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

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



Case Details (Reverse Sorted by Onset Date)

This is page 252 out of 8,010

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VAERS ID: 1764323 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 - / 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: vaccine administered 11 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. This case was linked to MOD-2021-332745. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information received contain No new information (NNI).


VAERS ID: 1764947 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Denies
Current Illness: Denies
Preexisting Conditions: Denies
Allergies: Denies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client received covid vaccine @ 2:15pm in left arm, complained of tingling in same arm down to elbow @ 2:20 pm. Client denies any shortness of breath, tightening of throat, chest pain. Denies itching, no swelling or redness noted at site. Client denies any medical conditions, not taking medication, denies allergies. Vital signs assessed, all within normal limits. Client advised to continue with observation. At 2:42 pm, client reports tingling has resovled, states she needs to leave at this time. Client advised to complete observation, also educated to follow up with primary care and ER precautions given. Vital signs stable, client leaves with steady gait @ 2:45 pm.


VAERS ID: 1764991 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-01
Onset:2021-09-07
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Brain natriuretic peptide normal, Chest X-ray normal, Cough, Electrocardiogram, Fibrin D dimer normal, Full blood count normal, Metabolic function test, Rhinorrhoea, SARS-CoV-2 test negative, Troponin normal, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Eliquis 5mg 2/day Ezetimbe 10mg 1/day Atorvastatin 40mg 1/day Losartan 50mg 1/day Metoprolo Succ 50mg 1/day Aspirin 81mg 1/day
Current Illness:
Preexisting Conditions: chronic heart disease
Allergies: sulfa
Diagnostic Lab Data: 9/7/2021: XR Chest 2 views: No acute cardiopulmonary pathology COVID-19 test: negative Troponin: negative BMP: normal BNP: normal CBC: normal other than elevated WBC (10.1) D-Dimer: 165 (reference range: 100-600) EKG: unremarkable
CDC Split Type:

Write-up: Covid-like symptoms - deep cough, runny nose. Treatment: none Diagnosis: Cough Outcome: treat symptoms


VAERS ID: 1765231 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-20
Onset:2021-09-07
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN620721 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: COVID 19


VAERS ID: 1765240 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-20
Onset:2021-09-07
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207721 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: COVID 19


VAERS ID: 1765552 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-05
Onset:2021-09-07
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, COVID-19, Computerised tomogram thorax abnormal, Coronary artery dissection, Cough, Fatigue, Feeling abnormal, Headache, Hypertension, Magnetic resonance imaging, Malaise, Nasopharyngitis, SARS-CoV-2 test positive, Sinus congestion, Sinus headache, Ultrasound scan, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Other ischaemic heart disease (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril; Atorvastatin; Fish Oil; Testosterone Gel; Cetirizine; Multivitamin; Glucosamine; Other Herbs; B2; Artichoke Extracts; COQ10; B3
Current Illness: None.
Preexisting Conditions: High Blood Pressure; High Cholesterol
Allergies: None.
Diagnostic Lab Data: CT Scan, MRI, 2-3 different ultrasounds.
CDC Split Type: vsafe

Write-up: My COVID symptoms started the evening of the 09/07/2021 and I started feeling kind of wonky and I scheduled my appointment at the urgent care that evening for the next morning. On 09/08/2021 I had tested positive for COVID, and it was the worst head cold I''ve ever had as well as Sinus headache and congestion. That passed after 2-3 days and then I had a lot of coughing and tiredness for the next 4-5 days. Then on 09/27/2021 I went to the ER with a headache and high blood pressure and visual changes. They performed a CT scan and discovered that I developed a dissection of carotid artery. One of things that is a potential cause is coughing, and I did have a lot of coughing after covid. My blood pressure remained high and we are still working on that. I did spend two nights in the hospital to rule out stroke and blood clots and there was no evidence of that. Other than that I am still working with hospital and neurology to get my meds in order, and I am on blood thinners to prevent clots and to manage risk factors. I was prescribed albuterol for cough and Flovent (steroid inhaler).


VAERS ID: 1765644 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-24
Onset:2021-09-07
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Vaccine positive rechallenge, X-ray of pelvis and hip
SMQs:, Arthritis (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: Painful joints, Feb 11, Pfizer, 71
Other Medications: Blood pressure Cholesterol 81 Asprin
Current Illness:
Preexisting Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Xrays with Cortisone shot in hiop
CDC Split Type:

Write-up: Extremely painful joints below the waist.


VAERS ID: 1767353 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101171538

Write-up: Rash; On my arm it itch really bad; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3182 and expiry date was not reported), via an unspecified route of administration, in Arm, on 07Sep2021, as unknown, a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient stated, on 07Sep2021, the patient got the Pfizer vaccination today and was getting a rash on arm where the patient''s got the vaccination and it was been really bad. The patient experienced on my arm it itches really bad. There was some background voice heard over the call and later consumer hung up abruptly hence further probing could not be done. Thus, limited information available on the call. Outcome of the events was unknown.


VAERS ID: 1767496 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Extra dose administered, Gait disturbance, Insomnia, Movement disorder, Musculoskeletal pain, Off label use, Pain in extremity, Sciatica
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), 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: CELEBREX; XELJANZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: RA (I am immunocompromised as I have Rheum Arthritis); Sulfonamide allergy (Sulfa based medicines)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101253614

Write-up: I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I started to feel lower back pain(on left side); I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 3 intramuscular, administered in Arm Left on 07Sep2021 10:00 (Batch/Lot Number: FD8448) as DOSE 3, SINGLE for covid-19 immunization (Age at vaccination: 48 years). The patient medical history included Rheumatoid arthritis from an unknown date and unknown if ongoing I am immunocompromised as I have Rheum Arthritis and Sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included celecoxib (CELEBREX, 200mg/Daily) taken for an unspecified indication, start and stop date were not reported; tofacitinib citrate (XELJANZ, 11mg/day) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient reported 1 week after receiving the 3rd dose he started to feel lower back pain (on left side) on 14Sep2021, 10 days after the booster I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg. I cannot walk, move or sleep without pain on 17Sep2021.The event ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received a treatment with Physical therapy and an anti-inflammatory prescription. The event outcome was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1768046 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 1 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Haemorrhage subcutaneous, Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash spreading from injection site down arm, chest and stomach. Where rash was present popped blood vessels appeared along the entire abdomen


VAERS ID: 1768538 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-09-01
Onset:2021-09-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Vaccination site discomfort, Vaccination site rash
SMQs:, 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: zyrtec, vitamin c, vitamin d, femquil
Current Illness: none
Preexisting Conditions: none
Allergies: penicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: I woke up with a swollen lymph node in the L side of my neck. I also had a red flat rash at the site of my vaccination. The rash lasted 3 days, started out diffuse and flat at the site, then made a circle, then progressed to a ring, then half a ring, then was gone. It itched if my clothing touched it, but no other time.


VAERS ID: 1768587 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1768596 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1768712 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure decreased, Hyperhidrosis, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Ten minutes after injection, patient began vomitng, diaphoretic and then nauseated, sounds amplified, and stated she felt like she could pass out. Patient reports she does experience these symptoms often with injections and blood draws. B/P was 86/52, pulse 79, spo2 99%. After a few minutes, reported feeling better. Vitals at that time 12:56 102/70 pulse 82 SPO2 98%. Feeling back to normal after another 10 minutes; B/P 104/70 Pulse 70 and SPO2 98%. Patient returned to base-line and left the facility at the conclusion of the 30 minute observation period.


VAERS ID: 1768920 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Diarrhoea, Eye pain, Headache, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (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: B 12, multivitamin, zinc calcium
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had severe pain after the shot around my left eye and temple area and diarrhea, more recently I have a pain around the back of my left leg, right above the knee area. And the front of my left leg looks and feels bruised as it I was struck by something


VAERS ID: 1768952 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-20
Onset:2021-09-07
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute fatty liver of pregnancy, Alanine aminotransferase increased, Alpha-1 anti-trypsin, Amylase decreased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatinine increased, Blood culture, Blood fibrinogen decreased, Blood glucose, Blood glucose normal, Blood magnesium increased, Blood pressure abnormal, Columbia suicide severity rating scale, Delivery, Exposure during pregnancy, HELLP syndrome, Haemoglobin normal, Haemostasis, Hepatic steatosis, International normalised ratio increased, Labour induction, Leukocytosis, Lipase normal, Liver function test increased, Mineral supplementation, Ocular icterus, Pathology test, Perinatal depression, Perineal injury, Perineal operation, Platelet count decreased, Postpartum haemorrhage, Primigravida, Transfusion, Ultrasound abdomen abnormal, Uterine atony, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Pregnancy-related hepatic disorders (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Accidents and injuries (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (narrow), Conjunctival disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Recipients: None Discharge: Summary: Admission Date: .07-Sep-2021 16:20:00 Discharge Date: 11-Sep-2021 Admission Reason: Acute fatty liver of pregnancy Final Discharge Diagnoses: Acute fatty liver of pregnancy Procedures: Date: 08-Sep-2021 05:22:00 Procedure Name: 1. Exam under anesthesia 2. JADA placement 3. Second degree perineal laceration repair Condition at Discharge: Satisfactory Disposition at Discharge: .Home Vital Signs: T P R BP SpO2 Value 36.4 72 18 127/74 99% Date/Time 9/11 9:14 9/11 9:14 9/11 9:14 9/11 9:14 9/11 9:14 Range (36.4C - 37C ) (62 - 72 ) (16 - 18 ) (116 - 127 )/ (74 - 78 ) (96% - 99% ) Highest temp of 37 C was recorded at 9/11 4:34 Hospital Course: DOA: 9/7 DOD: 9/8 NSVD c/b PPH 2/2 LUS atony, hemabate, cytotec, second pit bolus, FFP x1, Mg paused, JADA with 140cc of fluid, total EBL 800cc Preop Hgb 14.8 -- $g EBL 800cc -- $g 2hr post-op hgb 13.2 -- $g 14.1 -- $g 13.8 -- $g 13.0 28 y/o G1P1 now PPD#3 (9/11) s/p NSVD @ 38.5ga by 13 week US who initially presented for scleral icterus and was kept for induction due to concern for acute fatty liver or pregnancy. She denied HA, scotoma, CP, SOB, RUQ pain, ctx, LOF, VB, or decreased FM. Her pregnancy overall had been uncomplicated. On arrival, she had one severe range BP that resolved spontaneously. However she continued to have mild ranges and then was also noted to have abnormal HELLP labs (primarily elevated LFTs, Cr, t bili, and low fibrinogen). As a result, the concern was for severe PEC vs AFLP. She received 24 hrs of magnesium for the concern for severe preeclampsia. However, the clinical picture seemed more consistent with acute fatty liver of pregnancy. Hepatology was consulted and requested multiple hepatology labs. At time of delivery, patient did have uterine atony that required hemabate, cytotec, pit bolus x2, and placement of a JADA. After removal of the JADA, patient''s bleeding was stable. Total EBL was 800ccc. She also received 2U of FFP due to her fibrinogen being 158 on admission. Meanwhile, the patient''s blood work started to improve throughout her postpartum period (see trends below). She was deemed stable for discharge on PPD#3. Prior to discharge, hepatology requested an alpha-1-antitrypsin phenotype test which will be followed up with PCP. A PCP appointment was requested in 1-2 weeks. Patient will always have a BP check in 1 week with OB. She was discharged home with a BP cuff. ________________________________________________________________________________ ________ sPEC vs AFLP -Severe range BP x1 on admission, now normotensive to mild range (including mild range BPs $g 4hr apart) -P:C 0.94 -To trend labs q4hr -To trend labs q4hr -Hgb 14.8 -- $g EBL 800cc -- $g 2hr post-op hgb 13.2 -- $g 14.1 -- $g 13.8 -$g 13.0 -$g 15.1 -- $g 12.1 (9/10) -Plt 211 -$g 205 -$g 175 -$g 135 -$g 141 -$g 161 -$g 151 -$g 181 -- $g 139 (9/10) -Cr 2.77 -- $g 2.92 -$g 2.88 -$g 3.0 -$g 3.02 -$g 3.04 -$g 2.83 -$g 2.79 -- $g 2.01 (9/10) -ALT/AST 351/261 -- $g 320/241 -$g 273/196 -$g 195/156 -$g 166/149 -$g 137/131 -$g 132/131 -- $g 63/63 -Tbili 5.4 -$g 5.4 -$g 4.8 -$g 4.1 -$g 4.8 -$g 4.9 -$g 4.5 -$g 5.1 -- $g 3.1 (9/10) -INR 1.2 -- $g 1.1 -$g 1.1 -$g 1.1 -Fibrinogen 158 -- $g FFP x1 -- $g 169 -- $g FFP x1 -- $g 156 -- $g 162 -$g 167 -Amylase: 18, Lipase: 52 9/10 -s/p 4g Mg bolus, Mg level 4.39 -- $g Mg @ 1g/hr -$g Mg 4.47 -$g 4.55 -$g 5.27 -$g 6.41; finished Mg 1 g/hr at 0300 on 9/9 -RUQ US with hepatic steatosis, limited by habitus Leukocytosis - WBC 14 on admission -$g$g$g 27 -- $g 28 -- $g 26 -$g 24 - Will draw blood cx per hep rec Blood glucose - Glucose 50s -- $g amp D50 x2 -- $g D5NS @ 75cc/hr with q1hr POCTs -- $g improving 90-100s - Switch to fasting and 1 hr PP BG check Labor Course 1830 2.5/70/-2, for pit 2100 3.5/70/-2, AROM for clear 0200 9/90/+1 Discharge Information: and Continuing Care: Lab Results - Pending: Culture, Blood Drawn at 09-Sep-2021 14:36:00 Culture, Blood Drawn at 09-Sep-2021 14:34:00 Surgical Pathology Drawn at 08-Sep-2021 04:02:00 Alpha-1-Antitrypsin Phenotype, Serum Drawn at 07-Sep-2021 21:30:00 Radiology Results - Pending: None Columbia Suicide Risk: negative Discharge Instructions: Activity: Return to normal activity as tolerated Nutrition/Diet: Regular Additional Orders: Additional Instructions: pacifier use is best avoided during the initiation of breastfeeding and used only after breastfeeding is well established. In some infants, early pacifier use may interfere with establishment of good breastfeeding practices, whereas in others it may indicate the presence of a breastfeeding problem that requires intervention. Use of a pacifier may cause problems with latching, and lead to decreased milk supply by missing feeding opportunities. Pacifiers may be used during painful procedures, but are not otherwise recommended while the infant is learning to breastfeed.? Follow Up Appointments: Follow-Up - OB Provider: Physician/Dept/Service: OB Provider Call to Schedule in: 1 week Follow-Up Appointment 01: Physician/Dept/Service: Primary Care Reason for Referral: Acute fatty liver of pregnancy follow up Call to Schedule in: 1 week Discharge Medications: Home Medication Pepcid 20 mg oral tablet - 1 tab(s) orally 2 times a day ibuprofen 600 mg oral tablet - 1 tab(s) orally every 6 hours Tylenol Extra Strength 500 mg oral tablet - 2 tab(s) orally every 6 hours MiraLax oral powder for reconstitution - 17 gram(s) orally once a day PRN Medication Attestation: Note Completion: I am a: Resident/Fellow Attending Attestation I saw and evaluated the patient. I personally obtained the key and critical portions of the history and physical exam or was physically present for key and critical portions performed by the resident/fellow. I reviewed the resident/fellow?s documentation and discussed the patient with the resident/fellow. I agree with the resident/fellow?s medical decision making as documented in the note. I personally evaluated the patient on 11-Sep-2021 Electronic Signatures: Authored: Send Summary, Summary Content, Ongoing Care, Note Completion Authored: Ongoing Care, Note Completion Co-Signer: Summary Content, Ongoing Care, Note Completion


