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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 199 out of 8,010

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VAERS ID: 1768384 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-26
Onset:2021-09-13
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram head, Disturbance in attention, Feeling abnormal, Full blood count, Headache, Impaired work ability, Metabolic function test, Poor quality sleep, Pyrexia, Sleep disorder, Tinnitus, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multi mineral and vitamin, vitamin c, zinc, vitamin d, magnesium oxide
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: BMP and hemogram CT Head Sinus x-rays
CDC Split Type:

Write-up: Headache began 9/13/21, dull and continuous, then fever started 9/17/21 (still had headache). On 9/22/21 my head started to "buzz" and will not stop. Fever stopped around the same time as buzzing started. Headaches now come and go. Other symptoms currently experiencing are brain fog, unable to focus/concentrate, poor sleep waking up often and unable to get back to sleep. Unable to work at my job. Applied for short term disability for now.


VAERS ID: 1768404 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Unknown  
Location: Illinois  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Pt given expired vaccine. Moderna contacted and recommended to repeat the dose. Patient contacted and asked to return to clinic


VAERS ID: 1768821 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram head, Diarrhoea, Dizziness, Headache, Hypoaesthesia, Laboratory test, Limb discomfort, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Sexual dysfunction (broad)

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

Write-up: headache, dizziness, nausea, diarrhea, numbness in her left leg ( ?heaviness?).


VAERS ID: 1770430 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-06
Onset:2021-09-13
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood disorder (makes her susceptible to Deep vein thrombosis).
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to antibiotics (Tetracycline and Clindamycin); COVID-19 (he might have COVID-19 in January 2021 but there were no available COVID-19 test that time); Fatigue; Intermittent fever.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: cold; fever ramped up all day long; chills/shivering; horrible joint pain like its on fire; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PYREXIA (fever ramped up all day long), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 016B21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (he might have COVID-19 in January 2021 but there were no available COVID-19 test that time) in January 2021, Intermittent fever from January 2021 to February 2021 and Fatigue from January 2021 to February 2021. Concurrent medical conditions included Blood disorder (makes her susceptible to Deep vein thrombosis) and Allergic reaction to antibiotics (Tetracycline and Clindamycin). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced NASOPHARYNGITIS (cold), PYREXIA (fever ramped up all day long), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. On 13-Sep-2021, NASOPHARYNGITIS (cold), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire) had resolved. On 14-Sep-2021, PYREXIA (fever ramped up all day long) had resolved. No concomitant medication information provided. This case was linked to MOD-2021-320189 (Patient Link).


VAERS ID: 1770460 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient has not reported any adverse reactions to this dose yet No concomitant and treatment informations were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up include no new information.


VAERS ID: 1770604 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Genital herpes zoster, Intermenstrual bleeding, Pain, Pain assessment, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Opportunistic infections (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox (as a child); Chromosomal anomalies; Diabetes; Endocrine disorder; Immunocompromised; Obesity; Penicillin allergy; Respiratory disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: pain; Result Unstructured Data: Test Result:10; Test Name: Covid exam; Result Unstructured Data: Test Result:positive; Comments: both rechecks were negative; Test Name: Covid exam; Result Unstructured Data: Test Result:negative; Comments: both rechecks were negative; Test Name: Covid exam; Result Unstructured Data: Test Result:negative; Comments: both rechecks were negative
CDC Split Type: USPFIZER INC202101275165

Write-up: she was in full blown pain on scale 1-10 it was a 10; she thought she was getting her period because she normally gets a little discharge and thought her period was coming.; breaking out with shingles in the vaginal area; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FD8448; expiration date: not reported) via an unspecified route of administration, administered in left arm on 03Sep2021 (at the age of 34-years-old) at 13:30 as dose 1, single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Chicken pox as a child, allergy to penicillin, start and stop date was unknown. Patient previously took Penicillin for cystic acne and experienced neck got red and wheezing, like boils turning up on her face, chest, and back. Had no other shots the same day or 4 weeks prior. The patient''s concomitant medications were not reported.On 13Sep2021, patient experienced breaking out with shingles in the vaginal area.On 13Sep, does not know if she prolonged it or not, but she thought she was getting her period because she normally gets a little discharge and thought her period was coming. On Tuesday the 14Sep it got worse, by the 15Sep she was in full blown pain on scale 1-10 it was a 10. On Thursday the 16Sep she went to the emergency room. So everything really started on the 13th and it''s completely gone now she believes because of the medication the Ob/Gyn gave her. Again, mentions she took it for 10 days and her last dose was yesterday. Patient took treatment of Valopress, 2 pills for 10 days. On 15Sep2021, patient underwent lab tests and procedures which included pain assessment resulted 10, on and unspecified date underwent lab test of sars-cov-2 test resulted positive and negative, both rechecks were negative. Therapeutic measures were taken as a result of breaking out with shingles in the vaginal area (genital herpes zoster), she was in full blown pain on scale 1-10 it was a 10 (pain). The outcome of event breaking out with shingles in the vaginal area and she thought she was getting her period because she normally gets a little discharge and thought her period was coming was recovered in Sep2021. At the time of reporting, the event she was in full blown pain on scale 1-10 it was a 10 was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1770671 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL6204 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anal incontinence, Asthenia, Chills, Cough, Diarrhoea, Dizziness, Fatigue, Feeding disorder, Headache, Hyperhidrosis, Illness, Nasal discomfort, Nausea, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Throat irritation, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mycobacterium avium complex infection (Chronic 2x lyrs Mycobacterium avium No problem caused by)
Allergies:
Diagnostic Lab Data: Test Name: Covid test; Result Unstructured Data: Test Result:Negative; Comments: Covid
CDC Split Type: USPFIZER INC2021253956

Write-up: Dizzy; itching; Rash; tire easily; illness; Chills; Slight headache; Weakness that she could barely stand; Nose and throat felt on fire/burning sensation in nose and throat as if inhaled fire; Nose and throat felt on fire/ burning sensation in nose and throat as if inhaled fire; Nausea; Vomiting/vomited twice; Diarrhea occasionally; heavly sweating; Weight loss of 5 lbs; low grade fever beginning in late afternoon and night which became higher in afternoon; Cough was almost constant day and night and so severe she was incontinent of feces and barely had time to breathe between coughs.; Cough was almost constant day and night and so severe she was incontinent of feces and barely had time to breathe between coughs.; unable to eat and she stated food felt foreign to her; The initial case was missing the following minimum criteria: Suspect product is not reported or specified. Upon receipt of follow-up information on 20Sep2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non hcp (patient). A 84-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: EL6204) via an unspecified route of administration, administered in left arm (deltoid left) on unspecified date in 2021 at 02:00 PM (at the age of 84 years) as single dose for covid-19 immunisation. The patient''s medical history included chronic mycobacteria avium (chronic 2 lyrs mycobacterium avium) from 2000 to an unknown date and no problems caused. The patient''s concomitant medications were not reported. On unspecified date in 2021, 48 hours after taking vaccination, patient experienced dizzy which results hospitalization, slight headache and weakness that she could barely stand. On unspecified date in 2021 at 14:00, 24 hrs after taking second vaccine patient experienced burning sensation in nose and throat as if inhaled fire and on unspecified date in 2021, after 48 hours from vaccination at 08:00, patient experienced nausea, vomited twice, diarrhea occasionally, heavly sweating, weight loss of 5 lbs (pounds), low grade fever beginning in late afternoon and night which became higher in afternoon(Heavy might sweats), cough was almost constant in day and night and so severe and she was incontinent of feces, barely had time to breathe between coughs and also experienced chills. On unspecified date in 2021, patient was unable to eat and she stated food felt foreign to her, on 13Sep2021, patient covered in itching rash and tired easily and on unspecified date in 2021, patient stated she have never been so ill in her life and she was absolutely well before second vaccine. she felt that vaccine was responsible for my illness. Adverse events s resulted in physician office visit and symptoms persisted for weeks. Patient stated that she just want to report the symptoms she had after taking Pfizer Vaccine. One week ago (last Wednesday) she took vaccine and experienced events which lasted until this morning. When she got out of bed this morning, no longer dizzy, feel her old self. But she thought it was important to let us know that she did suffer side effects. No other products that were taken together with vaccine. The patient underwent lab tests and procedures which included covid test: negative on unspecified date (Covid). No treatment received for dizzy, slight headache and weakness that she could barely stand. The outcome of dizzy was not recovered, for slight headache and weakness that she could barely stand was recovered on unspecified date in 2021, for weight loss of 5 lbs was not recovered as of 13Sep2021 not regained her weight and for remaining all events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1771513 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Headache, Injection site pain, Retinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Retinal disorders (narrow)

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

Write-up: Headache, Retinal bleed, Injection site pain


VAERS ID: 1771746 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Chest pain that is unresolved


VAERS ID: 1771840 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-01-12
Onset:2021-09-13
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Headache, Oropharyngeal pain, SARS-CoV-2 test positive, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive Covid-19 PCR Test
CDC Split Type:

Write-up: C/O sore and scratchy throat, and headache


VAERS ID: 1771843 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-21
Onset:2021-09-13
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Exercise tolerance decreased, Fatigue, Headache, Immune system disorder, Immunisation, Myalgia, Nausea, Neutrophil count decreased, Vitamin D decreased, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REVLIMID; metformin; AMARYL; CYMBALTA; baby aspirin; levothyroxine; pantoprazole; FOSAMAX; vitamin B12 injection; ZETIA; allopurinol; ZYRTEC; FLONASE; IMODIUM; ZOFRAN; magnesium lactate; vitamin D3; krill oil; B complex; multivitamin; calci
Current Illness: MDS - Bone marrow cancer
Preexisting Conditions: Diabetes Type 2; Barrett''s esophagus with severe reflux; Stage 2 kidney disease; Osteoporosis; Hypothyroidism
Allergies: Penicillin; Sulfa allergies
Diagnostic Lab Data: 9/16 Blood work - WBC 2.4 to 1.9; Neutrophils 1.4 ? 0.9; 10/6 Blood work - WBC ? 2.3; Neutrophils 1.38
CDC Split Type: vsafe

Write-up: Extreme fatigue, weakness around 3 weeks after getting the shot. I was walking over a mile at least 3 times a week prior to the booster. I have not been able to do that since around the 13 of Sept. I have a lot of muscle pain, aches, I have horrendous diarrhea. I''ve had headaches, not bad just occasional, nausea. I''m just worn out. I went to the Dr. last Friday October 1st for telehealth. Basically, he ran a battery of lab tests if there was anything currently different than what they were previously. Taking IMODIUM for the diarrhea. Trying to get my energy back, immune system was shot. Nausea has been gone. A test related to symptoms for the medication for hypothyroidism was done. No relation. I got my vitamin D increased because levels were low. Being referred to the Oncologist at the end of November.


VAERS ID: 1772113 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-09-05
Onset:2021-09-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Angiogram, Anticoagulant therapy, Cerebral venous sinus thrombosis, Computerised tomogram head, Dizziness, Headache, Intensive care, Jugular vein thrombosis, Platelet count normal, Prothrombin time prolonged, Transverse sinus thrombosis, Venogram abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Imaging: MRV Brain: 9/20 Apparent filling defect with likely reflect nonocclusive thrombus is seen within the right transverse and sigmoid sinus. CTA Head: Nonocclusive small but long right transverse sinus, right sigmoid sinus, and right upper internal jugular vein thrombosis. Nonocclusive tiny left medial transverse sinus thrombosis Laboratory results: Platelets: 315; PT: 13.1; aPTT: 41.4
CDC Split Type:

Write-up: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u


VAERS ID: 1772161 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Headache, Illness, Nausea, Pain, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu vaccine, Pneumonia vaccines- will get achy and fatigued.
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sulpha
Diagnostic Lab Data: None performed
CDC Split Type: vsafe

Write-up: I experienced feverish, nausea, achiness in my head ached, I was very ill, few hours after my vaccine. I felt very weak and achy, slept a lot. The thing that frightened me the most was the fever. I took an anti nausea medication for relief of nausea. I do not have any symptoms today.


