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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 223 out of 8,010

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VAERS ID: 1769058 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal distension, Condition aggravated, Dysmenorrhoea, Full blood count normal, Haematocrit normal, Haemoglobin normal, Headache, Menstrual disorder, Migraine, Night sweats
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: azelastine-fluticasone 137-50 mcg/spray Spry 1 spray by Nasal route 2 (two) times daily. 2/8/21 2/8/22 Yes frovatriptan (FROVA) 2.5 MG tablet TAKE 1 TABLET BY MOUTH AT ONSET OF MIGRAINE. MAY REPEAT AFTER 2 HOURS AS NEEDED. DO NOT EXCEED$g 2
Current Illness: None
Preexisting Conditions: Allergic rhinitis ? GERD (gastroesophageal reflux disease) ? Hemophilia A carrier She has had prolonged bleeding with surgeries and menses and in ankle joint-symptomatic carrier 38% level ? History of night sweats ? Iron deficiency ? Migraine ? Pneumonia
Allergies: None
Diagnostic Lab Data: Repeat CBC after vaccine and adverse reaction showed normal H/H 14.2/43% Plts 301K (prior 328K)
CDC Split Type:

Write-up: Migraine headache shortly after vaccine administration. D5 after vaccine recurrent migraine. D10 got menstruakl cramping and onset of menses than continued through D13. In addition have had night sweats , headaches, mild cramping and bloating during, and since menstruating. Prior to this experience, my last menses was in December 2020 when I stopped taking the birth control pill. It took about a month after stopping the pill that my migraines (used to get them 3-4x/mo) and night sweats (that mostly occurred during menses) stopped so this experience has been concerning and disconcerting. It feels like this vaccine negatively affected my hormones.


VAERS ID: 1769091 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025C21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Extra dose administered, Influenza like illness, Multiple sclerosis, Musculoskeletal stiffness, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: Levothyroxine Sodium, Vesicare, Prozac, Aquifen, Glucosamine, Lutein, Slow niacin, Nature''s Bounty Cranberry capsules, Now Beta Carotene, Magnesium, Candibactin-BR, Fish Oil, Valerian Root, Natures Bounty Calcium w/D3, Ibuprofen
Current Illness: None
Preexisting Conditions: MS, Lower back pain
Allergies: NKA
Diagnostic Lab Data: None(did not seek medical care)
CDC Split Type: vsafe

Write-up: After my booster around 4pm had flu-like symptoms 103? Fever. MS issue with stiff muscles(lower body only) continued thru the next day. Convulsed the next night multiple times. (about 20 times) Back to normal mostly.


VAERS ID: 1770007 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-03-31
Onset:2021-09-10
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Mammogram abnormal, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic 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: Claritin otc as needed
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Mammogram Ultrasound
CDC Split Type:

Write-up: Right side axillary enlarged lymph nodes noted 5 months after vaccine. Abnormal lymph nodes per mammogram and ultrasound . Biopsy recommended per primary.


VAERS ID: 1770457 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-14
Onset:2021-09-10
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003F21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Pneumonia, Product dose omission issue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210910; Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: Positive.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine); Tired; Bilateral Pneumonia; COVID-19 disease; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral Pneumonia) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PNEUMONIA (Bilateral Pneumonia) (seriousness criterion medically significant), COVID-19 (COVID-19 disease), COUGH (Cough) and FATIGUE (Tired). On 11-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)). On 11-Sep-2021, PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)) had resolved. On 24-Sep-2021, PNEUMONIA (Bilateral Pneumonia) and COVID-19 (COVID-19 disease) had resolved. At the time of the report, COUGH (Cough) and FATIGUE (Tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. 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 is a case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This is a case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1771456 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (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: Zyprexa 15mg at bedtime
Current Illness: no
Preexisting Conditions: Psychiatric Illnesses
Allergies: penicillin
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient stated that his first dose of COVID was Moderna but after checking on show me vac it was actually Pfizer. Patient previously received Pfizer for first dose and then Moderna for second dose.


VAERS ID: 1771559 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-03
Onset:2021-09-10
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Aura, Bundle branch block left, Cardiac disorder, Cardiac stress test abnormal, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Headache, Loss of consciousness, Magnetic resonance imaging abnormal, Malaise, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Convulsions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Allergic reaction (hives) to Prevnar 13, vaccination date approx 2014.
Other Medications: Oxybutynin 5mg 2x/day Acyclovir 400mg 2x/day Loratadine 10mg 9/2021 1x/day Atorvastatin 20mg Flomax (Tamsulosin) 0.4mg Losartan 50mg Melatonin 3mg Vitamin B complex Vitamin D3 Omeprazole 20mg Iron supplement 27mg every other day Hydroxyzine
Current Illness:
Preexisting Conditions: Chronic Lymphocytic Leukemia (CLL) - being treated with targeted med Pitrubrutinib 150 mg/day (BTK inhibitor, as part of a clinical trial)
Allergies: Prevnar 13 (pneumonia vaccine)
Diagnostic Lab Data: 9/15/2021 - ECG - Research Center- Results: LBBB and elevated ST Segment 9/17/2021 - MRI - Medical Center - Results: normal, no evidence of ischemic event 9/20/2021 - ECG - Heart & Vascular -Results: LBBB 10/5/2021 - Echocardiogram and NM cardio stress test - Heart & Vascular - Results: mild septum thickening
CDC Split Type:

Write-up: Syncope event - I passed out just sitting at my dining table, for approximately 30 to 45 minutes. Upon coming to, I had full-visual-field "aura" like aura migraine, but completely filling my field of vision in both eyes, vs. usual partial aura. I had a continuous moderate headache for one week after fainting, felt generally under the weather, and had a mild temperature (99.6) for about 24 hours after the event.


VAERS ID: 1771737 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Condition aggravated, Oedema peripheral, Pulmonary oedema, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Acebutolol 400mg daily; Prilosec; Preservision; Furosemide 20mg daily; Amlodipine 5mg daily in am and 2.5mg daily in pm; Enalapril 20mg daily; Glimeperide 1mg twice daily; Levothyroxine 0.05mg daily; Timoptic 2.5mg L eye twice daily; Simv
Current Illness: None
Preexisting Conditions: Diabetes Hx of wheezing "with colds" - uses a nebulizer when needed HTN High cholesterol Macular degeneration "sticky aortic valve"
Allergies: Sulfa - rash "cough medicine" - rash (not codeine)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received the vaccine on 9/8/21. Woke up 9/10/21 w/a wheeze. When she didn''t respond to nebulizer Rx at home, she was taken to a walk in. She was found to have a wheeze and pedal edema and was subsequently transferred to hospital and admitted w/dx of CHF and pulmonary edema. Discharged home on 9/14/21. Per granddaughter, doctors do not believe dx was related to vaccine, but advised against the 2nd dose.


VAERS ID: 1771953 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Hypoaesthesia, Pain, Paraesthesia
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt reports numbness and tingling in hands and feet that started 2 days post-vaccination. Pt reports numbness and tingling is still ongoing, 1 month post-vaccination. Pt reports PCP prescribed Gabapentin, which is helping with pain and sensations, but reports sensation is still there.


VAERS ID: 1772365 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Lymph node pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: patient reported developing pain in lymph nodes of right arm and developing numbness in arm and into neck about 6 hours later.


VAERS ID: 1773462 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / N/A RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Patient believes he had a blood test while in the ER but was feeling really bad so he is not sure. He does not know the results.
CDC Split Type:

Write-up: At approximately 2 PM which was four hours after vaccination patient began to become ill. He developed headache, fever, chills, nausea and vomiting. He continued to have persistent vomiting throughout the night. He was seen in ER. He reports that he was given 2, IV''s of Ondansetron (4 mg each) at which time it brought his non stop vomiting under control. He was also given a shot of Toradol for his headache. He was given a prescription of Ondansetron and told to take Tylenol or Advil for his headache. His symptoms required that he take these medications for 3 days. Patient was home sick for 24 hours after ER visit and then was able to go to work again in the ER using his medications.


VAERS ID: 1775096 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-06
Onset:2021-09-10
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Heart rate increased, Oxygen saturation decreased, Respiratory tract congestion, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

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

Write-up: Symptom onset was 9/10/21; symptoms include cough, shortness of breath, congestion, diarrhea, wheezing, fatigue, low oxygen levels and rapid heart rate. Case was hospitalized; admitted on 9/13/2021 and discharged on 9-16-2021.


VAERS ID: 1775630 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Fatigue, Headache, Muscle spasms, Nausea, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (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: Zyrtec 10mg. Citalopram 20mg. Flovent 2 puffs BID. Gabapentin 300mg QHS for sleep.
Current Illness: None
Preexisting Conditions: Allergies, asthma
Allergies: Sulfa, iodinated dyes, eggs.
Diagnostic Lab Data: None, reported to doctor and monitored symptoms
CDC Split Type:

Write-up: 9/10/21 - day of vaccine: Headache started 2 hours after vaccine. 4-5/10 on pain scale. Unrelieved by Acetaminophen, Ibuprofen, or sleep. Lasted 1 week and disappeared. 9/11/21 - woke and got up out of bed only to sit down hard on the floor with extreme dizziness triggering nausea. It took about 15 mins to be able to stand up without it reoccurring. I''ve had to avoid sudden position changes, rapid head turns, bending over, and turning over quickly in bed since. Every time I forget the sudden dizziness reoccurs, approximately 4-5 times/week when I forget to move/bend correctly. 9/13 and 9/27/21: Sudden onset chest tightness and shooting chest pains, shortness of breath without wheezing or other typical asthma precursor symptoms for me. The symptoms do respond and clear with Albuterol but are completely different from any other asthma flares I''ve had over decades of asthma. 9/11/21 - Extreme fatigue. Sleeping 9 to 10 hours/night, falling asleep in meetings. Lasted approximately two weeks+ 9/23/21 - acute onset crampy right lower leg pain with no inciting injury. No redness or swelling, no increased pain with dorsiflexion. Improved with Ibuprofen and elevation. Gradual resolution over one week October 5th to 7th - woke during overnight of October 5th/6th with sudden onset upper and lower extremity joint pain - no redness or swelling. Elbows, wrists, knees, ankles. Improved with Acetaminophen or Ibuprofen and stretching


VAERS ID: 1776073 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-14
Onset:2021-09-10
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Systemic: erythema multiforme-Medium, Additional Details: She was diagnosed with erythema multiforme by a dermatologist on tops on both her hands.


VAERS ID: 1776692 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2558 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Condition aggravated, Crohn's disease, Diarrhoea, Fatigue, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; mercaptopurine; LEXAPRO
Current Illness: No
Preexisting Conditions: Crohn''s disease; depression; anxiety
Allergies: No
Diagnostic Lab Data: Covid on 19 sep2021
CDC Split Type: vsafe

Write-up: Fatigue and headache that evening at 8pm. Next day same. A week later after 9 nine days diagnosis Covid. 17 and 18 Sep - headache and congestion. On 19 urgent care and got tested. I deteriorated with fatigue and headache. By Wednesday, I had diarrhea and got 23Sep monoclonal infusion. After or 24Sep - my Covid symptoms were gone, Crohn''s systems flared up again. 24Sep stared the steroids.


VAERS ID: 1776793 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data: na
CDC Split Type:

Write-up: na


VAERS ID: 1776814 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data: na
CDC Split Type:

Write-up: pt received 1st pfizer vaccine on 9/5/21 at a pharmacy then came to our clinic on 9/10/21 and received a second pfizer vaccine (only 5 days apart and not 21 days) pt did not report any adverse events. we noticed when entering vaccine information from clinic back at our pharmacy


VAERS ID: 1778517 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Flushing, Hyperhidrosis, Incomplete course of vaccination, Injection site pain, Pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Medication errors (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? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Severe, Additional Details: caregiver (husband) came in to pharmacy to report severe reaction to his wife after covid 19 1st dose and hospitalization, he didnt want her to get second dose


VAERS ID: 1778957 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
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:

Write-up: Patient got moderna at 15yo as mistakenly ordered by provider. This RN noticed. Patient received 2nd dose moderna as recommended by the state - received on 10/11/21. No adverse reactions reported.


