hypertension arterial and uncontrolled calcific aortic stenosis from an unknown date and unknown if ongoing. He is an independent patient living at home. The patient''s concomitant medications were not reported. On 13Oct2021, the patient experienced vaccination failure. It was reported that vaccination by complete vaccination scheme with COMIRNATY (D1+D2), last dose on 17Apr2021. Hospitalization for hypoxic lung disease with Covid-19. Contamination during a ball. PCR Sars Cov2 was positive on 13Oct2021. Resuscitation management included oxygen therapy, dexamethasone, tocilizumab. Patient has not recovered at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830044 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: GBPFIZER INC202101380719

Write-up: Flu-like aching; Headache; Painful arm; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202110141031347530-TA6OS. Safety Report Unique Identifier GB-MHRA-ADR 26078681. A 53-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FJ5782), via an unspecified route of administration on 13Oct2021 (at the age of 53-year-old) as dose 3 (booster), single for covid-19 immunization. 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. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced painful arm, nausea on 13Oct2021 and flu-like aching, headache on 14Oct2021. The case was assessed as serious (medically significant) by the health authority. The outcome of events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1830058 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392946

Write-up: Tiredness; Diarrhea; Stomachache; Injection site pain; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110150832251710-QXJL5. Safety Report Unique Identifier GB-MHRA-ADR 26080995. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) dose 1 via an unspecified route of administration (at the age of 14 years) on 13Oct2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 13Oct2021, the patient experienced diarrhea, stomachache, injection site pain and tiredness. The outcome of the event diarrhea was reported as recovering while the other events stomachache, injection site pain and tiredness recovered on 15Oct2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1830059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Dyspnoea, Eructation, Headache, Heart rate, Heart rate irregular, Interchange of vaccine products, Malaise, Nausea, Off label use, Palpitations, SARS-CoV-2 test, Toothache
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MACUSHIELD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Macular degeneration
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: pulse; Result Unstructured Data: Test Result:erratic and uncountable; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392979

Write-up: palpitations/heart racing; my pulse was erratic and uncountable; I lay down, feeling quite unwell; I could not take a deep breath; nauseous; toothache; burping; headache; Then I felt bloated; Patient received SARS-COV-2 VACCINE on 28Jan2021, COVID-19 VACCINE ASTRAZENECA on 31Mar2021 and COMIRNATYin 2021 as third dose; Patient received SARS-COV-2 VACCINE on 28Jan2021, COVID-19 VACCINE ASTRAZENECA on 31Mar2021 and COMIRNATYin 2021 as third dose; 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-202110150840467330-B0MWO, Safety Report Unique Identifier GB-MHRA-ADR 26081212. A 76-year-old female patient received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) at dose 3 (booster), single for COVID-19 immunisation. Medical history included macular degeneration. The patient stated that she was apparently healthy, on no mo (as reported) prescribed medication and has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 11Oct2021 and meso zeaxanthin, xantofyl, zeaxanthin (MACUSHIELD) taken for macular degeneration, start and stop date were not reported. Historical vaccine included COVID-19 VACCINE ASTRAZENECA on 31Mar2021 for COVID-19 vaccination and SARS-COV-2 VACCINE on 28Jan2021 for COVID-19 vaccination. Patient received SARS-COV-2 VACCINE on 28Jan2021, COVID-19 VACCINE ASTRAZENECA on 31Mar2021 and COMIRNATY in 2021 as third dose. The patient experienced palpitations/heart racing on 13Oct2021 at 14:30 and toothache, burping and headache on 13Oct2021. The events were reported as serious (medically significant). The clinical course was reported as follows: suddenly around 14:30, my heart was racing, my pulse was erratic and uncountable and my ribcage felt too small for contents. I was burping as if my oesophagus was being squeezed and I could not take a deep breath - normal breathing was ok. Then I felt bloated and nauseous and developed a headache. My lower jaw felt as though I had toothache. I lay down, feeling quite unwell, then very slowly the headache subsided a bit, I slept for an hour and woke up, around 19:00, feeling much better. I still felt bloated and nauseous but palpitations were much less. Yesterday, the 14th, I still felt a little bit ''off-colour'' but with no recordable symptoms. 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. The outcome of palpitations/heart racing was recovered on 13Oct2021, not recovered for the events of toothache, burping and headache and unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830081 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cold sweat, Headache, Interchange of vaccine products, Nausea, Off label use
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADIPINE MR; LETROZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392943

Write-up: Shivering; Headache; Nausea; Clammy; Off-label use; Interchange of vaccine products; 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-202110151045417080-YCDS8. Safety Report Unique Identifier GB-MHRA-ADR 26081688. A 79-years-old female patient had received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FJ5782) via an unspecified route of administration on 13Oct2021 as dose 3 (booster), single (at the age of 79-years-old) for COVID-19 immunisation. Medical history included suspected COVID-19 from 18Mar2020 to an unknown date Unsure when symptoms stopped, neoplasm Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). The patient previously took Palbociclib from August 2019 to March 2020. Concomitant medication included nifedipine (ADIPINE MR) taken for hypertension; influenza vaccine (INFLUENZA VIRUS) from 14Sep2021 to an unspecified stop date; letrozole (LETROZOLE) taken for breast cancer stage iv. Patient previously received first dose of COVID-19 VACCINE ASTRAZENECA on 01Feb2021 and also received second dose of COVID-19 VACCINE ASTRAZENECA on 09Apr2021 for COVID-19 immunisation. On 14Oct2021, the patient experienced shivering, headache, nausea and clammy. Patient was treated with paracetamol for the events. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Not had a COVID-19 test. The outcome of the events shivering, nausea was resolved on 14Oct2021; headache was resolved on 15Oct2021 and clammy event was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Illness, Nausea, SARS-CoV-2 test, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393193