VAERS ID: 1773482 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Auditory disorder, Cardiac disorder, Chest pain, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hearing impairment (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Almost had to be admitted into Emergency room, but I left the hospital because they wouldn''t let my husband inside. I had severe heart issue! Not sure exactly what was wrong but I came close to having heart attack! This lasted for a few days. I had the worst dizziness that lasted more than 23 minutes! Chest pain, restricted breathing, and static sound in my head between the ears. The vaccine also left a taste in my throat even though I got the shot in my arm. My heart has not felt right since the vaccine! I felt wonderful just prior to getting the injection!


VAERS ID: 1775189 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Impaired work ability, Migraine, Photosensitivity reaction, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: hypogylcemia
Allergies: latex
Diagnostic Lab Data: n/a I don''t have health insurance
CDC Split Type:

Write-up: Starting within 30 minutes of receiving 2 dose of moderna vaccine I began to have intense sporadic migraine-like headaches, random fever & extreme photosensitivity & blurred vision which continues to this day. It is effecting my job since I work in an outdoor profession.


VAERS ID: 1775364 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Induration, Pain in extremity, Palpitations, Peripheral swelling, Pruritus, Skin irritation, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hard swollen arm with extreme pain, tenderness, itching and irritation. Followed by extremes shortness of breath with rest, heart palpitations and mild intermittent chest pain.


VAERS ID: 1776830 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-13
Onset:2021-09-13
   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 FC3181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:

Write-up: Very sore arm after 24 hours, fever and headache. After 48 hours, patient states that soreness went away , but when she tries to lift arm above shoulder still has pain. Has not seeked any treatment or otc medication use.


VAERS ID: 1776893 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-31
Onset:2021-09-13
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022M20A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B21-2A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Nasal congestion, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

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

Write-up: sore throat, nasal congestion


VAERS ID: 1776965 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-08
Onset:2021-09-13
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, Epidural injection, Exposure during pregnancy, Gestational hypertension, Induced labour, Premature labour, Traumatic delivery
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Multivitamin - 1 time a day; fish oil - 1000 mcg once a day; folic acid - 800 mcg once a day; allergy - generic Zyrtec once a day; Famotidine - 20 mg twice a day
Current Illness: no
Preexisting Conditions: migraine headaches without aura
Allergies: no
Diagnostic Lab Data: blood pressure, oxygen saturation and pulse Fetal monitoring and contractual monitoring - non stress testing They did a number of blood tests in monitoring. Gestational hypertension monitoring Heart Hospital
CDC Split Type: vsafe

Write-up: I was two weeks early with labor starting. I had gestational hypertension. I had one elevated blood pressure; 15 minutes later - sustained response - 146/97 in the morning. My OB got an admission time for alter that evening. My blood pressure was perfectly fine the entire time. (110/80 the whole time I was in the hospital.) It took about 48 hours from induction to birth. They induced me on Monday evening and baby was born 11:00 pm on Wednesday was when baby was born. Neopristal (they gave me lactacted ringers of the IV fluid) and Oxytocin - I had an epidural and then I suffered a level three tear. Baby was healthy 7 lb 15 oz - he was born on weeks 39 and 0 days. In recovery at this time. 1st Pregnancy - and first full term pregnancy Estimated due date was 09/29/2021 Notes: Got flu vaccine right after baby was born - maybe 9/20/2021 I got the TDAP vaccine - I think I got that sometime in July 2021.


VAERS ID: 1777589 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-09-13
Onset:2021-09-13
   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 FC2588 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Severe muscle soreness throughout the entire body.


VAERS ID: 1779881 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer booster dose given before it was approved.


VAERS ID: 1779919 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-06-02
Onset:2021-09-13
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, COVID-19, Condition aggravated, Myalgia, Nausea, Productive cough, Pyrexia, SARS-CoV-2 test positive, Sputum discoloured
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol (ACCUNEB) 0.63 MG/3ML nebulizer solution Take 1 ampule by nebulization every 6 (six) hours as needed for Wheezing. 30 ampule 1 ? albuterol (PROVENTIL) (2.5 MG/3ML) 0.083% nebulizer solution Take 1 ampule by nebulization every 4 (f
Current Illness:
Preexisting Conditions: Anemia heavy periods, corrected after hysterectomy ? Bipolar disorder (CMS/HCC) ? CHD (congenital heart disease) Patient denies but states that cardiologist says has a "stiff heart" ? CHF (congestive heart failure) (CMS/HCC) ? Chronic bronchitis (CMS/HCC) ? Chronic Thrombocytopenia (CMS/HCC) ? Clostridium difficile infection 09/23/2017 ? Colon polyp ? COPD (chronic obstructive pulmonary disease) (CMS/HCC) ? Cough ? Crohn''s disease (CMS/HCC) ? Depression
Allergies: Lisinopril
Diagnostic Lab Data: Meds given: dexamethasone (DECADRON) injection 8 mg (has no administration in time range) azithromycin (ZITHROMAX) tablet 500 mg COVID-19 RESULT Detected
CDC Split Type:

Write-up: Pt is a 47 yr/o female with a hx of Crohn''s disease, COPD, CHF, and sarcoidosis who presents with myalgias that began a few days ago. She has also felt feverish and has had a cough. Her cough is productive of yellow sputum. She has chronic nausea due to her hx of crohn''s disease, but has not had relief recently with her Zofran. She is on Mesalamine for her crohn''s disease. She is fully vaccinated for Covid19. Review of Systems. Positive for fever. Negative for activity change and unexpected weight change. HENT: Negative for congestion, sore throat and neck pain. Eyes: Negative for visual disturbance. Respiratory: Positive for cough. Negative for shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Positive for nausea. Negative for diarrhea and vomiting. Genitourinary: Negative for difficulty urinating and flank pain. Musculoskeletal: Positive for myalgias and back pain. Negative for joint swelling. Skin: Negative for rash. Neurological: Negative for seizures and headaches. Hematological: Negative for adenopathy. Psychiatric/Behavioral: The patient is not nervous/anxious.


VAERS ID: 1780156 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-09
Onset:2021-09-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / UNK - / IM

Administered by: Military       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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

Write-up: Patient reports subjective tinnitus developed without associated hearing loss.


VAERS ID: 1782490 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-27
Onset:2021-09-13
   Days after vaccination:229
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 12M20A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782555 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-30
Onset:2021-09-13
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Work       Purchased by: ?
Symptoms: Menstrual disorder
SMQs:

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

Write-up: I have changes to my period. The color of my period is brown and the flow is very light.


VAERS ID: 1782964 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-05
Onset:2021-09-13
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1784851 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-07
Onset:2021-09-13
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2011921A / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 1784864 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 2 LA / IM
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 026B21A / 1 LA / IM

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse.
Current Illness: None.
Preexisting Conditions: ADHD.
Allergies: Latex.
Diagnostic Lab Data: Patient had no adverse side effect.
CDC Split Type:

Write-up: 17 y/o given Moderna vaccine due to mom request. Patient had no side effects. Second dose given on 10/11/21 as advised by PCP and ID MD2005.


VAERS ID: 1785426 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-09-08
Onset:2021-09-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, Exposure during pregnancy, Parosmia
SMQs:, Taste and smell disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: Prenatal Vitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Some food smells turned to skunk-like. I was 6 weeks pregnant at the time, and it was a few days after my 1st vaccine dose when some food smells turned very sour. I have been pregnant two times previously, and neither of those pregnancies resulted in modified taste or smell. I lost my taste and smell initially in May 2021 when I presumably had COVID-19, but I didn''t ever test to confirm. Loss of taste and smell were the only symptoms. My taste and smell were recovering slowly when I became pregnant and received the 1st dose of the vaccine. I had not experienced a bad smell or taste up to that point. A few days later my smell started to turn sour. I have experienced some pregnancy related nausea and food aversions simultaneously. My estimated date of delivery is 05/08/2022.


VAERS ID: 1785436 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-09-09
Onset:2021-09-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Alopecia areata, Antinuclear antibody negative, Blood iron normal, C-reactive protein increased, Full blood count normal, Metabolic function test, Red blood cell sedimentation rate increased, Rheumatoid factor increased, Serum ferritin normal, Thyroid function test normal
SMQs:, Immune-mediated/autoimmune disorders (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: aspirin 81 mg tablet,delayed release 81 mg PO DAILY atorvastatin 40 mg tablet 40 mg PO QHS buspirone 15 mg tablet 15 mg PO TID calcium carbonate 600 mg (1,500 mg)-vitamin D3 2,500 unit capsule 1 cap PO QDAY escitalopram oxalate 20 mg table
Current Illness: MTX toxicity 8/28/21
Preexisting Conditions: RA, CAD, HLD, HTN, anxiety, depression, tobacco use
Allergies: No Known Allergies Allergy (Verified 09/30/21 13:37)
Diagnostic Lab Data: ANA negative, CRP and ESR elevated secondary to Chronic RA, RF levels elevated, CBC normal, CMP normal, iron panel normal, ferretin normal, CMP normal, thyroid panel normal
CDC Split Type:

Write-up: Patient developed diffuse alopecia areata 4 days after receiving her first COVID immunization. Hair was falling out in clumps, it was an abrupt onset. No pain or itching on the scalp. Patient labs have been monitored since her hospitalization for MTX toxicity, last dose of MTX was mid August and has not had any since. Her labs stabilized by discharge.


VAERS ID: 1785681 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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

Write-up: Ringing in ears. Began in left ear and then in both. Non stop since 3 days after second dose.


VAERS ID: 1786660 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Confusional state, Diplopia, Dizziness, Dysarthria, Dysuria, Gait disturbance, Heart rate decreased, Hypotension, Panic attack
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: clonazepam oral .25x3daily for panic disorder; mirtazepine .75 (remeron) oral for sleep 1x night
Current Illness:
Preexisting Conditions: Congenital Lipodystrophy Panic Disorder Social Anxiety Disorder PTSD
Allergies: Petroleum-based plastic product allergy since birth; Levaquin in Intravenous form results in profuse projectile vomiting for up to 72 hrs.
Diagnostic Lab Data: 10/14/21
CDC Split Type:

Write-up: Heart Rate dropped from 120 to 59 in less than 5 minutes at time of vaccination- I left as heart monitor was reading 65 BPM. Blood pressure remained lowest ever experienced. When I experienced double vision, rather in fact: quadruple vision and had not been able to urinate AT ALL from time of injection 2:00 pm Monday until 5:00 pm Tuesday. Dizzy, stumbling, slurring words, confused and panicked, I saw Dr. who IMMEDIATELY referred to to ER. ER was full. EMPLOYER MANDATED THIS SHOT FOR CONTINUED EMPLOYMENT, I had no money for ER; so i declined $$$ambulance$$$ told Dr. I would get a ride, then laid on the ground to die for 3 days. I did not die and returned to work only to be met with reprimandation for having to take 3 days off for my kidneys to start working again. Dr. wanted to check for blood clots in lungs; heart congestion, and clots in muscles. This costs money. My health post-vaccine is now uncertain. Prior to this I was 100% well and healthy physically. I previously had Covid and *had natural antibodies prior to this.


VAERS ID: 1700234 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Feeling abnormal, Magnetic resonance imaging head, Muscle spasms, Night sweats, Seizure, Tremor, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
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: brain MRI - 15th Sept FBE - 15th Sept urine sample - 15th sept potential follow up with lumbar puncture.
CDC Split Type:

Write-up: Night sweat, tremors, muscle spasms, seizures, brain fog.