VAERS ID: 1779555 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Cognitive disorder, Condition aggravated, Headache, Neck pain, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mild head injury
Preexisting Conditions: No
Allergies: Sulfa drugs; iodine; shellfish; insect bites (bees)
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: I began having low grade fever and joint aches on pains on 09/10/21. Due to a recent brain injury, I had been having trouble with processing thought. On 09/12/21, I noticed that those symptoms getting worse for about one week. On 10/05/2021, I had a fever of 99.6 and the next day no fever but a sore throat. I took a home covid test and it was negative. Thursday, 10/07/2021, stayed home to rest. On 10/8/2021, my temp went to 102.2 and had severe neck pain for a day. By morning it had improved. 10/09/21, I developed a headache during the day. I took a second test 10/12/2021, it came back negative.


VAERS ID: 1782289 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-12
Onset:2021-09-10
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GW0158 / 2 UN / SYR

Administered by: Public       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Hypertension
Allergies: Unknown
Diagnostic Lab Data: Antigen Test administered on 09/11/2021 at the Urgent Care Center.
CDC Split Type:

Write-up: Patient Contracted COVID-19.


VAERS ID: 1782300 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-01
Onset:2021-09-10
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21 / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 UN / SYR

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Diabetes Hypertension Cardiovascular Disease Current Smoker
Allergies: Unknown
Diagnostic Lab Data: PCR Test administered on 09/10/2021 at the Hospital
CDC Split Type:

Write-up: Patient Contracted COVID-19


VAERS ID: 1782337 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058EZ1A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011FZ1A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Condition aggravated, Eye swelling, Feeling cold, Gait disturbance, Headache, Induration, Lip swelling, Lymph node pain, Pain, Peripheral swelling, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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), 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: zoloft, gabapentine,wellbutrin, diazapam, amoxicillin had two doses left, centrum vitamin
Current Illness: had a upper respiratory infection prior to vaccine. That was why I was on the antibiotic
Preexisting Conditions: Chronic pain
Allergies: neosporin
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1st injection: after 15 minute monitor neck started to itch, hives on L arm and all over my neck and chest. About an half hour after that when I received Benadryl and shot of Solumedrol I started to get a rash around my lips and my lips swelled. I took another dose of benadryl. I went home and by the end of the day had 125mg of Benadryl. 2nd injection: PCP advised me to pre medicate and I took Benadryl and Clariton. I was fine thru my shift with taking 50mg of benadryl. When I got home around 9pm I laid in my chair and fell asleep. I woke up around 3am and was freezing and aching. I went to bed and when I woke up my eyes, jaw, lips and L arm were swollen. I could barely walk. I took a benadryl throughout the day. I had a severe headache. The Left lymph node was very sore and hard in the side of my neck. My facial swelling finally went down Sunday into Monday. I will not be receiving the booster. I was made to take the vaccine in the first place. I did not want to take but was afraid it was going to come down to me getting fired.


VAERS ID: 1782350 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Arthritis (broad)

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

Write-up: I have had my period every single day since my vaccine (about 4-5 weeks). This is not normal for me. I have been on a birth control pill that has helped regulate my period and menstrual cycle. My pills and my cycles have been very regulated for over 2+ years. I very rarely get my period, and when I do, it is very light spotting. However, since getting the vaccine, I have had my period since the vaccine. The flow varies from light to heavy and I continue to have normal period symptoms such as headaches, knee pain and cramps have been present since the vaccine. I have not been under any "stress" and nothing else seems to be out of ordinary for me. I went in for the vaccine while on my period (it was a light/spotting and normal period), thinking it would stop after a few days, but it never stopped.


VAERS ID: 1782412 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-09-10
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW01532 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure to SARS-CoV-2, Fatigue, Feeling hot, Headache, Influenza like illness, Loss of personal independence in daily activities, SARS-CoV-2 test negative
SMQs:, Dementia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: bleeding disorder - Vons Willebrands Type 2B
Allergies: codeine
Diagnostic Lab Data: COVID - test swab - maybe on the 7th day of my illness
CDC Split Type: vsafe

Write-up: Felt flu-ish- stayed in my jammies for an entire week. Couldn''t do anything. I had a horrible headache. super tired; (was exposed to COVID); I was fatigued and super hot and couldn''t cool down. After my fifth day of feeling horrible, We were having a huge spike in COVID cases when I was experiencing this and so my friends in the doctor office - said to stay at home and quarantine. Had a Parking lot - COVID nasal test - swab in the very front and I tested negative - they couldn''t go all the way to the back because of my bleeding disorder. He went maybe a quarter of an inch in my nostril. My son, 13, started experiencing the same symptoms. I took Excedrin Extra strength and also Nyquil both day and night time to help me feel better. I had the symptoms probably 7-10 days total. We had such a huge uptake of cases here and I called the County and they said there were no testing sites available even. They were all full. They said if I experienced shortness of breath to go to the hospital.


VAERS ID: 1782744 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-


VAERS ID: 1783094 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-09-04
Onset:2021-09-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pruritus, Injection site reaction, Rash macular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Almost a week after receiving the shot, my arm started itching and developed a whelp at the injection site on 9/10 at 11:00am. The whelp turned into a larger red blotchy spot by 9:00 pm on 9/10. The spot continued to grow on 9/11 and developed a darker red ring around the red blotchy spot around 2:30pm on 9/11. On 9/12, the spot began to fade and disappeared by end of day on 9/13.


VAERS ID: 1784819 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain
SMQs:

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: apples
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, headache, fatigue, soreness for 3 days. Treatment = rest


VAERS ID: 1784835 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-09-10
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 UN / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray abnormal, Cough, Decreased appetite, Dehydration, Diarrhoea, Dyspnoea, Electrocardiogram abnormal, Hypophagia, Inflammatory marker increased, Lung disorder, Nausea, Oxygen saturation decreased, Procalcitonin, Respiratory distress, Sinus tachycardia, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow)

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

Write-up: 64-year-old male who presented to ER with complaints of dehydration and shortness of breath. States he has had nausea, vomiting, diarrhea, nonproductive cough, decreased appetite, and decreased urine output since Monday. Has not had much intake and has not been able to take his med since Monday. He did not experience shortness of breath until today and reports receiving his Johnson & Johnson COVID vaccine in April. He denies fever, chest pain, sick contacts, or change in taste or smell. On my arrival, patient was noted to be on 6 L/NC of O2, with an SaO2 of 88-89%, then would temporarily go up above 90%. As we were talking further, SaO2 dipped to 77% and he had significant respiratory distress.


VAERS ID: 1784845 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-04
Onset:2021-09-10
   Days after vaccination:190
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 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood electrolytes normal, Blood test, COVID-19, COVID-19 pneumonia, Computerised tomogram thorax abnormal, Dizziness, Faeces discoloured, Haemoglobin decreased, Malaise, SARS-CoV-2 test positive, Transfusion
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 8-year-old female, has hypertension, being worked up for anemia, as well as has hypothyroidism, has not felt well in the last 1 week. She feels weak and dizzy, has no energy. She apparently underwent blood transfusion in the earlier part of this month. She did not feel much better. She has episodes of abdominal pain and black stools. Apparently, she has been taking iron therapy. Patient underwent workup, which reveals hemoglobin of 8.8. Electrolytes reveal unremarkable findings. She was tested for COVID, which was found to be positive.CT chest abdomen was consistent with atypical pneumonia of COVID-19.Patient admited for further management.


VAERS ID: 1784952 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-29
Onset:2021-09-10
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough, Feeling abnormal, Malaise, Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: None.
Allergies: Penicillin.
Diagnostic Lab Data: 09/10/2021 COVID test, positive; 09/20/2021 COVID test, negative.
CDC Split Type: vsafe

Write-up: I started feeling unwell on Thursday evening. I had fever, tunny nose, cough, chills, loss of taste and smell. I got tested for COVID on Friday and it came back positive. I felt pretty bad on Saturday. On Monday I received the monoclonal infusion and I felt better after that. On 09/20/2021 I tested negative. They recommended Theraflu and other over the counter medications.


VAERS ID: 1784956 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Pain
SMQs:, Extravasation events (injections, infusions and implants) (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: Eliquis Metoprolol Florastor probiotic
Current Illness:
Preexisting Conditions: Venous insufficiency History of DVT in legs
Allergies: Penicillin Amoxicillin Fluroquinolones Ampicillin Clindamycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very red arm at injection site Pain lifting arm Lasting 5Days


VAERS ID: 1785287 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-02-12
Onset:2021-09-10
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 2 - / -

Administered by: Private       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: Chronic Lung Disease, Cardiovascular Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized due to COVID-19. Patient is fully vaccinated.


VAERS ID: 1785368 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-16
Onset:2021-09-10
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 2 - / -

Administered by: Public       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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized due to COVID-19. Patient is fully vaccinated. Still in hospital.


VAERS ID: 1785511 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-05-11
Onset:2021-09-10
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 - / -

Administered by: Private       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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension, High cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized for 1 day due to COVID. Patient is fully vaccinated.


VAERS ID: 1785531 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Hypoaesthesia oral, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide 25mg Vitamin D2 81 mg Aspirin
Current Illness: Seasonal allergies
Preexisting Conditions: Hypertension
Allergies: Penicillin and other similar antibiotics Sensitivity to anesthesia - usually need higher than normal dose to be effective; often causes severe nausea
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Entire left arm immediately went completely numb. Felt like I was about to faint. Immediately drank cool water. Remained seated with head down and held ice-pack on the back of my neck in clinic for about 25-30 minutes before I felt stable enough to walk (assisted) out of the store. Numbness continued over 24 hours and included lips. Later in the evening and following day, I experienced muscle soreness in my lower back. Still experiencing feeling of pins and needles in my arm down into my fingertips.


VAERS ID: 1785686 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-07
Onset:2021-09-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstrual disorder, Ultrasound scan
SMQs:

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

Write-up: 3 days after receiving the 2nd pfizer dose I had terrible menstrual cramps. I had an ablation 10 years ago and no longer have periods. Cramping has intensified over the last month and I finally went in to get an ultrasound. the vaccine caused endometrial lining to re-grow back in "pockets". I now have 2 large blood filled areas in my uterus that is encapsulated by scar tissue so they will not drain. I am now going to have to have a hysterectomy because of this tissue regrowth.


VAERS ID: 1785962 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004F21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein normal, Chest X-ray normal, Chills, Dyspnoea, Dyspnoea exertional, Fatigue, Full blood count normal, Metabolic function test, Nausea, Pain, Pyrexia, Red blood cell sedimentation rate normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Shingrix , SOB on 12/15/2018, age 79 years
Other Medications: amLODIPine (NORVASC) 5 mg tablet Sig: Take 1 tablet by mouth Daily. ANORO ELLIPTA 62.5-25 MCG/INH inhaler Sig: USE 1 INHALATION DAILY atorvaSTATin (LIPITOR) 10 mg tablet Sig: Take 1 tablet by mouth nightly. cholecalciferol (VITAMIN D
Current Illness: None
Preexisting Conditions: Cardiac resynchronization therapy pacemaker (CRT-P) in place CAD (coronary artery disease) Permanent atrial fibrillation Peripheral arterial disease Acute heart failure with preserved ejection fraction S/P TAVR (transcatheter aortic valve replacement) PVD (peripheral vascular disease) S/p bilateral iliac kissing stents WHO group 1 pulmonary arterial hypertension Mixed hyperlipidemia RLS (restless legs syndrome) Interstitial lung disease Obstructive sleep apnea on CPAP Chronic respiratory failure with hypoxia Mixed restrictive and obstructive lung disease Rheumatoid arthritis involving multiple sites with positive rheumatoid factor Polycystic kidney disease Chronic prostatitis Chronic kidney disease, stage 3 (moderate) Depression Undifferentiated connective tissue disease Hx of agent Orange exposure Abnormality of gait Long term current use of anticoagulant
Allergies: Flagyl [Metronidazole] Other (See Comments) High 2/23/2017 States caused central nervous symptoms similar to a stroke. Sulfa Antibiotics Anaphylaxis High 5/17/2013 Zoster Vaccine Live Shortness Of Breath High 12/30/2019 Shigrix Vaccine-SOB Beta Adrenergic Blockers Nausea And Vomiting Medium Unspecified 12/8/2014 Pregabalin Swelling, Nausea And Vomiting Medium Unspecified 5/17/2013 Hands and feet "CHF symptoms" Oxycodone Rash Low 5/17/2013 Unsure of whether or not it caused the rash.
Diagnostic Lab Data: Labs: BMP, CDC, sed rate, C-reactive protein and Chest Xray: All within normal limits
CDC Split Type:

Write-up: First symptom noticed was N/V approximately 4 hours after vaccine administration, resolved after 6 hours. Approximately 6 hours following administration pt experienced shaking chills, low grade fever with body aches and fatigue. Approximately 9 hours post vaccination pt was noticing increased SOB with O2 sats which spouse states are usually mid 90''s were reading low 90''s. These symptoms decreased after day 2-3, improved at one week. Seen in OV 20 days following administration for fatigue. Pt continues to experience increased SOB with exertion and decreased home oxygen saturation levels below typical baseline. OV on 9/30/21 for symptoms indicates SpO2 reading of 93%. Prior to third dose pt had reduced Cellcept from 1000 mg daily to 500 mg daily for 2 weeks prior and had returned to full dose of Cellcept 2 weeks following, per instructions from rheumatologist. Spouse reports no other vaccine administrations or acute illnesses noticed in 1 month prior to vaccine administration. Pt has OV scheduled with pulmonology on 10/20/21. Spouse is instructed to seek emergency care if pt has worsening of SOB or SOB at rest. Inform this RN if any other changes in recovery. VAERS report to be submitted and updated as needed. Spouse verbalized understanding.