VAERS ID: 1769043 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl liquid
Current Illness:
Preexisting Conditions:
Allergies: Egg
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt throat started to swell after few hours along with trouble breathing. Pt too liquid benadryl and it went away after a few hours.


VAERS ID: 1770544 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-03-21
Onset:2021-09-07
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy, Drug eruption, Rash
SMQs:, Severe cutaneous adverse reactions (broad), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE; AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE
Current Illness: Autoimmune disorder (Lupus Diagnosed in August); Autoimmune disorder; Hypertension; Thyroid disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Biopsy; Result Unstructured Data: rash is due to drug eruption.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Drug Eruption / rash all over; Broke out in rash/rash is now all over the body; This spontaneous case was reported by a consumer and describes the occurrence of DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A, 031B21A and 003B21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder (Lupus Diagnosed in August), Hypertension, Thyroid disorder and Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for Autoimmune disorder NOS, AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder, ATORVASTATIN for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DRUG ERUPTION (Drug Eruption / rash all over) (seriousness criterion hospitalization) and RASH (Broke out in rash/rash is now all over the body) (seriousness criterion hospitalization). The patient was hospitalized from 20-Sep-2021 to 23-Sep-2021 due to DRUG ERUPTION and RASH. The patient was treated with PREDNISONE on 13-Sep-2021 for Adverse event, at a dose of 40 mg and PREDNISONE on 21-Sep-2021 for Adverse event, at a dose of Increased to 80 mg. At the time of the report, DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) rash is due to drug eruption.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported was taken off of amlodipine 2 days ago, patient also stated did not have problems prior to getting the third dose. it described it as drugs being the cause of the rash. patient took generic prednisone as injection and pill form. patient started generic prednisone on 13Sep2021 at 40mg then on 21Sep2021 was increased to 80mg. patient was been on it for 2 weeks. It clears then comes back. patient was concerned and cannot figure out what caused the rash. regular Rheumatologist Reporter3 believes it was due to the medication for Lupus but the Rheumatologist at the hospital Reporter2 thinks it is due to the Moderna vaccine. This case was linked to MOD-2021-339345 (Patient Link).; Sender''s Comments: This case concerns a 60 year old female with relevant medical history of autoimmune disease (Lupus) , who experienced the unexpected events of rash and drug eruption . These events occurred 6 days after vacciniaton with the 3rd dose of mRNA 1273(Moderna) . The rechallenge for this case is not applicable. The medical condtion of autoimmune disease, Lupus (since this disease can also present with rashes and predisposition to drug reactions) and medication of Hydroxychloroquine ( recently taken patient just recently diagnosed with lupus noted incidence of rashes can be experienced with the intake of this medicaiton) Amlodipine ( can also cause rashes but very rare incidence) are confounders for this case. The benefit-risk relationship of mRNA-1273(Moderna) is not affected by this report.


VAERS ID: 1772030 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-01
Onset:2021-09-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Chills, Dizziness, Extrasystoles, Fatigue, Feeling cold, Palpitations, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

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

Write-up: Fever, chills, irregular heart beat, with heart bounding hard and sensation of skipping beats and fluttering. This continued throughout the next day or so and slowly subsided. Pain in chest, feeing like some heavy weighted object on my chest, dizziness and fatigue. Frightening symptoms, it seemed my heartbeat was out of control. My oxygen meter showing lower than normal rating. Extremely exhausted and fell asleep not long after symptoms started and sleep for hours. I was wrapped in blankets wearing layers of clothes felt freezing cold.


VAERS ID: 1773654 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-20
Onset:2021-09-07
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Back pain, Chest pain, Dyspnoea, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: Covid-19 Rapid; Test Result: Negative ; Test Date: 20210903; Test Name: Covid-19 Rapid; Test Result: Positive
CDC Split Type: USPFIZER INC202101332000

Write-up: abdominal pain; nausea; bloating; back pain; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer. This is the second of two report referred to same patient and second dose only. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm on 20Jan2021 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.Vaccine facility type: Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included on 29Dec2020 dose 1 anatomical site of injection: arm deltoid, intramuscular Batch/Lot number: EL1284. On 07Sep2021 patient experienced back pain on with outcome of recovering, chest pain with outcome of recovering, shortness of breath on with outcome of recovering. In addition on an unspecified date abdominal pain on with outcome of recovering, nausea with outcome of recovering, bloating with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 and sars-cov-2 test: positive on 03Sep2021.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101168685 Same reporter/ patient/ product, different dose/AEs.


VAERS ID: 1775337 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Psychotic disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: 9/7/2021
Other Medications: On 9/7/21, the patient had 6 hours of psychosis, unaware of surroundings, unable to function in environment while working, unable to initiate activity, while sitting in a chair that resolved 9/7/21. When the 2nd dose was taken 10/07/21, p
Current Illness: Unknown
Preexisting Conditions: Heart valve problem
Allergies: Unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: My brother has continued episodes is psychodis


VAERS ID: 1775371 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-08-10
Onset:2021-09-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Deep vein thrombosis, Hypoxia, Pneumonia, Sepsis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prostate Cancer with metastasis to lungs and bones
Preexisting Conditions: DM
Allergies: Hydrocodone
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09/09/2021 hospitalized with DX Covid19, Pneumonia r/t corona virus disease 2019, Acute respiratory failure with hypoxia, hypoxemia, LLE DVT 09/24/2021 rehospitalized with hypoxia, pneumonia, sepsis


VAERS ID: 1775709 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A. Never been on birth control, no IUD.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Cephalexin
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Last menstrual period 8/22/2021. It is now October 10th, day 49 of my cycle. My cycles usually last 29-33 days. I am not and have never been pregnant.


VAERS ID: 1777308 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Feeling abnormal, Impaired driving ability, Mobility decreased
SMQs:, Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: Lisinopril 40mg Glimepiride 4mg Lipitor 20mg
Current Illness: None
Preexisting Conditions: Diabetes High BP
Allergies: Nka
Diagnostic Lab Data: None
CDC Split Type:

Write-up: That day the pt started experiencing and has since, brain scramble/fog. Having trouble driving, can only stay in the lane while staring at the lines. Zero engery. Lays in bed everyday. Having hard time sitting up.


VAERS ID: 1779603 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-07
Onset:2021-09-07
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Pain, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sinus disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: Systolic heart failure; asthma
Allergies: penicillin
Diagnostic Lab Data: COVID test - positive for COVID. - the first one was 8/26. Had another positive test result on 9/7. At Medical for COVID testing. Had a COVID test last MOnday with negative results.
CDC Split Type: vsafe

Write-up: I had vomiting; diarrhea and body aches. I had those symptoms for about 8 hours. I was taking Tylenol. The following day, I had what seemed to be like a sinus infection. That lasted for about a week. Was prescribed Prednisone and something else.


VAERS ID: 1782323 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthma, Condition aggravated, Dyspnoea, Inhalation therapy, Pruritus
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ProAir hfa, qvar 40
Current Illness: none
Preexisting Conditions: asthma
Allergies: iodine contrast
Diagnostic Lab Data: none
CDC Split Type:

Write-up: SOB and total body itching. flared up asthma needed inhalers and steroids


VAERS ID: 1782529 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-09
Onset:2021-09-07
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782767 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-15
Onset:2021-09-07
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B212A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045B21A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782866 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-08-28
Onset:2021-09-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Balance disorder, Brain stem thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Diplopia, Dizziness, Dysarthria, Echocardiogram, Magnetic resonance imaging head normal, Nausea, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atorvastatin 10mg Escitalopram 20mg Euthyrox 25mg Multivitamin 1 tablet Calcium w/ vitamin D 1 table
Current Illness: None
Preexisting Conditions: High cholesterol, maintained by medication
Allergies: Latex
Diagnostic Lab Data: Sept 7 CAT scan, found blood clot. Sept 8 MRI, no signs of additional clots. Sept 9 or 10 ultra sound of heart, heart and surrounding area looks good.
CDC Split Type:

Write-up: On the afternoon of Tuesday, Sept 7, 2021, 10 days after my second dose of the COVID vaccine, I started feeling dizzy, nausea, slurred speech, was taken to ER by ambulance, cat scan was done and a blood clot was found at the base of the brain stem. Was given tPA and admitted into the hospital. I was diagnosed as having a stroke. I was in the hospital for 2 weeks, for observation and therapy. I was discharged on Sept 21 and currently continuing outpatient, physical and occupational therapy. The stroke effected my balance and have double vision.


VAERS ID: 1782871 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-09
Onset:2021-09-07
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre natal vitamin, 250 mg magnesium and 100 mg CoQ10
Current Illness: none. Relating to Item 8: I was 8 weeks pregnant when I had a miscarriage on September 7.
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was 8 weeks pregnant when I had a miscarriage on September 7th. Estimated due date was April 22. This was my second pregnancy. 1st pregnancy had no complications during pregnancy and birth, had a healthy baby boy on July 23, 2020.