VAERS ID: 1714520 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG2872 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Heart rate increased, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Chest discomfort, heart palpitations, strong heartbeat even in resting state (sitting down), fatigue, dizzy, breathing shortness


VAERS ID: 1717502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
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: KRJNJFOC20210933446

Write-up: OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 6 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, frequency 1 total, administered in deltoid on 02-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 13-SEP-2021, the patient experienced other events, and was hospitalized (date unspecified). The number of days hospitalized was unspecified. 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: V0-20210933446-Covid-19 vaccine ad26.cov2.s-Other events.This event(s) is considered unassessable. The event(s) has an 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: 1720899 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-13
   Days after vaccination:74
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: Chest discomfort, Chest pain, Chills, Headache, Influenza, Pain in extremity, Peripheral swelling, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; PREGABALIN; SERTRALIN
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Flu symptoms; Itchy; Pain in arm; chills; tight chest; Chest pain; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25935536) 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 CHILLS (chills), CHEST DISCOMFORT (tight chest), PERIPHERAL SWELLING (Swollen arm), CHEST PAIN (Chest pain), HEADACHE (Headache), INFLUENZA (Flu symptoms), PRURITUS (Itchy) and PAIN IN EXTREMITY (Pain in arm) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included PREGABALIN for Anxiety, OMEPRAZOL and SERTRALIN for an unknown indication. In July 2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), CHEST DISCOMFORT (tight chest) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), PRURITUS (Itchy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), CHEST DISCOMFORT (tight chest) and PRURITUS (Itchy) was resolving and PERIPHERAL SWELLING (Swollen arm), CHEST PAIN (Chest pain), HEADACHE (Headache), INFLUENZA (Flu symptoms) and PAIN IN EXTREMITY (Pain in arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced events hot and cold sweats and swollen injection site and results were unknown. No treatment information were reported. Company comment: This case concerns a 27 year-old, female subject with no significant medical history, who experienced the unexpected events of Swollen arm, Chest pain, chills, tight chest, headache and flu like symptoms. The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The event was considered related.The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27 year-old, female subject with no significant medical history, who experienced the unexpected events of Swollen arm, Chest pain, chills, tight chest, headache and flu like symptoms. The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The event was considered related.The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1720900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-13
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Disease recurrence, Myocarditis, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (an illness or condition, not listed above, which reduces the immune response); Myocarditis (Had myocarditis Nov 20 most likely Covid related as working in office with multiple positive cases)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217563

Write-up: Chest pain - cardiac; radiating chest pain up neck and into jaw.; Myocarditis; Myocarditis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109151747212210-BTP6R, Safety Report Unique Identifier GB-MHRA-ADR 25946997. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA1027) via an unspecified route of administration on 23Jun2021 as a single dose for COVID-19 immunisation. Medical history included myocarditis from Nov2020 most likely COVID related as working in office with multiple positive cases; suspected COVID-19 from 20Nov2020 (also reported with an end date of 13Sep2021); and immunodeficiency: had an illness or condition, not listed above, which reduces the immune response (e.g. immunodef..) The patient was not enrolled in clinical trial. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced myocarditis, radiating chest pain up neck and into jaw, and on 13Sep2021, the patient experienced chest pain - cardiac; all were reported as serious for being life threatening and hospitalization from an unknown date. The clinical course was as follows: the patient previously had suspected COVID myocarditis spent a week intensive care, the patient was getting better and was getting radiating chest pain up neck and into jaw. The patient was waiting for cardiology appointment. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the events myocarditis and radiating chest pain up neck and into jaw was resolving; while that of chest pain - cardiac was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1721364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 4 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Extra dose administered, Off label use, Pain, Pain in extremity, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis (patient''s mother); COVID-19; Dermatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101214782

Write-up: The redness spread to the scalp over time, accompanied by itching.; Arm pain; Fever; Body pain; Rash; itching after 4th dose; Off-label use; Extra dose administered; This is a spontaneous report from a contactable pharmacist (patient herself). This is the second case of two linked cases. This case is for 2nd dose of BNT162B2 vaccine. A female patient of an unspecified age received fourth dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot number was not reported) via intramuscularly, in Arm on 13Sep2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from 11Nov2020 to an unknown date and dermatitis. The patient''s concomitant medications were not reported. The historical vaccines include third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot number was not reported) via intramuscularly, administered in Arm on 13Jul2021, single dose for COVID-19 immunization and experienced with Arm pain. Family history included the patient''s mother has atopic dermatitis. The patient experienced itching after 4th dose and the redness spread to the scalp over time, accompanied by itching on 13Sep2021. On 14Sep2021 the patient developed erythema, arm pain, fever, body pain and body rash. Clinical course included patient stated that Itching started under the breast 2 hours after vaccination. She used Loratidine on the evening of 13Sep2021 and the itching stopped. The itching became more severe on the morning of 14 September and started again, although Loratidine was used in the evening of 14Sep2021, it did not subside, and the patient stated that he had a very difficult night on 14 September. The redness spread to the scalp over time, accompanied by itching. The consumer also stated that she had experienced fever, arm pain and body pains and did not consider them serious. When the consumer woke up on the morning of 15Sep2021, she stated that all events had recovered, but she was afraid of the recurrence of itching and redness. She has not visited the doctor yet, but there is a request for medical information about the treatments she has applied and can apply. She stated that she will enter the emergency room in case of recurrence. Seriousness of event (itching) was reported as serious (medically significant). The patient received treatment with Parol (paracetamol) for arm pain and fever. And she stated that she had taken Claritin tablets with the active ingredient Loratidine. The outcome of events (off label use, extra dose administered and Rash) was reported as unknown and other events were recovered on 15Sep2021. Batch/lot number was requested.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. 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: 1722116 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

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

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

Write-up: Period pains; This case was received via Regulatory Authority (Reference number: 25931301) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of DYSMENORRHOEA (Period pains) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Period pains) 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 COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications are reported. No treatment medications are reported. Company comment: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of Dysmenorrhoea. The events occurred 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 benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of Dysmenorrhoea. The events occurred 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 benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1722124 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
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: Abdominal pain upper, Diarrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach pain; Diarrhoea; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25933970) 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 DIARRHOEA (Diarrhoea) and ABDOMINAL PAIN UPPER (Stomach pain) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea) had not resolved and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company comment: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of diarrhea and abdominal pain upper. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. It was noted that in the SD the reported height and weight of the patient was misleading.; Sender''s Comments: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of diarrhea and abdominal pain upper. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. It was noted that in the SD the reported height and weight of the patient was misleading.


VAERS ID: 1724770 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
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 jittery, Headache, Influenza like illness, Vomiting
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Flu like symptoms; Jitteriness; Vomited; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25938270) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), FEELING JITTERY (Jitteriness) and VOMITING (Vomited) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), FEELING JITTERY (Jitteriness) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) had not resolved, FEELING JITTERY (Jitteriness) was resolving and VOMITING (Vomited) 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 not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Batch number of the suspected product was unknown. The reporter did not provide causality. Company Comment: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, influenza like illness, feeling jittery, and vomiting. The events occurred on the same day or one day after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed.The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, influenza like illness, feeling jittery, and vomiting. The events occurred on the same day or one day after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.


VAERS ID: 1725029 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-09-13
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Arm soreness; Headache; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache) and MYALGIA (Body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 079C71A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache) and MYALGIA (Body aches). On 15-Sep-2021, HEADACHE (Headache) and MYALGIA (Body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided. This case was linked to c, MOD-2021-320084 (Patient Link).


VAERS ID: 1725842 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Body temperature, Cough, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 37.6
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: it numbs half of my right cheek and I feel a little numbness in my lips as well; No appetite; Cough; Muscle ache; Headache; Feverish; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25939956 ) 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 ADVERSE DRUG REACTION (it numbs half of my right cheek and I feel a little numbness in my lips as well), ADVERSE DRUG REACTION (No appetite), COUGH (Cough), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Feverish) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 14-Sep-2021. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced ADVERSE DRUG REACTION (it numbs half of my right cheek and I feel a little numbness in my lips as well) (seriousness criterion medically significant), ADVERSE DRUG REACTION (No appetite) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (it numbs half of my right cheek and I feel a little numbness in my lips as well), ADVERSE DRUG REACTION (No appetite) and HEADACHE (Headache) had not resolved and COUGH (Cough), MYALGIA (Muscle ache) and PYREXIA (Feverish) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.6 (High) 37.6. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. Company Comment : This case concerns a 27-year-old, male patient with suspected covid-19 (no covid-19 testing done), who experienced the unexpected events of hypoaethesia, appetite decreased, cough, myalgia, headache, pyrexia, fatigue and arthralgia. The events occurred approximately 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Events seriousness assessed as per Regulatory Authority reporting. The rechallenge was unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old, male patient with suspected covid-19 (no covid-19 testing done), who experienced the unexpected events of hypoaethesia, appetite decreased, cough, myalgia, headache, pyrexia, fatigue and arthralgia. The events occurred approximately 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Events seriousness assessed as per Regulatory Authority reporting. The rechallenge was unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1725848 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
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: Chills, Headache, Joint stiffness, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Myalgic encephalomyelitis
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.)
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: Stiffness; Chills; Headache; Nauseous; Stiffness joints; This regulatory authority case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiffness joints), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). Concurrent medical conditions included Myalgic encephalomyelitis. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced JOINT STIFFNESS (Stiffness joints) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). At the time of the report, JOINT STIFFNESS (Stiffness joints), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication use information was not provided by reporter. Patient began experiencing chills at around 8pm, and an on-again-off-again headache beginning around 10pm (vaccine was at 10am). The headache worsens when patient move then fades when patient stop moving. Patient began experiencing some feelings of stiffness and instability whilst walking (patient was slightly worried of legs will give way) and felt very slightly nauseous. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication use information was not provided by reporter. Company Comment: This case concerns a 23-year-old, female patient with relevant medical history of myalgic encephalomyelitis, who experienced the unexpected events of joint stiffness, chills, headache, and nausea. The events occurred approximately 1 day 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. However, patient''s underlying medical condition remains a contributory factor. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 23-year-old, female patient with relevant medical history of myalgic encephalomyelitis, who experienced the unexpected events of joint stiffness, chills, headache, and nausea. The events occurred approximately 1 day 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. However, patient''s underlying medical condition remains a contributory factor. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1725851 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: heartburn; Heart racing; This case was received via RA (Reference number: GB-MHRA-ADR 25941692) 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 DYSPEPSIA (heartburn) and PALPITATIONS (Heart racing) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concomitant products included METFORMIN from 25-Oct-2016 to an unknown date for an unknown indication. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPEPSIA (heartburn) (seriousness criterion medically significant). At the time of the report, DYSPEPSIA (heartburn) outcome was unknown and PALPITATIONS (Heart racing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. The patient experienced very fast heart beat during the first night. On the second night, heartburn continued. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment This case concerns a 45-year-old, female subject with relevant medical history of metformin intake and high body mass index (Overweight: 29.73), who experienced the unexpected events of dyspepsia and palpitations. The events palpitations and Dyspepsia occurred on the same day of administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The medical history of metformin intake, which may cause the event dyspepsia (heartburn), as well as higher body mass index remain as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.; Sender''s Comments: This case concerns a 45-year-old, female subject with relevant medical history of metformin intake and high body mass index (Overweight: 29.73), who experienced the unexpected events of dyspepsia and palpitations. The events palpitations and Dyspepsia occurred on the same day of administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The medical history of metformin intake, which may cause the event dyspepsia (heartburn), as well as higher body mass index remain as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.