VAERS ID: 1785982 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-03-18
Onset:2021-09-10
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Herpes zoster, Pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Diagnosed with shingles (pain, itching, rash)


VAERS ID: 1787747 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-08-12
Onset:2021-09-10
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Heart rate increased, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RX-Diltiazim for PACs, Multivitamins and minerals and herbals.
Current Illness: None
Preexisting Conditions: Heart palpitations/ Premature Atrial Contractions (PAC)
Allergies: Eggs and Morphine, latex
Diagnostic Lab Data: None yet.
CDC Split Type:

Write-up: Immune response began within 2 hours (Covid survivor.) Resting heart rate increased to 96bpm and stayed there for a month. Increase in palpitations noticed during workouts and continues to present while working out.


VAERS ID: 1703965 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: School       Purchased by: ?
Symptoms: Chest pain, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Chest pains
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None. Possibly Tylenol 3
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pains Legs went numb and for 6 days arm tingles


VAERS ID: 1707951 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   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: Chills, Hyperhidrosis, Migraine, Pain, Paraesthesia, SARS-CoV-2 test, Screaming
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: shivering; screaming; pins and needles; sweating; Generalised aching; Migraine; Heavy sweating; This case was received via the RA (Reference number: GB-MHRA-ADR 25922216) 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 CHILLS (shivering), SCREAMING (screaming), PARAESTHESIA (pins and needles), HYPERHIDROSIS (sweating), PAIN (Generalised aching), MIGRAINE (Migraine) and HYPERHIDROSIS (Heavy sweating) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-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 10-Sep-2021, the patient experienced PAIN (Generalised aching) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and HYPERHIDROSIS (Heavy sweating) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant), SCREAMING (screaming) (seriousness criterion medically significant), PARAESTHESIA (pins and needles) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering), SCREAMING (screaming), PARAESTHESIA (pins and needles) and HYPERHIDROSIS (sweating) outcome was unknown, PAIN (Generalised aching) was resolving and MIGRAINE (Migraine) and HYPERHIDROSIS (Heavy sweating) 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. No relevant concomitant medications were reported. No treatment information was provided. Reportedly, the patient was unable to sleep. Patient has not had symptoms associated with COVID-19. Patient is neither pregnant, nor is currently breastfeeding. 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: 1710379 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   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 FF2018 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Arthralgia, Cough, Dyspnoea, Neck pain, Pain in extremity, Throat irritation, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101193339

Write-up: Anaphylaxis; pain in the left shoulder; pain spread to the arms and neck; pain spread to the arms and neck; Feeling of scratchy throat; cough; Tremulousness of the whole body; Dyspnoea; This is a spontaneous report from a Physician received from the Agency (A). Regulatory authority report number is i21103653. A non-pregnant 53-year-old female patient received bnt162b2 (COMIRNATY Lot Number: FF2018; Expiration Date: 31Dec2021) via intramuscular injection on 10Sep2021 (at 53-year-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history was none. The patient had no Primary disease/complication or Pre-existing illness or Adverse reaction history or Alcohol or Smoking or Allergy or concomitant drugs. The patient''s concomitant medications were not reported. The event onset date was reported as 10Sep2021 (the same day of vaccination). On unspecified date, the outcome of the event was Recovered. The course of the event was as follows: On 10Sep2021, immediately after the vaccination, pain in the left shoulder appeared. After that, pain spread to the arms and neck. Feeling of scratchy throat appeared. After that, cough appeared. Tremulousness of the whole body, Dyspnoea also appeared. The patient received intramuscular injection of BOSMIN 0.5mg. Immediately improved. The reporter classified the event as serious (Life-threatening). There was no other procedure/diagnosis besides the above drugs. The reporting physician commented as follows: Immediately after intramuscular injection, symptoms that seemed to be adverse events appeared. After that, it became a continuously serious symptom one after another. It was necessary until the BOSMIN injection. It improved immediately 3 to 5 minutes after the administration. It could be considered anaphylaxis.


VAERS ID: 1714585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
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: Cold-stimulus headache, Dyspnoea, Insomnia, Pain in extremity, Pyrexia, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: feeling freezing; Fever; Difficulty breathing; Hypersensitive skin; Difficulty sleeping; Pain in arm; This case was received via regulatory authority(Reference number: 25927146) 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 DYSPNOEA (Difficulty breathing), SENSITIVE SKIN (Hypersensitive skin), INSOMNIA (Difficulty sleeping), PAIN IN EXTREMITY (Pain in arm), COLD-STIMULUS HEADACHE (feeling freezing) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-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 10-Sep-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant), INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced COLD-STIMULUS HEADACHE (feeling freezing) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Difficulty breathing), SENSITIVE SKIN (Hypersensitive skin), INSOMNIA (Difficulty sleeping), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) had not resolved and COLD-STIMULUS HEADACHE (feeling freezing) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that, the events started with fever, feeling freezing when patient was burning up. It stayed and then patient''s legs started feeling painful and like there were bugs under patient skin. Both stayed and it then felt like patient could not get a full breath, patient''s arm that got injected was also very sore to the point of not being able to move it. She had not been tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This case concerns a female subject, who experienced the expected / unexpected (labeled/not labeled) event/s of DYSPNOEA, SENSITIVE SKIN, INSOMNIA, PAIN IN EXTREMITY, PYREXIA and COLD-STIMULUS HEADACHE. The events DYSPNOEA, SENSITIVE SKIN, INSOMNIA, PAIN IN EXTREMITY and PYREXIA occurred on the same day after the second dose of Spikevax. The event COLD-STIMULUS HEADACHE occurred in an unknown date. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax in not affected by this report. There is a discrepancy in the encoding of the event "feeling freezing", it would be better encoded as feeling cold.; Sender''s Comments: This case concerns a female subject, who experienced the expected / unexpected (labeled/not labeled) event/s of DYSPNOEA, SENSITIVE SKIN, INSOMNIA, PAIN IN EXTREMITY, PYREXIA and COLD-STIMULUS HEADACHE. The events DYSPNOEA, SENSITIVE SKIN, INSOMNIA, PAIN IN EXTREMITY and PYREXIA occurred on the same day after the second dose of Spikevax. The event COLD-STIMULUS HEADACHE occurred in an unknown date. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax in not affected by this report. There is a discrepancy in the encoding of the event "feeling freezing", it would be better encoded as feeling cold.


VAERS ID: 1714588 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   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: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis, Influenza like illness, Pyrexia, SARS-CoV-2 test, Stiff leg syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; 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: sweating; shivering; Tiredness; Headache; Aching joints; High temperature; Stiff leg syndrome; Flu-like aching; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25928606) 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 INFLUENZA LIKE ILLNESS (Flu-like aching), STIFF LEG SYNDROME (Stiff leg syndrome), HYPERHIDROSIS (sweating), PYREXIA (High temperature), CHILLS (Chills), ARTHRALGIA (Aching joints), CHILLS (shivering), FATIGUE (Tiredness) and HEADACHE (Headache) in a 35-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 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced STIFF LEG SYNDROME (Stiff leg syndrome) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching), STIFF LEG SYNDROME (Stiff leg syndrome), PYREXIA (High temperature), CHILLS (Chills), ARTHRALGIA (Aching joints), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved and HYPERHIDROSIS (sweating) and CHILLS (shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provider by the reporter. Treatment information was not provided. It was reported that at night after vaccination symptoms started patient for one minute was roasting to the point where she was sweating then had cold, shivering and got goosebumps. Could not lift own body weight as patient was that achy from head to toe it hurt. Patient head was pounding and she felt tired to the point patient could fall asleep all day. Patient could not move arm that had the jab. She had a sore arm. Adverse reaction did not occur as a result of an exposure during pregnancy. Patient had a PCR test and lateral flow test all were negative. Company comment: This case concerns a 35 year-old, female subject with no relevant medical history, who experienced the unexpected events of Influenza like illness, stiff leg syndrome, hyperhidrosis, pyrexia, chills, arthralgia, fatigue, chills and headache. Time to onset from vaccination was not reported for the events chills and hyperhidrosis. The events Influenza like illness and chills occurred on the same date of vaccination with second dose of Spikevax. The events pyrexia, arthralgia, headache stiff leg syndrome and fatigue occurred approximately 1 day after the second dose of Spikevax. The rechallenge was negative.The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 35 year-old, female subject with no relevant medical history, who experienced the unexpected events of Influenza like illness, stiff leg syndrome, hyperhidrosis, pyrexia, chills, arthralgia, fatigue, chills and headache. Time to onset from vaccination was not reported for the events chills and hyperhidrosis. The events Influenza like illness and chills occurred on the same date of vaccination with second dose of Spikevax. The events pyrexia, arthralgia, headache stiff leg syndrome and fatigue occurred approximately 1 day after the second dose of Spikevax. The rechallenge was negative.The benefit-risk relationship of drug Spikevax is not affected by this report.