VAERS ID: 1782961 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-01
Onset:2021-09-07
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782963 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-03
Onset:2021-09-07
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ686 / UNK - / -
EBZR: EBOLA ZAIRE (ERVEBO) / MERCK & CO. INC. EL3302 / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1783158 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-04-01
Onset:2021-09-07
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID hospitalization after full vaccination.


VAERS ID: 1784818 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-15
Onset:2021-09-07
   Days after vaccination:235
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 2 UN / IM

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

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

Write-up: 74-year-old female patient with past medical history of COPD, chronic kidney disease, hypertension, hyperlipidemia comes to the hospital with complaint of subjective fever and shaking chills for a week. The patient never took temperature at home. Today the patient''s condition got worsen she vomited x2 therefore came to ER. The patient denies shortness of breath, cough, chest pain, back pain, urinary symptoms, diarrhea and constipation.


VAERS ID: 1785303 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-11
Onset:2021-09-07
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 - / -

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Pneumonia
SMQs:, Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes, Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PUI was hospitalized 9/8/21-9/11/21. Diagnosed with pneumonia. She is still very weak. Fully vaccinated


VAERS ID: 1785606 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-17
Onset:2021-09-07
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Hypophagia, Nausea, Pneumonia, Poverty of speech, Sinusitis, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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

Write-up: She''s in the hospital and can''t talk much, she has pneumonia and breathing issues. They are not sure how the virus was contracted. PUI had no appetitie and didn''t eat for 3 days. They thought at first that she had sinus infection. PUI is on steroids and antibiotics. She was nauseated but never vomited. She had a heart attack years ago and has had bladder cancer.


VAERS ID: 1693345 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / N/A LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test normal, Burning sensation, Chest X-ray normal, Chest pain, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram normal, Feeling abnormal, Gastrointestinal disorder, Head discomfort, Limb discomfort, Panic disorder, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Hat fever
Diagnostic Lab Data: 08/09/2021 - visit to the ER Medical tests performed - heart ultrasound, ECG, blood test, heart Xray. Tests results did not show anything concerning or out of the ordinary
CDC Split Type:

Write-up: Chest pain and burning sensation, shortness of breath, brain fog, head pressure, dizziness, limbs pressure and pain, stomach gargling, tachicardia, night panic


VAERS ID: 1695141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210919198

Write-up: OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 5 decade old male of unspecified 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, intramuscular, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total administered on deltoid, 06-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced other events. The patient was hospitalized (date and days unspecified) and was underwent inpatient treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of other events was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210919198-COVID-19 VACCINE AD26.COV2.S.- Other events. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1696100 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain upper, Burning sensation, Fatigue, Feeling abnormal, Headache, Malaise, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (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: Had reaction to influenza shot 15 years ago, got really sick with flu like symptoms and have never had since in case. Has react
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin, latex
Diagnostic Lab Data: Did not go to doctor as I was told it is normal to feel sick after the first shot .
CDC Split Type:

Write-up: Same day- has the sore arm almost Immediately and then progressed that night, but was just very sore . Next day woke up and felt like I was hungover- body was sore and I felt sick all day and has bad headache on left side . By 2 pm felt like my body was burning up, lasted a couple of hours , and it came back for the next 6 days - the headaches abs the burning feeling.Woke up every day feeling tired, not well and the headache lasted about 3-4 days. The burning feeling stopped yesterday but then I got bad stomach pains in left side under ribs on and off all day. Woke up today, felt better than I have all week and only had the stomach pain a couple times today . Unsure if that is related or a coincidence, will be monitoring that.


VAERS ID: 1697911 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Pain in extremity, Tinnitus
SMQs:, Hearing impairment (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: DEPFIZER INC202101175198

Write-up: Day 1 after vaccination of severe tinnitus; Hearing loss Left ear; Severe pain in the vaccine arm; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: 1E021A), via an unspecified route of administration, administered in Arm Left on 07Sep2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient experienced hearing loss Left ear (vaccination site) approximately 10 hours after primary vaccination on 07Sep2021 19:00. Day 1 after vaccination of severe tinnitus on 08Sep2021 and only 30% hearing on left ear and severe pain in the vaccine arm on 07Sep2021, cannot be lifted. Patient visited physician office. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1701012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN J07BC03 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diabetic ketoacidosis, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: Arterial hypertension; Hypothyroidism; Type II diabetes mellitus
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 antigen test; Result Unstructured Data: positive; Test Date: 20210910; Test Name: COVID-19 PCR test; Result Unstructured Data: positive
CDC Split Type: BGJNJFOC20210922579

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; DIABETIC KETOACIDOSIS; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 49 year old female of unspecified race and ethnic origin. Initial information processed with additional information received from reporter on 13-SEP-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes type 2, hypothyroidism, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported and batch number: J07BC0 expiry: UNKNOWN) dose was not reported, 1 total administered on left arm (shoulder) 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 8-SEP-2021, the patient had positive COVID-19 antigen test. On 10-SEP-2021, she had positive PCR test (confirmed clinical vaccination failure). She did not have an antibodies test. On 7-SEP-2021, the patient had her first COVID-19 symptoms (confirmed covid-19 infection). On 8-SEP-2021, she was transported into a hospital she was accepted in due to Diabetic ketoacidosis. The patient hospitalized on unspecified date and days. The patient was in critical condition now, she was incubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, diabetic ketoacidosis and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with Product Quality Complaint : 90000193101.; Sender''s Comments: V0: 20210922579- COVID-19 VACCINE AD26.COV2.S- Diabetic ketoacidosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY 20210922579- COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210922579-COVID-19 VACCINE AD26.COV2.S- Confirmed covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1703616 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Hyperhidrosis, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
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: aches; no appetite; metallic taste; fatigue; sweating; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25905588) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included CITALOPRAM from 01-Nov-2018 to an unknown date for Anxiety state. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), PAIN (aches), DECREASED APPETITE (no appetite), DYSGEUSIA (metallic taste) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweating), PAIN (aches), DECREASED APPETITE (no appetite), DYSGEUSIA (metallic taste) and FATIGUE (fatigue) outcome was unknown and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient also developed aches, no appetite, fatigue, when eating and drinking there was a slight metallic taste. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No treatment details were provided.. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in the Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1703633 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: pain; sweating; unwell; shivering; Shivers; Tiredness; Nauseous; Bone pain; Feeling unwell; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25909292) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), HYPERHIDROSIS (sweating), BONE PAIN (Bone pain), MALAISE (Feeling unwell), MALAISE (unwell), CHILLS (shivering), CHILLS (Shivers), FATIGUE (Tiredness) and NAUSEA (Nauseous) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criterion medically significant), MALAISE (Feeling unwell) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant), MALAISE (unwell) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, PAIN (pain), HYPERHIDROSIS (sweating), BONE PAIN (Bone pain), MALAISE (Feeling unwell), MALAISE (unwell), CHILLS (shivering), CHILLS (Shivers), FATIGUE (Tiredness) and NAUSEA (Nauseous) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant information was provided. patient woke in extreme pain and discomfort at 3.45am through the night, legs were trebling uncontrol and full body was shivering patient took painkillers. patient felt overall extremely unwell and was struggling to breath patient was trying to calm down but had a terrible experience. patient still feel terribly unwell with all of the above symptoms .Breathing which is ok now. patient feel so unwell. Patient was not enrolled in clinical trial Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1704533 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Angina pectoris, Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: None
Current Illness: Athsma
Preexisting Conditions: None
Allergies: Pencillion
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart hurts, shortness of breath, feel heart pounding soreness


VAERS ID: 1704881 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Acute myocarditis; This case was received via the Regulatory Authority (Reference number: GB-MHRA-EYC 00260072) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with COLCHICINE for Myopericarditis, at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (Acute myocarditis) was resolving. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. The reporter stated that the patient was generally fit and well. Patient was admitted with chest pain that was reportedly worse on inspiration. Lab tests were reported without date as Troponin $g9000 and ECG showing global ST elevation. This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 3 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The events were considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 3 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The events were considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1704941 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling of body temperature change, Headache, Rash macular, SARS-CoV-2 test, Vaccination site pain
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; hot and cold; my arm was extremely painful ( almost like a dead weight); feel very tired; Blotchy rash; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 25909363) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy rash) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 02-Aug-2021 to 11-Aug-2021. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced RASH MACULAR (Blotchy rash) (seriousness criterion medically significant). 07-Sep-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot and cold), VACCINATION SITE PAIN (my arm was extremely painful ( almost like a dead weight)) and FATIGUE (feel very tired). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (PARACETAMOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Blotchy rash) had not resolved and HEADACHE (Headache), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), VACCINATION SITE PAIN (my arm was extremely painful ( almost like a dead weight)) and FATIGUE (feel very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had the vaccine on Sunday afternoon and the next day, his arm was extremely painful (almost like a dead weight) which was like reaction for the first vaccine, so the patient thought nothing of it. Then, the same evening she began to feel very tired, hot, and cold and had a headache, so she came home and napped for 3 hours and took paracetamol. The painkillers helped and her arm felt better. The following day, her arm felt sore but not as painful however after the patient had shower and noticed a rectangular size red blotch on arm where the vaccine was injected which was not mentioned as a side effect. The patient was not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1704943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Dizzy spells; Blurred vision; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25909816) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) and VISION BLURRED (Blurred vision) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and VISION BLURRED (Blurred vision) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizzy spells) and VISION BLURRED (Blurred vision) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company comment: This case concerns a female of unknown age with serious unexpected events of dizziness and vision blurred. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a female of unknown age with serious unexpected events of dizziness and vision blurred. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1705073 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-09-07
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: sars-cov-2 test; Test Result: Negative; Comments: DE: Variant PCR based on B.1.617.2; N501Y negative.
CDC Split Type: ATPFIZER INC202101142595

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority AT-BASGAGES-2021-043068. A 44-year-old female patient received bnt162b2 (COMIRNATY), on 12Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) as dose 1, single, then on 06Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) as dose 2, single, both via an unspecified route of administration for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included SARS-COV-2 test negative (DE: Variant PCR based onB.1.617.2; N501Y negative) on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705700 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness postural, Feeling of body temperature change, Headache, Hypoaesthesia, Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Sensitive skin, Vaccination site pain, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN [SERTRALINE]
Current Illness: Anxiety
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pain; Sensitive skin to the touch; Burning up and also freezing; Couldn?t feel my feet of fingers at some points; Pain where I got the injection; Fever; Chills; Generalized muscle aches; Nausea; Headache dull; Dizzy on standing; Blurry vision; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25911315) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Generalized muscle aches), NAUSEA (Nausea), HEADACHE (Headache dull), DIZZINESS POSTURAL (Dizzy on standing) and VISION BLURRED (Blurry vision) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE (SERTRALIN [SERTRALINE]) from 03-Jan-2021 to an unknown date for Anxiety. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), MYALGIA (Generalized muscle aches) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and VISION BLURRED (Blurry vision) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant), SENSITIVE SKIN (Sensitive skin to the touch), FEELING OF BODY TEMPERATURE CHANGE (Burning up and also freezing), HYPOAESTHESIA (Couldn?t feel my feet of fingers at some points) and VACCINATION SITE PAIN (Pain where I got the injection). At the time of the report, PAIN (Pain) had not resolved, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Generalized muscle aches), NAUSEA (Nausea), HEADACHE (Headache dull), DIZZINESS POSTURAL (Dizzy on standing) and VISION BLURRED (Blurry vision) was resolving and SENSITIVE SKIN (Sensitive skin to the touch), FEELING OF BODY TEMPERATURE CHANGE (Burning up and also freezing), HYPOAESTHESIA (Couldn?t feel my feet of fingers at some points) and VACCINATION SITE PAIN (Pain where I got the injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant, Patient was not currently breastfeeding On an unknown date in Sep 2021, the patient also experienced sensitive skin to the touch, burning up and also freezing, pain where I got the injection and couldn''t feel my feet of fingers at some points. Treatment information was not provided. Company Comment: This case concerns a 21 year-old, female patient with no relevant medical history, who experienced the unexpected events of Pain, Pyrexia, chills, Myalgia, nausea, headache, Dizziness postural and Vision blurred. The events Pyrexia, chills, Myalgia, nausea, headache, Dizziness postural and Vision blurred occurred approximately one day after the second dose of mRNA-1273 (Moderna COVID 19 vaccine) and the event pain had unknown onset date. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 21 year-old, female patient with no relevant medical history, who experienced the unexpected events of Pain, Pyrexia, chills, Myalgia, nausea, headache, Dizziness postural and Vision blurred. The events Pyrexia, chills, Myalgia, nausea, headache, Dizziness postural and Vision blurred occurred approximately one day after the second dose of mRNA-1273 (Moderna COVID 19 vaccine) and the event pain had unknown onset date. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1705701 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Headache, Lethargy, SARS-CoV-2 test, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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 Date: 20210906; 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: Tight chest; Headache; Sensitive skin; Lethargic; This case was received (Reference number: GB-MHRA-ADR 25913268) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight chest), HEADACHE (Headache), SENSITIVE SKIN (Sensitive skin) and LETHARGY (Lethargic) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant) and LETHARGY (Lethargic) (seriousness criterion medically significant). On 07-Sep-2021, SENSITIVE SKIN (Sensitive skin) and LETHARGY (Lethargic) had resolved. On 08-Sep-2021, HEADACHE (Headache) was resolving. At the time of the report, CHEST DISCOMFORT (Tight chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-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 product use was not provided by the reporter. No treatment information was provided. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of chest discomfort, headache, sensitive skin and lethargy. The events occurred approximately 2 days after a non-specified dose of mRNA-1273. The rechallenge was unknown since no information about specified dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting; however, the events do not meet the criteria for seriousness.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of chest discomfort, headache, sensitive skin and lethargy. The events occurred approximately 2 days after a non-specified dose of mRNA-1273. The rechallenge was unknown since no information about specified dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting; however, the events do not meet the criteria for seriousness.