VAERS ID: 1729182 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
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: Back pain, Hot flush, Migraine, Nausea, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Heart pounding; Nausea; Migraine; Back pain; Fever chills; Hot flushes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25938636) 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), BACK PAIN (Back pain), PYREXIA (Fever chills), HOT FLUSH (Hot flushes), PALPITATIONS (Heart pounding) and NAUSEA (Nausea) 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 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and HOT FLUSH (Hot flushes) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), BACK PAIN (Back pain), PYREXIA (Fever chills), HOT FLUSH (Hot flushes), PALPITATIONS (Heart pounding) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company comment: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of migraines, back pain, pyrexia, hot flush, palpitations, and nausea. The events occurred approximately 1 day after the second dose . The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of migraines, back pain, pyrexia, hot flush, palpitations, and nausea. The events occurred approximately 1 day after the second dose. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1729185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
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: Chills, Headache, Myalgia, Nausea, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever; Chills; Headache; Nausea; Muscle ache; Pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25939890) 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 PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache) and PAIN (Pain) 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 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache) and PAIN (Pain) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information were provided by the reporter. Patient symptoms was worse throughout the night after evening jab of second dose. No treatment information was provided by the reporter. Company Comment: This case concerns a unknown age, female patient with no relevant medical history, who experienced the unexpected events of Pyrexia, Chills, Headache, Nausea, Myalgia and Pain. The events occurred approximately on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna covid- 19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a unknown age, female patient with no relevant medical history, who experienced the unexpected events of Pyrexia, Chills, Headache, Nausea, Myalgia and Pain. The events occurred approximately on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna covid- 19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1729186 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Palpitations, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: aches all over body; headache; palpitations; Vomiting; Heart pounding; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25940237) 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 PAIN (aches all over body), HEADACHE (headache), PALPITATIONS (palpitations), PALPITATIONS (Heart pounding) and VOMITING (Vomiting) 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 13-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 13-Sep-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (aches all over body) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and PALPITATIONS (palpitations) (seriousness criterion medically significant). At the time of the report, PAIN (aches all over body), HEADACHE (headache) and PALPITATIONS (palpitations) outcome was unknown, PALPITATIONS (Heart pounding) had not resolved and VOMITING (Vomiting) 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) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment history was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of pain, headache, palpitations (palpitations and heart pounding) and vomiting. The events of palpitations (palpitations and heart pounding) occurred the same day after the second dose of mRNA 1273, the event of vomiting occurred the next day after the second dose of mRNA 1273, the onset date for the events of pain, and headache is not known. The rechallenge was unknown and no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting,; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of pain, headache, palpitations (palpitations and heart pounding) and vomiting. The events of palpitations (palpitations and heart pounding) occurred the same day after the second dose of mRNA 1273, the event of vomiting occurred the next day after the second dose of mRNA 1273, the onset date for the events of pain, and headache is not known. The rechallenge was unknown and no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting,


VAERS ID: 1729192 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pain, Palpitations, Pyrexia, Seizure
SMQs:, Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Nausea; Ache; Convulsions; Fever; Palpitations; This case was received via RA (Reference number: 25941157) 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 PALPITATIONS (Palpitations), NAUSEA (Nausea), PAIN (Ache), SEIZURE (Convulsions) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 2 dosage form. On 13-Sep-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion disability). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion disability), PAIN (Ache) (seriousness criterion disability), SEIZURE (Convulsions) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). At the time of the report, PALPITATIONS (Palpitations), NAUSEA (Nausea) and SEIZURE (Convulsions) had resolved and PAIN (Ache) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided Treatment information was not provided. Company comment:This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of palpitations, nausea, pain, seizure, and pyrexia. The event palpitation occurred on the same date after the second dose of Spikevax. For the events nausea, pain, seizure and pyrexia, 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 terms and 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 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of palpitations, nausea, pain, seizure, and pyrexia. The event palpitation occurred on the same date after the second dose of Spikevax. For the events nausea, pain, seizure and pyrexia, 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 terms and 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: 1729424 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-13
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive, 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: 20210913; Test Name: Nasal Swab; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: IEPFIZER INC202101211132

Write-up: Tested positive for Covid-19 on 15Sep after having received 2 vaccine doses; Tested positive for Covid-19 on 15Sep after having received 2 vaccine doses; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (COMIRNATY), via intramuscular route of administration at the left arm on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient had received the first dose of vaccine at the age of 48 years old on unknown date in Jan2021. The patient medical history and concomitant medications were not reported. The patient experienced that there was a positive COVID-19 virus test, via nasal swab on 13Sep2021 with outcome of recovering. The patient didn''t received treatment for the event. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1729595 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden hearing loss
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101180139

Write-up: Sudden hearing loss; This is a spontaneous report from a contactable nurse via medical information team. A patient of unspecified age and gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and steroid prednisolone (PREDONINE) (Batch/Lot number was not reported), oral tablet taken from 06Sep2021 for a week, at an unspecified dose for an unspecified indication. The patient''s medical history and concomitant medications were not reported. On 13Sep2021 the patient experienced sudden hearing loss. The patient planned to receive dexamethasone sodium phosphate (DEXART) by drip from 13Sep2021 as a treatment for sudden hearing loss. The patient was planned the second vaccination of BNT162 (COMIRNATY) "on 11Sep2021" (as reported) but the patient was worried about if there would be any adverse reactions. The action taken with prednisolone in response to the event was reported as not applicable. The event outcome was unknown at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information , a possible contributory role of the suspect product BNT162B2 to the development of events sudden hearing loss cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1730650 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-09-13
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: diarrhea; cramps; Stomach cramps; This case was received via regulatory agency (Reference number: ADR 25957195) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), MUSCLE SPASMS (cramps) and ABDOMINAL PAIN UPPER (Stomach cramps) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (diarrhea) (seriousness criterion medically significant) and MUSCLE SPASMS (cramps) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (diarrhea) and MUSCLE SPASMS (cramps) was resolving and ABDOMINAL PAIN UPPER (Stomach cramps) 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. Adverse reaction did not occur as a result of an exposure during pregnancy. This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of upper abdominal pain, diarrhea and muscle spasms. The events occurred approximately 25 days after the second dose of Moderna CoviD-19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. 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 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of upper abdominal pain, diarrhea and muscle spasms. The events occurred approximately 25 days after the second dose of Moderna CoviD-19 Vaccine. The event was considered related to the study drug, per the reporter''s assessment is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. 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: 1732474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210943273

Write-up: SEIZURE; FALL; This spontaneous report received from a health care professional via a Regulatory Authority (DE-PEI-202100188978) on 22-SEP-2021 concerned a 20 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-01 expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced seizure and fall on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure and fall was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1732884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain in arm
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205371

Write-up: Fever; shaky; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-APPCOVID-20210913173330 with Safety Report Unique Identifier GB-MHRA-ADR 25933212. A 20-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Sep2021 as a single dose for COVID-19 immunisation. Medical history included pain in arm. The patient was not pregnant and was not breastfeeding at the time of this report. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 10Sep2021, the patient underwent a COVID-19 virus test and the result was negative. Concomitant medications included paracetamol (MANUFACTURER UNKNOWN) from 12Sep2021 taken for arm pain and was unknown if ongoing. On 13Sep2021 at 05:00, the patient woke up with a fever and was shaky. The event fever was reported as serious for being medically significant. The clinical outcome of the event fever was not recovered while that of the event shaky was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733032 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
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: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205313

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109130843328060-KCBTE with Safety Report Unique Identifier of GB-MHRA-ADR 25930448. A female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have symptoms associated with COVID-19, and was not enrolled in the clinical trial. Concomitant medications were not reported. On 13Sep2021, 2 days after the vaccination, the patient experienced swollen lymph nodes which was reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1733056 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   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: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205393

Write-up: Faint; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109131300149790-KQEYK, Safety Report Unique Identifier GB-MHRA-ADR 25931691. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153), via an unspecified route of administration on 13Sep2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. On 13Sep2021, the patient was fainted 2 minutes after vaccination. This report was not related to possible blood clots or low platelet counts. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event fainted was recovered on 13Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   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 FE8087 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MILLINETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Testosterone
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101205568

Write-up: chills; projectile vomited; nausea; Stomach pain; Vomiting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109132121593910-RHIMB. Safety Report Unique Identifier GB-MHRA-ADR 25934719. A 21-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 12Sep2021 (Batch/Lot Number: FE8087, Solution for injection) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 from 08Oct2020 to an unknown date unsure when symptoms stopped, blood testosterone from an unknown date and unknown if ongoing. Patient is not currently breastfeeding. Concomitant medication included Ethinylestradiol, Gestodene (MILLINETTE) taken for blood testosterone from 05Jan2021 to an unspecified stop date. The patient previously took first dose of BNT162B2 for COVID-19 Immunization. The patient experienced chills on an unspecified date, projectile vomited on an unspecified date, nausea on an unspecified date, vomiting on 13Sep2021, stomach pain on 13Sep2021 17:30. Stomach pains and nausea started at 5.30pm after eating 3 crisps. Projectile vomited at 7.15pm. Vomited again and Stomach pain got much worse at about 8pm. Vomited once since. Has chills and feels unwell- in bed. All events are medically significant. 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: positive on Yes - Positive COVID-19 test. The outcome of the events vomiting and stomach pain was not recovered and recovering for other events. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1733097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
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: Coagulation time, Deep vein thrombosis, Embolism, Fibrin D dimer, International normalised ratio, Peripheral swelling, Platelet count, Platelet factor 4, Prothrombin level, Tenderness, Thrombocytopenia
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Activated Partial Thromboplastin Clotting Time; Result Unstructured Data: Test Result:29.9; Test Date: 20210914; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000; Test Date: 20210914; Test Name: INR; Result Unstructured Data: Test Result:1.1; Test Date: 20210914; Test Name: Platelet count; Result Unstructured Data: Test Result:259; Test Date: 20210914; Test Name: Platelet factor 4; Result Unstructured Data: Test Result:Anti-PF4 antibodies were not identified; Comments: Anti-PF4 antibodies were not identified; Test Date: 20210914; Test Name: PT; Result Unstructured Data: Test Result:13.0
CDC Split Type: GBPFIZER INC202101205582