VAERS ID: 1716044 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   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: Influenza like illness, Lymphadenopathy, Maternal exposure during breast feeding
SMQs:, Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Flu like symptoms; Maternal exposure during breast feeding; Swollen glands; This case was received via RA (Reference number: GB-MHRA-ADR 25923317) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and LYMPHADENOPATHY (Swollen glands) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and LYMPHADENOPATHY (Swollen glands) had not 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. It is reported that patient experienced swollen gland in neck same side as vaccine given and had strong flu like symptoms. Company comment- This case concerns 28 year-old, female subject with no relevant medical history, who experienced the unexpected events of influenza like illness and lymphadenoptahy. The event occurred approximately same day after the second dose of Moderna Covid -19 vaccine. The event was considered related to the study drug. The concurrent events of maternal exposure during breastfeeding is unrelated. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-323240 (Parent-Child Link). See case MOD-2021-323240 for details regarding the child case.; Sender''s Comments: This case concerns 28 year-old, female subject with no relevant medical history, who experienced the unexpected events of influenza like illness and lymphadenoptahy. The event occurred approximately same day after the second dose of Moderna Covid -19 vaccine. The event was considered related to the study drug. The concurrent events of maternal exposure during breastfeeding is unrelated. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1716060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Ache; Headache; Nausea; Chills; Feverish; This case was received via RA (Reference number: GB-MHRA-ADR 25927936) 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 PAIN (Ache), PYREXIA (Feverish), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, PAIN (Ache) had not resolved, PYREXIA (Feverish), HEADACHE (Headache) and CHILLS (Chills) was resolving and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient is not enrolled in clinical trial. Treatment medication was not provided by the reporter. This case concerns a female subject, of unknown age, with no relevant medical history, who experienced the unexpected events of pyrexia, headache, nausea, chills and pain. The event pyrexia occurred on the day of administration of the second dose. The event start dates of headache, nausea, chills and pain were not provided. The rechallenge was unknown since no information about the first dose was provided. The events pyrexia, headache, nausea and chills are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Sender''s Comments: This case concerns a female subject, of unknown age, with no relevant medical history, who experienced the unexpected events of pyrexia, headache, nausea, chills and pain. The event pyrexia occurred on the day of administration of the second dose. The event start dates of headache, nausea, chills and pain were not provided. The rechallenge was unknown since no information about the first dose was provided. The events pyrexia, headache, nausea and chills are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


VAERS ID: 1716062 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Loss of consciousness, Musculoskeletal stiffness, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: Pentasa; Vitamin D NOS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Headache; Stiffness; Fever; Tiredness; Blackout; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25928467) 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 NAUSEA (Nausea), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Fever), FATIGUE (Tiredness), LOSS OF CONSCIOUSNESS (Blackout) and DIZZINESS (Dizziness) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. Previously administered products included for an unreported indication: IRON. Concomitant products included MESALAZINE (PENTASA) for Colitis, VITAMIN D NOS for an unknown indication. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 10-Sep-2021, PYREXIA (Fever) and FATIGUE (Tiredness) was resolving, LOSS OF CONSCIOUSNESS (Blackout) and DIZZINESS (Dizziness) had resolved. At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient have had successful avnrt ablation treatment. Patient had Regularly low on Iron in blood but cannot take supplements due to irritation of his bow she disease colitis Patient stand up or sit long enough to brush her teeth, blacked out when walking to her bedroom, and near fainted. Really struggled to change into her pjs and had to get someone else to close her curtains and bring her a cold flannel as she was incapable. This was around 16 hours after the injection after a full working day sitting at a computer. Company comment This case concerns a 25 year female who experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), NAUSEA (Nausea), HEADACHE (Headache), DIZZINESS (Dizziness), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Fever) and FATIGUE (Tiredness). The events occurred 14 hours after the second dose. Dechallenge was unknown and Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns a 25 year female who experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), NAUSEA (Nausea), HEADACHE (Headache), DIZZINESS (Dizziness), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Fever) and FATIGUE (Tiredness). The events occurred 14 hours after the second dose. Dechallenge was unknown and Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.


VAERS ID: 1717497 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Paralysis
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210932898

Write-up: ACUTE PARALYSIS; DIZZINESS; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 5 decade old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered, vaccinated on deltoid on 07-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 10-SEP-2021, the patient experienced acute paralysis, dizziness, headache and outpatient treatment administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute paralysis, dizziness and headache was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210932898-covid-19 vaccine ad26.cov2.s-acute paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1717498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 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: KRJNJFOC20210933011

Write-up: OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 3 decade old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported,1 total, administered at deltoid on 07-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 10-SEP-2021, the patient experienced other events, and was hospitalized (date unspecified). Patient received inpatient treatment. Number of hospitalization days were not reported. 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: 20210933011-covid-19 vaccine ad26.cov2.s-other events. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1717503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: KRJNJFOC20210933766

Write-up: ACUTE PARALYSIS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 4 decade old male patient 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 in the deltoid on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced acute paralysis. On an unspecified date, the patient received outpatient treatment (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210933766- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Acute paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1720862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201009; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101190748

Write-up: Headache; Dizzy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109100456441360-GIRMW. Safety Report Unique Identifier : GB-MHRA-ADR 25921455. A 19-year-old male patient received BNT162B2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (yes-positive COVID-19 test) on 09Oct2020. The patient experienced headache (medically significant), dizzy (medically significant) on 10Sep2021. Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The clinical outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1720863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-10
   Days after vaccination:27
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: Dysmenorrhoea, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190739

Write-up: Cramps menstrual; Menstrual flooding; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109100505290660-I4FIO, Safety Report Unique Identifier GB-MHRA-ADR 25921494. A 29-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date for covid-19 immunisation. The patient experienced menstrual cramps and menstrual flooding on 10Sep2021. The clinical course was reported as follows, this happened with her first period after the first jab too. Her periods returned to her usual flow with no cramping thereafter. She not had severe menstrual cramps before. She did not have any cramps since she was 13. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1720866 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Myocarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25926018) 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 CHEST PAIN (Chest pain) and MYOCARDITIS (Myocarditis) in a 24-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 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown and MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. The day after the first dose patient had really bad pain to the left of chest that went into back as breathed in. patient wasnt sure whether it was related to the vaccine or not. patient had second dose yesterday and had the same chest pain today, however it was been as severe as the first one Company comment: This case concerns a 24 year-old, female subject with no reported medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. Time to onset from vaccination was not reported for the event chest pain. The event myocarditis occurred approximately 1 day after the second dose of Spikevax. The rechallenge was positive for event chest pain. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 24 year-old, female subject with no reported medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. Time to onset from vaccination was not reported for the event chest pain. The event myocarditis occurred approximately 1 day after the second dose of Spikevax. The rechallenge was positive for event chest pain. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report.


VAERS ID: 1720867 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Malaise, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALIN; AMITRIPTYLINE; BUPRENORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hip surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Feel light headed; Feeling sick; Headache; Swollen arm; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25928090) 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 PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Feel light headed), MALAISE (Feeling sick) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. The patient''s past medical history included Endometriosis on 11-Sep-2019, Hip surgery in 2016 and Hip surgery in 2019. Concomitant products included PREGABALIN from 20-May-2020 to an unknown date and BUPRENORPHINE from 11-Jul-2019 to an unknown date for Pain in hip, AMITRIPTYLINE from 13-Mar-2018 to an unknown date for Poor sleep. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Feel light headed) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) had not resolved, DIZZINESS (Feel light headed) outcome was unknown and MALAISE (Feeling sick) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. On 10-Sep-2021 at 5:30, patient had the COVID vaccine. Later that night patient started to feel sick and had a pounding headache, arm was hot, swollen, and hard. At the time of this report, patient still had headache and was feeling sick. She was also feeling lightheaded. company comment: This case concerns a 20-year-old, female patient with no relevant medical history who experienced the unexpected events of peripheral swelling, dizziness, malaise, and headache. The events occurred approximately 1 day after the second dose of Moderna COVID-19 VACCINE. The rechallenge was not applicable since only information about the second dose was disclosed. The event Peripheral swelling is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 20-year-old, female patient with no relevant medical history who experienced the unexpected events of peripheral swelling, dizziness, malaise, and headache. The events occurred approximately 1 day after the second dose of Moderna COVID-19 VACCINE. The rechallenge was not applicable since only information about the second dose was disclosed. The event Peripheral swelling is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 VACCINE is not affected by this report.


VAERS ID: 1720873 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swollen lymph nodes; Fever chills; Fever; Headache; This case was received on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Fever chills), PYREXIA (Fever) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved, PYREXIA (Fever chills) and PYREXIA (Fever) was resolving and HEADACHE (Headache) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided.; Sender''s Comments: This regulatory authority case concerns a 27-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of headache, lymphadenopathy and pyrexia. The event headache occurred on the same day as the second dose of Spikevax administered. whereas time to onset for the remaining events was not provided. Rechallenge was not applicable. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report


VAERS ID: 1720889 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure via breast milk, Maternal exposure during breast feeding
SMQs:, Neonatal exposures via breast milk (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: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during breast feeding; Vaccine exposure via breast milk; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25929398) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna CoviD-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Breast feeding (I am still breastfeeding (six months post partum) with no premenstrual cramping). No Medical History information was reported. On 10-Sep-2021, the mother received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Sep-2021, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) (seriousness criterion medically significant). On 10-Sep-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Transmammary) was unknown. No Concomitant product use was reported. No treatment information was provided. Company comment: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs This case was linked to MOD-2021-317539 (Parent-Child Link). See case MOD-2021-317539 for details regarding the Parent case.; Sender''s Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs


VAERS ID: 1720890 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
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: Arthralgia, Chills, Facial paralysis, Fatigue, Headache, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: Migraine headache; Joint pain; intense fever; fatigue; shivering; Feverish; Frontal headache; Facial palsy; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25929456) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Facial palsy), MIGRAINE (Migraine headache), ARTHRALGIA (Joint pain), HEADACHE (intense fever), FATIGUE (fatigue), CHILLS (shivering), PYREXIA (Feverish) and HEADACHE (Frontal headache) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), HEADACHE (intense fever) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and HEADACHE (Frontal headache) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial palsy) and ARTHRALGIA (Joint pain) had not resolved, MIGRAINE (Migraine headache), PYREXIA (Feverish) and HEADACHE (Frontal headache) was resolving and HEADACHE (intense fever), FATIGUE (fatigue) and CHILLS (shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 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 she experienced Intense fever, facial palsy , shivering , fatigue , arm still dead where injected. Treatment information was not provided. This case concerns a 37 year-old female subject, with no relevant medical history, who experienced the unexpected events of FACIAL PARALYSIS, HEADACHE, FATIGUE, CHILLS, HEADACHE, MIGRAINE, ARTHRALGIA AND PYREXIA. The event of Facial paralysis occurred on the same day after the first dose of Spikevax. Rest of the events occurred on an unknown date The rechallenge was not applicable as there is no information about second dose. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were indeed medically significant.; Sender''s Comments: This case concerns a 37 year-old female subject, with no relevant medical history, who experienced the unexpected events of FACIAL PARALYSIS, HEADACHE, FATIGUE, CHILLS, HEADACHE, MIGRAINE, ARTHRALGIA AND PYREXIA. The event of Facial paralysis occurred on the same day after the first dose of Spikevax. Rest of the events occurred on an unknown date The rechallenge was not applicable as there is no information about second dose. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were indeed medically significant.


VAERS ID: 1721237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: KRJNJFOC20210933611

Write-up: OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 6 decade old male patient 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: 211A21A and expiry: 14-DEC-2021) dose was not reported, 1 total, administered in deltoid on 09-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 10-SEP-2021, the patient experienced other events (unspecified). On an unspecified date, the patient was hospitalized (reported as 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: 20210933611- COVID-19 VACCINE AD26.COV2.S-other events. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1722112 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Migraine, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: YASMIN
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: Migraine headaches; Headache; Itching; Rash; Fever; Swelling; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25930889) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (Rash), PYREXIA (Fever), SWELLING (Swelling), MIGRAINE (Migraine headaches) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) from 01-Jun-2012 to an unknown date for Birth control pill. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine headaches) (seriousness criterion medically significant). On 13-Sep-2021, HEADACHE (Headache) was resolving. At the time of the report, PRURITUS (Itching), RASH (Rash), PYREXIA (Fever) and SWELLING (Swelling) had not resolved and MIGRAINE (Migraine headaches) 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) was unknown. Rechallenge is reported as Unknown with respect to events. It was reported that the patient had extremely itchy arm and swelling with a rash around injection sight. Migraine headaches for 2 days. 3 days of fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment information was not provided. This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of pruritus, swelling and migraine, and the expected events of rash, pyrexia and headache. The events occurred on the day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The patients'' use of birth control pills can be a confounder for the occurrence of events headache and migraine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of pruritus, swelling and migraine, and the expected events of rash, pyrexia and headache. The events occurred on the day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The patients'' use of birth control pills can be a confounder for the occurrence of events headache and migraine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1724422 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Insomnia, Joint noise, Myalgia, Pyrexia, Thirst, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191676

Write-up: High temperature; Headache; Injection site pain; Muscle ache; Muscle pain; Insomnia; Joint clicking; Thirst; Increased thirst; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is -MHRA-APPCOVID-202109110023301150-UYGQC. Safety Report Unique Identifier is -MHRA-ADR 25926931. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number FE8087), dose 2 via an unspecified route of administration on 10Sep2021 (age at the time of vaccination was 32-year-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) as dose 1, single on unspecified date for COVID-19 immunization. On 10Sep2021, the patient experienced high temperature, headache, injection site pain, muscle ache, muscle pain, insomnia, joint clicking, thirst and increased thirst. Patient haD not tested positive for COVID-19 since having the vaccine. The events were serious (medically significant). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724632 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   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 FF2153 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191647

