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From the 10/8/2021 release of VAERS data:

Found 781,870 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 435 out of 7,819

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VAERS ID: 1744375 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone decreased, Dyspnoea, Fibrin D dimer increased, Heart rate increased, Laboratory test, Supraventricular extrasystoles, Thyroxine increased, Tremor, Tri-iodothyronine increased, Weight decreased
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propanolol for benign tremors- prescribed not taking
Current Illness: none
Preexisting Conditions: G6pd
Allergies: Shellfish and Sulfa
Diagnostic Lab Data: TSH- <0.01 9/27/21 T3- 6.21 9/28/ 21 T4-3.25 9/28/21 D-dimer 421 9/28/21
CDC Split Type:

Write-up: I had PAC''s and fast heart rate after my first vaccine. I saw a cardiologist and nothing else was done. After my second does 09/05/21 Lot # FC3182. I again began having fast heart rate, shortness of breath, weight loss and more tremors than usual, I contacted my healthcare provider who ordered labs and testing. My TSH levels went from 3.01 in June of 2021 to <0.01 on the 27th of September.


VAERS ID: 1745002 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2021-03-25
Onset:2021-08-16
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arterial occlusive disease, Coronary angioplasty, Flatulence, Gastrointestinal disorder, Myocardial infarction, Sleep disorder, Somnolence
SMQs:, Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sulfasalazine - 500 mgs - I take either two-six of these every day to prevent colitis; arthritis in hands: Etodolac - I take twice a day - 500 mg; Simvastatin - 80 mg once a day
Current Illness: no
Preexisting Conditions: sleep apnea; a couple of bouts with colitis but not in years; Diverticulitis - have been dealing with that for many years but it hasn''t been causing me problems in years, either; arthritis in my hands.
Allergies: none
Diagnostic Lab Data: 25th of August - Hospital ER - they put some dye in me and went up my wrist up one of my arteries and used a balloon to open up an artery that was starting to clog up. I was awake but 1/2 groggy through the process. They said there may be a couple of things that I made need to do in the future but this is all for now.
CDC Split Type: vsafe

Write-up: The 15th, we moved son to location, I started having gas pains. My family doctor - I''ve been having problem with digestive system a little. Doctor had said that I maybe might have had a hiatal hernia (before all the gas symptoms started in August). The gas would come and go - last a 1/2 day and then go away and eventually it was all day and got to a point I could not sleep for 30 hours. I went to ER - they checked my heart and said I was having a heart attack. 18 session rehab - I go in and they hook me up to a box and sticky things and I do 3 exercises for about 40 minutes and the lady looks at a machine and there is a lecture every time. I do it every Monday, Wed, Friday and I am half way through. Their object is to tell me where I stand when I''m done with the 18 sessions.


VAERS ID: 1745162 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Confusional state, Contusion, Decreased appetite, Fatigue, Headache, Heavy menstrual bleeding, Paraesthesia, Pyrexia, Thrombosis
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Heavy menstrual bleeding, quarter sized clots, loss of appetite, high fever, headache, tingling in left arm and both legs, tiredness, confusion, random bruising. Most symptoms lasted for a week and a half. Still having issues with menstruation.


VAERS ID: 1746595 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-04
Onset:2021-08-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site rash, Muscular weakness, Rash, Rash papular, Rash pruritic, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Muscle weakness in arms and legs. Rash on left arm from injection site to wrist, inside of elbow. Red raised itchy painful. Extreme shakeiness in body.


VAERS ID: 1747720 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C219 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: high
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Sore arm; He did have a temperature; first vaccine to underage patient on 16/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C219) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) had resolved. On 18-Aug-2021, PAIN IN EXTREMITY (Sore arm) and PYREXIA (He did have a temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Body temperature: increased (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. It was reported that patient went to get the second dose on 17-SEP-2021 but did not get the second dose because as he was under age. The clinic did not have any vaccines made by other manufacturers. His mother was concerned because he could not get another vaccine until he would be 16. He had a letter from the vaccine provider for his school as the vaccine was required.


VAERS ID: 1747795 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-06
Onset:2021-08-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Headache, Hot flush, Hypoaesthesia, Muscle spasms, Pain in extremity, Product dose omission issue
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood work; Result Unstructured Data: everything seemed fine
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: did not get her second dose; Lots of headache/I wake up with headaches; I have spasms in my back; Tightness in my chest/Lots of tightness; Numbness in my fingers; Pain in my arms and chest; Pain in my arms and chest; My body felt flushy and hot that lasted 2- 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest) and CHEST PAIN (Pain in my arms and chest) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second dose ). The patient was treated with METOPROLOL for Adverse reaction, at a dose of 1 DF twice a day. At the time of the report, MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get her second dose ) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything seemed fine. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication of the patient was not reported. The patient did not know if she had fever. The patient had different issues every day and was still experiencing all side effects. The patient did not get her second dose because she was referred to her cardiologist who gave her medicine that did not work. Mother of the patient died with COVID in December and all of her family members tested positive for COVID, only her had not.


VAERS ID: 1747880 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dry throat, Fatigue, Feeling abnormal, Headache, Insomnia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Dehydration (broad)

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

Write-up: throat is dry; cannot fall asleep at night; Throat is itchy; fatigued; when I lay down at night it feels like I''m drowning; really dry cough; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (when I lay down at night it feels like I''m drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night) and THROAT IRRITATION (Throat is itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (really bad headache). On 22-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (really dry cough). On an unknown date, the patient experienced FEELING ABNORMAL (when I lay down at night it feels like I''m drowning), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 17-Aug-2021, HEADACHE (really bad headache) had resolved. At the time of the report, FEELING ABNORMAL (when I lay down at night it feels like I''m drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. The patient took other treatment medication include cough drops, cough syrup to relieve the symptoms. It was reported that the day after receiving the vaccine she had a really bad headache which lasted for 2 days. Seven days after receiving the vaccine she started to have a really dry cough that she could not get rid of. When she laid down at night it felt like she was drowning. Her throat was itchy and dry. She also felt fatigued and cannot sleep the whole night through.


VAERS ID: 1747917 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-16
Onset:2021-08-16
   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 3180 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Extra dose administered, Fatigue, Insomnia, Off label use, Pain in extremity, Rhinorrhoea, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065961

Write-up: sore left arm; sore left hip; Sniffles; Trouble sleeping; Tired; Tender and swollen under left arm; Tender and swollen under left arm; Shot # 3- Booster; Shot # 3- Booster; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 3180), via an unspecified route of administration, administered in Left arm on 16Aug2021 16:30 at the age of 45-years-old as dose 3, single for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6201), via an unspecified route of administration, administered in Left arm on 24Mar2021 08:15 at the age of 44-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 17Aug2021. On 16Aug2021 at 16:30, the patient experienced shot # 3- booster (off label use), shot # 3- booster (extra dose administered) and on 16Aug2021 at 21:00, the patient experienced sore left arm, sore left hip, sniffles, trouble sleeping, tired, tender and swollen under left arm. No treatment was received for adverse events. The case was reported as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of events was unknown. Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1747920 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-16
   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 FC3181 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Fatigue, Nausea, Off label use, Pain, Taste disorder
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: USPFIZER INC202101072813

Write-up: had the standard achiness; had a little fatigue that started in the afternoon; had nausea in the middle of the night; he got the booster of the Pfizer COVID vaccine; he got the booster of the Pfizer COVID vaccine; has an incredibly awful metallic taste that won''t go away and everything tastes horrible; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FC3181), dose 3 via an unspecified route of administration on 16Aug2021 as dose 3, single (at the age of 68-years-old) for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date as dose 2, single both taken for covid-19 immunization. It was reported that the patient did not experience any side effects for first two doses but experienced side effects from third one. On 16Aug2021, the patient has not had a loss of his sense of taste, but he has an incredibly awful metallic taste that would not go away, and everything tastes horrible. The achiness started at bedtime around 10:30 PM. The patient had a little fatigue that started in the afternoon and when he went to bed, he had nausea in the middle of the night and it all cleared up by the morning, 17Aug2021. The only thing that lingered was this bad taste in his mouth. The outcome of the event taste disorder was not recovered while outcome of the events pain, fatigue and nausea was recovered on 17Aug2021. Follow-up attempts were completed. No further information was expected.