VAERS ID: 1707926 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-07
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Influenza, Insomnia, Pain of skin, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPINE; SERTRALINE
Current Illness: Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Skin pain; Flu symptoms; Appetite lost; Insomnia; Fatigue; This case was received via regulatory authority on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Skin pain), INFLUENZA (Flu symptoms), DECREASED APPETITE (Appetite lost), INSOMNIA (Insomnia) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3004223 and 3002621) for COVID-19 vaccination. Concurrent medical conditions included Depression. Concomitant products included QUETIAPINE from 07-Jun-2013 to an unknown date and SERTRALINE from 06-Mar-2012 to an unknown date for Depression. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PAIN OF SKIN (Skin pain) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PAIN OF SKIN (Skin pain) was resolving and INFLUENZA (Flu symptoms), DECREASED APPETITE (Appetite lost), INSOMNIA (Insomnia) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient was not enrolled in clinical trial. Patient was not having symptoms associated to COVID-19. Patient was not currently breastfeeding. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1707935 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Sickness; Chills; Generalised muscle aches; Chronic headaches; High temperature; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25916170) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), NAUSEA (Nausea), ILLNESS (Sickness), CHILLS (Chills), MYALGIA (Generalised muscle aches) and HEADACHE (Chronic headaches) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and HEADACHE (Chronic headaches) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 08-Sep-2021, CHILLS (Chills) and MYALGIA (Generalised muscle aches) had resolved. On 09-Sep-2021, HEADACHE (Chronic headaches) had resolved. At the time of the report, PYREXIA (High temperature) had not resolved and NAUSEA (Nausea) and ILLNESS (Sickness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No Treatment Medication reported. Company comment: This case concerns a 22 year-old, male subject with no relevant medical history, who experienced the unexpected events of pyrexia, nausea, illness, chills, myalgia and headache. The events pyrexia, nausea, illness, myalgia and headache occurred on the same date of vaccination. The event chills occurred approximately 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 22 year-old, male subject with no relevant medical history, who experienced the unexpected events of pyrexia, nausea, illness, chills, myalgia and headache. The events pyrexia, nausea, illness, myalgia and headache occurred on the same date of vaccination. The event chills occurred approximately 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report.


VAERS ID: 1707938 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-09-07
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 virus test positive.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Aches & pains in legs; Headache; Fatigue; Fever; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25916357) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches & pains in legs), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 24-May-2021. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 08-Sep-2021, CHILLS (Chills) had resolved. On 09-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches & pains in legs) was resolving and HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test positive.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Patient had all these symptoms after first vaccine too on the 10th July. Debilitating. patient felt like patient had a terrible flu with the worst headache. 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 Treatment information was not provided. Company comment: This case concerns a 38 year-old, female subject with a history of Suspected Covid -19, who experienced the unexpected events of Pain in extremity. The event occurred apptoximately after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. Per the reporter''s assessment is not provided.The benefit-risk relationship of drug mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 38 year-old, female subject with a history of Suspected Covid -19, who experienced the unexpected events of Pain in extremity. The event occurred apptoximately after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. Per the reporter''s assessment is not provided.The benefit-risk relationship of drug mRNA-1273 in not affected by this report.


VAERS ID: 1707939 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Pain in arm; Headache; Dizziness; Nausea; This case was received via the RA (Reference number: GB-MHRA-ADR 25917009) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 22 year-old, female subject with no relevant medical history, who experienced the unexpected pain in the extremity. The event occurred approximately after the first dose of Moderna CoviD-19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 22 year-old, female subject with no relevant medical history, who experienced the unexpected pain in the extremity. The event occurred approximately after the first dose of Moderna CoviD-19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1707950 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site mass, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (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: 20210909; 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: Injection site lump; This case was received via RA (Reference number: GB-MHRA-ADR 25921887) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Injection site lump) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant). At the time of the report, INJECTION SITE MASS (Injection site lump) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-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 medications were not reported. No treatment details were provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1707952 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Pyrexia, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: LOGYNON; PARACETAMOL AND CODEINE PHOSPHATE (I)
Current Illness:
Preexisting Conditions: Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Low back pain; Itchy rash; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25922227) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), PYREXIA (Fever) and RASH PRURITIC (Itchy rash) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL (PARACETAMOL AND CODEINE PHOSPHATE (I)) for Low back pain, ETHINYLESTRADIOL, LEVONORGESTREL (LOGYNON) for an unknown indication. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced BACK PAIN (Low back pain) (seriousness criterion medically significant) and RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Low back pain) and RASH PRURITIC (Itchy rash) had not resolved and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment details were reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine .Patient is not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1709742 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-09-07
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Amnesia, Balance disorder, Chest pain, Confusional state, Dizziness, Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Mood altered, Myalgia, Pyrexia, Suspected COVID-19, Swelling, Vaccination site mass, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Sweaty; Pain abdominal; Dizziness; Loss of memory; Loss of balance; Blurry vision; High temperature; Muscle pain; inappropriate schedule of vaccine administration; suspect COVID 19; Mood change; Swelling; Headache; Fatigue; Vaccination site lump; Confused; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25914529) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), HYPERHIDROSIS (Sweaty), CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain abdominal), VACCINATION SITE MASS (Vaccination site lump), CONFUSIONAL STATE (Confused), DIZZINESS (Dizziness), AMNESIA (Loss of memory), BALANCE DISORDER (Loss of balance), VISION BLURRED (Blurry vision), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (High temperature), MOOD ALTERED (Mood change) and MYALGIA (Muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Suspected COVID-19 since 07-Sep-2021. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), VACCINATION SITE MASS (Vaccination site lump) (seriousness criterion medically significant), CONFUSIONAL STATE (Confused) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MOOD ALTERED (Mood change) (seriousness criterion medically significant). 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) and SUSPECTED COVID-19 (suspect COVID 19). On 08-Sep-2021, the patient experienced HYPERHIDROSIS (Sweaty) (seriousness criterion medically significant), ABDOMINAL PAIN (Pain abdominal) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), AMNESIA (Loss of memory) (seriousness criterion medically significant), BALANCE DISORDER (Loss of balance) (seriousness criterion medically significant), VISION BLURRED (Blurry vision) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling), HYPERHIDROSIS (Sweaty), CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain abdominal), VACCINATION SITE MASS (Vaccination site lump), CONFUSIONAL STATE (Confused), DIZZINESS (Dizziness), AMNESIA (Loss of memory), BALANCE DISORDER (Loss of balance), VISION BLURRED (Blurry vision), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (High temperature), MOOD ALTERED (Mood change), MYALGIA (Muscle pain) and SUSPECTED COVID-19 (suspect COVID 19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patients last memory was walking out from vaccine to sit for 15 minutes. Patient had feeling of headache and was unable to remember much after vaccination till next days and felt unwell. Patient had not tested positive for COVID-19 since having the vaccine This case concerns a 25- year-old, female who experienced the unexpected events of swelling, hyperhidrosis, vaccination site mass, chest pain, confusional state, mood altered, abdominal pain, dizziness, amnesia, fatigue, pyrexia, headache, balance disorder, vision blurred, myalgia and suspected COVID 19 . The events occurred approximately 70 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The event Suspect COVID 19 was reported as relevant history but was also captured as an event considering the date of onset. Seriousness is retained as reported by RA. The event of inappropriate schedule of vaccination was captured. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender''s Comments: This case concerns a 25- year-old, female who experienced the unexpected events of swelling, hyperhidrosis, vaccination site mass, chest pain, confusional state, mood altered, abdominal pain, dizziness, amnesia, fatigue, pyrexia, headache, balance disorder, vision blurred, myalgia and suspected COVID 19 . The events occurred approximately 70 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The event Suspect COVID 19 was reported as relevant history but was also captured as an event considering the date of onset. Seriousness is retained as reported by RA. The event of inappropriate schedule of vaccination was captured. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.


VAERS ID: 1709942 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

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

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

Write-up: Period pains; Night sweats; Nauseous; Headache; Fever chills; This case was received (Reference number: GB-MHRA-ADR 25911150) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains), NIGHT SWEATS (Night sweats), NAUSEA (Nauseous), HEADACHE (Headache) and PYREXIA (Fever chills) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SERTRALINE from 21-May-2021 to an unknown date for Mood swings, VITAMIN D [VITAMIN D NOS] from 11-Jun-2021 to 25-Jul-2021 for Vitamin D. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 07-Sep-2021, NIGHT SWEATS (Night sweats) and PYREXIA (Fever chills) had resolved. At the time of the report, DYSMENORRHOEA (Period pains) and HEADACHE (Headache) was resolving and NAUSEA (Nauseous) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 21 year-old female subject with no reported past medical history who experienced the unexpected events of dysmenorrhea, night sweats, nausea, headache and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown as there is no information available about the first dose. The events nausea, headache and pyrexia are consistent with the current understanding of the mechanism of action of the study medication. The use of concomitant medication sertraline remains a confounder for nausea and headache. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 21 year-old female subject with no reported past medical history who experienced the unexpected events of dysmenorrhea, night sweats, nausea, headache and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown as there is no information available about the first dose. The events nausea, headache and pyrexia are consistent with the current understanding of the mechanism of action of the study medication. The use of concomitant medication sertraline remains a confounder for nausea and headache. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1709943 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Fatigue, Lymph node pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Backache; Lymph node pain; Armpit pain; Joint pain; Muscle pain; Chills; Tiredness; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25911173) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), LYMPH NODE PAIN (Lymph node pain), AXILLARY PAIN (Armpit pain), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BACK PAIN (Backache) (seriousness criterion medically significant), LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 08-Sep-2021, LYMPH NODE PAIN (Lymph node pain), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and CHILLS (Chills) had resolved. At the time of the report, BACK PAIN (Backache) and FATIGUE (Tiredness) was resolving and AXILLARY PAIN (Armpit pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment: This case concerns a 28 Y/O F with serious unexpected back pain, lymph node pain, axillary pain, arthralgia, myalgia, chills, and fatigue. Latency 1 day after 2nd dose mRNA-1273. Events resolving. Rechallenge not applicable. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 28 Y/O F with serious unexpected back pain, lymph node pain, axillary pain, arthralgia, myalgia, chills, and fatigue. Latency 1 day after 2nd dose mRNA-1273. Events resolving. Rechallenge not applicable. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1709961 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

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

Write-up: Faint; This case was received via RA (Reference number: GB-MHRA-ADR 25916709) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Faint) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). On 07-Sep-2021, SYNCOPE (Faint) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter reported Fainted during 15 minute post vaccine waiting time. Given water and laid down with legs raised.. No concomitant and treatment medications were reported. Company Comment: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred during 15 minutes post vaccine waiting time after the second dose of Moderna COVID19 vaccine. The rechallenge was unknown as there is no information available about the first dose. The benefit-risk relationship of Moderna COVID19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred during 15 minutes post vaccine waiting time after the second dose of Moderna COVID19 vaccine. The rechallenge was unknown as there is no information available about the first dose. The benefit-risk relationship of Moderna COVID19 vaccine is not affected by this report.