Write-up: Sickness; Ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109100717341500-KNINP and Safety Report Unique Identifier is GB-MHRA-ADR 25925428. An 18-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 on unspecified date for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced sickness and ache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. No - Negative COVID-19 test. The outcome of sickness was recovering and ache was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724635 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-10
   Days after vaccination:3
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: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101191541

Write-up: Palpitations; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109100823046210-2TVLW, Safety Report Unique Identifier GB-MHRA-ADR 25922467. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 07Sep2021, as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 10Sep2021, 3 days after the first dose of vaccine, the patient experienced palpitations. Event was reported as serious, medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative, on unspecified date. The clinical outcome of event was not resolved. No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1724648 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Oxygen saturation, 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: Test Name: BP; Result Unstructured Data: Test Result: Normal; Test Name: peripheral oxygen; Result Unstructured Data: Test Result: Normal
CDC Split Type: GBPFIZER INC202101191702

Write-up: Fainting; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101238223010-BG1FO, Safety Report Unique Identifier GB-MHRA-ADR 25923756. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2153 and Expiration date was unknown), via an unspecified route of administration on 10Sep2021 (at the age of 17-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Sep2021 the patient experienced fainting. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included blood pressure measurement: normal and oxygen saturation: normal. The clinical outcome of the event was recovered in 30 minutes on 10Sep2021. Suspected Reactions assessed as Please provide details of any relevant investigations or tests conducted: "BP (Blood pressure) and peripheral oxygen normal" No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724672 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   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: Asthenia, Fatigue, Headache, Influenza like illness, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191475

Write-up: Fatigue; Pains in legs; Headache; Flu like symptoms; Body aching; Feels like a lack of energy; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109101901280500-49RRF, Safety Report Unique Identifier GB-MHRA-ADR 25925557. A 18-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient was not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not had symptoms associated with COVID-19, Patient was not pregnant, Patient was not currently breastfeeding. Initially after receiving a vaccine patient was fine. On 10Sep2021, 1 day after second dose the patient experienced fatigue, pains in legs, headache, flu like symptoms, body aching, feels like a lack of energy. The events were reported as medically significant. it was reported that After waking up next morning patient whole body hurts struggle to stand for long time almost flu like symptoms in regards to body aching- Feels like a lack of energy patient had a strong headache also. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on unspecified date. The outcome of the events fatigue, pains in legs, headache were recovering and outcome of other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   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: Abdominal pain, Chest discomfort, Headache, Lymphadenopathy, Muscle spasms, Myalgia, Nausea, Neck pain, Renal pain, Sweating fever
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; GABAPENTIN; SERTRALINE
Current Illness: Depression; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191650

Write-up: Leg spasm; Sweating fever; Chest tightness; Abdominal pain; Headache; Kidney pain; Muscular pains; Neck pain; Swollen glands; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109102107579510-9XA74 and Safety Report Unique Identifier GB-MHRA-ADR 25926275. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: unknown), via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing pain and depression. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication included codeine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); both for pain; and sertraline (MANUFACTURER UNKNOWN) for depression, all from an unspecified date and unknown if ongoing. On 10Sep2021, the patient experienced leg spasm. On an unspecified date in 2021, she experienced sweating fever, chest tightness, abdominal pain, headache, kidney pain, muscular pains, neck pain, swollen glands, and nausea. The events were considered as medically significant. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724686 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Folate deficiency; Iron deficiency; Menstrual disorder; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191677

Write-up: itchiness; Itching; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109102358120630-ERH8J. Safety Report Unique Identifier GB-MHRA-ADR 25926927. A 19-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 10Sep2021 (at the age of 19-Years-old) as dose 2, single for COVID-19 immunization. Medical history included vitamin d deficiency, folate deficiency, iron deficiency, anaemia and menstrual disorder from an unknown start and stop date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Concomitant medication(s) included citalopram taken for an unspecified indication from Oct2020 to Oct2020. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The patient experienced itchiness on an unspecified date and itching on 10Sep2021. Severe itchiness started approximately 2hrs after administration of vaccine across all of body. The adverse events were considered as serious with seriousness criteria of medically significant. The outcome of the event itchiness was recovering while the outcome of the itching was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-10
   Days after vaccination:7
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: C-reactive protein, Chest pain, Echocardiogram normal, Electrocardiogram, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: CRP 51; Result Unstructured Data: Test Result:51; Comments: 51; Test Name: echo; Result Unstructured Data: Test Result:No rub and normal bedside echo; Comments: No rub and normal bedside echo; Test Name: ECG; Result Unstructured Data: Test Result:Acute pleuritic chest pain with postional exacerba; Comments: Acute pleuritic chest pain with postional exacerbation and saddle ST segments; Test Date: 20210625; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191561

Write-up: chest pain; Pericarditis; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109111101366370-0QBO5. Safety Report Unique Identifier: GB-MHRA-ADR 25927934. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FE3380), via an unspecified route of administration on 03Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was normally well and healthy. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced chest pain on an unspecified date. The patient experienced pericarditis on 10Sep2021. The patient reported that no relate to possible blood clots or low platelet counts. Since the vaccination, the patient was not tested positive for COVID-19. The patient lab test which included COVID-19 virus test was no-negative. COVID-19 test on 25Jun2021, electrocardiogram (ECG) was acute pleuritic chest pain with postional exacerbation and saddle ST segments; echo (echocardiogram) was no rub and normal bedside echo and CRP (C-reactive protein) was 51 (units was unspecified) on an unknown date. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   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: Pain, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191523

Write-up: swollen arm; Painful to touch; Swollen arm, armpit and chest on the side of the vaccine up to and including the collarbone; Feeling swollen; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109111418346250-DTPYT.Safety Report Unique Identifier GB-MHRA-ADR 25928299. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received historical vaccine first dose of BNT162B2 for COVID-19 immunisation (Dose 1). The patient experienced swollen arm (medically significant), painful to touch, and swollen arm, armpit and chest on the side of the vaccine up to and including the collarbone (medically significant) on an unspecified date, the event feeling swollen (medically significant) on 10Sep2021. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test). It was reported that patient was only on the contraceptive pill. 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. The outcome of the events swollen arm, painful to touch and swollen arm, armpit and chest on the side of the vaccine up to and including the collarbone was unknown while the event feeling swollen was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724736 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Inappropriate schedule of product administration, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191664

Write-up: Sore throat; Dry cough; Headache; Nasal congestion; vaccine is administered outside of the range 19 - 42 days after the first dose; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111923514130-CYRYX Safety Report Unique Identifier GB-MHRA-ADR 25928651. A 20-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2153, Expiry date was not reported), via an unspecified route of administration on 10Sep2021 (at the age of 20-Year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported) on 16Jul2021 for COVID-19 immunization. Unsure if patient has had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. On 10Sep2021, patient experienced sore throat, dry cough, headache, nasal congestion, vaccine is administered outside of the range 19 - 42 days after the first dose. The events caused medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 10Sep2021 (No - Negative COVID-19 test). The outcome of the events was sore throat, dry cough, headache, nasal congestion was recovering and events was vaccine is administered outside of the range 19 - 42 days after the first dose was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   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: Fatigue, Headache, Inappropriate schedule of product administration, Influenza, Insomnia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101191525

Write-up: Nausea; Flu; Headache; Tiredness; Feverish; Insomnia; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109112347534140-EFVZO, Safety Report Unique Identifier GB-MHRA-ADR 25928776. A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 10Sep2021 (Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) on 25Jun2021 for COVID-19 immunisation. On 11Sep2021, the patient experienced nausea, flu, headache, tiredness, feverish and insomnia and on 10Sep2021, inappropriate schedule of vaccine was administered. Unsure if patient had symptoms associated with COVID-19. Patient was not pregnant and currently not breastfeeding. The patient underwent sars-cov-2 test which was inconclusive test on 19Jan2021. Patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. The outcome of all the events was not resolved except for the event inappropriate schedule of vaccine was administered the outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724756 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Dizziness, Fatigue, Hyperhidrosis, Pain, Pain in extremity, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Pain in left arm ( injection arm ) and armpit; Shivering; felt like I was going to faint or be sick; tired; Sweating; Chills; Chest pain; Heart pounding; Dizziness; Generalised aching; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25929033) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain in left arm ( injection arm ) and armpit), PAIN (Generalised aching), CHILLS (Chills) and CHILLS (Shivering) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in left arm ( injection arm ) and armpit) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), DIZZINESS (felt like I was going to faint or be sick) and FATIGUE (tired). On 11-Sep-2021, DIZZINESS (Dizziness) was resolving. At the time of the report, CHEST PAIN (Chest pain), HYPERHIDROSIS (Sweating), PAIN (Generalised aching) and CHILLS (Chills) had not resolved, PALPITATIONS (Heart pounding) was resolving and PAIN IN EXTREMITY (Pain in left arm ( injection arm ) and armpit), CHILLS (Shivering), DIZZINESS (felt like I was going to faint or be sick) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned by reporter. The patient developed pain in left arm (injection arm) and armpit, and left side of chest, aching and very tired The patient felt everything went white and felt like I was going to faint or be sick, followed by extreme chills and shivering, sweats, heart pounding and 2 days after,developed chest pain and muscle aches. No treatment medication information was mentioned by reporter. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of chest pain, palpitations, dizziness, chills, hyperhidrosis, pain in extremity, pain and chills. Time to onset from vaccination was not reported for the events chills and pain in extremity. The events dizziness, palpitations and pain occurred on the same date after the second dose of Spikevax. The events chest pain, hyperhidrosis and chills occurred 1 day 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 Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of chest pain, palpitations, dizziness, chills, hyperhidrosis, pain in extremity, pain and chills. Time to onset from vaccination was not reported for the events chills and pain in extremity. The events dizziness, palpitations and pain occurred on the same date after the second dose of Spikevax. The events chest pain, hyperhidrosis and chills occurred 1 day 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 Spikevax in not affected by this report.


VAERS ID: 1724809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-10
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 antibody test; Test Result: Positive ; Comments: Test Date: 20210821; Test Name: COVID-19 virus test; Test Result: Negative ; Comments; Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Positive ; Comments:
CDC Split Type: HKPFIZER INC202101223241

Write-up: Tested positive for Covid-19 and carries L452R Mutant strain; Tested positive for Covid-19 and carries L452R Mutant strain; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003549), license party for bnt162b2 (COMIRNATY). This is one of three reports. As of 0:00 am, 12Sep2021, DH announced that three additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 3 cases that confirmed COVID-19 after Comirnaty vaccination. A 36-year-old female patient started to received two doses of bnt162b2 (COMIRNATY, solution for injection, lot number was unknown) via unspecified route of administration on 10Jun2021 as DOSE 1 SINGLE and on 01Jul2021 as DOSE 2 SINGLE for COVID-19 immunization. The patient medical history, concomitant medications and past product were not reported. On 21Aug2021, blood specimen tested positive for anti-spike protein antibody. The patient tested negative. on 21Aug2021. On 10Sep2021, the patient tested positive for COVID-19 and carries the L452R mutant strain but does not carry the N501Y or E484K mutant genes. On 10-Sep-2021, the patient developed symptoms 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. Initial report was received on 13-Sep-2021. This is one of three reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003548 (master case), 2021FOS003549 and 2021FOS003550. At the time of the report, the outcome of the events was unknown. Follow-up closed, no further information is possible. Causality assessment was provided with the event as possible per reporter and company.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223236 same reporter/product, different patient/event;HK-PFIZER INC-202101223269 same reporter/product, different patient/event


VAERS ID: 1724990 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   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 FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101192877

Write-up: Cough; sweaty; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126520. A 57-year and 11-month-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 10Sep2021 15:40 (at the age of 57-year and 11-month-old) (Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunization. The patient had no medical history and concomitant medications were not reported. On 10Sep2021 at 15:50 (10 minutes after vaccination), the patient experienced sweaty and cough. On 10Sep2021 (the day of the vaccination), the outcome of both event was recovered. There was no decrease in blood pressure. The symptoms alleviated with intravenous drip of SOLU-MEDROL 125 g. The patient underwent lab test included Body temperature before vaccination showed 36.2 centigrade. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2.