VAERS ID: 1747945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   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 EW0168 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Fatigue, Headache, Malaise, Myalgia, Off label use, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site pain, Weight
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), 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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Crohn''s disease (A chemo drug to keep my Crohn''s under control); Immunocompromised
Allergies:
Diagnostic Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:295 lbs; Test Date: 20210829; Test Name: Weight; Result Unstructured Data: Test Result:290 lbs; Comments: Actually, I am 290, I measured myself today 290 (Not confirm, Hence not captured in tab).
CDC Split Type: USPFIZER INC202101128205

Write-up: low grade fever; headaches; I was very tired, Tiredness; Injection site pain; site is red; slight swelling in the arm; muscle pain kind of all over; didn''t feel well; whole arm was pain; had kind of few side effects for third shot; had kind of few side effects for third shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received third dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiry date: unknown), via an unspecified route on 16Aug2021, as a single dose for covid-19 immunization. Medical history included Crohn''s disease for which patient takes chemo drug to keep Crohn''s under control, asthma and patient was immuno-compromised. Concomitant medications included mother drugs: pantoprazole, mild Calcium, alendronate sodium (FOSAMAX), mercaptopurine (PURINETHOL, 6-MP) and immuno-compromise drug, a chemodrug (further clarification unknown if patient was suffering from side effects hence captured as suspect of unspecified medication). Historical vaccine included first dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN5318) on 05Feb2021 and second dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN6201) on 26Feb2021 both as a single dose for covid-19 immunization and experienced no side effects. Patient did not receive any other vaccines prior to the COVID vaccine. On an unknown date (age at the time of onset of reaction/event: 65-year-old), patient experienced few side effects for third shot: injection site pain hurt for over a week/almost a week and half. Just was started feeling better. Patient was very tired/tiredness, had headaches and muscle pain kind of all over. Also, had a low-grade fever, slight swelling in the arm, site is red, didn''t feel well and whole arm was pain. Patient guess would be that the first shot to the second shot was so bad that his body did not have the chance to build up antibodies and response. So, when the third shot came around, it was really worked. Patient did not receive any treatment for the events. He was just happy that he had response. The patient underwent lab test and procedure which included weight measurement of 295 Ibs on an unknown date and 290 lbs on 29Aug2021 (actually, she was 290, measured himself today 290, not confirmed). No blood work was done. The clinical outcome of the events following third dose was patient feeling fine now, it''s just, patient was trying to report what he had. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1749413 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Electrocardiogram normal, Fatigue, Headache, Laboratory test normal, Nausea, Pain, Pyrexia, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No but I had just given birth on 6/4/2021
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data: I have seen my dr & had over the phone appointments where they ruled out my symptoms as anxiety/hormonal since I am 2 months postpartum. I''ve had labs done twice showing nothing is wrong with me I have had and EKG done on my heart where they found nothing. I have been given lexapro and hydroxyzine to take for the anxiety this has been causing but to no affect does it take away the fatigue and dizziness. I''ve had ultrasound done for blood clots which came back negative.
CDC Split Type:

Write-up: 6 hours after vaccination I experienced headache, fever, body ache, chills, nausea and fatigue. It took 1-2 days for those symptoms to go away all of them except for the fatigue. About 2 days after vaccination I started feeling lightheaded and dizziness added onto the fatigue that has not gone away since. No matter how much sleep I get/what I do I still seem tired and can''t stop the lightheaded/dizziness.


VAERS ID: 1752035 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Latex allergy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient was healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101219389

Write-up: whole left side of my body that is numb and tingly and cold.. even my arm; feet have stronger tingle and pain when she stand; having facial numbness; tingling on left side of face/ feet have stronger tingle and pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169, Expiration date: Not reported), via an unspecified route of administration in left arm on 16Aug2021 at 09:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunization in a hospital. There was no patient''s medical history reported. The patient was healthy and had known allergies to codeine and latex. There were no concomitant medications/any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination and didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Twenty five minutes after the vaccination, the patient began to have facial numbness and tingling on the left side of the face on 16Aug2021 at 09:25. Two days later on 18Aug2021, the patient''s feet have stronger tingle and pain when she standup and currently after 4 weeks in Sep2021, the patient''s whole left side of the body was numb, tingly and cold even in her arm. These events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. It was unknown if the patient received treatment for these events. The outcome of the events was not recovered at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1752085 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-03
Onset:2021-08-16
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Colitis, Computerised tomogram, Gastritis, Intestinal obstruction, Pharyngeal inflammation, Proctitis, Vulvovaginal inflammation
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ct scan; Result Unstructured Data: Test Result:Results Unknown
CDC Split Type: USPFIZER INC202101226468

Write-up: Blockage in colon; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient''s medical history was not reported. The patient was not pregnant. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included metformin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient experienced blockage in colon on 16Aug2021, acute inflammation of colon, rectum, vagina, stomach and throat on 16Aug2021. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included computerised tomogram: results unknown on 2021. Therapeutic measures were taken as a result of the events which included Antibiotics. The outcome of the events was recovering. Not tested for COVID post vaccination. The reporter assessed the events as not serious. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1753798 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-29
Onset:2021-08-16
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Blood test, Computerised tomogram head, Dizziness, Head discomfort, Hyperacusis, Loss of personal independence in daily activities, Magnetic resonance imaging head, Migraine, Nausea, Photophobia, Tinnitus, Vertigo positional, Vibratory sense increased, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: levaquin
Diagnostic Lab Data: URGENT CARE VISIT - Series of blood tests and exams 8/16/2021 ER VISIT - CT scan head 8/18/2021 ER VISIT - Full panel of blood work and exams 8/18/2021 ER VISIT - Blood work and exams 8/31/2021 MRI - brain and brain stem 8/26/2021 MRI - inner ear with and without contrast 9/22/2021
CDC Split Type:

Write-up: The following symptoms started on August 16, 2021: Positional vertigo, nausea, dizziness, ringing in ears, sensitivity to light, sensitivity to sound, difficulty focusing, loss of balance, vibrating head sensations, migraines, head pressure. These symptoms are persistent and have caused substantial disruption of my ability to conduct normal life functions.


VAERS ID: 1755782 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Feeling jittery, Flushing, Heart rate, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: fast
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Numb Tongue/Tip of the tongue still numb; Jittery; Numb Face with tingling; Flushing; Chest pain; Heart was fast; Shortness of breath/Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing) and CHEST PAIN (Chest pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing). At the time of the report, HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: fast fast. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the shot the patient waited more than 15 minutes and within 30 minutes felt a numb tongue, jittery, numb face with tingling, flushing, chest pain, her heart was fast, shortness of breath/hard time breathing for about 6 hours. But the tip of tongue was still numb since then. No Concomitant medications were provided. No treatment medications were provided.


VAERS ID: 1757562 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none known
Allergies: none
Diagnostic Lab Data: CT on 10/2
CDC Split Type:

Write-up: pleural effusion


VAERS ID: 1758581 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-06-25
Onset:2021-08-16
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 RA / SYR

Administered by: Pharmacy       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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro; Doxylamine; Prenatal; Vitamin C
Current Illness: None
Preexisting Conditions: Anxiety; Depression
Allergies: None
Diagnostic Lab Data: 8/17/2021: Sars-Cov-2 by PCR (TF) Covid Test- positive.
CDC Split Type: vsafe

Write-up: 8/16/2021 I started to have COVID symptoms which I think I got from my husband because he wasn''t vaccinated at that time. He had tested positive for COVID a day before. I was taking care of him while he had COVID and then I started showing symptoms the night of 8/16/2021. I ordered a online request for a COVID test. Then I went to the local Urgent Care to do the test on 8/17/2021. I got the results the next day on 8/18/2021, and tested positive for COVID. My symptoms weren''t as bad as my husbands. I didn''t lose my taste or smell. I had body aches, but I was still able to take care of him because he wasn''t doing so well. We did the 10 days of isolation and quarantine. The body aches had died down after a few more days, and now I am fine.


VAERS ID: 1759183 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Immediate post-injection reaction
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid Multi vitamin Low dose aspirin
Current Illness: None
Preexisting Conditions: Hypothyroid
Allergies: None
Diagnostic Lab Data: I did not get help, as I was aware Bell Palsy could be a side effect. Doctor said it was not Bells Palsy because I did not have facial drooping.
CDC Split Type:

Write-up: Immediately neck, face and right side of my head went numb like I had novocaine. Stayed numb for 3 days then lessened over several more days.


VAERS ID: 1759546 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-03-31
Onset:2021-08-16
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest pain, Exposure to SARS-CoV-2, Fatigue, Pain, Rash, SARS-CoV-2 test positive, Sinus operation, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: MMR as a child, do not have my record of this at this time.
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Food allergies, tree nuts and sesame
Diagnostic Lab Data: August 16, 2021-Rapid covid test from medical center - negative August 22, 2021 - Ellume home covid test - negative August 23, 2021 - PCR test from medical center - positive
CDC Split Type:

Write-up: Exposed to a co-workers daughter August 13, 2021 who became symptomatic and tested positive for Covid August 15. Tonsilitis from sinus drainage started the morning of August 16. Went for Covid rapid test that morning. Test was negative. Went back to the doctor that afternoon. They swabbed for strep, which was also negative. 10 day dose of Amoxicillin and step down pack of Methylprednisolone prescribed and started that evening. August 22, the coworker developed symptoms and tested positive. Tested with Ellume home test that day, also negative. Went for PCR to confirm the negative on August 23, received positive result on August 25. Covid symptoms remained extremely minor - skin rashes, some minor aches that resolved after an hour or so, chest pain that resolved after an hour or so. Fatigue lasting an entire day on September 4 was the worst symptom.