Write-up: Thromboembolic event; Thrombocytopenia; Left arm swelling; Left arm swelling with tenderness; DVT; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). The regulatory authority report number is RA-WEBCOVID-202109140658157290-TTGUT, Safety report unique identifier is RA-ADR 25936903. A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included non-smoker from an unknown date and unknown if ongoing. The patient had no history or current malignancy. The patient had no concurrent or recent intracranial infections. The patient had no recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had no recent trauma and head injury. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. On 13Sep2021, the patient experienced DVT. On an unspecified date, the patient had left arm swelling with tenderness, thromboembolic event and thrombocytopenia. Patient presented with left arm swelling and blood test showed high d dimer. This was diagnosed with D dimer (positive). The platelet count was not <150 A- 109/L. The patient underwent lab tests and procedures which included coagulation time: 29.9, fibrin d dimer: d-dimer was not $g4000, international normalised ratio: 1.1, platelet count: 259, platelet factor 4: anti-pf4 antibodies were not identified and prothrombin level: 13.0 on 14Sep2021. The reporter considered the events as serious (medically significant). The outcome of event DVT was recovering and unknown for other events. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1733098 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nausea; Maternal exposure during pregnancy; arm pain; Vomiting; Fever; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25938221) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 27-year-old female patient (gravida 1) 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. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 13-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 13-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 13-Sep-2021, PYREXIA (Fever) had resolved. On 14-Sep-2021, VOMITING (Vomiting) had resolved. At the time of the report, NAUSEA (nausea) had not resolved, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and PAIN IN EXTREMITY (arm pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient was administered with the jab in the morning at 08.30AM, then had arm pain all day, progressed into nausea at 4.30PM, this progressed into fever at 8PM and then vomiting for an hour, total 5 times within an hour. Patient has not tested positive for COVID-19 since having the vaccine Details of previous pregnancies: First pregnancy,12 weeks now Patient was exposed to the medicine before pregnancy. Company comment: This case concerns a 27-year-old female pregnant patient who experienced the events Nausea, vomiting, pyrexia, pain in arm and maternal exposure during pregnancy. The patient received the second dose of vaccine at 12 weeks of gestation. No information was provided regarding first dose. The events occurred the same day the patient receive the second and most recent dose of mRNA-1273 Moderna vaccine. Events were classified as serious by regulatory authority (seriousness criteria: Other). However, as per medical criteria none of the events was serious (not ADR listed and resolved). No causality assessment was provided by the reporter. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old female pregnant patient who experienced the events Nausea, vomiting, pyrexia, pain in arm and maternal exposure during pregnancy. The patient received the second dose of vaccine at 12 weeks of gestation. No information was provided regarding first dose. The events occurred the same day the patient receive the second and most recent dose of mRNA-1273 Moderna vaccine. Events were classified as serious by regulatory authority (seriousness criteria: Other). However, as per medical criteria none of the events was serious (not ADR listed and resolved). No causality assessment was provided by the reporter. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1733108 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   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: Arthralgia, Feeling abnormal, Hyperhidrosis, Lymphadenopathy, Myalgia, Nausea, Peripheral swelling, Pyrexia, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: COVID-19 VACCINE MODERNA; NAPROXEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache tension; Nausea; Swollen glands; Fuzzy head; Swollen arm; Fever; Sweating; Generalized muscle aches; Joint ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25951868) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HYPERHIDROSIS (Sweating), MYALGIA (Generalized muscle aches), ARTHRALGIA (Joint ache), TENSION HEADACHE (Headache tension), NAUSEA (Nausea), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen glands) and FEELING ABNORMAL (Fuzzy head) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included NAPROXEN from 01-Jul-2021 to an unknown date for Period pains, COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for Vaccination. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), MYALGIA (Generalized muscle aches) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and FEELING ABNORMAL (Fuzzy head) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced TENSION HEADACHE (Headache tension) (seriousness criterion medically significant). On 15-Sep-2021, PYREXIA (Fever) was resolving, HYPERHIDROSIS (Sweating), MYALGIA (Generalised muscle aches) and ARTHRALGIA (Joint ache) had resolved. At the time of the report, TENSION HEADACHE (Headache tension), PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen glands) had not resolved and NAUSEA (Nausea) and FEELING ABNORMAL (Fuzzy head) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided Company Comment: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of pyrexia, hyperhidrosis, myalgia, arthralgia, tension headache, nausea, peripheral swelling, lymphadenopathy and feeling abnormal. The events pyrexia, hyperhidrosis, myalgia, arthralgia, peripheral swelling occurred on the same day after second dose of Spikevax. The events nausea, feeling abnormal and lymphadenopathy occurred 1 day after second dose of Spikevax. The event tension headache occurred 2 days after second dose of Spikevax. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.; Sender''s Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of pyrexia, hyperhidrosis, myalgia, arthralgia, tension headache, nausea, peripheral swelling, lymphadenopathy and feeling abnormal. The events pyrexia, hyperhidrosis, myalgia, arthralgia, peripheral swelling occurred on the same day after second dose of Spikevax. The events nausea, feeling abnormal and lymphadenopathy occurred 1 day after second dose of Spikevax. The event tension headache occurred 2 days after second dose of Spikevax. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.


VAERS ID: 1733399 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Antithrombin III, Antithrombin III deficiency, Haematocrit, Haematocrit increased, Haemoglobin, Haemoglobin increased, Red blood cell count, Red blood cell count increased
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Antithrombin III; Result Unstructured Data: Test Result:deficiency; Test Name: Haematocrit; Result Unstructured Data: Test Result:high; Test Name: Haemoglobin; Result Unstructured Data: Test Result:high; Test Name: Red blood cell count; Result Unstructured Data: Test Result:increased
CDC Split Type: ITPFIZER INC202101239589

Write-up: Following administration of the second dose of COVID Pfizer vaccine (20 days after inoculation), a significant increase in relevant elevation of hematocrit; Following administration of the second dose of COVID Pfizer vaccine (20 days after inoculation), a significant increase in relevant elevation of Erythrocytes; Following administration of the second dose of COVID Pfizer vaccine (20 days after inoculation) decrease of antithrombin III; Following administration of the second dose of COVID Pfizer vaccinum (20 days after inoculation), a significant increase in relevant elevation of hemoglobin; This is a spontaneous report from a contactable consumer downloaded from the the regulatory authority number is IT-MINISAL02-787562. A 66-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), second dose via an unspecified route of administration, administered in right arm (right shoulder) on an unspecified date as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. The patient experienced following administration of the second dose of covid Pfizer vaccine (20 days after inoculation), a significant increase in relevant elevation of hematocrit, erythrocytes, hemoglobin on 13Sep2021, following administration of the second dose of covid Pfizer vaccine (20 days after inoculation) decrease of antithrombin iii on 13Sep2021. The case was reported as serious per life threatening. The patient underwent lab tests and procedures which included antithrombin iii: deficiency, haematocrit: high, haemoglobin: high, red blood cell count: increased all on an unspecified date. The outcome of events was not resolved. Impact on quality of life was 10/10. Reporter comment: No previous pathology. Tests performed even before double dose. Everything was normal before the vaccine. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Reporter''s Comments: No previous pathology. Tests performed even before double dose. Everything was normal before the vaccine.


VAERS ID: 1733435 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Body temperature, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: Medical History/Concurrent Conditions: Light-headed feeling (at the time of blood collection before)
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: blood pressure; Result Unstructured Data: Test Result:blood pressure decreased mildly; Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101191943

Write-up: consciousness disturbed; Vasovagal reflex; blood pressure decreased mildly; Transient loss of consciousness; This is a spontaneous report from a contactable physician received via regulatory authorities. Regulatory authority report number is v21127808. A 16-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 13Sep2021 09:00 (at the age of 16-year-old) (Batch/Lot Number: FD1945; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. Medical history included Light-headed feeling at the time of blood collection before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient was not pregnant. The patient''s concomitant medications were not reported. Body temperature before vaccination was 35.8 degrees Centigrade on 13Sep2021. On 13Sep2021 at 09:00 (after the vaccination), the patient experienced transient loss of consciousness. The reporter classified the event as non-serious. The outcome of the event was recovered on an unspecified date with treatment including observation in bed. Since the vaccination, the patient has not been tested for COVID-19. On 13Sep2021 at 09:10 (the day of vaccination), the patient experienced vasovagal reflex. On 13Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: the patient experienced consciousness disturbed for several seconds and blood pressure decreased mildly. The patient was placed in a supine position, quickly after which the symptom improved. No drug was administered. After being observed for 30 minutes, the patient returned home. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was reported as the patient said she was in extreme tension. The reporting physician commented as follows: the patient stated that she had had a light-headed feeling at the time of blood collection before. The vaccinator was asking each patient questions, and when vagal reflex was suspected, the vaccinator was performing an injection with the patient placed in a supine position. However, it was occasionally impossible to grasp such a patient at the time of medical interview. The vaccinator suggested that the item concerning vagal reflex should be added in the questionnaire. Outcome of the events consciousness disturbed, vasovagal reflex and blood pressure decreased mildly was recovered on 13Sep2021.


VAERS ID: 1736073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210944550

Write-up: DEEP VEIN THROMBOSIS LEG; LUNG EMBOLISM; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100194276) on 23-SEP-2021 concerned a 76 year old male. The patient''s weight was 65 kilograms, and height was 168 centimeters. The patient''s concurrent condition included: arterial hypertension. 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 20-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced deep vein thrombosis leg and lung embolism. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis leg, and lung embolism. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736329 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-13
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Influenza, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Headache; Flu; Tiredness; Second dose of Moderna Vaccine received after 80 days from the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) 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 PYREXIA (Fever), HEADACHE (Headache), INFLUENZA (Flu) and FATIGUE (Tiredness) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna Vaccine received after 80 days from the first dose). On 14-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 13-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna Vaccine received after 80 days from the first dose) had resolved. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), INFLUENZA (Flu) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was unknown. Company Comment: This case concerns a 36-year-old, male subject with no reported relevant medical history, who experienced the unexpected event of Influenza and expected events of Pyrexia, Headache, Fatigue. The event occurred on the next day after the second dose of the Moderna COVID-19 Vaccine administration. The rechallenge was not applicable. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old, male subject with no reported relevant medical history, who experienced the unexpected event of Influenza and expected events of Pyrexia, Headache, Fatigue. The event occurred on the next day after the second dose of the Moderna COVID-19 Vaccine administration. The rechallenge was not applicable. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug is not affected by this report.


VAERS ID: 1736335 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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 Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Armpit pain; Injection site redness; Fever; Pain injection site; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25946931) 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 AXILLARY PAIN (Armpit pain), INJECTION SITE PAIN (Pain injection site), INJECTION SITE ERYTHEMA (Injection site redness) and PYREXIA (Fever) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant). On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, AXILLARY PAIN (Armpit pain), INJECTION SITE PAIN (Pain injection site) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided. The patient was not enrolled in clinical trial. Company Comment: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of axillary pain, injection site pain, injection site erythema and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of axillary pain, injection site pain, injection site erythema and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1736350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-09-13
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Muscular weakness, Nasal congestion, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pain and weakness in the injected arm started immediately; Chills; Nose congestion; Dizziness; Fever chills; Headache; Fatigue; Fever; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25954893) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Pain and weakness in the injected arm started immediately), CHILLS (Chills), NASAL CONGESTION (Nose congestion), DIZZINESS (Dizziness), PYREXIA (Fever), PYREXIA (Fever chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced NASAL CONGESTION (Nose congestion) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Pain and weakness in the injected arm started immediately) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 14-Sep-2021, NASAL CONGESTION (Nose congestion), DIZZINESS (Dizziness) and PYREXIA (Fever chills) had resolved. On 15-Sep-2021, PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULAR WEAKNESS (Pain and weakness in the injected arm started immediately) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient had pain and weakness in the injected arm started immediately and then went away after about 10 minutes but returned after a few hours. Patient also reported that this was not go away using paracetamol and contributed to a loss of sleep and lasted three days and disrupted sleep over two nights. The patient experienced fever and fever chills during night and continued throughout the following day and night but were gone the following morning, also had headache after waking up with the fever and was continuous for three days despite taking paracetamol and staying hydrated and was severe. It was reported that the day after vaccination patient was spent with the fever , headache and arm pain, all of which were strong and also accompanied by dizziness and brain fog.Mild nose congestion was experienced throughout the late afternoon and evening. Fatigue worsened over the day and following day but was likely a result of the poor sleep caused by other symptoms rather than purely the vaccine itself. The patient was not able to complete her everyday tasks due to the overall symptoms and they disrupted her day badly and also stated that, with the first and third day symptoms providing a simple nuisance. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of muscular weakness, chills, nasal congestion, dizziness, pyrexia, headache and fatigue. The events occurred between the same day and 1 day after the second dose of mRNA-1273. 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 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 or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of muscular weakness, chills, nasal congestion, dizziness, pyrexia, headache and fatigue. The events occurred between the same day and 1 day after the second dose of mRNA-1273. 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 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 or meet the criteria to be medically significant.


VAERS ID: 1736371 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Nausea; Fever; Chills; This case was received via RA (Reference number: GB-MHRA-ADR 25964874) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 14-Sep-2021, CHILLS (Chills) had resolved. On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. 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. After vaccination patient were experienced some arm pain Symptoms started to abate the day after. Company comment This case concerns a 26 year-old male patient with no reported medical history who experienced the unexpected events of pyrexia, chills, and nausea. The events pyrexia and chills occurred approximately 1 day after the second dose of mRNA-1273. The event of nausea occurred on an unknown date. The rechallenge was unknown as first dose information and subsequent events was not provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.; Sender''s Comments: This case concerns a 26 year-old male patient with no reported medical history who experienced the unexpected events of pyrexia, chills, and nausea. The events pyrexia and chills occurred approximately 1 day after the second dose of mRNA-1273. The event of nausea occurred on an unknown date. The rechallenge was unknown as first dose information and subsequent events was not provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.