VAERS ID: 1725028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-10
   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 FE1573 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest pain, Echocardiogram, Magnetic resonance imaging heart, Myocarditis, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: Test Result:742; Test Name: CRP; Result Unstructured Data: Test Result:102; Test Date: 20210910; Test Name: ECHO; Result Unstructured Data: Test Result:hypokinesia; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:is still pending; Test Name: Troponin; Result Unstructured Data: Test Result:666
CDC Split Type: MTPFIZER INC202101216149

Write-up: perimyocarditis; chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number MT-ADM-3092021. A 13-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FE1573, Expiry date: unknown), dose 1 intramuscular on 08Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced peri myocarditis (hospitalization, life threatening) and chest pain (hospitalization, life threatening) on 10Sep2021. The patient underwent lab tests and procedures which included echocardiogram: hypokinesia on 10Sep2021 and c-reactive protein: 102 on unknown date, troponin: 666 on unknown date, blood creatine phosphokinase: 742 on unknown date, magnetic resonance imaging heart: is still pending on unknown date. Therapeutic measures were taken as a result of peri myocarditis, chest pain. The clinical outcome of events was recovering. Sender comments: Peri myocarditis is listed as a rare side-effect on the SmPC (Summary of Product Characteristics) and therefore the side-effect is expected. Chest pain is listed on the SmPC (Summary of Product Characteristics), however the frequency is not known and therefore the side-effect is unexpected. Challenge; very suggestive, Re-challenge: RO and de-challenge; inconclusive C2 Signs and symptoms: compatible, lab test: L+ and alternate non-drug explanation: absent: S3. Outcome I3 Probable. No follow-up attempts possible. No further information expected.


VAERS ID: 1725850 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), 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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210814; 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: Migraine; Foggy feeling in head; Fever; This case was received via regulatory authority (Reference number: ADR 25939706) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PYREXIA (Fever) and FEELING ABNORMAL (Foggy feeling in head) in a 26-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 since 07-Aug-2021. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant). On 11-Sep-2021, the patient experienced MIGRAINE (Migraine) (seriousness criteria disability and medically significant) and FEELING ABNORMAL (Foggy feeling in head) (seriousness criteria disability and medically significant). At the time of the report, MIGRAINE (Migraine) and FEELING ABNORMAL (Foggy feeling in head) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-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 use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 26-year-old, male patient with no relevant medical history, who experienced the unexpected events of migraine, pyrexia, and feeling abnormal. The events occurred approximately 3 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax 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 26-year-old, male patient with no relevant medical history, who experienced the unexpected events of migraine, pyrexia, and feeling abnormal. The events occurred approximately 3 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax 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: 1725854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac discomfort, Dyspnoea, Headache, Hypertension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210942288

Write-up: HYPERTENSION; BREATHING DIFFICULT; HEADACHE; HEART PRESSURE SENSATION OF; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, GR-GREOF-20217999) on 22-SEP-2021 and concerned a 28 year old male. The patient''s weight was 140 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 1 total, start therapy date were not reported for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-SEP-2021, the patient experienced heart pressure sensation of. On an unspecified date, the patient experienced hypertension, breathing difficult, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypertension, and headache, had not recovered from breathing difficult, and the outcome of heart pressure sensation of was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).


VAERS ID: 1726155 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
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: DEJNJFOC20210943311

Write-up: Headache; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021179471) on 22-SEP-2021 concerned a 25 year old female of an unspecified race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 10-SEP-2021, the patient experienced headache. On an unspecified date she was hospitalized. The number of days hospitalized was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1728585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-10
   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 - / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101191215

Write-up: dose 1 on 16Jun2021 / dose 2 on 08Sep2021; urticaria / mainly on the face and left arm; my throat was hurting a little; This is a spontaneous report from a contactable consumer (patient) received through COVAES portal. A 36-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in right arm on 08Sep2021 08:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of Comirnaty on 16Jun2021 applied at 09:00 am on the right arm. The patient''s medical history and concomitant medications were not reported. Patient was allergy to the tapazol and Mercurio Cromo. Patient took the vaccine on Wednesday morning on 08Sep2021 and on Thursday night and on Friday night her throat was hurting a little and on Friday night to Saturday urticarias appeared on skin. Mainly on the face and left arm. Antiallergic treatment received. Patient was recovering from the events. No COVID prior vaccination, No COVID tested post vaccination. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1729129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Burning sensation, Cough, Dizziness, Headache, Musculoskeletal discomfort, Oropharyngeal pain, Pyrexia, Vaccination site erythema
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:high temperature
CDC Split Type: GBPFIZER INC202101191807

Write-up: burning sensation; cough; Dizziness; Injection site redness; Headache; High temperature; Coughing; Sore throat; Neck discomfort; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109110953380790-3OS2T, Safety Report Unique Identification Number: GB-MHRA-ADR 25927846. A 29-year-old patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on 10Sep2021 (Lot Number: unknown) as single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2021 to an unknown date. The patient concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient had experienced burning sensation, cough on an unspecified date. On 10Sep2021 the patient had experienced neck discomfort, coughing, sore throat, high temperature. On 11Sep2021 the patient had experienced dizziness, injection site redness, headache. The events seriousness was assessed as medically significant. As soon as patient had the injection patient got a burning sensation in the neck which was still present. Within an hour patient started to cough and got a sore throat. During the night patient had a high temperature and pain from the injection site. This morning patient felt dizzy, hot and had a headache. And redness and hotness coming from the injection site. Patient had COVID in July and patient felt better with COVID than patient had with the injection. The patient underwent lab tests and procedures which included Body temperature: high temperature on 10Sep2021. The outcome of the events burning sensation, cough, coughing, sore throat was recovering and neck discomfort, dizziness, injection site redness, high temperature, headache was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
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: Arthralgia, Asthenia, Back pain, Chest pain, Chills, Fatigue, Joint stiffness, Lymphadenopathy, Migraine, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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), 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: Chronic fatigue syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191467

Write-up: Backache; Sore throat; Stiff joint; Migraine; Chest pain; Weakness; fatigue; chills; Fever; Fatigue extreme; Swollen lymph nodes; Joint pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109112139102250-CSL97. Safety Report Unique Identifier GB-MHRA-ADR 25928728. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Lot number: unknown and Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included chronic fatigue syndrome from an unknown date. Patient has not had symptoms associated with covid-19. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced joint pain on 10Sep2021, swollen lymph nodes on 11Sep2021, backache, sore throat, stiff joint, migraine, chest pain, weakness, fatigue, chills, fever and fatigue extreme on an unspecified date. It was reported that chronic fatigue syndrome It had been almost impossible to leave bed. Her back and all of joints are so painful that even slightly moving hurts. This was accompanied by a constant migraine and fatigue. Patient had been getting sharp chest pains which still haven''t stopped more than 48 hours after the vaccine and now her lymph nodes under her arms are swollen and very tender. She had been very close to calling for medical advice. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of events fatigue, chills and fever was recovering and not recovered for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1729171 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-10
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DULOXETINE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menstrual cramps; These symptoms went away when I was on the pill so I do feel that this period is irregular and is due to my second vaccine; Prolonged heavy periods; This case was received via (Reference number: GB-MHRA-ADR 25935519) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) and DYSMENORRHOEA (Menstrual cramps) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002621) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Heavy periods. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Birth control, DULOXETINE for Major depressive disorder. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) (seriousness criterion disability). On an unknown date, the patient experienced DYSMENORRHOEA (Menstrual cramps) (seriousness criterion disability) and MENSTRUATION IRREGULAR (These symptoms went away when I was on the pill so I do feel that this period is irregular and is due to my second vaccine). At the time of the report, HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) had not resolved and DYSMENORRHOEA (Menstrual cramps) and MENSTRUATION IRREGULAR (These symptoms went away when I was on the pill so I do feel that this period is irregular and is due to my second vaccine) outcome was unknown. Treatment medication was not provided by the reporter. Patient reported that she had heavy prolonged period with severe cramping and passing of big blood clots, she usually had periods that last about 3 days with limited discomfort. Patient had a history of very painful and heavy periods when she was not on the contraceptive pill and had seen a doctor about this in the past with the outcome being suspected endometriosis. Patient reported that the symptoms went away when she was on the pill, so she felt that this period was irregular and was due to her second vaccine. This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected event of Heavy Menstrual Bleeding and Dysmenorrhea. The event Heavy Menstrual Bleeding occurred approximately 71 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine), and the event Dysmenorrhea occurred at an unknown number of days after the second 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 mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected event of Heavy Menstrual Bleeding and Dysmenorrhea. The event Heavy Menstrual Bleeding occurred approximately 71 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine), and the event Dysmenorrhea occurred at an unknown number of days after the second 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 mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.


VAERS ID: 1729173 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

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

Write-up: headache; Vaginal bleeding/Heavy bleeding; This case was received via the RA (Reference number: GB-MHRA-ADR 25937428) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VAGINAL HAEMORRHAGE (Vaginal bleeding/Heavy bleeding) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding/Heavy bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) and VAGINAL HAEMORRHAGE (Vaginal bleeding/Heavy bleeding) 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. No concomitant and treatment information was provided. Patient experienced heavy bleeding out with normal cycle and severe headache ongoing at the time reporting. Company Comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaginal bleeding, and headache. The events occurred approximately 2 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaginal bleeding, and headache. The events occurred approximately 2 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1729175 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Epistaxis, Feeling abnormal, Insomnia, Limb discomfort, Pyrexia, SARS-CoV-2 test, Vaccination complication
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Heavy arm; I felt really low; Struggled to sleep; Fuzzy head; Nose bleed; Fever; Chills; This case was received (Reference number: GB-MHRA-ADR 25937682) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavy arm), EPISTAXIS (Nose bleed), FEELING ABNORMAL (Fuzzy head), PYREXIA (Fever) and CHILLS (Chills) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced EPISTAXIS (Nose bleed) (seriousness criterion medically significant). On 13-Sep-2021, the patient experienced FEELING ABNORMAL (Fuzzy head) (seriousness criterion medically significant). On an unknown date, the patient experienced LIMB DISCOMFORT (Heavy arm) (seriousness criterion medically significant), VACCINATION COMPLICATION (I felt really low) and INSOMNIA (Struggled to sleep). On 11-Sep-2021, EPISTAXIS (Nose bleed), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, LIMB DISCOMFORT (Heavy arm) was resolving, FEELING ABNORMAL (Fuzzy head) had not resolved and VACCINATION COMPLICATION (I felt really low) and INSOMNIA (Struggled to sleep) 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. No relevant concomitant medications were reported. Patient noticed slight blood from nose and spilt as well, that indicated either he had a nose bleed or internal bleeding during sleep, felt really low, had heavy arm throughout next day and in night she struggled to sleep and she can''t think clearly. No treatment information was provided. Patient has not tested positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. Company comment: This case concerns a 34-year-old, male patient with no relevant medical history, who experienced the unexpected events of pyrexia, chills, epistaxis, feeling abnormal, and limb discomfort. The events occurred approximately 1-3 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) 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 34-year-old, male patient with no relevant medical history, who experienced the unexpected events of pyrexia, chills, epistaxis, feeling abnormal, and limb discomfort. The events occurred approximately 1-3 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) 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: 1729204 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Headache, 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: Immunodeficiency (taking other treatments or medicines, not listed, known to lower the immune response)
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: Headaches; Menstrual cramp; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25949532) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and DYSMENORRHOEA (Menstrual cramp) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Previously administered products included for an unreported indication: SERTRALINE. Concurrent medical conditions included Immunodeficiency (taking other treatments or medicines, not listed, known to lower the immune response). On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DYSMENORRHOEA (Menstrual cramp) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headaches) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headaches) had not resolved and DYSMENORRHOEA (Menstrual cramp) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by the reporter. It was reported that the patient had headache but then she started getting periods pain. However, she was not due on her periods or ovulation. She was getting sharp pain in her ovaries and after her first jab her periods was so heavy and lasted almost a week. No treatment information was provided by the reporter. Company Comment - This case concerns a 33-year-old, female patient with previous relevant medical history of Immunodeficiency, who experienced the unexpected events of dysmenorrhea and headaches. Dysmenorrhea occurred 1 day after the second dose of Spikevax. For the event headache, the time to onset from vaccination was not reported. 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 assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 33-year-old, female patient with previous relevant medical history of Immunodeficiency, who experienced the unexpected events of dysmenorrhea and headaches. Dysmenorrhea occurred 1 day after the second dose of Spikevax. For the event headache, the time to onset from vaccination was not reported. 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 assessed as per Regulatory Authority reporting.