VAERS ID: 1759760 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site paraesthesia
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: unknown
Current Illness: none on vaccine consent form
Preexisting Conditions: none on vaccine consent form
Allergies: nka on vaccine consent form
Diagnostic Lab Data: na
CDC Split Type:

Write-up: constant tingling around injection shot and down arm started on 8/16/21 and is still continuing


VAERS ID: 1759828 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-28
Onset:2021-08-16
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest discomfort, Chills, Diarrhoea, Feeling abnormal, Headache, Loss of consciousness, Migraine, Nasal congestion, Pruritus, Pyrexia, SARS-CoV-2 test positive, Sinusitis, Swelling, Vaccine breakthrough infection, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: flu shot 12 years ago, from the live virus, up the nose, I ended up with the flu symptoms.
Other Medications: Chlorthalidone 25 mg od losartan potassium 25 mg od klor-conm 20 mg 4 tablets a day Zyrtec 10mg od Flonase 50mcg one spray on each side Vit D-3 1000 iu docusate sodium 100 mg od
Current Illness: no
Preexisting Conditions: high blood pressure I have had kidney stones twice, once in 2006 and 15 years after that
Allergies: penicillin and it derivatives
Diagnostic Lab Data: COVID-19- TEST -positive
CDC Split Type: vsafe

Write-up: 3 weeks prior to 08/16/2021- I had a migraine headache that was continuous for 3 weeks and a sinus infection. On 08/11/2021-I went in for the visit and my sinuses and ear were full of fluid. Dr. assistant prescribed my antibiotic- z-pack. My symptoms resolved after the antibiotics. On 08/16/2021, Monday, I did not feel right. I did not have a fever, or a cough. I could still taste, smell and and I still had my appetite. I did not have any of the classic symptoms. That night I got up to go to the bathroom and vomited, and had diarrhea (and I normally do not vomit) and I passed out afterwards. It was only a one shot of vomiting and diarrhea. I did not know I passed out. My husband found me on the floor. The next morning, Tuesday, 08/17/2021, I didn''t feel well. I had a low grade fever and chills. I went and bought an over-the-counter COVID-19 test and the results were negative. That same day, I went to the clinic, and they administered a COVID-19 test and it was positive. For 2 days after, I had fever, chills , heavy chest, massive headache. I felt like someone was sitting on my chest and head. The headache was worse than a migraine. The pain felt different than a migraine, a pain I had never felt before. I took Tylenol and it broke my fever, but it was no match for my headache. By Friday my symptoms, began to resolve. I did have a little congestion . A week after my Pfizer 2nd dose - I developed COVID arm. It felt like a bee sting, hot to the touch, swollen and really itched. And went away after a week on it''s own.


VAERS ID: 1761338 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Aphasia, Chills, Dysphemia, Fatigue, Feeling abnormal, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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: Vitamin D
Current Illness: none
Preexisting Conditions: none
Allergies: Iodine, prednisone, shrimp
Diagnostic Lab Data: none : I was just notified of the reaction
CDC Split Type:

Write-up: Chills, and violent shaking , could barely speak , and stuttering. Vomiting for 3 hours Following day: brain fog and exhaustion


VAERS ID: 1762198 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-07
Onset:2021-08-16
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Cough, Exposure to SARS-CoV-2, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Statin, Vitamin D, Vitamin C, Iron, Calcium, multi-vitamin, flaxseed
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Negative for COVID19
CDC Split Type:

Write-up: I woke up with a sore throat, slight cough, stuffy nose. I contacted my doctor to be tested, even though the sore throat seemed like drainage. My husband had cold symptoms too and felt worse. We both got tested. I was negative for the C. Virus but my husband tested positive. I tested 6 days later when they released him and was still negative in my Covid test.


VAERS ID: 1763937 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cough, Epistaxis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Food allergy; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 20210817; Test Name: Blood pressure; Result Unstructured Data: 198/126 mmHg
CDC Split Type: USJNJFOC20211004085

Write-up: BLOOD PRESSURE HIGH; COUGHED; NOSE BLEED; This spontaneous report received from a patient concerned a 69 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes, penicillin allergy, and allergy to almonds and himalayan salt. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and talc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, after five months of vaccination, the patient had blown nose hard and had a smaller nosebleed that stopped on its own. On 17-AUG-2021, the patient coughed hard and had a big nosebleed occurred it was gushing. She took a picture of what came out in the sink she stated that it was a huge blood clot. The patient taken to emergency room via ambulance and patient stated that it was huge blood clot and was holding a shoe box to catch the blood in the ambulance and the patient''s blood pressure (BP) was measured and it was 198/126 mm/Hg and patient stated that she could have had heart attack or stroke. On 17-AUG-2021, the patient admitted to emergency room and patient received anesthetic and catharized it. The patient didn''t remember if any test or blood work done and on same night (AUG-2021), the patient was discharged and nose bleeding didn''t occur again. On an unspecified date in 2021, the patient''s blood pressure measure and it was high but not like previously measured on 17-AUG-2021. The patient stated that, "it was hard to tell with my diabetes cause it was similar symptoms. On 02-OCT-2021, the patient came to get flu shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed, was recovering from blood pressure high, and the outcome of coughed was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211004085-Covid-19 vaccine ad26.cov2.s- Blood pressure high, Nose bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1764783 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Electric shock sensation, Headache, Limb discomfort, Mobility decreased, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC advil for aches and pains only as needed
Current Illness: none
Preexisting Conditions: recent diagnosis of Grave''s disease (thyroid)
Allergies: none known
Diagnostic Lab Data: patient is uninsured and is being seen at a community clinic, approval for xray orders (lumbar and bilateral hips) are currently pending. Patient is being treated with conservative treatment including low back stretches, NSAIDs and encouraged of decreased exercise, especially movements that increase pain.
CDC Split Type:

Write-up: mild headache for several days after then resolved and had onset of tingling and "shooting pain sensation like electric shocks radiating toward her head and all extremities with increased weakness and pain in low back with pressure sensation with aching pain radiating in saddle formation from low back to bilateral hips toward her knees with heaviness in the feet. Painful to walk down stairs specifically in the knees. Significant reduction in range of motion with back. Previously patient had been very active, lifting weights, working out, push ups, planks, running. Now unable to tolerate plan position, running or any twisting of low back. Denies any specific back injury or trauma, no falls or MVA (motor vehicle accident)


VAERS ID: 1764824 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-22
Onset:2021-08-16
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / 1 AR / IM

Administered by: Private       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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: unknown
Allergies: n/a
Diagnostic Lab Data: + Covid NAAT test on 8/6/2021.
CDC Split Type:

Write-up: Covid 19 break-through infection 8/6/2021, received REGEN-COV due to risk factors next day.


VAERS ID: 1764840 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-24
Onset:2021-08-16
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 AR / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 AR / IM

Administered by: Private       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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: none
Allergies: n/a
Diagnostic Lab Data: + covid NAAT test 8/16/2021
CDC Split Type:

Write-up: Covid 19 break-through infection 08/16/2021


VAERS ID: 1765009 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-08
Onset:2021-08-16
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchospasm, COVID-19, Chronic obstructive pulmonary disease, Dyspnoea, Hypercapnia, Hypoxia, Intensive care, Positive airway pressure therapy, SARS-CoV-2 test positive, Thoracic vertebral fracture
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen, albuterol, atorvastatin, calcium/vit D, cinacalcet, b12, colace, hctz, duonebs, Imdur, lactulose, synthroid, metoprolol, senna spironolactone, trazodone
Current Illness: none known
Preexisting Conditions: COPD, hypertension, thyroid,
Allergies: alendroic acid, pencillin
Diagnostic Lab Data: 8/16/21 - COVID PCR positive
CDC Split Type:

Write-up: The patient presented to the ED with COVID 19 and hypoxia, and was found to have an acute T12 compression fracture. At the time of admission to general medicine, she was found to have worsening hypoxia and hypercarbia and increased work of breathing with bronchospastic pathophysiology. She was treated with dexamethasone, remdesivir, bronchodilators, azithromycin for COPDe. She was placed on BiPAP which she tolerated. She was transferred to the ICU for further care. Family was updated and at bedside.


VAERS ID: 1765155 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-03-09
Onset:2021-08-16
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: COVID hospitalization after full vaccination.