VAERS ID: 1709975 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042223 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Erythema, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Redness; Burning sensation; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25921284) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation) and ERYTHEMA (Redness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30042223) for COVID-19 vaccination. Concomitant products included SERTRALINE from 12-Nov-2019 to an unknown date for Depression, LEVOTHYROXINE SODIUM from 31-Aug-2021 to an unknown date for Hypothyroidism, OMEPRAZOL [OMEPRAZOLE] from 06-Mar-2019 to an unknown date for Irritable bowel, IBUPROFEN from 01-Jan-2020 to an unknown date for Pain relief, DESOGESTREL from 01-Jan-2018 to an unknown date for Pregnancy. On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (Burning sensation) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (Burning sensation) and ERYTHEMA (Redness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not reported. Patient stated she had poor bone density due to previous use of the contraceptive injection Patient had not had symptoms associated with COVID-19 Patient was not pregnant. Patient was not currently breastfeeding. Patient experienced burning feeling down the entire arm. Patient use arm without severe pain. Big red patch around injection side. Patient was not enrolled in clinical trial. Company comment- This case concerns a 32 year-old, female subject with a history of Hypothyroidism and Depression who experienced the unexpected events of Burning Sensation and Erythema. The event occurred approximately after the first dose of Moderna Covid -19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 32 year-old, female subject with a history of Hypothyroidism and Depression who experienced the unexpected events of Burning Sensation and Erythema. The event occurred approximately after the first dose of Moderna Covid -19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1709993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101168349

Write-up: Painful periods; This is a solicited report from the RA Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202109070026559950-NUOX0, Safety report unique identifier is GB-MHRA-ADR 25903715. A 17-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 03Sep2021 as dose 1, single for covid-19 immunization. Medical history included suspected covid-19 (unsure when symptoms started and stopped) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was not currently breastfeeding. On 07Sep2021, the patient experienced painful periods. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on an unspecified date. The reporter considered the event as serious (medically significant). No causality was provided for painful periods. Patient was not enrolled in clinical trial. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event dysmenorrhea and the suspect drug BNT162B2. 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: 1710365 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Hypopnoea, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: Test Result: 80 level; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.6 Centigrade; Comments: before vaccination; Test Date: 20210907; Test Name: Oxygen saturation; Test Result: 88%.
CDC Split Type: JPPFIZER INC202101178684

Write-up: Loss of consciousness (80 level); Blood pressure decreased; Breathing shallow; Urinary incontinence; Sat (saturation) 88%; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21126205. A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Sep2021 11:25 (Batch/Lot Number: FD0349; Expiration Date: 31Oct2021) (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was a 38-year and 0-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 07Sep2021 around 11:25 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via an unspecified route of administration for COVID-19 immunization. On 07Sep2021 around 11:35 (on the same day of the vaccination), the patient experienced adverse events. On 07Sep2021 (on the same day of the vaccination), the outcome of the events was recovered with the treatment. The course of the event was as follows: The patient experienced loss of consciousness, blood pressure decreased, breathing shallow and urinary incontinence 10 minutes to 15 minutes after the vaccination. The patient experienced blood pressure 80 level and sat (saturation) 88%. The reporting physician the event as serious (Life-threatening) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was recovering after oxygen administration and fluid replacement.


VAERS ID: 1714580 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Hypersensitivity, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOOTS ALLERGY RELIEF; CLENIL MODULITE; FLUCLOXACILLIN; PARACETAMOL; SALBUTAMOL
Current Illness: Asthmatic (Asthmatic Patient has not had symptoms associated with COVID-19)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: allergic reaction; pain; Chest got tight; Swelling arm; This case was received via Regulatory Authority(Reference number: ADR 25916730) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PAIN (pain) and PERIPHERAL SWELLING (Swelling arm) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthmatic (Asthmatic Patient has not had symptoms associated with COVID-19). Concomitant products included CHLORPHENAMINE MALEATE (BOOTS ALLERGY RELIEF) from 07-Sep-2021 to an unknown date and FLUCLOXACILLIN from 07-Sep-2021 to an unknown date for Large arm swelling, PARACETAMOL from 31-Aug-2021 to an unknown date for Pain relief, BECLOMETASONE DIPROPIONATE (CLENIL MODULITE) from 31-Aug-2021 to an unknown date for Shortness of breath, SALBUTAMOL from 31-Aug-2021 to an unknown date for Wheezing. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest got tight). At the time of the report, HYPERSENSITIVITY (allergic reaction), PAIN (pain) and CHEST DISCOMFORT (Chest got tight) outcome was unknown and PERIPHERAL SWELLING (Swelling arm) 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. On exactly a week later the arm developed a large round bump which stands out and causes numbness and soreness. This began to impact my breathing as his chest got tight and every time he breathed in, patient would get a sharp pain in his heart area. He went to the GP who stated that the bump ws quite large and one of the bigger sized ones he''s seen. The local area was also warm, so he have been prescribed antibiotics and also advised to take Loratadine as it looks like some sort of allergic reaction and infection. After one day of medication, there has been no improvement and the soreness and numbness is still present. Treatment details includes: Antibiotics,advised on taking some antihistamine 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 35 year-old, male with a history of asthma, who experienced the unexpected events of Hypersentivity, Pain and Peripheral swelling. The events Hypersentivity and Pain occurred on an unknown date. The event Peripheral swelling occurred approximately 18 days after the first dose. The rechallenge was not applicable, as the events happened after the first dose. The medical history of asthma remains as confounder. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This case concerns a 35 year-old, male with a history of asthma, who experienced the unexpected events of Hypersentivity, Pain and Peripheral swelling. The events Hypersentivity and Pain occurred on an unknown date. The event Peripheral swelling occurred approximately 18 days after the first dose. The rechallenge was not applicable, as the events happened after the first dose. The medical history of asthma remains as confounder. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1714775 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-09-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004215 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Asthenia, Back pain, Body temperature, Headache, Intervertebral disc protrusion, Mobility decreased, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 39.3C; Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 39.1; Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 38.7C
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Anxious; 39.3C fever,39.1 fever; Almost fainted in the shower during the evening; Could not move from his bed; No more strength; Herniated disc and had strong back pain again; Herniated disc and had strong back pain again; Headache that doesn''t fade, like his head will explode; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Almost fainted in the shower during the evening) in a 23-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3004219 and 3004215) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc and had strong back pain again) and BACK PAIN (Herniated disc and had strong back pain again). 07-Sep-2021, the patient experienced HEADACHE (Headache that doesn''t fade, like his head will explode). On 08-Sep-2021, the patient experienced SYNCOPE (Almost fainted in the shower during the evening) (seriousness criterion medically significant), MOBILITY DECREASED (Could not move from his bed), ASTHENIA (No more strength) and PYREXIA (39.3C fever,39.1 fever). On an unknown date, the patient experienced ANXIETY (Anxious). The patient was treated with PARACETAMOL (DAFALGAN) for Adverse event, at a dose of 4 dosage form once a day and Bed rest for Syncope. At the time of the report, SYNCOPE (Almost fainted in the shower during the evening), MOBILITY DECREASED (Could not move from his bed), ASTHENIA (No more strength), INTERVERTEBRAL DISC PROTRUSION (Herniated disc and had strong back pain again), BACK PAIN (Herniated disc and had strong back pain again), ANXIETY (Anxious) and HEADACHE (Headache that doesn''t fade, like his head will explode) outcome was unknown and PYREXIA (39.3C fever,39.1 fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 39.3 (High) 39.3C, 39.1 (High) 39.1 and 38.7 (High) 38.7C. Concomitant product use was not provided by the reporter. The patient had a headache since the vaccination that did not fade, like his head will explode. On the first day, he could not move from his bed, he had no more strength and almost fainted in the shower during the evening. 39.3C fever. On Thursday, it was the same, fever and could not move out of the bed. On Friday (at the time of this report) it does not go away. 39.1 fever in the morning then better around 10AM, 38.7C this afternoon. it was still ok this morning but as the day goes by, it gets worst. Treatment, recommended on the phone by a medical center: dafalgan and rest. Patient takes 4 Dafalgan/day The patient suffered from an herniated disc and had strong back pain again, since the vaccination. This case was linked to MOD-2021-317791 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up information included batch number for both the doses.


VAERS ID: 1716032 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Photophobia, SARS-CoV-2 test
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), COVID-19 (broad)

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

Write-up: Light sensitivity to eye; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25916782) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Light sensitivity to eye) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 2 dosage form. On 07-Sep-2021, the patient experienced PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion disability). At the time of the report, PHOTOPHOBIA (Light sensitivity to eye) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced extreme light sensitivity Since having the vaccine. Treatment information was not provided. Company Comment: This case concerns a 26 year-old, male subject with no relevant medical history, who experienced the unexpected event of Photophobia. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 26 year-old, male subject with no relevant medical history, who experienced the unexpected event of Photophobia. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report.


VAERS ID: 1716053 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Pyrexia, SARS-CoV-2 test
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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped).
Allergies:
Diagnostic Lab Data: Test Date: 20200930; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach cramps; Fever chills; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25926908) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps), FATIGUE (Fatigue) and PYREXIA (Fever chills) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 30-Sep-2020. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced FATIGUE (Fatigue) (seriousness criteria disability and medically significant). On 08-Sep-2021, the patient experienced PYREXIA (Fever chills) (seriousness criteria disability and medically significant). On 09-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criteria disability and medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) and FATIGUE (Fatigue) had not resolved and PYREXIA (Fever chills) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Patient was not enrolled in clinical trial. Company comment This case concerns a 20 year old male who on 07-Sep-2021, experienced FATIGUE (Fatigue) (seriousness criterion disability) and then on 08-Sep-2021, experienced PYREXIA (Fever chills) (seriousness criterion disability) after the second dose of the vaccine. Dechallenge was unknown. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns a 20 year old male who on 07-Sep-2021, experienced FATIGUE (Fatigue) (seriousness criterion disability) and then on 08-Sep-2021, experienced PYREXIA (Fever chills) (seriousness criterion disability) after the second dose of the vaccine. Dechallenge was unknown. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.


VAERS ID: 1716056 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Vertigo; This case was received via (Reference number: GB-MHRA-ADR 25927783) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not test positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No concomitant product was reported. No treatment medication was reported. This case concerns a 48 year-old, female subject with no relevant medical history, who experienced the unexpected event of Vertigo. The event occurred approximately 3 days after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. As per the reporter''s assessment it was not provided. The benefit-risk relationship of Moderna covid-19 vaccine, is not affected by this report.; Sender''s Comments: This case concerns a 48 year-old, female subject with no relevant medical history, who experienced the unexpected event of Vertigo. The event occurred approximately 3 days after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. As per the reporter''s assessment it was not provided. The benefit-risk relationship of Moderna covid-19 vaccine, is not affected by this report.