VAERS ID: 1729563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-09-10
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORVASC; TRIATEC [RAMIPRIL]; TORVAST; CARDIOASPIRINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210910; Test Name: SARS-CoV-2 Rapid Antigen Test; Test Result: Positive ; Test Date: 20210911; Test Name: SARS-CoV-2; Test Result: Positive
CDC Split Type: ITPFIZER INC202101188886

Write-up: SARS-CoV-2 Rapid Antigen Test positive; SARS-CoV-2 Rapid Antigen Test positive; This is a spontaneous report from a Pfizer Sponsored program ("Pfizer Colleagues Immediate Family and Household Vaccination Program") from a contactable physician. A 65-year-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: ET3045), via an intramuscular route of administration on 14May2021 administered in Deltoid Left as a dose 2 single for COVID-19 Immunization. The patient had received first dose bnt162b2 (COMIRNATY; Solution for injection; Lot Number: ET3045), via an intramuscular route of administration on 23Apr2021 administered in Deltoid Left as a dose 1 single for COVID-19 Immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate (NORVASC); ramipril (TRIATEC); atorvastatin calcium (TORVAST); acetylsalicylic acid (CARDIOASPIRINA) (all taken for an unspecified indication, start and stop date were not reported). The patient was not a smoker/former smoker. On 10Sep2021, the patient had SARS-CoV-2 Rapid Antigen Test positive. The patient displays clinical signs at rest indicative of severe systemic illness included fever 38 C. The patient did not require supplemental oxygen (including high flow or ECMO) or mechanical ventilation. He was not experienced Multiorgan failure, Respiratory, Cardiovascular, Gastrointestinal/Hepatic, Vascular, Renal, Neurologic, Hematological, Dermatological symptoms/signs during the COVID-19 illness. He had no pre-existing diseases worsened during the SARS-CoV2 infection. He had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included body temperature: 38 centigrade on an unknown date, sars-cov-2 antibody test: positive on 10Sep2021, sars-cov-2 test by PCR: positive on 11Sep2021. It was reported Nasopharyngeal swab: E-gene (Sarbecovirus): present, Ct (Amplification cycles) 14.98, RdRp/S-gene (SARS-CoV-2) present, Ct (Amplification cycles) 15.93, N-gene (SARS-CoV-2) present, Ct (Amplification cycles) 15.88. Therapeutic measures were taken as a result of events and treatment included Ibuprofen. The outcome of the events was not recovered. No additional information needed. No further information expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure and COVID-19 and the suspect drug bnt162b2.


VAERS ID: 1729656 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypersensitivity, Oropharyngeal pain, Oxygen saturation, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210910; Test Name: SPO2; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101191991

Write-up: pharyngodynia; Pharyngeal oedema; allergies; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126517. This is the first of two reports. The patient was a 59-year old female (age at vaccination).Body temperature before vaccination was 36.5 degrees Centigrade.There were 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): the patient had allergic reaction at the first vaccination (Pharyngodynia).On 10Sep2021 at 14:00(the day of vaccination) , the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose at the age of 59-year-old for COVID-19 immunization.Event onset date reported as 10Sep2021 at 14:00(the day of vaccination).On 10Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows:There was pharyngodynia 5 minutes after injection, and SPO2 and dyspnoea were normal. Considering pharyngeal oedema due to allergies, antihistamine was administered by intravenous drip.After 30 minutes, the patient was feeling better and returned home.The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101206666 Same reporter/patient, different dose/event.


VAERS ID: 1729659 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Fall, Feeling abnormal, Heart rate
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Hypoglycaemia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:82/40; Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:138/58; Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210910; Test Name: pulse; Result Unstructured Data: Test Result:76; Test Date: 20210910; Test Name: pulse; Result Unstructured Data: Test Result:87
CDC Split Type: JPPFIZER INC202101192028

Write-up: Anaphylactic shock; fell; Cold sweat; blood pressure 82/40; feels poorly; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126495. A 20-year and 9-month-old male patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 10Sep2021 15:01 (Lot Number: FF9944; Expiration Date: 30Nov2021) as dose 1, single (at the age of 20-year-old) for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. The patient''s family history was unknown. 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). Medical history was reported as none. The patient''s concomitant medications were not reported. On 10Sep2021 at 15:10 (9 minutes after the vaccination), the patient experienced Anaphylactic shock. On 10Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: At 15:00 (as reported), the patient complained of feels poorly, at 15:10 fell, blood pressure 82/40, cold sweat. Pulse 76. BOSMIN 0.3ml was injected subcutaneously to upper arm at 15:15 for shock vitals. 15:20 Blood pressure 138/58. Pulse 87. Subjective symptom improved. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: BOSMIN injection was effective for anaphylactic shock. The outcome of events was recovered on 10Sep2021.


VAERS ID: 1729672 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Feeling abnormal
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:50s; Comments: at around 09:30; reached a maximum of 50s; Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:increased gradually; Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101192519

Write-up: Anaphylactic shock; Feels poorly; the patient''s blood pressure reached a maximum of 50s; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126481. The patient was a 42-year and 3-month-old (age at the vaccination) male. Body temperature before vaccination was 36.3 degrees Centigrade on 10Sep2021. The patient''s family history was not provided. 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 10Sep2021 at 09:20 (the day of the vaccination, at 42-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was reported as 10Sep2021 at 09:30 (the day of the vaccination). On 10Sep2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 10Sep2021 at around 09:20 (the day of the vaccination), the patient received the vaccination as mentioned above. On 10Sep2021 at around 09:30 (10 minutes after the vaccination), the patient appeared Feels poorly, and the patient''s blood pressure reached a maximum of 50s, after securing the route, ADRENALINE Injection 0.3 mg and SOLU-CORTEF 200mg were administered. The patient''s blood pressure increased gradually, and the patient was taken by emergency transport to the hospital, after the observation, the patient returned home. The reporter classified the event as serious (medically significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: It was considered as an anaphylactic shock to the vaccine. The outcome of the events was recovered on 10Sep2021.


VAERS ID: 1729674 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchospasm, Hypersensitivity, Oropharyngeal discomfort, Tracheal stenosis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101192560

Write-up: Tracheal stenosis; Pharynx strange sensation of; temporary Allergic reaction; Bronchospasm; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126527. A 41-year-old (41-year and 2-month-old) female patient received BNT162b2 (COMIRNATY), second dose, via an unspecified route of administration on 10Sep2021 18:15 (Lot Number: FF9944; Expiration Date: 30Nov2021) at the age of 41 years old, as single dose for covid-19 immunisation. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination on 10Sep2021 was 36.8 degrees Centigrade. On 10Sep2021 at 18:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Sep2021 at 18:15 (the day of vaccination), the patient experienced bronchospasm. On 10Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the events was reported as follows: After the second dose, Pharynx strange sensation of and Tracheal stenosis were complained by patient. The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Suspected to be the temporary Allergic reaction.


VAERS ID: 1729680 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure decreased, Blood pressure measurement, Body temperature, Feeling abnormal, Gait disturbance, Hyperhidrosis, Pulse abnormal
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: auscultation; Result Unstructured Data: Test Result:Feeble pulse was present; Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:could not be measured; Test Date: 20210910; Test Name: blood pressure; Result Unstructured Data: Test Result:112/48 mmHg; Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101192810

Write-up: feels poorly; sweating all over the body; Difficulty in walking; Feeble pulse; blood pressure could not be measured; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126456. A 14-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Sep2021 13:35 (Batch/Lot Number: FF5357; Expiration Date: 30Nov2021) at the age of 14-years-old as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was a 14-year and 11-month-old male (age at vaccination). Body temperature before vaccination was 36.5 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that the patient''s elder sister experienced anaphylactoid symptoms 3 days before. On 10Sep2021 at 13:35 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF5357, Expiration date 30Nov2021) via an Intramuscular route of administration as a single dose for COVID-19 immunisation. The onset date was reported as 10Sep2021 at 13:40 (5 minutes after the vaccination). The course of the event was as follows: Four minutes (as reported) after receiving the intramuscular injection, the patient experienced feels poorly, sweating all over the body, and difficulty in walking. Feeble pulse was present on auscultation. The blood pressure could not be measured. The blood pressure returned to 112/48 mmHg owing to an intramuscular injection of adrenaline 0.3 mg. The patient was transferred to other hospital. The outcome of the events was unknown. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1729694 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Oxygen saturation, Pallor, Presyncope, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:86/72 mmHg; Comments: 11:02; Test Date: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:146/80 mmHg; Comments: 11:10; Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210910; Test Name: pulse test; Result Unstructured Data: Test Result:142; Comments: 11:02; Test Date: 20210910; Test Name: Oxygen saturation; Test Result: 96 %; Comments: 11:02; Test Date: 20210910; Test Name: Oxygen saturation; Test Result: 98 %; Comments: 11:10
CDC Split Type: JPPFIZER INC202101198430

Write-up: Blood pressure 146/80; Blood pressure 86/72; Heart rate 142; Convulsion; Pallor facial; vagal relex/ Vasovagal reaction; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126526. The patient was a 17-year-old male. Body temperature before vaccination was 36.2 degrees Centigrade on 10Sep2021. Medical history was not reported. The patient previously took DPT vaccine for immunisation and experienced swelling in armpit. Concomitant medication was not reported. On 10Sep2021 at 10:45 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at 17-year-old for COVID-19 immunization. On 10Sep2021 at 11:00 (15 minutes after the vaccination), the patient experienced vasovagal reaction. The course of the event was as follows: At 10:55, the patient received vaccination. At 11:00, the symptoms of convulsion, pallor facial and vagal relex occurred. At 11:02, BP 86/72, Pulse 142, Oxygen saturation 96%. At 11:10, the symptom of convulsion subsided. BP 146/80, Oxygen saturation 98%. On 10Sep2021 (the day of vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was illegible characters. The reporting physician commented as follows: When receiving the second dose of vaccination, it was necessary to lay down and after that have an observation of 30 minutes.; Reporter''s Comments: When receiving the second dose of vaccination, it was necessary to lay down and after that have an observation of 30 minutes.