VAERS ID: 1765199 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-04
Onset:2021-08-16
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Covid19


VAERS ID: 1765912 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-05
Onset:2021-08-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test negative
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALMODIPINE MERFORMIN TRESIBA ASPIRIN LOSARTAN LEFLONUMIDE FERROUS SULFATE PREDNISNE
Current Illness:
Preexisting Conditions: DIABETIS ARTRITIS HIGH BLOOD PRESSURE
Allergies: ORENCIA
Diagnostic Lab Data: ANTIABIOTICS RAPID COVI TEST-NEGATIVE COVI TEST-NEGATIVE
CDC Split Type:

Write-up: DEVELOPD PNEUMONIA 11 DAYS AFTEER REEIVING FIR DOSE OF PFIZER VACCINE


VAERS ID: 1766114 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-05
Onset:2021-08-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test negative
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: libalo enalapril metorololun
Current Illness: High blood presure
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: antibiotics rapid covid test/negative covid test negative
CDC Split Type:

Write-up: Developed pneumonia 11 days after receiving the firt dose.


VAERS ID: 1767093 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   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 FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Asthenia, Dizziness, Heart rate, Heart rate increased, Nervousness, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Verbatim: allergy to penicillin)
Allergies:
Diagnostic Lab Data: Test Name: Heart beat; Result Unstructured Data: Test Result:Heart beat went up; Comments: Heart beat went up and she told the pharmacist.
CDC Split Type: USPFIZER INC202101069690

Write-up: Heart beat went up; Pharmacist asked her if she was nervous or having anxiety and she said yes; Pharmacist asked her if she was nervous or having anxiety and she said yes; left arm sore; extremely dizzy; extremely weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: FA7485, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 59-year) in left arm on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included allergy to penicillin, from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Time the vaccination was given: 1430- 1445. Prior vaccinations (within 4 weeks) were reported none. On 16Aug2021 the patient experienced extremely dizzy, extremely weak; on 17Aug2021 the patient experienced left arm sore; on an unspecified date the patient experienced heart beat went up, pharmacist asked her if she was nervous or having anxiety and she said yes. Adverse events not required to emergency room/physician office. The patient underwent lab tests and procedures on an unspecified date which included heart rate: heartbeat went up. It was reported that she was leery and nervous to get the second dose. It was reported that "she was calling about the Pfizer covid vaccine. She received it on Monday and immediately was extremely dizzy and weak. Heart beat went up and she told the pharmacist. Pharmacist asked her if she was nervous or having anxiety and she said yes. The pharmacist stated it could be since she was nervous and was told to sit as long as she needed. She felt like she could not get up and walk and got very weak. Her dizziness did not go away for almost an hour. With that kind of reaction, she was asking if she should she get the second dose. Advised to consult with hcp. The dizziness and weakness started within seconds of her receiving the vaccine, immediately. Her left arm was still a bit sore but that was expected, it was much better and sore if she pushed on her shoulder area. The soreness started yesterday. She got to the point when she was sitting in the pharmacy and then she got to where she could get up and walk to her car but did not drive right away. She sat in her car for a while since she did not feel comfortable driving since she was still dizzy. Clarified the really bad dizziness lasted for about an hour. Then about 2 to 3 hours later she was fine." The clinical outcome of the events "dizzy, extremely weak" was resolved on 16Aug2021; outcome of the event "left arm sore" was resolving; while the outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1767582 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-02
Onset:2021-08-16
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Bronchitis, COVID-19, Condition aggravated, Cough, Fatigue, Headache, Illness, Nodule, Oropharyngeal pain, Positron emission tomogram, Pyrexia, SARS-CoV-2 test, Sneezing, Vaccination failure, X-ray
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: FOSAMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue (she couldn''t get out of bed because her fatigue was that bad); Flu (when she was in her 40s she had the flu for a week); Nasal allergy (post nasal drip from the seasonal allergies); Osteoporosis; Seasonal allergy (she already had a sore throat from her seasonal allergies); Sore throat (she already had a sore throat from her seasonal allergies)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:190/100; Test Name: blood pressure; Result Unstructured Data: Test Result:125/82; Test Name: Fever; Result Unstructured Data: Test Result:100.3; Test Name: Fever; Result Unstructured Data: Test Result:97.5; Test Name: PET; Result Unstructured Data: Test Result:osteoporosis; Test Date: 20210816; Test Name: Covid test; Test Result: Positive ; Comments: swab up her nose thing for COVID; Test Name: X-ray; Result Unstructured Data: Test Result:little nodule on the right side and that she had l; Comments: they saw a little nodule on the right side and that she had little collapsed air sacs at the bottom, they called it mild alterio bilateral (documented as provided by caller), but they were not concerned with that.
CDC Split Type: USPFIZER INC202101275213

Write-up: felt sick but she had fatigue for 10 days; cough got so bad; headache; received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; viral bronchitis; sneezing all day; sore throat from her seasonal allergies and then it just got horrible, the sore throat did; sore throat from her seasonal allergies and then it just got horrible, the sore throat did; blood pressure there was 190/100/blood pressure was 125/82; little nodule on the right side; fever of 100.3; felt sick but she had fatigue for 10 days; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program support. A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number-EN6200) via an unspecified route of administration on 02Mar2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number E19267) via an unspecified route of administration on 11Feb2021 (age at the time of vaccination was 69-years-old) as dose 1, single for covid-19 immunisation. The patient''s medical history included osteoporosis, when she was in her 40s she had the flu for a week, she could not get out of bed because her fatigue was that bad and she already had a sore throat, post nasal drip from her seasonal allergies. There were other products. The patient''s concomitant medications included ongoing alendronate sodium (FOSAMAX), 70 mg weekly, indicated for osteoporosis from 01Aug2021. It was reported that Patient had 2nd doses back in Mar2021 and then both her and her husband had breakthrough COVID cases. She tested positive on 16Aug2021. Hers also went into viral bronchitis. The caller is calling today because she is wondering about the booster vaccine, it says to get it at least 6 months afterwards but how soon should she get it after having COVID. Caller states that her specific question is if they both had the Pfizer COVID vaccine and then had the breakthrough case of the delta variant when should they get the booster. She confirms that she would like to complete the report prior to speaking to medical information because the isn''t keeping track and she knows of 20 people who have had COVID and none of them have had any contact with each other including her 40 year old nephew who is vaccinated and was as sick as her and she doesn''t know why. For the booster is says to wait at least 6 months but does that mean no sooner than 6 months or what. It is very confusing. Attempted to confirm when the viral bronchitis had began and she started to speak on how her case of COVID was like the worst case of the flu that she has ever had, when she was in her 40s she had the flu for a week and she couldn''t get out of bed because her fatigue was that bad. With COVID she had started out sneezing all day and she already had a sore throat from her seasonal allergies and then it just got horrible, the sore throat did, then she had a headache, fever of 100.3, her normal is 97.5 so she felt sick but she had fatigue for 10 days to where she just laid in bed or on the couch and watched TV. She would have headache all day long and all the doctor said was to take Tylenol and Mucinex and if she got bad then she needed to go to the emergency room. You just never know when a person walks in that door because she knows a 30-year-old cop, he wasn''t vaccinated, but he died in about 5 to 10 days and he was getting ready to get vaccinated. She says after COVID she had felt better for like 7 days and she had a great time then because it was labor day weekend and they had went kayaking, swimming and boating and then on 10Sep2021 she had an acute attack of viral bronchitis and went to the urgent care who said she also had oral thrush but then she went to an ENT doctor two weeks later who said that she didn''t have oral thrush. They gave her a wash because she had a sore throat even though she felt fine and she thought that it was just her post nasal drip from the seasonal allergies so she had a virtual visit and was prescribed 5 days of prednisone. That made her throat better but then 2 days afterwards she had quit and it hurt just as bad as before. The doctor had prescribed her prednisone, Mucinex tablets and nystatin to swish in her mouth for the oral thrush, even though the ENT said that she didn''t have that. She also had an x-ray when she first went to the urgent care and they thought that they saw a little nodule on the right side and that she had little collapsed air sacs at the bottom, they called it mild alterio bilateral (documented as provided by caller), but they were not concerned with that. Then 3 days later her cough got so bad and she had went back to urgent care because she wanted another x-ray to be sure that she didn''t get pneumonia and her blood pressure there was 190/100 so they kicked her out and said to go to the emergency room because they thought that maybe she had a blood clot. She went to the emergency room and they took another x-ray and said that they saw nothing and that her lungs look totally fine. By the time she left the emergency room her blood pressure was 125/82 or something like that so they said to go home and finish her prednisone and if she didn''t feel better to follow up with her primary care provider. And that''s where she is and she finally got to go see the ENT again and they looked at her throat and prescribed two nasal sprays. Her post nasal drip is about 95% cleared and her throat is about 95% cleared so she is feeling good. Her question is just about getting the booster, why do they say 6 months and not any sooner. Everyone who she knows who had a breakthrough case got it within 4 to 4 1/2 months. she only takes Fosamax which she started on 01Aug2021 because her PET scan showed osteoporosis. It is the generic form that starts with "A" but it is 70 mg once a week, or 70 whatever the units are. she provided that she actually went the the urgent care on 11Aug2021 and she was negative for COVID at that time and they said that maybe she came in too soon so she went back 5 days later and that''s when she was positive. she provided that she forgot to mention this but both her and her husband had lost their smell and taste. On labor day weekend she wasn''t able to smell bleach and couldn''t smell anything but now her taste and smell are about 95% back and her husband is starting to get his taste back but he said that everything smelt like diesel fuel and he still has not gotten his back all the way. The patient underwent lab test and procedures included blood pressure measurement: 190/100 and 125/82, Body temperature: 100.3 and 97.5, Positron emission tomogram: osteoporosis, X-ray: little nodule on the right side and on 16Aug2021, swab up her nose thing for COVID (SARS-CoV-2 test): positive. The outcome of sneezing all day, sore throat, cough was recovering and outcome of other events was unknown. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1768423 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-08-02
Onset:2021-08-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Gait disturbance, Pain, Pain in extremity, Peripheral artery thrombosis, Surgery, Ultrasound Doppler abnormal, X-ray
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor, Low dose ASA, Xarelto, Metformin, Vitamin D3, Zinc, Elderberry, Pomegranate
Current Illness: None
Preexisting Conditions: High cholesterol, diabetes
Allergies: PCN, Percocet, Tramadol
Diagnostic Lab Data: Blood work, X-ray, Ultrasound 8/17-8/18
CDC Split Type:

Write-up: Left leg pain developed on 8/16/21 in the evening. Acute and unremitting pain started at approximately 2000 hours 8/17/21. The patient could barely walk and was transported to the ER. A large clot in his left iliac artery was found and patient underwent emergency surgery on 8/18/21 at approximately 0300 hours.


VAERS ID: 1769065 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-03-02
Onset:2021-08-16
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0021A2A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardioversion, Condition aggravated, Electrocardiogram abnormal
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (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: Simvastatin, Levothyroxine, amlodipine, chlorthalidone, psylium fiber, docusate sodium, milk of magnesia, glucosamine, aspirin
Current Illness: no acute illnesses
Preexisting Conditions: hypertension, paroxysmal A fib, elevated cholesterol
Allergies: none
Diagnostic Lab Data: EKG to verify AFib
CDC Split Type:

Write-up: Recurrence of AFib which did not respond to ?Pill in a pocket? chemical cardioversion


VAERS ID: 1578994 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: High temperature (around 40?C), headache, lightheadedness, and feeling tired hours after the vaccination. Paracetamol and rest. Drink plenty of water.


VAERS ID: 1631881 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling cold
SMQs:, Anticholinergic syndrome (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: FLUOXETINE; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response); Lactation decreased; Neutropenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; Coldness; This case was received Regulatory Authority MHRA (Reference number: 25807124) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FEELING COLD (Coldness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Neutropenia, Anorexia and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response). Concomitant products included FLUOXETINE from 01-Aug-2020 to 01-Jul-2021 for Low mood, IBUPROFEN from 01-Aug-2021 to 02-Aug-2021 for Migraine. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and FEELING COLD (Coldness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness) and FEELING COLD (Coldness) had not resolved. No treatment medications reported Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patients'' past medical history of Neutropenia, Anorexia and Immunodeficiency could be confounding factors to the occurrence of events.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patients'' past medical history of Neutropenia, Anorexia and Immunodeficiency could be confounding factors to the occurrence of events.


VAERS ID: 1633906 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Facial pain, Fatigue, Headache, Limb discomfort, Pain in extremity, Sinus pain, Vaccination site swelling
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Arthritis (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: Asthma; Hay fever; Insect bite NOS; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Papule
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sinus pain; Pain in face; Aching limbs; Aching joints; Tiredness; Headache; Vaccination site swelling; Back ache; Heaviness in limbs; Chest aching; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25806397) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest aching), SINUS PAIN (Sinus pain), FACIAL PAIN (Pain in face), BACK PAIN (Back ache), LIMB DISCOMFORT (Heaviness in limbs), PAIN IN EXTREMITY (Aching limbs), ARTHRALGIA (Aching joints), FATIGUE (Tiredness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Papule and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Concurrent medical conditions included Asthma, Hay fever and Insect bite NOS. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced CHEST PAIN (Chest aching) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), LIMB DISCOMFORT (Heaviness in limbs) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and VACCINATION SITE SWELLING (Vaccination site swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced SINUS PAIN (Sinus pain) (seriousness criterion medically significant), FACIAL PAIN (Pain in face) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aching limbs) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest aching), BACK PAIN (Back ache), LIMB DISCOMFORT (Heaviness in limbs), FATIGUE (Tiredness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Vaccination site swelling) had not resolved and SINUS PAIN (Sinus pain), FACIAL PAIN (Pain in face), PAIN IN EXTREMITY (Aching limbs) and ARTHRALGIA (Aching joints) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was taking regular steroid treatment. This case concerns a 36-year-old female with serious unexpected events of chest pain, back pain, limb discomfort, fatigue, headache, vaccination site swelling, sinus pain, facial pain, pain in extremity, and arthralgia. Event latency one day after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 36-year-old female with serious unexpected events of chest pain, back pain, limb discomfort, fatigue, headache, vaccination site swelling, sinus pain, facial pain, pain in extremity, and arthralgia. Event latency one day after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1634275 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: Vomiting; Nausea; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 25803137) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) 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 (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1634284 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Eye swelling, Eyelid pain, Fatigue, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; FAMOTIDINE; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Joint pain; Fever; Fatigue; tender right eyelid; sore injection site; muscle pain; Eyes swollen; This case was received via Regulatory Authority (Reference number: 25803429) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swollen), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 34-year-old female 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. The patient''s past medical history included Lactation decreased. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), CITALOPRAM for Depression, PARACETAMOL from 15-Aug-2021 to an unknown date for Fever, IBUPROFEN for Joint pain. On 14-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced EYE SWELLING (Eyes swollen) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), EYELID PAIN (tender right eyelid), VACCINATION SITE PAIN (sore injection site) and MYALGIA (muscle pain). At the time of the report, EYE SWELLING (Eyes swollen), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved and EYELID PAIN (tender right eyelid), VACCINATION SITE PAIN (sore injection site) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient woke up the second day after the vaccine with a swollen left eyelid and tender right eyelid, no discharge, not impeding vision. On the first day, had experienced sore injection site, fever, muscle/joint pain and fatigue but no eye symptoms. Second day some remaining fever and sore injection site. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1634291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Faint; This case was received via The Regulatory Authority (Reference number: GB-MHRA-ADR 25804615) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Faint) 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 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). On 16-Aug-2021, SYNCOPE (Faint) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient did not had any past history of fainting or nervousness after having vaccines/blood tests. Patient fainted during the 15 minute observation period after receiving the vaccination. However, upon recovery, the patient said she did not had anything to eat in the morning and had a busy morning. The patient stayed on the floor for 10 minutes with legs raised, 10 minutes sat on the floor and 10 minutes on the chair. The patient fully recovered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1634297 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: fever; Hallucination; This case was received via Agency Regulatory Authority (Reference number: 25805612) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever). On 16-Aug-2021, HALLUCINATION (Hallucination) had resolved. At the time of the report, PYREXIA (fever) 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. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1634307 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature fluctuation, Headache, Hyperhidrosis, Myalgia, Rash, SARS-CoV-2 test, Vaccination site rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; MIGRALEVE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: vaccination site rash; vaccination site rash; temperature fluctuation; Myalgia; Sweating; Rash; Headache dull; This case was received via regulatory authority (Reference number: 25806350) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), RASH (Rash) and HEADACHE (Headache dull) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL (CERELLE) for Contraception, BUCLIZINE HYDROCHLORIDE, CODEINE PHOSPHATE, PARACETAMOL DC 96% (MIGRALEVE) for Migraine aura, PROPRANOLOL for Migraine with aura. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced the first episode of VACCINATION SITE RASH (vaccination site rash), the second episode of VACCINATION SITE RASH (vaccination site rash), BODY TEMPERATURE FLUCTUATION (temperature fluctuation) and MYALGIA (Myalgia). At the time of the report, HYPERHIDROSIS (Sweating) and HEADACHE (Headache dull) was resolving, RASH (Rash) had not resolved and last episode of VACCINATION SITE RASH (vaccination site rash), BODY TEMPERATURE FLUCTUATION (temperature fluctuation) and MYALGIA (Myalgia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1634310 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Lactation decreased
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.MOD20212

Write-up: Sensitive skin; Headache; Fever; Muscle ache; Joint ache; Chills; Fatigue; This case was received via regulatory authority (Reference number: 25806650) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive skin), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (Sensitive skin), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Fatigue) 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. No concomitant product was reported. No treatment medications was reported. Patient had no symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events'' seriousness was provided by RA.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events'' seriousness was provided by RA.