VAERS ID: 1738746 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205333

Write-up: Faint; This is a spontaneous report from a contactable healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109131537485530-WG3M1 with Safety Report Unique Identifier GB-MHRA-ADR 25932505. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 13Sep2021 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and did not have a COVID-19 test. The patient was not enrolled in a clinical trial. On 13Sep2021, the patient fainted during 15 minutes post vaccine waiting period. The patient was uninjured and therapeutic treatment included water and glucose tablet. He was moved to cooler area of the vaccine area. The patient did not test positive for COVID-19 since having the vaccine. The clinical outcome of the event fainted was resolved on 13Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Myalgia, Pain of skin, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORIDAY [NORETHISTERONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome (hypermobile)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101211336

Write-up: Pain all over the skin; Random patches of numbness; Tingling skin; Muscle pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory Authority report number GB-MHRA-WEBCOVID-202109132143096350-DBH4A, Safety Report Unique Identifier GB-MHRA-ADR 25934807. A 27-year-old female patient (non-pregnant) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153), via an unspecified route of administration on 12Sep2021 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (hypermobile) from unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. Concomitant medication included norethisterone (NORIDAY) taken for contraception from 20Dec2011. On 13Sep2021, the patient experienced random patches of numbness, tingling skin, and muscle pain. On unspecified date, the patient experienced pain all over the skin. The patient had negative COVID-19 virus test on unspecified date. The outcome of the event pain all over the skin was unknown, while for the other events was not recovered. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211351

Write-up: Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory Authority report number GB-MHRA-WEBCOVID-202109140932092620-UJXAD, Safety Report Unique Identifier of GB-MHRA-ADR 25937719. A 24-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/Lot Number: not known), via an unspecified route of administration on 12Sep2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. On 13Sep2021, 1 day after the vaccination, the patient experienced chest pain; which was reported as serious for being medically significant. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event chest pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738786 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Headache, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101211322

Write-up: Muscle ache; Headache; Nauseous; Dizziness; Acute chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109141135464000-NFNAF with Safety Report Unique Identifier is GB-MHRA-ADR 25938326. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fg3712) via an unspecified route of administration on 13Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. Concomitant medications were not reported. The patient experienced muscle ache on unspecified date, acute chest pain on 13Sep2021, and headache, nauseous, and dizziness on 14Sep2021. These events were reported as serious for being medically significant. The clinical outcome of the events was not resolved at the time of this report. On an unknown date, the patient underwent a COVID-19 virus test and the result was negative. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738811 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dysgeusia, Dyspepsia, Headache, Heart rate, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative
CDC Split Type: GBPFIZER INC202101211504

Write-up: Heartburn; Muscle ache; Heart rate; Taste metallic; Weakness; Headache fullness; High temperature; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141427087930-N0LSG, Safety Report Unique Identifier GB-MHRA-ADR 25939567. The female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FG9019) via an unspecified route of administration on 13Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 13Sep2021, the patient experienced heartburn, muscle ache, heart rate, taste metallic, weakness, headache fullness and high temperature. The seriousness criteria of the events considered as medically significant. 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 the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211546

Write-up: Pericarditis; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141459225210-49YJG. A 28-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 13Sep2021, the patient experienced pericarditis. The event assessed as medically significant. The outcome of the event was reported as recovering. Additional information: Patient is not enrolled in clinical trial. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No". No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738853 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Flatulence, Headache, Hyperhidrosis, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Perforation; Pins and needles; Surgery (Experienced a perforated duodenum in 2017)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211425

Write-up: hours; approx; injection site bled then pain at the site almost immediately; Joint pain; Sweating; Chills; Flatulence; Pain injection site; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109142144298530-SLVD0, Safety Report Unique Identifier GB-MHRA-ADR 25941691. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 13Sep2021 (age at the time of vaccination 50-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (Lot Number: not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included surgery from 2017 to 2017 (experienced a perforated duodenum in 2017 and required emergency surgery and life support in ITU (4 day stay in ITU)), pins and needles, pain and perforation from an unknown date and unknown if ongoing. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included amitriptyline taken for pins and needles; buprenorphine (BUTEC) taken for pain; desogestrel (CERAZETTE [DESOGESTREL]) taken for an unspecified indicatpiion and lansoprazole taken for perforation all start date and stop date were not provided. On an unspecified date, the patient experienced hours, approx, injection site bled then pain at the site almost immediately. On 13Sep2021, patient experienced pain injection site, increasing in intensity. Sweating begun approx 2 hours after vaccination followed by flatulence, fatigue, chills (all within 6 hours). As 24hrs later (on 14Sep2021) came joint pain with fatigue, chills and sweating coming in waves. All the events were assessed as medically significant. The outcome of hours, approx, injection site bled then pain at the site almost immediately was recovered on an unspecified date and other events pain injection site, fatigue, joint pain, sweating, chills, flatulence were not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1738854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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 INC202101211428

Write-up: Facial palsy; This is a spontaneous report from a contactable consumer, received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109142149575220-YHLWN, Safety Report Unique Identifier GB-MHRA-ADR 25941678. A female patient of an unspecified age received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection), via an unspecified route of administration on 12Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since had the vaccine and was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and did not have a COVID-19 test. On 13Sep2021, the patient experienced facial palsy. The case classified as serious (medically significant). The outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1738892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Chest pain, Computerised tomogram thorax, Fibrin D dimer, Lung neoplasm malignant, Platelet count, Pulmonary embolism, Pulmonary infarction, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown results; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:PE confirmed on CT PA, no right heart strain; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000; Test Name: platelet count; Result Unstructured Data: Test Result:1.5; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217695

Write-up: pulmonary infarct; lung; chest pain; Pulmonary embolism; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109151209370100-ITXWF, Safety Report Unique Identifier GB-MHRA-ADR 25945015. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on 09Sep2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. The patient experienced pulmonary infarct, chest pain and lung (lung neoplasm malignant) on an unspecified date, and pulmonary embolism on 13Sep2021. Seriousness criteria were reported as medically significant and hospitalization. Patient hospitalized due to these events on an unspecified date. The patient was presented to A&E with pleuritic chest pain. PE confirmed on CT PA, no right heart strain. Pulmonary infarct in right lung base. The patient underwent lab tests and proce-dures which included antibody test with unknown results and computerized tomogram thorax: PE con-firmed on CT PA, no right heart strain, fibrin d dimer was d-dimer was not greater than 4000 and platelet count was 1.5 on an unspecified date, and negative sars-cov-2 test on an unspecified date No - Negative COVID-19 test. The outcome of pulmonary embolism was not recovered, while outcome of other events was unknown. It was unknown if anti-PF4 antibodies identified. Platelet count was not less than 150-109/L. Patient''s report was related to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No fur-ther information is expected.


VAERS ID: 1738986 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-13
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, SARS-CoV-2 test
SMQs:, 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: Painful periods (4 years ago for the first day or so, but haven''t had that in a long time)
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: Painful periods; Period pains; This case was received (Reference number: GB-MHRA-ADR 25959860) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Painful periods) and DYSMENORRHOEA (Period pains) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Painful periods (4 years ago for the first day or so, but haven''t had that in a long time). On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion disability). On an unknown date, the patient experienced DYSMENORRHOEA (Painful periods) (seriousness criterion disability). At the time of the report, DYSMENORRHOEA (Painful periods) and DYSMENORRHOEA (Period pains) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information included painkillers. It was reported that after her first jab she had two early periods they were about 2 to 3 days earlier which was unusual. She had only ever been late or on time in the last year I have pretty much been on time or 1 day late. She had very painful first days and used to get painful periods 4 years ago for the first day or so but have not had that in a long time. This was debilitating pain which did not go away with painkillers or ease over the day. Most recently after her 2nd jab in August she had since experienced dark blood for 4 days. She occasionally get dark blood 1 or 2 days before her period but very very lightly just a spot of it a day, however this was everyday for 4 days and on at least 8 occasions throughout the day had been dark brown blood. She was due on her period in 3 days, but was thinking she might not come on concerning to miss a period after a vaccine and worrying about dark blood which was not period related. Company Comment: This case concerns a 25-year-old, female patient with a relevant medical history of painful periods 4 years ago, who experienced the unexpected events dysmenorrhea and dysmenorrhea. The events occurred approximately 24 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''s assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 25-year-old, female patient with a relevant medical history of painful periods 4 years ago, who experienced the unexpected events dysmenorrhea and dysmenorrhea. The events occurred approximately 24 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''s assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1739415 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Body temperature, Dyspnoea, Flushing, Hypoaesthesia, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade
CDC Split Type: JPPFIZER INC202101199503

Write-up: Anaphylaxis; Flushed face; pyrexia with the level of 37s centigrade; Dyspnoea; Blood pressure decreased; numbness of both fingers; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21127818. A 31-year-old (reported as 31-year and 5-month-old) female patient received bnt162b2 (COMIRNATY, solution for injection, lot number FG0978, expiration date 30Nov2021) via an unspecified route of administration on 13Sep2021 09:45 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination (13Sep2021) was 36.8 centigrade. The patient''s medical history was not reported. The patient had no family history. The patient''s concomitant medications were not reported. On an unspecified date, the patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, lot number unknown, expiration date unknown) via an unspecified route of administration as dose 1, single for COVID-19 immunisation and she experienced headache, low grade fever, and general malaise strongly persisted for 2 days. 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) as follows: after the first vaccination, headache, low grade fever, and general malaise strongly persisted for 2 days. On 13Sep2021 at 10:08 (the day of the vaccination), the patient experienced anaphylaxis. On 13Sep2021 (the day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: flushed face, pyrexia with the level of 37s centigrade, blood pressure decreased, and dyspnea appeared. At 10:08 and 11:00, epinephrine (BOSMIN) 0.3 mg was intramuscularly and subcutaneously injected respectively. Dyspnea and numbness of both fingers did not improve, so emergency transport. The reporter classified the event as serious (hospitalized from 13Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. On 13Sep2021 (the day of the vaccination), the outcome of the events was resolving.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101215306 Same reporter/patient, different event/dose


VAERS ID: 1739476 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005692 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Anaphylactic reaction, Contusion, Disorientation, Fall, Restlessness, Subcutaneous haematoma
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Not clear consciousness; Fall; Subcutaneous hematoma in left occipital region; Orientation disturbed; Bruise of head; Unrest; Anaphylaxis; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094164) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the RA (Ref, v21127819?v21128202). On an unknown date, body temperature before vaccination: 35.5 degrees Celsius. On 13-Sep-2021, at 16:27, the patient received the 1st dose of this vaccine. At 16:39, during follow-up, the patient fell from a chair. The symptom of Pallor facial and not clear consciousness developed. The patient was moved to the ER booth and the lower extremities were elevated in a recumbent position. BP 121/86, PR 84, SpO2 99%. At 16:41, the patient was called to the ambulance because of head bruising and persistent unrest and orientation disturbance. Blood pressure tended to decrease rapidly (BP 107/72). The patient was suspected to have anaphylaxis grade 2 or higher and was given Adrenaline. At 16:45, the intravenous route was secured, and the administration of lactate ringer solution was started. Administration of oxygen was started. BP 126/82, HR 100 range. At 17:00, the paramedics have arrived. Just before transport, there was a subcutaneous hematoma in the left occipital region. There was an orientation disturbed (about JCS 1-2, unable to remember having had this vaccination, unable to tell the month and day). There was unrest. BP 126/82, HR 110 range. At 17:20, an ambulance left for the hospital. Later on the same day, the patient''s symptoms improved. The outcome of the fall, not clear consciousness, bruise of head, unrest, orientation disturbed, anaphylaxis, subcutaneous hematoma in the left occipital region was reported as resolving. Follow-up investigation will be made. Reporter comments continuation: In a post-discharge interview with the patient, it was confirmed that there was no history of vagal reflex and no extreme anxiety about the vaccination. In retrospect, the possibility of anaphylactic shock is high. The possibility of head bruise is considered as another factor. Company Comment: This case concerns a 36 year old male patient with no medical history reported, who experienced the unexpected serious events of fall, not clear consciousness, bruise of head, unrest, orientation disturbed, subcutaneous hematoma in the left occipital region and expected serious event of anaphylaxis, within the same day after the first dose of mRNA-1273 vaccine. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.; Reporter''s Comments: The skin and mucous membrane symptoms and respiratory symptoms were not clear, and the possibility that it was a vagal reflex cannot be denied, but it occurred a few minutes after the vaccination. As circulatory symptoms, there was a rapidly progressive decrease in blood pressure, there was no obvious bradycardia, and there were loss of consciousness, orientation disturbed, and unrest as neurological symptoms. Therefore, anaphylaxis Grade 2 was suspected. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 36 year old male patient with no medical history reported, who experienced the unexpected serious events of fall, not clear consciousness, bruise of head, unrest, orientation disturbed, subcutaneous hematoma in the left occipital region and expected serious event of anaphylaxis, within the same day after the first dose of mRNA-1273 vaccine. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1739477 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004666 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