VAERS ID: 1729698 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

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: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:95/50; Comments: the day of vaccination; Test Date: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:120; Comments: the day of vaccination
CDC Split Type: JPPFIZER INC202101213211

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 16-year-old male. It was unknown whether the patient had any other medical history or not. On 10Sep2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown), at the age of 16-year-old, via an unspecified route of administration for COVID-19 immunization. On 10Sep2021 (after the vaccination), the patient experienced anaphylactic shock. The clinical course was reported as follows: After 4 to 5 minutes of vaccination, the patient felt cold, sweaty and in shock. He dripped 0.3ml of BOSMIN intravenously. The blood pressure was 95/50 and then returned to 120. He rested at home after recovering and continued to recover after that. The outcome of the event was recovered on 10Sep2021 with treatment including 0.3ml of BOSMIN intravenously. The reporter classified the anaphylactic shock as serious (life-threatening). The reporter stated that the anaphylactic shock definitely related to the BNT162B2. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylactic shock and 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: 1729875 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-09-10
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Hyperpyrexia, Inappropriate schedule of product administration, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: hyperpyrexia; Result Unstructured Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: Late second dose administered (two months and two days after the first dose); This case was received (Reference number: NL-LRB-00683649) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 on 12-Mar-2020. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), MALAISE, CHILLS, FATIGUE and NAUSEA. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late second dose administered (two months and two days after the first dose)). On 11-Sep-2021, NAUSEA had resolved. At the time of the report, HYPERPYREXIA, MALAISE, CHILLS and FATIGUE was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late second dose administered (two months and two days after the first dose)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: (High) No concomitant medications were reported by the reporter. No treatment information was provided by the reporter. Reporter''s causality was not provided. Company Comment: This is a case of Inappropriate schedule of product administration for this 26-year-old, female patient with no relevant medical history. The patient received the second dose of the vaccine 2 months and 3 days after the first dose which is considered to be Inappropriate schedule of product (vaccine) administration. The patient also experienced the unexpected events of Hyperpyrexia and Malaise, as well as the expected events chills, nausea and fatigue. All reported events occurred on the same day after the administration of the second dose of Spikevax. The rechallenge was unknown since there''s no information if there were any events after the first dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The company causality for the event Inappropriate schedule of product administration is not applicable, while the company causality for the remaining reported events is assessed as possible. The benefit-risk relationship of Spikevax is not affected by this report. The event Hyperpyrexia was automatically upgraded as it is on IME list and was assessed as serious during medical review, based on medical judgement (having in mind that body temperature was 40.5 to 42 degrees Celsius). The action taken with the suspect vaccine was not applicable. Batch number of the suspect product was unknown.; Sender''s Comments: This is a case of Inappropriate schedule of product administration for this 26-year-old, female patient with no relevant medical history. The patient received the second dose of the vaccine 2 months and 3 days after the first dose which is considered to be Inappropriate schedule of product (vaccine) administration. The patient also experienced the unexpected events of Hyperpyrexia and Malaise, as well as the expected events chills, nausea and fatigue. All reported events occurred on the same day after the administration of the second dose of Spikevax. The rechallenge was unknown since there''s no information if there were any events after the first dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The company causality for the event Inappropriate schedule of product administration is not applicable, while the company causality for the remaining reported events is assessed as possible. The benefit-risk relationship of Spikevax is not affected by this report. The event Hyperpyrexia was automatically upgraded as it is on IME list and was assessed as serious during medical review, based on medical judgement (having in mind that body temperature was 40.5 to 42 degrees Celsius).


VAERS ID: 1729926 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure fluctuation, Discomfort, Erythema, Hot flush, Hypothermia, Oedema peripheral, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: hypothermia; patient started to have blushes; Her ears were getting hot/her right ear started to heat and at night it was very unpleasable; discomfort; tremblors; variation on her blood pressure; edemas on her legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (hypothermia) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vertigo. Concomitant products included BETAHISTINE (HISTINA [BETAHISTINE]) for Vertigo. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criterion medically significant), ERYTHEMA (patient started to have blushes), HOT FLUSH (Her ears were getting hot/her right ear started to heat and at night it was very unpleasable), DISCOMFORT (discomfort), TREMOR (tremblors), BLOOD PRESSURE FLUCTUATION (variation on her blood pressure) and OEDEMA PERIPHERAL (edemas on her legs). The patient was treated with PARACETAMOL at an unspecified dose and frequency and PARACETAMOL (PANASORBE) at an unspecified dose and frequency. At the time of the report, HYPOTHERMIA (hypothermia), ERYTHEMA (patient started to have blushes), HOT FLUSH (Her ears were getting hot/her right ear started to heat and at night it was very unpleasable), DISCOMFORT (discomfort), TREMOR (tremblors) and BLOOD PRESSURE FLUCTUATION (variation on her blood pressure) outcome was unknown and OEDEMA PERIPHERAL (edemas on her legs) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. The reporter reported that some of these symptoms had disappeared . Patient was fine during the day and event of right ear started to heat gets worst at night.Patient took treatment Paracetamol from time to time to treat symptoms. Patient thought the nurse told her to take Ben-u-ron but she took Panasorbe instead. This case concerns an 81-year-old female with a serious unexpected event of hypothermia, and non-serious erythema, hot flush, discomfort, tremor, blood pressure fluctuation, and oedema peripheral. Latency 2 days after first dose mRNA-1273. Event outcome unknown. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns an 81-year-old female with a serious unexpected event of hypothermia, and non-serious erythema, hot flush, discomfort, tremor, blood pressure fluctuation, and oedema peripheral. Latency 2 days after first dose mRNA-1273. Event outcome unknown. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1730649 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Foetal hypokinesia, Headache, Maternal exposure during pregnancy, Myalgia, Rash, SARS-CoV-2 test, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Hypersensitivity (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: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; 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: my unborn baby ? s movements became less that day too ! the day after that i had a huge red; Weakness; Tiredness; Muscle ache; Vaccination site warmth; Vaccination site induration; headache; Vaccination site erythema; Maternal exposure during pregnancy; Skin rash; This case was initially received viaRegulatory Authority (Reference number: GB-MHRA-ADR 25942200) on 15-Sep-2021. The most recent information was received on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of FOETAL HYPOKINESIA (my unborn baby ? s movements became less that day too ! the day after that i had a huge red), ASTHENIA (Weakness), FATIGUE (Tiredness), MYALGIA (Muscle ache), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration), RASH (Skin rash), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient 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 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Sep-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). On an unknown date, the patient experienced FOETAL HYPOKINESIA (my unborn baby ? s movements became less that day too ! the day after that i had a huge red) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Vaccination site warmth) (seriousness criterion medically significant), VACCINATION SITE INDURATION (Vaccination site induration) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (Vaccination site erythema) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, FOETAL HYPOKINESIA (my unborn baby ? s movements became less that day too ! the day after that i had a huge red) and HEADACHE (headache) was resolving, ASTHENIA (Weakness), FATIGUE (Tiredness), MYALGIA (Muscle ache), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and RASH (Skin rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Treatment medication was not provided by the reporter . Patient is not enrolled in clinical trial Patient was exposed to the medicine Second-trimester (13-28 weeks). Patient stated that she felt very poorly the following day, every muscle in her body ached, she was extremely tired and weak, very painful headache and couldn''t go about any daily business. Her unborn baby''s movements became less that day too! The day after that she had a huge red, hard and hot mark around the injection site at least 4-5 big and she couldn''t lift her arm due to the amount of pain it was causing. Also at the same time she noticed a rash on both arms which she still have 4 days later, the rash looks different to any rash she have had before in her life too. Company Comment: This case of maternal exposure during pregnancy concerns a 36-year-old female patient, who experienced the serious unexpected events of Foetal hypokinesia, Asthenia, Vaccination site warmth, Vaccination site induration, rash, headache, myalgia, fatigue, Vaccination site erythema approximately 1 day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2021: Significant follow-up received on 19-sep-2021 and updated action taken, event removed, additional events were added and contains additional information; Sender''s Comments: This case of maternal exposure during pregnancy concerns a 36-year-old female patient, who experienced the serious unexpected events of Foetal hypokinesia, Asthenia, Vaccination site warmth, Vaccination site induration, rash, headache, myalgia, fatigue, Vaccination site erythema, with no reported relevant history. The events occurred approximately 1 day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable, applicable since only information about the second dose was disclosed. The events were considered possibly related to Moderna COVID-19 Vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1732926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-10
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Scan
SMQs:, Termination of pregnancy and risk of abortion (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: FOLIC ACID; LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Overweight; Polycystic ovary; Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:baby''s heartbeat couldn''t be found
CDC Split Type: GBPFIZER INC202101191474

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109102339493490-VXFUG. Safety Report Unique Identifier GB-MHRA-ADR 25926921. A 28-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 05Aug2021 (Lot Number: FF3319) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder, a bit overweight, Polycystic ovary, and hypothyroidism. Her thyroid level had always been at a steady level and her doctor suspected she might have very mild PCOs although not confirmed with a scan, therefore she was on metformin for this. She was a bit overweight but fairly fit and do regular weekly exercise. The patient doesn''t smoke and drink much. She doesn''t take drugs. She eats fairly healthily with minimal red meats. Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported; levothyroxine taken for hypothyroidism from 01Aug2018 to an unspecified stop date; and metformin taken for polycystic ovaries from 01Jun2021 to an unspecified stop date. The patient experienced miscarriage of pregnancy (assessed as medically significant) on 10Sep2021 with outcome of not recovered. The patient was around 6 weeks pregnant when she had her second Pfizer vaccine and a scan at 11 weeks confirmed she had a missed miscarriage as the baby''s heartbeat couldn''t be found. She was told the baby had died at around 9 weeks. This means the baby died 2-3 weeks after the vaccine and she can''t help but wonder if the second vaccine could have caused this. The patient underwent lab tests and procedures which included Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This was her first pregnancy. The patient had her second Pfizer vaccine when she was 6 weeks pregnant. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1732934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Vaccination site mass
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; INDAPAMIDE; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Kidney disorder; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191675

Write-up: Armpit pain; Injection site lump; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111922233480-B9E4A, Safety Report Unique Identifier GB-MHRA-ADR 25928652. A 29-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number not reported) via unspecified route of administration in left arm on 09Sep2021 as single dose for COVID-19 immunisation. Medical history included hypertension, suspected COVID-19 from 03Aug2021 to 11Aug2021 and scarred and shrunken kidney (fully working though). Concomitant medications included amlodipine from 12Jul2015; indapamide from 02Jan2016 and losartan for hypertension from 02Feb2020; all to an unspecified stop date for hypertension. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number not reported) via unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 10Sep2021 (after 1 day of vaccination) patient experienced armpit pain and injection site lump. Very painful lump in arm pit affecting use of left arm (vaccine site arm), very large painful red hard lump at vaccine site. The outcome of events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adnexa uteri pain, Diarrhoea, Dizziness, Heavy menstrual bleeding, Nausea
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196562

Write-up: ovarian pain; Heavy periods; Dizziness; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, this report is received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109121306132360-TWRQX, and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25929086. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2153), dose 1 via an unspecified route of administration on 10Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced immediate feeling of nausea after injection and diarrhea on 10Sep2021, dizziness on 11Sep2021, very heavy period two weeks early on 12Sep2021 and strong hormonal reaction pain in ovaries on an unspecified date. Outcome of the event nausea, heavy periods and dizziness was reported as not recovered, outcome of the event diarrhea was reported as recovering, outcome of the event ovarian pain was reported as unknown at this time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732962 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Chest pain, Inappropriate schedule of product administration, Vaccination site mass
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196517

Write-up: chest pain; Armpit pain; Breast pain female; Injection site lump; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109121321550310-Q8OIB, safety report unique identifier is GB-MHRA-ADR 25929093. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), dose 2 via an unspecified route of administration on 10Sep2021 as dose 2, single for covid-19 immunisation. Medical history included contraception. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication(s) included desogestrel (CERELLE) taken for contraception. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on 03Jul2021 as dose 1, single for COVID-19 immunization. The patient experienced chest pain on an unspecified date, inappropriate schedule of vaccine administered on 10Sep2021, armpit pain, breast pain female, injection site lump on 11Sep2021. Red solid lump where vaccine was, constant pain/ache on breast, armpit and arm. Also had some chest pain. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events armpit pain, breast pain female, injection site lump was reported as not recovered and outcome of all the other events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1732968 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neuralgia, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196448

Write-up: tingling; nerve pain across upper back and upper arms; chapped burning pain which feels hot to touch; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). Regulatory authority report number -RA-WEBCOVID-202109121644127450-5TQSW, Safety Report Unique Identifier -RA-ADR 25929229. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 10Sep2021 (Lot Number: FE3380) (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19 and not had a COVID test. The patient was not enrolled in clinical trial. The patient was not breastfeeding at the time of the report. It was reported that, the patient had no previous medical complaints of that nature. The patient medical history and concomitant medications were not reported. On 10Sep2021, 4 hours after vaccination, the patient experienced nerve pain across upper back and upper arms, tingling and chapped burning pain which felt hot to touch. The patient received treatment for the events included pain killers cocodamol and ibuprofen. The patient attended the urgent care at hospital who confirmed the pain was nerve pain. The patient was given details of medications which could help, but the side effects far outweighed the benefits which she would receive from the medications so she decided against taking any such medications. The patient had not tested positive for COVID-19 since having the vaccine. The outcome of the events nerve pain across upper back and upper arms, tingling and chapped burning pain was not recovered. No follow-up attempts are needed. No further information is expected.


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