VAERS ID: 1634322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; LOPERAMIDE; MEBEVERINE; MESALAZINE; RAMIPRIL; THEICAL D3.
Current Illness: Suspected COVID-19 (Unsure when symptoms started.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101069555

Write-up: COVID-19 pneumonia; Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108171546202170-V0EVN. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25811796. A 50-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: ER1741) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW4109) as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing suspected covid-19 Unsure when symptoms started. Concomitant medication(s) included amlodipine, loperamide, mebeverine, mesalamine, Ramipril and calcium carbonate, cholecalciferol (THEICAL D3), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sars-cov-2 infection on 16Aug2021, covid-19 pneumonia, drug ineffective on an unspecified date with outcome of unknown. Event drug ineffective resulted in hospitalization, disability and rest events resulted in hospitalization, disability and was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive and Positive COVID-19 test. Outcome of the event drug ineffective was unknown and rest events was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1634362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101089538

Write-up: Dose 1: 19Jun2021 dose 2: 15Aug2021 inappropriate schedule of vaccination administered; Chills; Fever; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 29Aug2021, this case now contains serious adverse reactions. Information processed together. This is a solicited report from the Regulatory Authority from a contactable consumer. This is the second of two reports. The first is a report downloaded from the Regulatory Agency (MHRA), Regulatory authority report number is GB-MHRA-YCVM-202107041215039990-GXURE, Safety Report Unique Identifier GB-MHRA-ADR 25592005. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Aug2021 (Lot Number: FF3319) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had not had symptoms associated with COVID-19, had not had a COVID-19 test and was not enrolled in a clinical trial. The patient''s concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FA1027) on 19Jun2021 and experienced pain in arm and muscle ache. The patient experienced chills and fever on 16Aug2021. The outcome of the events chills and fever was recovered on 16Aug2021. The patient has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the events chills and fever with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events 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: 1634526 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure normal, Body temperature, Dysphoria, Heart rate, Heart rate irregular, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: BP; Result Unstructured Data: Test Result:89/54; Test Date: 20210816; Test Name: BP; Result Unstructured Data: Test Result:106/69; Comments: at 12:20; Test Date: 20210816; Test Name: BP; Result Unstructured Data: Test Result:123/83; Comments: 1 hour later; Test Date: 20210816; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210816; Test Name: pulse; Result Unstructured Data: Test Result:49; Comments: irregular (at 12:20); Test Date: 20210816; Test Name: pulse; Result Unstructured Data: Test Result:71; Comments: after 1 hour; Test Date: 20210816; Test Name: Spo2; Result Unstructured Data: Test Result:97%; Test Date: 20210816; Test Name: Spo2; Result Unstructured Data: Test Result:99%; Comments: at 12:20; Test Date: 20210816; Test Name: Spo2; Result Unstructured Data: Test Result:99%; Comments: after 1 hour
CDC Split Type: JPPFIZER INC202101059430

Write-up: Vasovagal reflex; Blood pressure decreased; Dysphoria; Pulse was irregular; This is a spontaneous report from a contactable other health care professional received from the regulatory authority. Regulatory authority report number is v21123556. A 33-year and 6-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF2782 and Expiration date: 30Nov2021), via an unspecified injection route of administration on 16Aug2021 at 12:10 (the day of vaccination, at the age of 33-year and 6-month-old), as a single dose for COVID-19 immunisation. Body temperature before vaccination was 36.4 degrees centigrade on 16Aug2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient medical history included Atrioventricular block (which has been followed-up without necessity of treatment). Concomitant medications were not reported. On 16Aug2021 at 12:20 (10 minutes after vaccination), the patient experienced Vasovagal reflex, blood pressure decreased, pulse was irregular and dysphoria. The course of the event was as follows: on 16Aug2021, the patient complained of Dysphoria during the period of monitoring after the vaccination, and the symptom was reported to a nurse. Vital signs were measured (Blood pressure (BP) of 89/54, Oxygen saturation (SpO2) of 97%). According to the instruction provided by a physician, vascular access was promptly secured to provide rapid infusion of Soldem3A 500 mL at a rate of 100 drops or more/min. Ten minutes after that, BP was 106/69, Pulse rate (P) was 49, and SpO2 was 99%. Pulse was irregular. One hour later, the patient felt better with BP of 123/83, P of 71, and SpO2 of 99%. The patient went home while being accompanied by the patient s guardian. As other treatment, fexofenadine tablet 1 sachet 60 mg was orally administered. The outcome of the events was reported as unknown. The reporting other HCP non-serious and assessed that the causality between the event and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases was unknown. The reporting physician commented as follows: There was no description of information including medical history in the prevaccination screening questionnaire. After the vaccination, patient mother reported that the patient had history of atrioventricular block which has been followed-up without necessity of treatment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1634558 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003182 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Presyncope, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: At 15:00: 95/58 mmHg; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: At 15:40: 106/56 mmHg; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: At 16:20: 101/66; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: At 16:45: 100/58; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: At 15:30:88/56 mmHg; Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: At 15:00: 60; Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: At 15:40 58; Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: At 16:20: 62; Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: At 16:45: 66; Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: At 15:30: 60; Test Date: 20210816; Test Name: Oxygen saturation; Result Unstructured Data: At 15:00: 98%; Test Date: 20210816; Test Name: Oxygen saturation; Result Unstructured Data: At 15:30: 99%; Test Date: 20210816; Test Name: Oxygen saturation; Result Unstructured Data: At 15:40: 99%; Test Date: 20210816; Test Name: Oxygen saturation; Result Unstructured Data: At 16:20: 99%; Test Date: 20210816; Test Name: Oxygen saturation; Result Unstructured Data: At 16:45:99%
CDC Split Type: JPTAKEDA2021TJP080034

Write-up: Convulsion; Syncope; Vasovagal reflex; This case was received via The Regulatory Authority (Reference number: 2021TJP080034) on 16-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of SEIZURE (Convulsion) and SYNCOPE (Syncope) in a 20-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003182) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reflex). At the time of the report, SEIZURE (Convulsion), SYNCOPE (Syncope) and PRESYNCOPE (Vasovagal reflex) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Blood pressure measurement (120-80): 95/58 (Low) At 15:00: 95/58 mmHg, 106/56 (normal) At 15:40: 106/56 mmHg, 101/66 (normal) At 16:20: 101/66, 100/58 (normal) At 16:45: 100/58 and 88/56 (Low) At 15:30:88/56 mmHg. On 16-Aug-2021, Heart rate: 60 (Low) At 15:00: 60, 58 (Low) At 15:40 58, 62 (Low) At 16:20: 62, 66 (normal) At 16:45: 66 and 60 (Low) At 15:30: 60. On 16-Aug-2021, Oxygen saturation: 98% (normal) At 15:00: 98%, 99% (normal) At 15:30: 99%, 99% (normal) At 15:40: 99%, 99% (normal) At 16:20: 99% and 99% (normal) At 16:45:99%. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SEIZURE (Convulsion), SYNCOPE (Syncope) and PRESYNCOPE (Vasovagal reflex) to be not related. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1634692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, Dysstasia, Headache, Nausea, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: 20210817; Test Name: body temperature; Result Unstructured Data: Test Result:increased (37.4 degree centigrade); Comments: increased (37.4 degree centigrade)
CDC Split Type: PTPFIZER INC202101075327

Write-up: nausea; weakness; headache; body temperature increased (37.4 ?C); could not stand on her feet for more than 5 consecutive minutes; mild pain at the vaccination site; This is a spontaneous report from a contactable consumer, the patient herself. A 29-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Lot number: FE4728) via an intramuscularly, administered in Arm Left on 16Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) on 19Jul2021 (Lot number: FF0688) as DOSE 1, single for covid-19 immunization. On 16Aug2021, the day of vaccination, the patient experienced only mild pain at the vaccination site. On the following day (17Aug2021), the patient experienced nausea, weakness, headache, body temperature increased (37.4 degree centigrade) and could not stand on her feet for more than 5 consecutive minutes, having to immediately seat or lay down. The event could not stand on her feet for more than 5 consecutive minutes was serious (disability). The patient underwent lab tests and procedures which included body temperature increased (37.4 degree centigrade). At the time of the report, the outcome of the events was recovered on an unspecified date of 2021. Follow-up attempts are completed. No further Information is expected.