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

Write-up: Anaphylaxis; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP094182) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 29-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004666) for COVID-19 vaccination. Concurrent medical conditions included Allergy to nuts. On 13-Sep-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Sep-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). On 13-Sep-2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No concomitant medications use was reported. No treatment information was provided. This case concerns a 29 year old female patient with medical history of food allergy (nuts), who experienced the expected serious event of Anaphylaxis, within the same day after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 29 year old female patient with medical history of food allergy (nuts), who experienced the expected serious event of Anaphylaxis, within the same day after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1740784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dizziness postural, Headache, Nausea, Palpitations, Postmenopausal haemorrhage
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101198144

Write-up: Feeling dizzy; dizziness while bending down; experienced palpitations; nausea; headache; felt a buzzing, trembling vibration inside the left side of her chest; stopped having her period (menaupause) last year and 13SEP2021 she had a bleed; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 14Sep2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 04Sep2021 09:30 (at the age of 56 years old) as dose 1, single for COVID-19 immunisation. Medical history included stopped having her period (menopause) on an unspecified date in 2020. The patient has no recent surgeries, no allergies and does not have a GP. There were no concomitant medications. The patient reported feeling dizzy, dizziness while bending down, nausea, headache and palpitations on an unspecified date. She reported that nothing has changed in her daily routine and that she is in great health. She also reported that she had stopped having her period (menopause) last year (2020) and on 13Sep2021, she had a bleed that lasted for 2 days. It was lighter and shorter than a normal period. She woke up on 14Sep2021 morning and felt a buzzing, trembling vibration inside the left side of her chest. The buzzing lasts for a few seconds and then stops. It is ongoing. She spoke to a nurse. The patient said that she is very fit (56 years old but feels like 36, takes no medication, has a very good diet and used to be a fitness instructor). She has not seen a doctor yet. The outcome of the event chest discomfort was not recovered. The outcome of the event postmenopausal bleeding was recovered on 14Sep2021 while for the rest of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1742042 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown; Comments: result was not reported
CDC Split Type: CVPFIZER INC202101275151

Write-up: "we got sick"; This is a spontaneous report from a contactable other healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Sep2021 (batch/lot number was not provided) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 infection. The patient reported that he was around some people who were all vaccinated and "we got sick" on 13Sep2021. No treatment was received in response to the event. The outcome of the event was reported as not recovered. The event was reported as serious, disabling. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on an unknown date, result was not reported. The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender''s Comments: The information available in this report is limited and the reported event illness cannot be totally excluded/assessed. This case will be reassessed when additional information becomes available. 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: 1742479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: ASPIRIN; DIHYDROCODEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19; Comments: Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Pain; 25 weeks pregnant; This case was received via RA (Reference number: RA-ADR 25936055) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Not had a COVID-19 test. The patient''s past medical history included Suspected COVID-19 from 01-Mar-2020 to 30-Mar-2020. Concomitant products included DIHYDROCODEINE from 01-Aug-2021 to an unknown date for Pain relief, ASPIRIN from 01-Aug-2021 to an unknown date for Pregnant. On 13-Sep-2021, the patient received first 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 13-Sep-2021, the patient experienced NAUSEA (Nausea), PAIN (Pain) and MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant). On 13-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant) had resolved. At the time of the report, NAUSEA (Nausea) and PAIN (Pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient was 25 weeks pregnant. This case concerns a female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy, nausea and pain. The patient received the first dose of vaccine at 25 weeks of gestation. The events nausea and pain occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy, nausea and pain. The patient received the first dose of vaccine at 25 weeks of gestation. The events nausea and pain occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1742480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Genital herpes, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Genital herpes; Pregnancy (despite having 3 pregnancies in this time which is commonly known to bring on reoccurrences)
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211507

Write-up: broke out in sores and blisters by the Monday; Genital herpes; This is a spontaneous report from a contactable consumer or other non hcp received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109140805371020-T0JP8. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25937655. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 10Sep2021 as Dose 1,Single for Covid-19 immunization. Medical history included genital herpes, pregnancy, despite having 3 pregnancies in this time which is commonly known to bring on reoccurrences. Concomitant medication(s) included naproxen (NAPROFEN [NAPROXEN]). The patient experienced genital herpes on 13Sep2021, broke out in sores and blisters by the monday (blister) on an unspecified date. It was reported that she was diagnosed with first occurrence of Genital Herpes 9 years ago. never had a 2nd reoccurrence / outbreak at all across the 9 years (despite having 3 pregnancies in this time which is commonly known to bring on reoccurrences) had COVID jab on the Friday. Broke out in sores and blisters by the Monday. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Dec2020 No - Negative COVID-19 test. The outcome of the event genital herpes was reported as not recovered and for broke out in sores and blisters was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742482 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Insomnia, Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nauseated; Nausea; Muscle ache; Sleep loss; Pain in arm; Sweating; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25937597) 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 INSOMNIA (Sleep loss), PAIN IN EXTREMITY (Pain in arm), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), MYALGIA (Muscle ache) and NAUSEA (Nauseated) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DESOGESTREL (CERELLE) for an unknown indication. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced INSOMNIA (Sleep loss) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nauseated) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Sleep loss), PAIN IN EXTREMITY (Pain in arm), NAUSEA (Nausea) and MYALGIA (Muscle ache) had not resolved, HYPERHIDROSIS (Sweating) was resolving and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-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. The patient experienced pain and swelling in arm and was unable to move it without crying and felt sick. The patient had no sleep due to pain and arm was throbbing. It was reported that patient felt bruised and was nauseated all night like a bad flu. No treatment information was provided. Company comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of insomnia, pain in extremity, hyperhidrosis, nausea and myalgia.The events of insomnia, pain in extremity, hyperhidrosis, and myalgia occurred same day after the second dose of mRNA vaccine and the event of myalgia occurred on the next day after the second dose of mRNA 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 vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of insomnia, pain in extremity, hyperhidrosis, nausea and myalgia.The events of insomnia, pain in extremity, hyperhidrosis, and myalgia occurred same day after the second dose of mRNA vaccine and the event of myalgia occurred on the next day after the second dose of mRNA 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 vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1742570 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Body temperature, Body temperature fluctuation, Depressed level of consciousness, Fatigue, Feeling abnormal, Headache, Injected limb mobility decreased, Insomnia, Musculoskeletal stiffness, Oropharyngeal pain, Paraesthesia, SARS-CoV-2 test, Vaccination site inflammation, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Iron deficiency.
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Body Temperature; Result Unstructured Data: Test Result: fluctuation; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101217878

Write-up: Headache; Body temperature fluctuation; Consciousness clouding; Fatigue; Sore throat; brain fog; arm was tingly; injection site pain; Inflammation at site of injection; Bizarre dreams; arm became slightly stiff/less mobile; arm became slightly stiff/less mobile; Sleep was interrupted; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109152106279670-Y6IVW, Safety Report Unique Identifier GB-MHRA-ADR 25948325. A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 13Sep2021 at around 15:00 (at the age of 31 years) as dose 2, single for covid-19 immunization. Medical history included iron deficiency from an unknown date and unknown if ongoing. Slight iron deficiency diagnosed but prescribed supplements not taken yet. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Concomitant medications were not reported. The patient reported that, on 13Sep2021 by 19:00, she started experiencing injection site pain (vaccination site pain). On 13Sep2021, she also started experiencing inflammation at site of injection (vaccination site inflammation), bizarre dreams, sleep was interrupted and arm became slightly stiff/less mobile. On 14Sep2021, at 10:00, she started experiencing headache. On 14Sep2021, she also started experiencing consciousness clouding, body temperature fluctuation, fatigue, sore throat, brain fog and arm was tingly. The case was reported as serious with seriousness criteria as other medically important condition for the events injection site pain, inflammation at site of injection, bizarre dreams, headache, consciousness clouding, body temperature fluctuation, fatigue and sore throat. As per the additional details, she reported that, vaccine was around 3pm, by 7pm roughly the site of injection began hurting and the upper arm became slightly stiff/less mobile. Sleep was interrupted and dreams were weird. In the morning the day after her second dose, around 7:30 am, she became unusually awake, since waking her arm was tingly and felt tight down to the fingertips on the injected side. Injection site pain was stronger, and the arm was fairly stiff. Fatigue, brain fog and temperature fluctuation started shortly after waking up and became too difficult to continue working (desk job at home) by 2pm, lasting until around 7pm. From around 10 am, she had noticed a headache which got stronger through the day but got less strong towards the evening around 8 pm. She felt a sore throat in the "glands" for a few hours approx. 3pm to 7pm. On the following day remaining symptoms were very mild, although brain fog and headache were still a slight annoyance. The patient underwent lab tests and procedures which included body temperature which had fluctuation on 14Sep2021 and COVID-19 virus test (sars-cov-2 test) with negative result on an unspecified date (No - Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for the events arm became slightly stiff/less mobile, sleep was interrupted, brain fog and arm was tingly was unknown and the outcome for the rest of the events was reported as recovering, at the time of report. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1742597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217807

Write-up: Loss of appetite; Swollen lymph nodes; This is a spontaneous report from a contactable consumer and received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160716481750-XREUG. Safety Report Unique Identifier [GB-MHRA-ADR 25949636] A 29-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 11Sep2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient had swollen lymph nodes under armpit and above collar bone on the same side of the injection site, Loss of appetite. On 13Sep2021, the patient experienced swollen lymph nodes, on an unspecified date patient experienced loss of appetite. The patient underwent lab tests and procedures which included sars-cov-2 test no - negative COVID-19 test on 10Sep2021. The outcome of the event swollen lymph nodes was not resolved, and loss of appetite was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1742618 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101224930

Write-up: Muscle ache; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160924044430-TVTBW. Safety Report Unique Identifier is GB-MHRA-ADR 25951216 A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Sep2021 (lot number: Ff8222) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date to 14Sep2021 (unsure when symptoms started). Patient had no current illnesses or conditions. Not had a COVID-19 test and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced headache on 13Sep2021 with outcome of not recovered and muscle ache on 14Sep2021 with outcome of not recovered. Events were reported as medically significant by health authority. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742637 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-13
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (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? Yes, ? days
   Extended hospital stay? 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 INC202101224867

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161252548540-NR8BX and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25952464. An 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 19Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 13Sep2021, the patient experienced pericarditis. 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: negative on No - Negative COVID-19 test. The clinical outcome of the event was recovering. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1742644 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Burning sensation, Lymphadenopathy, SARS-CoV-2 test, Vaccination site bruising, Vaccination site swelling
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224732