VAERS ID: 1716069 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-09-07
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Decreased appetite, Fatigue, Heart rate, Inappropriate schedule of product administration, Malaise, Pyrexia, SARS-CoV-2 test, Sensitive skin, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: 123
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sensitive skin; Feeling sick; Tiredness; High temperature; Armpit pain; no appetite; sleeping for 14 hours; aching of my hips; Inappropriate schedule of vaccine administered; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25928828) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive skin), MALAISE (Feeling sick), FATIGUE (Tiredness), PYREXIA (High temperature) and AXILLARY PAIN (Armpit pain) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3004222 and 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 25-Jun-2021 to 06-Jul-2021. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and ARTHRALGIA (aching of my hips). 07-Sep-2021, the patient experienced DECREASED APPETITE (no appetite) and SOMNOLENCE (sleeping for 14 hours). 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 09-Sep-2021, SENSITIVE SKIN (Sensitive skin), MALAISE (Feeling sick), FATIGUE (Tiredness), PYREXIA (High temperature) and AXILLARY PAIN (Armpit pain) had resolved. At the time of the report, DECREASED APPETITE (no appetite), SOMNOLENCE (sleeping for 14 hours) and ARTHRALGIA (aching of my hips) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Heart rate: 123 (Inconclusive) 123. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It is stated that patient became ill, exactly 12 hours after second injection. First with aching of hips followed by feeling sick, no appetite, soar skin, burning up, heart rate whilst in bed was 123 and ended up sleeping for 14 hours. Patient had COVID exactly a week after her first injection and the symptoms were exactly the same to what she got after her second jab. It is stated that with the second jab, patient was ill for two and half days with COVID, it was nearly 10 days. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This is a case of Inappropriate schedule of vaccine administered for this 29-year-old female patient, who experienced the unexpected event of Sensitive skin, malaise, fatigue, pyrexia and axillary pain. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This is a case of Inappropriate schedule of vaccine administered for this 29-year-old female patient, who experienced the unexpected event of Sensitive skin, malaise, fatigue, pyrexia and axillary pain. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1716117 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Maternal exposure during pregnancy, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID
Current Illness: Pregnancy
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: Pain in arm; Light-headed; Tiredness; Nauseous; Maternal exposure during pregnancy; This case was received via RA (Reference number: -MHRA-ADR 25928223) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light-headed), FATIGUE (Tiredness), NAUSEA (Nauseous) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 21-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 07-Sep-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-Jan-2022. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 08-Sep-2021, DIZZINESS (Light-headed) had resolved. On 09-Sep-2021, PAIN IN EXTREMITY (Pain in arm) and NAUSEA (Nauseous) had resolved. On 10-Sep-2021, FATIGUE (Tiredness) was resolving. At the time of the report, 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that this was her first pregnancy and patient were on her second trimester. She underwent scans or investigations, results were normal or average. No treatment information was provided. This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and unexpected events of pain in extremity, dizziness and the expected events of fatigue and nausea. The patient received the second dose of vaccine at an unknown week of gestation. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and unexpected events of pain in extremity, dizziness and the expected events of fatigue and nausea. The patient received the second dose of vaccine at an unknown week of gestation. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1716794 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Insomnia, Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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: Medical History/Concurrent Conditions: Anxiety; Low blood pressure; Stress
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176203

Write-up: Feeling unwell; Fever; Diarrhoea; Tiredness; Arm pain; Insomnia; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210908063827. Safety Report Unique Identifier GB-MHRA-ADR 25910305. A 29-year-old non pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot Number: FF2153), via an unspecified route of administration, on 07Sep2021 (at the age of 29-year-old), as dose 2, single for COVID-19 immunization. Medical history included Low blood pressure, anxiety and stress from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was not pregnant and not currently breastfeeding. Historical vaccine included BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), on 08Jun2021 as dose 1, single for covid-19 immunization. On 06Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative No - Negative COVID-19 test. On 07Sep2021, the patient experienced nausea, arm pain, insomnia and tiredness. On 08Sep2021, feeling unwell, fever, diarrhoea. It was reported that her arm hurt within minutes of having the vaccine at 9am, then the pain has been got worse since. And she felt tired from around 2pm yesterday afternoon and have on and off been exhausted. The patient sleep for hours and her heart rate has been raised over night, still it was at 83 BPM while she sat on the couch. She has felt sick since the early hours of this morning and very hot too. The patient called her General Practitioner this morning as she feels terrible. Patient was not enrolled in clinical trial. The outcome of the 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: 1717045 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Faint
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176224

Write-up: felt faint; Fainting; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109071249093480-7F8Y8.Safety Report Unique Identifier GB-MHRA-ADR 25906538. A 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 07Sep2021 (age at the time of vaccination was 18-year-old) (Batch/Lot Number: fe3380) as DOSE 2, SINGLE for covid-19 immunization. Medical history included faint from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization and experienced feeling faint. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. On 07Sep2021, the patient experienced fainting. On an unspecified date patient had felt faint. Patient had her covid vaccination. Had a history of feeling faint after vaccination. Reassured patient and patient decided to go ahead with vaccination. Patient felt faint and started to faint during sitting down for her 15 minutes observation. IA caught the patient before she hit the floor. Patient was not unconscious. Provided patient with glass of water and laid patient on the ground with legs raised. Patient felt better after 2 minutes. Patient stayed lay down for 15 minutes on the floor. After this she felt better so put her sitting back upright for another 5 minutes. Patient went home at 10.50 with no further issues. Dad was present throughout. The outcome of fainting was resolved on 07Sep2021. The outcome of felt faint was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717356 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Eye irritation, Fungating wound, Pyrexia, Vaccination site reaction
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related conditions (narrow), Corneal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210933065

Write-up: FUNGATING WOUND; VACCINATION SITE REACTION; BURNING EYES; VESICLES; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority (IT-MINISAL02-785396) on 17-SEP-2021 and concerned a 58 year old male male of unknown race and ethnicity. The patient''s weight was 73 kilograms and height was 177 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: 21C18-03 expiry: unknown) dose was not reported, 1 total, administered on 06-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 07-SEP-2021, the patient experienced fungating wound, vaccination site reaction, burning eyes, vesicles and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination site reaction, fever, fungating wound, burning eyes and vesicles. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Not noteworthy pathologies.


VAERS ID: 1717445 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Dysphoria, Heart rate, Heart rate decreased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatitis atopic
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:60; Comments: 5 minutes after vaccination; Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:105/70; Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased again; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210907; Test Name: HR; Result Unstructured Data: Test Result:45; Comments: 5 minutes after vaccination; Test Date: 20210907; Test Name: HR; Result Unstructured Data: Test Result:65
CDC Split Type: JPPFIZER INC202101169936

Write-up: Anaphylaxis; blood pressure decreased to 60(Ps); HR decreased to 45; Dysphoria; This is a spontaneous report from a contactable physician received from the regulatory authority report numbers are v21126105 and v21126123. A 20-years and 3-months-old male patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, lot number FF5357, expiration date 30Nov2021) via an unspecified route of administration on 07Sep2021 at 12:15 (the day of vaccination, at the age of 20-years-old) as dose 1, single for COVID-19 immunization. The patient had no family history and had a medical history of dermatitis atopic. Concomitant medications were not reported. Body temperature before vaccination, on 07Sep2021, was 36.5 degrees Centigrade. On 07Sep2021at 12:20 (5minutes after vaccination), the patient experienced anaphylaxis, blood pressure decreased to 60(Ps), HR decreased to 45 and dysphoria. The course of the event was as follows: 5 minutes after vaccination, the patient experienced dysphoria, blood pressure decreased to 60(Ps), heart rate (HR) decreased to 45. The patient received BOSMIN 0.3 injection on right lower leg. Normal saline 500+ Atarax-P 1/2 drip infusion. On 07Sep2021, blood pressure 105/70, HR 65, the symptoms were recovering and the level of consciousness was normal. The reporting physician classified the event as non-serious (mild symptom) and the causality was not provided. The reporting physician commented as follows: it was considered as anaphylaxis caused by vaccination. Antiallergic agent was prescribed and the patient went back. On 07Sep2021, blood pressure decreased again and the patient was transported to privacy hospital. On 07Sep2021, the outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1717461 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Dyskinesia, Dyslalia, Fall, Hypoaesthesia, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101198409

Write-up: fell down; Cerebral infarction(Posterior circulation acute Infarction); Numbness of left upper limb; Dyslalia; Movements involuntary of left lower limb; Queasy; This is a spontaneous report from Other Health Care Professional received from the RA. Regulatory authority report number is v21126178. A 77-year and 0-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number: FE8162, Expiration date: 30Nov2021) via an unspecified route of administration, on 06Sep2021 (the day of vaccination, at the age of 77-year and 0-month-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees centigrade, on 06Sep2021. The patient medical history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included Breast cancer. The patient had no family history. The patient had no history of allergy and adverse event. Concomitant medications were not reported. On 07Sep2021 at 01:00 (1 day after vaccination), the patient experienced Cerebral infarction (Posterior circulation acute Infarction). On 07Sep2021 (the same day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 06Sep2021 (the day of vaccination), the patient received the first dose of vaccination (the time was unknown). After the vaccination, nothing abnormal. On 07Sep2021 around 01:00 (1 day after vaccination), the patient was aware of Numbness of left upper limb. Dyslalia gradually appeared. Movements involuntary of left lower limb and Queasy was noted. At 06:00, the patient fell down and requested an emergency. Outcome of the events was unknown. The reporter classified the event as serious (hospitalized) and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Breaking news, the causality was unknown. After observation, detailed report scheduled (Report may be withdrawn if relationship was denied). Lot number was rough, and it may be corrected. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720773 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:High temperature
CDC Split Type: GBPFIZER INC202101176071

Write-up: Headache; High temperature; Joint ache; Light-headed; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109080729569910-CFN2F, Safety Report Unique Identifier GB-MHRA-ADR 25910425. A 24-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 07Sep2021 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. The patient did not have COVID-19 test. On 07Sep2021, the patient experienced headache, high temperature, joint ache and light-headed; all the events were reported as serious and medically significant. The patient was administered vaccine in the morning and he began to feel some side effects late in the evening. All the side effects seem to have worsened when he woke up. The patient had not tested positive for COVID-19, since having the vaccine. The clinical outcome of headache, high temperature, joint ache and light-headed was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720792 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Paraesthesia, SARS-CoV-2 test, Tinnitus
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (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: 20210906; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182414

Write-up: Abnormal touch sensation; Tinnitus; Dizziness; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Authority report number GB-MHRA-WEBCOVID-202109081416451390-FHFFK, Safety Report Unique Identifier GB-MHRA-ADR 25911964. A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported, Solution for injection), via an unspecified route of administration on 06Sep2021, as a 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 not currently breastfeeding. Patient was not enrolled in clinical trial. On 07Sep2021, the patient experienced dizziness, tinnitus and on 08Sep2021, had abnormal touch sensation. The events were serious (medically significant). The patient underwent lab tests which included SARS-CoV-2 Test: Negative (No - Negative COVID-19 test) on 06Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1720799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

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

Life 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 INC202101182420

Write-up: Fever; Frontal headache; Localized muscle pain; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109081701187130-1HJYV, Safety Report Unique Identifier GB-MHRA-ADR 25913274. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF8222), via an unspecified route of administration on 07Sep2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccination included that the patient received BNT162B2 on an unspecified date as a dose 1, single for COVID-19 immunisation. Patient had 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. On 07Sep2021, the patient experinced localized muscle pain and fatigue. On 08Sep2021, the patient had fever and frontal headache. All the events were serious (medically significant). The outcome of the event localized muscle pain was not recovered and the events fever, fatigue and frontal headache was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Condition aggravated, Fatigue, Lymph node pain, Lymphadenopathy, Pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Other ischaemic heart disease (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: FINASTERIDE; ASPIRIN (E.C.)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Male pattern baldness; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182443

Write-up: Lymph node pain; Swollen and painful lymph node; ache; Chest pain - cardiac; Medical history included chest pain from an unknown date; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109090337109050-PTNI9; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25915282. A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), second dose via an unspecified route of administration on 07Sep2021 5:00 PM at DOSE 2, SINGLE for COVID-19 immunization. Medical history included chest pain from an unknown date and unknown if ongoing , androgenetic alopecia from an unknown date and unknown if ongoing. Concomitant medication(s) included finasteride (FINASTERIDE) taken for an unspecified indication from 29Mar2021 to an unspecified stop date; acetylsalicylic acid (ASPIRIN (E.C.)) taken for chest pain from 08Sep2021 to 08Sep2021. On 08Sep2021 02:00 PM patient experienced ache in left side of chest around heart area started and gradually got a little worse to a mild pain at around 07:00 PM. Chest ache seems to have mostly subsided after sleep around 3:30am on 09Sep2021, Swollen and painful lymph node in armpit at 3:30am 09Sep2021, tiredness on 07Sep2021, injection site pain (injection site pain) on 07Sep2021. 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: no - negative covid-19 test on 02Sep2021. The outcome of Events for fatigue, ache , chest pain was recovered and for injection site pain was recovering and for other was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720819 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Medication errors (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: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190682

Write-up: sore armpit of the arm I had the vaccine in; Inappropriate schedule of vaccine administered; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109090939102740-B9OKP. Safety Report Unique Identifier GB-MHRA-ADR 25916833. A 31-year-old non-Pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FF2153) via an unspecified route of administration on right arm on 06Sep2021 as single dose for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FD5613) on 05Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes on 07Sep2021, sore armpit of the arm i had the vaccine in and inappropriate schedule of vaccine administered on an unspecified. Patient stated that really sore armpit of the arm I had the vaccine in. Right deep inside my armpit. On 03Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The outcome of the events swollen lymph nodes was not recovered, sore armpit of the arm i had the vaccine and inappropriate schedule of vaccine administered was reported as unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1720827 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Diarrhoea, Feeling cold, Hyperaesthesia, Hypersensitivity, Lip swelling, Paraesthesia, Swelling, Swelling face, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190746