VAERS ID: 1634698 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004218 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Maternal exposure during breast feeding, Musculoskeletal stiffness, Nausea, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Neonatal exposures via breast milk (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (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: SEMODERNATX, INC.MOD20212

Write-up: was ready to faint; Nausea; Maternal exposure during breast feeding; felt sick; pain in the body; stiffness; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (was ready to faint) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 16-Aug-2021, the patient experienced MALAISE (felt sick), PAIN (pain in the body), MUSCULOSKELETAL STIFFNESS (stiffness), HEADACHE (Headache), CHILLS (chills) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 17-Aug-2021, the patient experienced SYNCOPE (was ready to faint) (seriousness criterion medically significant) and NAUSEA (Nausea). At the time of the report, SYNCOPE (was ready to faint), MALAISE (felt sick), PAIN (pain in the body), MUSCULOSKELETAL STIFFNESS (stiffness), HEADACHE (Headache), CHILLS (chills) and NAUSEA (Nausea) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medications provided. No treatment medications were reported Company Comment: This is a case of product exposure during pregnancy with associated adverse events in the mother. Based on temporal association a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse events in the mother. Based on temporal association a causal relationship cannot be excluded.


VAERS ID: 1636023 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Headache, Nausea, Pain in extremity, Pyrexia, Retching, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: IBUPROFEN; PARACETAMOL
Current Illness: Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Taste metallic; Dry heaves; Nausea; Headache; Fever; Painful arm; This case was received via RA (Reference number: 25809483) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic), PAIN IN EXTREMITY (Painful arm), RETCHING (Dry heaves), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Pain. Concomitant products included IBUPROFEN and PARACETAMOL for Pain. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant), RETCHING (Dry heaves) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, DYSGEUSIA (Taste metallic), PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache) had not resolved and RETCHING (Dry heaves) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication use information was not provided by reporter. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude. The Company believe none of the events meet serious criteria and the case is non-serious.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude. The Company believe none of the events meet serious criteria and the case is non-serious.


VAERS ID: 1636028 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-16
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration, Influenza like illness, Nausea, Pain in extremity, SARS-CoV-2 test, Throat irritation
SMQs:, Acute pancreatitis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITYN [LORATADINE]; VENLAFAXINE
Current Illness: Allergic rhinitis; Depression; Hay fever; Irritable bowel syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Inappropriate schedule of product administered; Flu-like aching; Raw throat; Feeling dazed; Headache dull; Nausea; Tiredness; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25809935) on 18-Aug-2021 and was forwarded to the company on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), PAIN IN EXTREMITY (Painful arm), THROAT IRRITATION (Raw throat), FEELING ABNORMAL (Feeling dazed), HEADACHE (Headache dull), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Anxiety and Headache. Concurrent medical conditions included Irritable bowel syndrome, Allergic rhinitis, Depression since 2016 and Hay fever since 2016. Concomitant products included VENLAFAXINE for Depression, LORATADINE (CLARITYN [LORATADINE]) for Hay fever. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), THROAT IRRITATION (Raw throat) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling dazed) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administered). The patient was treated with PARACETAMOL ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching), PAIN IN EXTREMITY (Painful arm), THROAT IRRITATION (Raw throat), FEELING ABNORMAL (Feeling dazed), HEADACHE (Headache dull), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient felt quick onset of the majority of symptoms the morning after second jab was received. Fluids, paracetamol and rest used as treatment. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Causality for inappropriate schedule of product administered is not applicable.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Causality for inappropriate schedule of product administered is not applicable.


VAERS ID: 1636032 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disorientation, Migraine, Nausea, Palpitations, SARS-CoV-2 test, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201026; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Blurred vision; Migraine; Disorientation; Heart racing; Nausea; This case was received via Regulatory authority RA (Reference number: GB-MHRA-ADR 25810216) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), MIGRAINE (Migraine), DISORIENTATION (Disorientation), PALPITATIONS (Heart racing) and NAUSEA (Nausea) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 on 26-Oct-2020. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), DISORIENTATION (Disorientation) (seriousness criterion medically significant) and PALPITATIONS (Heart racing) (seriousness criterion medically significant). On an unknown date, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurred vision) was resolving and MIGRAINE (Migraine), DISORIENTATION (Disorientation), PALPITATIONS (Heart racing) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1636033 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, 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? 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.MOD20212

Write-up: Fever; Aching joints; Tiredness; This case was received via RA (Reference number: ADR 25810265) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Aching joints) and FATIGUE (Tiredness) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), ARTHRALGIA (Aching joints) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were assessed serious as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were assessed serious as per regulatory authority report.


VAERS ID: 1636034 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Pain, SARS-CoV-2 test, Vaccination site movement impairment, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: numbness of h; reduced movement of arm; increasing arm pain at site of injection; pain to shoulder; Pain; This case was received via Regulatory Authority (Reference number: 25810277) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of h) and PAIN (Pain) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (numbness of h) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced movement of arm), VACCINATION SITE PAIN (increasing arm pain at site of injection) and ARTHRALGIA (pain to shoulder). At the time of the report, HYPOAESTHESIA (numbness of h), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced movement of arm), VACCINATION SITE PAIN (increasing arm pain at site of injection) and ARTHRALGIA (pain to shoulder) outcome was unknown and PAIN (Pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Increasing arm pain at site of injection and in to shoulder. Numbness of hand and reduced movement of arm. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were reported as serious due to important medical event by the Regulatory Authority.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were reported as serious due to important medical event by the Regulatory Authority.


VAERS ID: 1636036 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hyperhidrosis, Limb injury, Loss of personal independence in daily activities, Myalgia, Night sweats, Pain, Pain in extremity, Pyrexia, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: night sweats; pain; Extremely sore arm; Disturbed sleep; Unable to do any everyday activity; Fatigue; Muscle ache; Fever; Heavy sweating; Arm injury; This case was received via Regulatory authority RA (Reference number: GB-MHRA-ADR 25810330) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), HYPERHIDROSIS (Heavy sweating), LIMB INJURY (Arm injury), PAIN (pain), MYALGIA (Muscle ache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 28-year-old female 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. The patient''s past medical history included Lactation decreased. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPERHIDROSIS (Heavy sweating) (seriousness criterion medically significant), LIMB INJURY (Arm injury) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced NIGHT SWEATS (night sweats) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Extremely sore arm), SLEEP DISORDER (Disturbed sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do any everyday activity). At the time of the report, NIGHT SWEATS (night sweats), PAIN (pain), PAIN IN EXTREMITY (Extremely sore arm), SLEEP DISORDER (Disturbed sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do any everyday activity) outcome was unknown, HYPERHIDROSIS (Heavy sweating) and PYREXIA (Fever) was resolving and LIMB INJURY (Arm injury), MYALGIA (Muscle ache) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter stated that patient had Extremely sore arm, unable to do any everyday activity even after painkillers. Can hardly move arm without extreme pain, disturbed sleep. Fever and night sweats overnight and fatigue. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1636058 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tiredness; Joint ache; Aching joints; Muscle ache; Tired all the time; This case was received via Reference number: GB-MHRA-ADR 25814821) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tired all the time), ARTHRALGIA (Aching joints), MYALGIA (Muscle ache), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) in a 32-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 Lactation decreased. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced FATIGUE (Tired all the time) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tired all the time), ARTHRALGIA (Aching joints), MYALGIA (Muscle ache), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 test. Patient was experienced tiredness, joint ache after the COVID-19 vaccine. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1636059 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Night sweats, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), 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? 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.MOD20212

Write-up: night; sweating; Night sweat; This case was received via RA (Reference number: 25815348) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (night), HYPERHIDROSIS (sweating) and NIGHT SWEATS (Night sweat) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced NIGHT SWEATS (Night sweat) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (night) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating) (seriousness criterion medically significant). At the time of the report, SEIZURE (night) and HYPERHIDROSIS (sweating) outcome was unknown and NIGHT SWEATS (Night sweat) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1636063 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling cold, Pain in extremity
SMQs:, 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: ACRIVASTINE; CETIRIZINE HYDROCHLORIDE; PARACETAMOL
Current Illness: Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Coldness; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 25810244 ) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and FEELING COLD (Coldness) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy. Concomitant products included ACRIVASTINE from 20-Jun-2021 to an unknown date and CETIRIZINE HYDROCHLORIDE from 20-Jul-2021 to an unknown date for Pollen allergy, PARACETAMOL from 16-Aug-2021 to an unknown date for Vaccination. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced FEELING COLD (Coldness) (seriousness criterion medically significant). On 17-Aug-2021, FEELING COLD (Coldness) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1636164 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004667 / UNK LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Chills, Injection site erythema, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: We have just received the news that some of the vaccines from Moderna that were distributed in were contaminated. My husband and I have received the second dose of the vaccine on August 15, 2021 in the city . Throughout the night of the following day, we felt unwell with fever, chills, and a red spot on the arm we received the vaccine. This symptoms lasted for almost a whole week. We both had the same symptoms. We had a flight on August 17, two days after the vaccination, and we didn?t have time to make na appointment with a doctor and report the symptoms. We would like to have clarified what tipe of contamination we were exposed to and what protection this contaminated doses of the vaccine offer. It is necessary that this information is clarified as soon as possible, since our health is priority. I am attaching to this email our record of vaccination so your company can give me the proper clarifications. We are currently in , and we are waiting for the company?s reply regarding the health risks and immunity as well as what should be done at this time.