Write-up: Deep Burning sensation in arm; extremely Sore armpit; swelling Injection site feels Very Bruised; feels Very Bruised; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161353458020-9E7VX. A 58-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 12Sep2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. Medical history included suspected covid-19 from 10Mar2021 to an unknown date (unsure when symptoms stopped). The patient''s concomitant medications were not reported. On 13Sep2021, the patient developed swollen lymph nodes. On an unknown date, the patient started feeling deep burning sensation in arm, extremely sore armpit and swelling injection site feels very bruised. On an unknown date, the patient underwent lab tests which included sars-cov-2 test and results were negative. The outcome of the event swollen lymph node was reported as not recovered, while for the other events it was reported as unknown. Case narrative: Deep Burning sensation in arm and extremely Sore armpit with swelling Injection site feels Very Bruised Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-13
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225534

Write-up: Menstruation abnormal; first period after the vaccine was very heavy and there were large clots; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161817535670-WFXX7. Safety Report Unique Identifier is GB-MHRA-ADR 25954685. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 05Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Regarding concomitant medications, patient was currently taking (ongoing) the following: 50 mg tramadol, 10 mg amitriptyline hydrochloride (AMITRIPTYLINE), and 50 mg sertraline hydrochloride (SERTRALINE). The patient experienced menstruation abnormal on 13Sep2021. The clinical course was reported as follows: The patient''s first period after the vaccine was very heavy and there were large clots (2021). No chance of her being pregnant. Lasted 12 hours of continuous heavy bleeding then all of a sudden stopped. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious per other medically important condition. The patient underwent a COVID-19 virus test on 24Aug2021 with the following result: No - Negative COVID-19 test. The outcome of the event menstruation abnormal was recovered on 16Sep2021, while outcome of the remaining event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1743071 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Drug eruption, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic drug rash; Allergic reaction to food
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101207205

Write-up: redness on the whole body skin; drug eruption; This is a spontaneous report from a contactable Other Health Professional received from the regulatory authority. Regulatory authority report number is v21126733. A 39-year and 4-month-old female patient received first dose bnt162b2 (COMIRNATY; solution for injection; Lot Number: FD0349; Expiration Date: 31Oct2021) via an unspecified route of administration on 13Sep2021 at 08:40 (the day of vaccination; age at vaccination 39-year and 4-month-old) as dose 1, single for covid-19 immunisation. Body temperature before vaccination was 36.6 degrees Centigrade on 13Sep2021. 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): allergies due to drug eruption or food. Medical history included allergies due to drug eruption or food. The patient concomitant medications were not reported. The patient experienced redness on the whole body skin and drug eruption on 13Sep2021 at 09:20 (the day of vaccination). The course of the event was as follows: 40 minutes after vaccination, redness on the whole body skin and drug eruption are considered. Therapeutic measures were taken as a result of redness on the whole body skin and drug eruption with steroid infusion. The patient underwent lab tests and procedure which included body temperature result was 36.6 Centigrade before vaccination on 13Sep2021. On 13Sep2021 (the day of vaccination), the outcome of the events was recovering. The reporting Other Health Professional 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. The reporting Other Health Professional commented as follows: It was considered to be a drug eruption, and it was promptly relieved by steroid infusion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1743210 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005293 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Exercise-induced anaphylaxis (Exercise-induced anaphylaxis); Food allergy (Wheat allergy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vagal reflex; Chest pain; This case was received via regulatory authority (Reference number: 2021TJP094359) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a (physician), was received via the PMDA (Ref, v21126703). Loss of consciousness was assessed as serious by the MAH. On an unknown date, body temperature before vaccination: 36.6 degrees Celsius. On 13-Sep-2021, at 19:02, the patient received the 1st dose of this vaccine. At 19:05, vagal reflex developed. The patient experienced loss of consciousness, but recovered immediately. 98%, 118/84, 36.5 degrees Celsius. It was unclear if rash developed. There was no swelling in the neck. There was no oral swelling. The patient had slight chest pain. At 20:30, the symptoms were improving, and the patient returned home in a stable condition. 37.4 degrees Celsius. The outcome of vagal reflex, loss of consciousness, and chest pain was reported as recovering. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant previous medical history, who experienced the serious, unexpected event of Loss of consciousness. The event occurred three minutes after the first dose of mRNA-1273. The rechallenge is unknown since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1743213 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-09-13
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: PCR test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 infection; Lack of drug effect; This case was received via Regulatory Authority (Reference number: 2021TJP095071) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Regulatory Authority (TASK0021730). COVID-19 infection was assessed as serious. On 13-Jul-2021, at 11:10, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 10-Aug-2021, at 11:10, the patient received the 2nd dose of this vaccine. On 13-Sep-2021, the patient underwent PCR testing. The patient tested positive and was noted to have COVID-19 infection. The patient was completely asymptomatic. On 14-Sep-2021, the symptoms resolved. The outcome of COVID-19 infection was reported as resolved. Follow-up investigation will be impossible due to non-cooperation of the reporter. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Sender''s Comments: This case concerns a 32-year-old male patient with no relevant medical history, who experienced the unexpected event of COVID-19 pneumonia, vaccination failure was considered as an additional event. The event occurred approximately 1 month after the second dose of Moderna COVID-19 Vaccine. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1746723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Migraine, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225200

Write-up: cramps outside of my expected period; Vaginal bleeding; Migraine headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161327478900-YVVW1, Safety Report Unique Identifier GB-MHRA-ADR 25952791. A 20-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Sep2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunization. Medical history included suspected COVID-19 (unsure when symptoms stopped) from 20Jul2021 to an unknown stop date. The patient concomitant medications were not reported. The patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not breastfeeding. The patient underwent lab tests and procedures which included sars-cov-2 test was positive (Yes - Positive COVID-19 test) on 24Jul2021. The patient experienced migraine headache on 13Sep2021, vaginal bleeding on 14Sep2021, cramps outside of my expected period on an unspecified date. The events considered medically significant. The reporter stated that it gave her absolute exhaustion for two days where all she could do was sleep, followed by light vaginal bleeding and cramps outside of her expected period. The outcome of the events was migraine headache was recovering, vaginal bleeding was not recovered, cramps outside of my expected period was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-13
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225036

Write-up: dizziness; Painful periods; Heavy periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161622393030-FV7EF. Safety Report Unique Identifier GB-MHRA-ADR 25953933. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunization. The patient received historical vaccine of BNT162B2 dose 1 for COVID-19 immunisation on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced dizziness, painful periods on an unspecified date, heavy periods on 13Sep2021. Significantly heavier and painful than normal, consequently suffering severe dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No - Negative COVID-19 test) on an unspecified date. The patient has not had symptoms associated with COVID-19. The patient was not pregnant. 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 outcome of the events painful periods was unknown, heavy periods was recovering, dizziness was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746816 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Dyspnoea, Hyperhidrosis, Nervousness, Pain, Paraesthesia, Skin temperature, Somnolence
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225122

Write-up: Anxiety attack; Short of breath; Drowsiness; Skin temperature; Pain; sweaty; nervous; light headed; tingling; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109162313143660-G6VUP Safety Report Unique Identifier GB-MHRA-ADR 25956568. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 13Sep2021 (at the age of 31-Year-old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included steroid therapy from an unknown date and unknown if ongoing Taking regular steroid treatment (eg. orally or rectally). Taking inhalers on a daily base and have done so since she was a baby. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medications included fluticasone furoate (FLUTICASONE FUROATE); loratadine (LORATADINE); omeprazole (OMEPRAZOLE); salbutamol sulfate (VENTOLIN [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported. On unspecified date in 2021, the patient experienced sweaty, nervous, light headed and tingling. On 13Sep2021, pain, drowsiness and skin temperature. On 16Sep2021 with anxiety attack, short of breath. She went for a short walk to the shop and back which is estimated as a 4 minutes walk to destination. She became very light headed, struggling to breath, right arm, hand and fingers tingling slightly. Became very sweaty and extremely nervous and had to take deep breaths, started to see black dots in eyes. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event pain was recovered on 16Sep2021, skin temperature was recovered on unspecified date in 2021, events sweaty, nervous, anxiety attack, short of breath, drowsiness was not recovered and unknown for events light headed, tingling. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1747048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-13
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210913; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101231418

Write-up: Carducci cluster. Molecular swab positive in the vaccinated person.; drug ineffective; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority-WEB [IT-MINISAL02-787218]. A 96-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FF7481 and expiry dates: 30Nov2021), via an Intramuscular, in Arm Left, on 05Aug2021, as single dose, 0.3 ml, for COVID-19 immunisation and second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FF2752 and expiry dates: 30Nov2021), via an Intramuscular, in Arm Left, on an unspecified date, as single dose, 0.3 ml, for COVID-19 immunisation. The patient''s medical history included Neoplasm NOS. Concomitant medications were not reported. On 13Sep2021, the patient experienced Carducci cluster. Molecular swab positive in the vaccinated person and vaccination failure. The patient underwent lab test and procedure included COVID-19 PCR test with negative result on 23Aug2021, 25Aug2021, 30Aug2021, and 06Sep2021; however, it was positive on 13Sep2021. Outcome of the events was not recovered. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF7481. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1747052 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Off label use, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101250421

Write-up: Off-Label use; Interchange of vaccine products; on 13Sep2021 reported pericarditis under drug treatment; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-788330. A 29-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FG7387, Expiry date:30Nov2021), via intramuscular route of administration on 11Sep2021 in Arm Right dose 2 (initial pfizer dose), 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included VAXZEVRIA as dose 1 on 06Jun2021 (Batch Number: 210095) for COVID-19 immunization. On 13Sep2021, the patient experienced pericarditis. Therapeutic measures were taken as a result of on 13sep2021 reported pericarditis under drug treatment. The outcome for the event pericardi-tis was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1747102 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Headache, Heart rate, Nausea, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Duodenal stenosis (post-surgery)
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: BP; Result Unstructured Data: Test Result:110/70; Comments: At 10:50; Test Date: 20210913; Test Name: BP; Result Unstructured Data: Test Result:105/64; Comments: At 10:57; Test Date: 20210913; Test Name: BP; Result Unstructured Data: Test Result:96/63; Comments: At 13:15; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: At 10:57; Test Date: 20210913; Test Name: P; Result Unstructured Data: Test Result:70; Comments: At 10:50; Test Date: 20210913; Test Name: P; Result Unstructured Data: Test Result:64; Comments: At 10:57; Test Date: 20210913; Test Name: P; Result Unstructured Data: Test Result:89; Comments: At 13:15; Test Date: 20210913; Test Name: SaO2; Result Unstructured Data: Test Result:98(r.a) %; Comments: At 10:50; Test Date: 20210913; Test Name: SaO2; Result Unstructured Data: Test Result:98(r.a) %; Comments: At 10:57; Test Date: 20210913; Test Name: SaO2; Test Result: 96 %; Comments: At 13:15
CDC Split Type: JPPFIZER INC202101209685

Write-up: headache; Mild vomiting once the patient vomited small amount of gastric fluid; Queasy; feeling poorly; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21126795. A 40-year and 6-month-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 13Sep2021 10:37 (Lot Number: FF5357; Expiration Date: 30Nov2021) (at age of 40-year and 6-month-old ) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included duodenal stenosis (post-surgery). The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees Centigrade. Event onset date was reported as 13Sep2021 at 10:50 (the day of vaccination). The course of the event was as follows: On 13Sep2021 at 10:37, vaccination was received. At 10:50, the patient experienced queasy and feeling poorly, BP 110/70, P 70, SaO2 98% (r.a) At 10:57, the patient experienced queasy and headache, BP 105/64, P 64, SaO2 98% (r.a) BT 36.3 degrees Centigrade. Mild vomiting once, the patient vomited small amount of gastric fluid, and drip infusion was performed. At 13:15, BP 96/63, SpO2 96%, P 89, the patient went home. The outcome of the events was resolved on 13Sep2021. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Unevaluable since the patient had similar symptoms after previous surgery relation. No follow-up attempts are needed. No further information is expected; Reporter''s Comments: Unevaluable since the patient had similar symptoms after previous surgery relation.


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