Write-up: Allergic reaction; Tingling; cold sensation on back of neck; body shaking; feeling faint; face swollen; lips swollen; confused; tingling of lips; Increased skin sensitivity; Neck swelling; Diarrhoea; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109091055537650-IUM2F, Safety Report Unique Identifier GB-MHRA-ADR 25917305. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 07Sep2021 (age at the time of vaccination was 28-year-old) (Batch/Lot Number: FE8087) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced feeling faint initially (medically significant), confused, tingling of lips, increased skin sensitivity, neck swelling, diarrhoea, allergic reaction, tingling, cold sensation on back of neck, face swollen, lips swollen, body shaking. Patient was slightly confused upon asking questions. Ambulance arrived and administered Piriton tablet and observed patient in ambulance. Patient went home and around 4 hours after vaccination noticed one side of face and lips were swollen. Went to A&E and given steroids and kept for observation. Therapeutic measures were taken as a result of allergic reaction. The report was not relate to possible blood clots or low platelet counts. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Discomfort, Peripheral swelling, Tenderness, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Kyleena coil Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190750

Write-up: discomfort; All pain localised to injected side; Armpit pain; Swelling arm; Shoulder pain; Tenderness; This is a spontaneous report from a contactable consumer received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109092209434540-EKUY9. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25920962. A female patient of an unspecified age received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history was 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 patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient previously took kyleena on an unspecified date. On an unspecified date the patient experienced discomfort, all pain localized to injected side. On 07Sep2021 the patient experienced armpit pain, swelling arm, shoulder pain, tenderness. Therapeutic measures were taken as a result of armpit pain, swelling arm. The events were assessed as medically significant. It was reported that Severe pain in and swelling of armpit that is relieved but not resolved by paracetamol (2x 500mg four times a day). Pain (presumably lymph node) that is internal / behind pec. All pain localized to injected side. Swelling and tenderness of back of injected arm but minimal sensitivity at injection site. Am able to drive and perform other activities but taking breaks from prolonged mouse use due to constant discomfort that leads to pain. Outcome of Event was Not recovered while All pain localized to injected side was Unknown No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720857 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Body temperature increased, Feeling abnormal, Headache, Lymphadenopathy, Pain in extremity, Pyrexia, Rash macular, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Drug allergy (Allergy to fentanyl)
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (Factor V Leiden Endometriosis); Hemiplegic migraine
Allergies:
Diagnostic Lab Data: Test Name: body temprature; Result Unstructured Data: High; Comments: Had fever of 38.5; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Comments: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sleepy; blotchy; after the first moderna dose felt fuzzy headed; Aches & pains in legs; Back pain; Swollen glands; Fever; Head pain; This case was received (Reference number: GB-MHRA-ADR 25921252) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), RASH MACULAR (blotchy), FEELING ABNORMAL (after the first moderna dose felt fuzzy headed), PAIN IN EXTREMITY (Aches & pains in legs), BACK PAIN (Back pain), LYMPHADENOPATHY (Swollen glands), HEADACHE (Head pain) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The patient''s past medical history included Endometriosis (Factor V Leiden Endometriosis) and Hemiplegic migraine. Previously administered products included for Drug use for unknown indication: FENTANYL. Concurrent medical conditions included Drug allergy (Allergy to fentanyl). On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (sleepy) (seriousness criterion medically significant), RASH MACULAR (blotchy) (seriousness criterion medically significant) and FEELING ABNORMAL (after the first moderna dose felt fuzzy headed) (seriousness criterion medically significant). On 08-Sep-2021, PAIN IN EXTREMITY (Aches & pains in legs) and PYREXIA (Fever) had resolved with sequelae. At the time of the report, SOMNOLENCE (sleepy), RASH MACULAR (blotchy) and FEELING ABNORMAL (after the first moderna dose felt fuzzy headed) outcome was unknown, BACK PAIN (Back pain) and HEADACHE (Head pain) was resolving and LYMPHADENOPATHY (Swollen glands) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: high (High) High. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient took first moderna dose had experienced felt fuzzy headed, couldnt concentrate, very sleepy, sore arm. Symptoms Passed within one day after 8 days later symptoms was reappeared and had a blotchy red rash around the injection site. Patient also had periods have been heavier and more painful than before. Patient felt much worse when he had second dose of vaccine and had fever 38.5, extremely sore back, legs, ribs, shoulders, calves and ankles Head pain which came on during the 15 minute reaction time. glands in collar bone on the injection side was very swollen and painful. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant product use was not provided. Treatment information was not provided. Company comment: This case concerns a 35-year-old, female patient who experienced the unexpected events of Somnolence, Rash macular, Feeling abnormal, Pain in extremity, Back pain, Lymphadenopathy, Headache and Pyrexia. The events occurred 2 days after the second dose vaccination. The rechallenge is unknown as per Regulatory Authority report. The benefit-risk relationship of Spikevax (mRNA-1273 - Moderna COVID-19 Vaccine) is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 35-year-old, female patient who experienced the unexpected events of Somnolence, Rash macular, Feeling abnormal, Pain in extremity, Back pain, Lymphadenopathy, Headache and Pyrexia. The events occurred 2 days after the second dose vaccination. The rechallenge is unknown as per Regulatory Authority report. The benefit-risk relationship of Spikevax (mRNA-1273 - Moderna COVID-19 Vaccine) is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1720885 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-07
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Headache, Myocarditis, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocarditis
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: chest tightness; shortness of breath; fever; headache; nausea; Acute myocarditis; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25929225) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (chest tightness), DYSPNOEA (shortness of breath), PYREXIA (fever), HEADACHE (headache), NAUSEA (nausea) and MYOCARDITIS (Acute myocarditis) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. Concurrent medical conditions included Acute myocarditis. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 07-Sep-2021, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). On 11-Sep-2021, MYOCARDITIS (Acute myocarditis) had resolved with sequelae. At the time of the report, CHEST DISCOMFORT (chest tightness), DYSPNOEA (shortness of breath), PYREXIA (fever), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information was not provided by reporter. The patient was diagnosed with acute myocarditis with marked troponin rise to $g16000. Echocardiography demonstrating mild impairment in left ventricular systolic function was reported. This case concerns a 19-year-old male patient with relevant medical history of Acute myocarditis, who experienced the unexpected events of Chest discomfort, Dyspnoea, Pyrexia, Headache and Nausea , and expected event of Myocarditis ,event Myocarditis occurred 15 days after second dose of Moderna CoviD-19 vaccine . The onset dates of Chest discomfort, Dyspnoea, Pyrexia, Headache and Nausea was not reported. The rechallenge was unknown since no information about the first dose was disclosed . The reporter did not provide any causality assessment. The medical history of Acute myocarditis remains a confounder. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna CoviD-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old male patient with relevant medical history of Acute myocarditis, who experienced the unexpected events of Chest discomfort, Dyspnoea, Pyrexia, Headache and Nausea , and expected event of Myocarditis ,event Myocarditis occurred 15 days after second dose of Moderna CoviD-19 vaccine . The onset dates of Chest discomfort, Dyspnoea, Pyrexia, Headache and Nausea was not reported. The rechallenge was unknown since no information about the first dose was disclosed . The reporter did not provide any causality assessment. The medical history of Acute myocarditis remains a confounder.The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna CoviD-19 vaccine is not affected by this report.


VAERS ID: 1720968 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-07
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 antibody test; Test Result: Positive ; Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210907; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202101223233

Write-up: TESTED POSITIVE FOR COVID-19 AND CARRIES THE L452R MUTANT STRAIN; TESTED POSITIVE FOR COVID-19 AND CARRIES THE L452R MUTANT STRAIN; This is a spontaneous report from a non-contactable healthcare professional Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from Regulatory Authority (manufacturer control number: HK-Fosun-2021FOS003536), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 09-Sep-2021, RA announced that two additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 2 cases that confirmed COVID-19 after Comirnaty vaccination. A 56-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 10-Apr-2021 and 01-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 24-Jul-2021, the patient''s blood specimen tested positive for anti-spike protein antibody. The patient tested negative on 16-Aug-2021 and then travelled on 18-Aug-2021. On 07-Sep-2021, the patient arrived by flight. His specimen collected upon arrival on the same day tested positive for COVID-19 and carries the L452R mutant strain but does not carry the N501Y or E484K mutant genes. The patient was asymptomatic and confirmed as COVID-19. The adverse event ''tested positive for COVID-19 and carries the L452R mutant strain'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 10-Sep-2021. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003535 (master case) and 2021FOS003536. Follow-up closed, no further information is possible. Causality Assessment: Asymptomatic COVID-19, Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223239 same reporter/product, different patient/event


VAERS ID: 1721172 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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: JPPFIZER INC202101167562

Write-up: Tension shock; The patient was passed out when he react to reality; the patient felt giddiness and closed his eyes; This is a spontaneous report from a contactable Physician received via the regulatory authority. A 27-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 07Sep2021 10:15 (Batch/Lot number: FF0834) as single dose for covid-19 immunisation (Age at vaccination 27 years) The patient medical history and concomitant medications were not reported. The patient experienced tension shock (medically significant) on 07Sep2021 10:30 with outcome of recovered, the patient was passed out when he react to reality (medically significant) on 07Sep2021 10:30 with outcome of recovered, the patient felt giddiness and closed his eyes (medically significant) on 07Sep2021 10:30 with outcome of recovered. Therapeutic measures were taken as a result of the reported events including: rapid fluid replacement and lifting of the lower limbs and lower legs. Course of the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 07Sep2021 at 10:15 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF0834(as reported), Expiration date unknown, Dosage was unknown) intramuscular in the arm left for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. On 07Sep2021 at 10:30 (15 min after vaccination), the patient experienced passed out, tension shock and giddiness. After the first vaccination, the patient was followed up on the seat. within 4 minutes after following up, the patient felt giddiness and closed his eyes. The patient was passed out when he react to reality. The patient had no memory about he was moved to bed and pat on face. The event was considered as a tension shock. The outcome of the events was recovered with the treatment included rapid fluid replacement and lifting of the lower limbs and lower legs. The reporter classified the events as non-serious. Follow-up activities closed: Follow-up activities are not possible.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Shock, Loss of Consciousness, Dizziness and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1721214 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Liver disorder
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Acute liver disorder; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP088530) on 09-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This spontaneous case was reported by a physician and describes the occurrence of LIVER DISORDER (Acute liver disorder) in a 3-decade-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced LIVER DISORDER (Acute liver disorder) (seriousness criteria hospitalization prolonged and life threatening). At the time of the report, LIVER DISORDER (Acute liver disorder) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LIVER DISORDER (Acute liver disorder) to be possibly related. On an unknown date, in hepatic function test alanine transaminase & aspartate aminotransferase level were high which were indicative of acute liver disorder which led to patient being hospitalized. No concomitant medications were provided. No treatment information was provided. This case concerns a 3 decade-old male patient, who experienced the unexpected event of Liver disorder. The event occurred the day after the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: Since AST was fairly high level of 3,000, which was indicative of acute liver disorder; thus, the patient was taken to the emergency hospital.; Sender''s Comments: This case concerns a 3 decade-old male patient, who experienced the unexpected event of Liver disorder. The event occurred the day after the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1721227 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (Febrile convulsion (childhood))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Grip strength decreased in the left hand; Numbness in the left hand and forearm; Numbness in the left hand and forearm; This case was received via Agency Regulatory Authority (Reference number: 2021TJP092460) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref,v21126301). On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 07-Sep-2021, at 15:18, the patient received the 1st dose of this vaccine. At 15:35, grip strength decreased in the left hand and numbness in the left hand and forearm developed. The symptoms did not spread to other areas. Blood pressure, pulse and SpO2 were normal, and consciousness was clear. The possibility of peripheral nerve disorder caused by intramuscular injection could not be denied. The patient went home once, and then visited an emergency department and a family doctor due to subsequent symptoms. The outcome of grip strength decreased in the left hand and numbness in the left hand and forearm was reported as ongoing. 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. This case concerns a 23-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of Grip strength decreased in the left hand and numbness in the left hand and forearm. The events occurred on the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the events happened after the first dose. 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.; 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 23-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of Grip strength decreased in the left hand and numbness in the left hand and forearm. The events occurred on the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the events happened after the first dose. 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.