Write-up: Sickness; Headache; Nausea; Projectile vomiting; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151211242870-FMK7B Safety Report Unique Identifier GB-MHRA-ADR 26081978. A 29-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), Dose 2 via an unspecified route of administration on 12Oct2021 (Lot number was not known) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected covid-19 from an unknown date and unknown if ongoing (Unsure when symptoms started, Unsure when symptoms stopped). Patient was not pregnant at the time of vaccination; patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced sickness, nausea, headache, Projectile vomiting on 13Oct2021. It was reported that nausea started the day after her second dose of the Pfizer vaccine. Projectile vomiting started a few hours later, lasting through to the next day. Terrible headache throughout also. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). The clinical outcome of events sickness and nausea was recovering, headache was not recovered, and projectile vomiting was recovered on an unknown date in Oct2021. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830112 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Musculoskeletal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101393107

Write-up: Numbness in shoulder; Shoulder blade pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110151447545260-1ZRSH, Safety Report Unique Identifier GB-MHRA-ADR 26082636. A 16-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8288) via an unspecified route of administration on 13Oct2021 as dose 1 (at the age of 16 years old), single for COVID-19 immunisation. Medical history included suspected covid-19 (Unsure when symptoms started, unsure when symptoms stopped), COVID-19. Concomitant medications were not reported. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 13Oct2021, the patient experienced numbness in shoulder and shoulder blade pain. The events were assessed as medically significant. It was reported that patient left shoulder blade (in the arm which was injected) has felt numb and causes pain when using since having the injection. Her shoulder now clicks and is painful on rotation. Patient have not had any shoulder issues before. She believed that this is because the injection was too high in her arm as it seemed to be almost on her shoulder and the impacts were almost immediate. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Yes - Positive COVID-19 test) on 18Aug2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830125 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101393026

Write-up: Painful arm; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151638574790-ZVBMG, safety report unique identifier is GB-MHRA-ADR 26082842. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF8288), via an unspecified route of administration on 13Oct2021 (at the age of 12 years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. 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 experienced painful arm on 13Oct2021. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative (No-Negative COVID-19 test) on an unspecified date. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-13
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (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: 20211014; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392996

Write-up: Burning sensation; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151644078590-EHLAG. Safety Report Unique Identifier is GB-MHRA-ADR 26082848. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Patient has not had symptoms associated with COVID-19. On 13Oct2021, the patient experienced burning sensation. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 14Oct2021 No - Negative COVID-19 test. The clinical outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1830134 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache, Lymphadenopathy, Malaise, Muscle spasms, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Splenic marginal zone lymphoma
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393096

Write-up: Headache; Chills; Tiredness; Diarrhoea; Fever; Nausea; Vomiting; Enlarged lymph nodes (excl infective); Feeling unwell; Coughing; Fatigue; Foot cramps; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the regulatory authority report number GB-MHRA-WEBCOVID-202110151800565150-RFZLS, Safety Report Unique Identifier GB-MHRA-ADR 26083044. A 54-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Oct2021 (at the age of 54-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history included splenic marginal zone lymphoma. The patient concomitant medications were not reported. 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. On 13Oct2021, the patient experienced headache, chills, tiredness, diarrhoea, fever, nausea, vomiting, enlarged lymph nodes (excl infective), feeling unwell, coughing, fatigue, foot cramps. The events were reported as medically significant and disability. Adverse reactions did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date No - Negative COVID-19 test. Outcome of headache, tiredness, nausea, enlarged lymph nodes (excl infective), feeling unwell, coughing, fatigue was not recovered. Outcome of chills, fever, vomiting was recovering, Outcome of diarrhoea, foot cramps was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-02
Onset:2021-10-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dysmenorrhoea, Heavy menstrual bleeding, Hypomenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101393214

Write-up: This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110151910073610-RWIMV, Safety Report Unique Identifier GB-MHRA-ADR 26083322. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Formulation: Solution for injection, Lot Number: FF8222), via an unspecified route of administration on 02Oct2021 as dose 1, single for COVID-19 immunization. The medical history included suspected covid-19 from 11Oct2021 and ongoing. The patient concomitant medications were not reported. The patient experienced sars-cov-2 infection on 13Oct2021, painful periods on an unspecified date, light periods on an unspecified date, prolonged periods on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 13Oct2021 (Yes - Positive COVID-19 test). The patient was not enrolled in clinical trial. The events was reported eventually medically significant. The outcome of the events was recovered for Light periods on an unspecified date, recovering for Prolonged periods, Painful periods, SARS-CoV-2 infection. No follow-up attempts are needed. No further information is expected.


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