VAERS ID: 1722076 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE430 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Haemoglobin, Heart rate, Mouth haemorrhage, Oxygen saturation, Respiratory rate
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CANNABIS
Current Illness: Cannabis abuse, unspecified use (Currently smelling of cannabis. Sign that he smoked cannabis yesterday and this morning still. Patient used cannabis prior to vaccination.)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain; Blood loss of (NOS); Upset stomach; Comments: The patient had no known allergy and patient was seen by doctor previously.
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Respiratory rate; Result Unstructured Data: 14 {breaths}/min; Test Date: 20210907; Test Name: Heart rate; Result Unstructured Data: 86 {beats}/min; Test Date: 20210907; Test Name: O2 saturation; Result Unstructured Data: 100 %; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: 37.3 C; Test Date: 20210907; Test Name: Hemoglobin; Result Unstructured Data: 9.1 g/dL; Test Date: 20210907; Test Name: BP; Result Unstructured Data: 141/67 mmHg
CDC Split Type: ZAJNJFOC20210936890

Write-up: MOUTH BLEED; This spontaneous report received from a health care professional concerned a 27 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: upset stomach, abdominal pain, lost blood, and smoked cannabis and other pre-existing medical conditions included the patient had no known allergy and patient was seen by doctor previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE430, and expiry: 23-MAY-2023) dose was not reported, 1 total, administered on 07-SEP-2021 11:20 for prophylactic vaccination. Patient used cannabis and other unknown drugs prior to vaccination. On 07-SEP-2021, within 10 minutes of vaccine administration, the patient experienced mouth bleed, and was hospitalized. Laboratory data included: BP (NR: not provided) 141/67 mmHg, Body temperature (NR: not provided) 37.3 C, Heart rate (NR: not provided) 86 {beats}/min, Hemoglobin (NR: not provided) 9.1 g/dL, and Respiratory rate (NR: not provided) 14 {breaths}/min, O2 saturation (NR: not provided) 100 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mouth bleed. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210936907.; Sender''s Comments: V0: 20210936890-covid-19 vaccine ad26.cov2.s- Mouth bleed. 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: MEDICAL HISTORY


VAERS ID: 1724546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176079

Write-up: Armpit pain; Lymph nodes enlarged; 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-202109080754034680-N3OMA, Safety Report Unique Identifier GB-MHRA-ADR 25910501. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Sep2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. On 07Sep2021, 1 day after the vaccination, the patient experienced armpit pain and lymph nodes enlarged; both the events were reported as serious for being medically significant. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event armpit pain and lymph nodes enlarged was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724555 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Contusion, Diarrhoea, Hyperhidrosis, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101182300

Write-up: Abdominal pain; Diarrhea; Vomiting; Sweating; Bruising of leg; 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-202109080920034940-JB9HG with Safety Report Unique Identifier GB-MHRA-ADR 25910749. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not pregnant and was not breast feeding at the time of the report. Concomitant medications were not reported. On 06Nov2020, the patient underwent COVID-19 virus test and the result was positive. On 07Sep2021, the patient experienced bruising of leg; on 08Sep2021, abdominal pain, diarrhea, vomiting and sweating; all were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events bruising of leg, abdominal pain, diarrhea, vomiting and sweating was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724557 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Diarrhoea, Headache, Maternal exposure during pregnancy, Myalgia, Nausea, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; FOLIC ACID; LEVOTHYROXINE; SERTRALINE
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38.0; Comments: fever (mild at 38.0)
CDC Split Type: GBPFIZER INC202101182348

Write-up: Diarrhea; Fever; Nausea; Patient was exposed to the medicine first-trimester/ pregnant; headache; sore muscles; pain at injection site; feeling of weakness; 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-202109081001170680-OKKU1, Safety Report Unique Identifier of GB-MHRA-ADR 25911181. A 34-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380), via an unspecified route of administration on 07Sep2021 at the age of 34 years old as a single dose for COVID-19 immunisation. Medical history included ongoing pregnancy, depression and hypothyroidism. The patient had no symptoms associated with COVID-19, not had a COVID-19 test and not enrolled in clinical trial. The patient was not currently breastfeeding. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) for pregnancy, folic acid (MANUFACTURER UNKNOWN) for folic acid supplementation, levothyroxine (MANUFACTURER UNKNOWN) for hypothyroidism and sertraline (MANUFACTURER UNKNOWN) for depression; all from unknown dates and unknown if ongoing. The patient was exposed to the medicine first-trimester (1-12 weeks). It was reported that patient was 9 weeks pregnant. On an unknown date in 2021, the patient experienced headache, pregnant, sore muscles and feeling of weakness; On 08Sep2021, the patient experienced diarrhea, fever and nausea; all the events were reported as serious for being medically significant. On an unknown date in 2021, the patient experienced pain at injection site. On an unknown date, the patient underwent body temperature and the result was mild fever with 38.0 (unspecified units). The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome for the events headache, sore muscles, pain at injection site and feeling of weakness was unknown. The clinical outcome for the events diarrhea, fever and nausea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210908; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182356

Write-up: Nausea; Headache; Cold sweat; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202109081456506320-PEWUJ with Safety Report Unique Identifier GB-MHRA-ADR 25912546. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration on 06Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant and was not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On 07Sep2021, the patient experienced nausea, headache, and cold sweat; all reported as serious for being medically significant. The patient underwent lab tests and procedures on 08Sep2021 which included COVID-19 virus test: No-negative covid-19 tests. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event nausea and cold sweat were recovered on 07Sep2021; while that of the event headache was recovered on 08Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724578 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chills, Hyperhidrosis, Pyrexia, Thirst
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN
Current Illness: Allergy (Patient took allergy tablets)
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis (Patient took naproxen for arthritis); COVID-19 virus test (Positive)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: excessive thirst; shivering; tight chest; high temperature; sweating; Shivers; This case was received (Reference number: GB-MHRA-ADR 25913768) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THIRST (excessive thirst), CHILLS (shivering), CHEST DISCOMFORT (tight chest), PYREXIA (high temperature), HYPERHIDROSIS (sweating) and CHILLS (Shivers) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The patient''s past medical history included Arthritis (Patient took naproxen for arthritis) and COVID-19 virus test (Positive) on 21-Apr-2020. Previously administered products included for Arthritis: NAPROXEN. Past adverse reactions to the above products included No adverse reaction with NAPROXEN. Concurrent medical conditions included Allergy (Patient took allergy tablets). Concomitant products included NAPROXEN for Arthritis. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On an unknown date, the patient experienced THIRST (excessive thirst) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), CHEST DISCOMFORT (tight chest) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating) (seriousness criterion medically significant). On 08-Sep-2021, CHILLS (Shivers) had resolved with sequelae. At the time of the report, THIRST (excessive thirst), CHILLS (shivering), CHEST DISCOMFORT (tight chest), PYREXIA (high temperature) and HYPERHIDROSIS (sweating) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had a high temperature, shivering and sweating, all her body ached especially legs and head, tight chest, excessive thirst and swollen and painful at jab sight. Treatment medication was not provided by the reporter. Patient took allergy tablets. Patient''s all body ached, swollen and painful at jab sight. Company Comment: This case concerns a 22 year-old, male subject with a history of allergy and arthritis, who experienced the unexpected events of thirst, chills, chest discomfort, pyrexia, hyperhidrosis and chills . Time to onset from vaccination was not reported for the events thirst, chills, chest discomfort, pyrexia and hyperhidrosis. The event chills on the same date after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The medical history of allergy and arthritis remain as confounders. The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 22 year-old, male subject with a history of allergy and arthritis, who experienced the unexpected events of thirst, chills, chest discomfort, pyrexia, hyperhidrosis and chills . Time to onset from vaccination was not reported for the events thirst, chills, chest discomfort, pyrexia and hyperhidrosis. The event chills on the same date after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The medical history of allergy and arthritis remain as confounders. The benefit-risk relationship of drug Spikevax is not affected by this report.


VAERS ID: 1724594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190689

Write-up: cellulitis; painful; Patient felt tired; unwell; Swollen glands; This is a spontaneous report from a contactable other hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202109090923403550-BF3ME. Safety Report Unique Identifier GB-MHRA-ADR 25916840. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number: FD8813, Expiry date: unknown), dose 1 via an unspecified route of administration on 05Sep2021 as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for hypertension, start and stop date were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced cellulitis, painful, Patient felt tired, unwell on an unspecified date and swollen glands on 07Sep2021. It was reported that day 2 post vaccination, patient had left swollen under armpit tissue. Appeared cellulitis and painful. Patient felt tired and unwell. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative covid-19 test on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "None". The clinical outcome of swollen glands was not recovered, and other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724598 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101190678

Write-up: customer faint; pain; Vomited; become hot; This is a spontaneous report from a contactable other hcp. This is the first of 2 reports. This case is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091001315200-I8NTC. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25916878. A 24-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection, Batch/Lot Number: FE3380), dose 1 via an unspecified route of administration on 07Sep2021 (age at the time of vaccination was 24-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 07Sep2021, patient vomited during 15-minute post vaccine waiting period. Witnessed another customer faint (medically significant) which caused him to vomit and become hot. Patient confessed afterwards that he had "smoked something" for help with the pain of the vaccine. Given water and moved to cooler area of the vaccine pod. The report was not related to possible blood clots or low platelet counts. The outcome of Vomited was recovered on 07Sep2021. The outcome of faint, become hot and pain was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101197657 Same drug/Different patient/Different events


VAERS ID: 1724640 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ocular hyperaemia, SARS-CoV-2 test, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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: Blurry vision
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191668

Write-up: Blury vision; Bloodshot eye; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101015580820-0WKCA, Safety Report Unique Identifier GB-MHRA-ADR 25923064. A 27-year-old patient of an unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not reported), dose 2 via an unspecified route of administration on 06Sep2021 as single dose for COVID-19 immunisation. Medical history included vision blurred from 07Aug2021 to an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 07Sep2021, the patient experienced bloodshot eye. On an unspecified date, the patient experienced blury vision. On 06Sep2021, the patient underwent lab tests and procedures which included SARS-COV-2 test: negative. The outcome of bloodshot eye was not recovered. The outcome of blury vision was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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

Life 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 INC202101191672

Write-up: Chest pain; Joint pain; Fever; Painful L arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109110006298180-LR7I5, Safety Report Unique Identifier GB-MHRA-ADR 25926929. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF3319), via an unspecified route of administration on 07Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not had symptoms associated with COVID-19. Patient did not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced painful l arm on 07Sep2021, chest pain and joint pain on 08Sep2021, fever on 08Sep2021. The outcome of event chest pain and painful l arm was recovering. The outcome of event joint pain was not recovered. The outcome of event fever was recovered on 09Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724719 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191732

Write-up: loose stools/ diarrhea; Stomach pain/ stomach aches; Nausea; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111234134460-5VRXW. A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 07Sep2021 (at the age of 25-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 07Sep2021, the patient had stomach pains, loose stools/ diarrhea and random stomach aches resulting in his needed to use the restroom up to a dozen times a day and had a nausea. The case was assessed as serious (disability). Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. Outcome of the events were not resolved. No follow-up attempts are possible, information about lot/batch number cannot be obtained, No further information is expected.


VAERS ID: 1724743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate decreased, Off label use, Product use issue
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Gestational diabetes ((resolved)); Graves'' disease; Nasal polyps; Pain
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:dropped several times below 60 bpm
CDC Split Type: GBPFIZER INC202101191484

Write-up: off label use; Heart rate low; Drug use in unapproved population; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109112226381520-BEPHX. Safety Report Unique Identifier GB-MHRA-ADR 25928751. A 36-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot Number: FE8087), via an unspecified route of administration on 07Sep2021 as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date with unspecified Batch/Lot number as dose 1, single for COVID-19 immunisation. The patient''s medical history included ongoing breast feeding, basedow''s disease (remission), nasal polyps, pain from an unknown date and unknown if ongoing, gestational diabetes from an unknown date and unknown if ongoing (resolved). Concomitant medications included paracetamol (PARACETAMOL) taken for pain, start and stop date were not reported. Patient had no symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. On 07Sep2021, the patient experienced drug use in unapproved population, off label use. On 11Sep2021, the patient experienced heart rate low. The events were assessed as medically significant. The patient underwent lab tests and procedures which included Heart rate: dropped several times below 60 bpm. Outcome of Event was unknown while Not recovered for Heart rate low. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101202069 baby case


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