VAERS ID: 1638366 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oedema, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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.MOD20212

Write-up: Leg swelling; Oedema; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25811161 ) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of OEDEMA (Oedema) and PERIPHERAL SWELLING (Leg swelling) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced OEDEMA (Oedema) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Leg swelling) (seriousness criterion medically significant). At the time of the report, OEDEMA (Oedema) had not resolved and PERIPHERAL SWELLING (Leg swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter.Treatment product was not provided by the reporter. Lab data was not provided. Within a couple of hours after 2nd dose patient had developed leg swelling, swelling around neck and both arms. Advised antihistamines. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been provided at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.. Very limited information has been provided at this time


VAERS ID: 1638368 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Stiffness; Chest pain; Dizziness; Nausea; Tiredness; Injection site pain; Headache; Fever; This case was received via a regulatory authority on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), CHEST PAIN (Chest pain), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Tiredness), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving, CHEST PAIN (Chest pain), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Tiredness), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were assessed serious as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events were assessed serious as per regulatory authority report.


VAERS ID: 1638369 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, 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), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210815; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Chills; Joint ache; Nausea; This case was received via Regulatory Authority (Reference number: 25811903) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint ache) and NAUSEA (Nausea) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PARACETAMOL from 16-Aug-2021 to an unknown date for Fever. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint ache) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1638371 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest pain, Chills, Fatigue, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (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: FLUOXETIN; ISOPROPANOL; TRAMADOL
Current Illness: Anxiety; Bulimia
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: Back pain; Fatigue; Headache; Nausea; Shivers; Pain chest; This case was received via a regulatory authority on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Shivers) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety and Bulimia. Concomitant products included ISOPROPANOL from 07-Sep-2020 to an unknown date for Anxiety, FLUOXETINE HYDROCHLORIDE (FLUOXETIN) from 07-Sep-2020 to an unknown date for Bulimia, TRAMADOL from 22-Jul-2021 to 02-Aug-2021 for Tooth extraction. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced CHEST PAIN (Pain chest) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Pain chest) was resolving and BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Shivers) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1638373 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-08-16
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Migraine, 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Migraine headache; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 25813183) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion disability). At the time of the report, MIGRAINE (Migraine headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this event has been provided at this time. Also, there seems to be an interchange in the encoded dates of dose 1(12-AUG-2021) and dose 2 (12-JUN-2021) of the Moderna vaccine. No further follow-up information is expected. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial; Sender''s Comments: Very limited information regarding this event has been provided at this time. Also, there seems to be an interchange in the encoded dates of dose 1(12-AUG-2021) and dose 2 (12-JUN-2021) of the Moderna vaccine. No further follow-up information is expected.


VAERS ID: 1638374 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Dizziness, Fatigue, Headache, Hot flush, Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]
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.MOD20212

Write-up: Dizziness; Hot flushes; Painful arm; Cough; Increased thirst; Nausea; Shivers; Muscle ache; Tiredness; Headache; This case was received via Regulatory Authority (Reference number: ADR 25813852) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HOT FLUSH (Hot flushes), PAIN IN EXTREMITY (Painful arm), COUGH (Cough), THIRST (Increased thirst), NAUSEA (Nausea), CHILLS (Shivers), MYALGIA (Muscle ache), FATIGUE (Tiredness) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included DESOGESTREL (CERAZETTE [DESOGESTREL]) for an unknown indication. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), HOT FLUSH (Hot flushes) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), THIRST (Increased thirst) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 16-Aug-2021, DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. On 17-Aug-2021, HOT FLUSH (Hot flushes) and CHILLS (Shivers) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm), COUGH (Cough), THIRST (Increased thirst), MYALGIA (Muscle ache), FATIGUE (Tiredness) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment details were provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1638376 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sharp shooting pains in my legs and side of my body lower/upper; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25814516) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (sharp shooting pains in my legs and side of my body lower/upper) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL from 16-Aug-2021 to an unknown date for Headache. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (sharp shooting pains in my legs and side of my body lower/upper) (seriousness criterion medically significant). At the time of the report, PAIN (sharp shooting pains in my legs and side of my body lower/upper) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. It was reported that Patient received the vaccine, and suddenly became very sore headed and sharp shooting pains in his legs and side of his body lower/upper. Patient were aware of the sore head, but the sharp shooting pains were not described. They have been a lot milder this evening but were represent when woke up. Patient was still feeling the aches and pains that reporter was informed that he would get. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1638891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper
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: USJNJFOC20210835106

Write-up: STOMACH PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-AUG-2021, the patient experienced stomach pain. The action taken with covid-19 vaccine was not applicable. The outcome of stomach pain was not reported. This report was non-serious.


VAERS ID: 1640584 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fatigue; Dizzy; Light-headed; Headache; Fever; Chills; Nausea; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25819756) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), DIZZINESS (Dizzy) and DIZZINESS (Light-headed) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Lactation decreased. On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and DIZZINESS (Dizzy) (seriousness criterion medically significant). 17-Aug-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant). On 17-Aug-2021, PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), DIZZINESS (Dizzy) and DIZZINESS (Light-headed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not breastfeeding and was not enrolled in clinical trial. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1640592 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coeliac disease, Condition aggravated, SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coeliac disease
Preexisting Conditions: Medical History/Concurrent Conditions: Seizure
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.MOD20212

Write-up: Coeliac disease; Condition aggravated; Seizures; This case was received via RA (Reference number: GB-MHRA-ADR 25817120) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COELIAC DISEASE (Coeliac disease) and SEIZURE (Seizures) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Seizure. Concurrent medical conditions included Coeliac disease. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced COELIAC DISEASE (Coeliac disease) (seriousness criteria medically significant and life threatening) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, COELIAC DISEASE (Coeliac disease), SEIZURE (Seizures) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. No relevant treatment medication information provided. As per report patient experienced seizure after two and was admitted to the hospital. Subsequently he had experienced 5 further seizures over 24 hours. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s past medical history remains a confounder.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s past medical history remains a confounder.


VAERS ID: 1640594 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-16
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Movement disorder, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: arm pain; fatigue; Fever; Joint ache; Decreased arm swing; Swollen arm; Muscle ache; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25817497) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), MOVEMENT DISORDER (Decreased arm swing) and PERIPHERAL SWELLING (Swollen arm) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criteria disability and medically significant) and MYALGIA (Muscle ache) (seriousness criteria disability and medically significant). On 17-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant), ARTHRALGIA (Joint ache) (seriousness criteria disability and medically significant), MOVEMENT DISORDER (Decreased arm swing) (seriousness criteria disability and medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) (seriousness criteria disability and medically significant) and FATIGUE (fatigue) (seriousness criteria disability and medically significant). At the time of the report, PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue) outcome was unknown, HEADACHE (Headache), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), MOVEMENT DISORDER (Decreased arm swing) and PERIPHERAL SWELLING (Swollen arm) had not resolved and PYREXIA (Fever) was resolving. 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: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1640602 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No medical history reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: chills; Slight fever; Dizziness; Fever chills; Headache; Tiredness; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25819258) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever chills), HEADACHE (Headache), FATIGUE (Tiredness), PYREXIA (Slight fever) and DIZZINESS (Dizziness) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history reported. Concomitant products included SERTRALINE for Anxiety. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced PYREXIA (Slight fever) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). At the time of the report, CHILLS (chills) had resolved, PYREXIA (Fever chills), HEADACHE (Headache), FATIGUE (Tiredness) and PYREXIA (Slight fever) was resolving and DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient felt very tired after getting back from his jab then fell asleep a couple of hours later. He ended up sleeping for about 20 hours, waking up a few times for short periods. He woke up properly for a few hours the day after but only stayed awake for a few hours before going to sleep again, most of the symptoms have reduced a lot in severity but the dizziness had gotten way worse than it was before. His heart rate seems to be quite elevated compared to normal at about 90bpm resting rather than 60 normal. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. RA case reported as medically important but MA deems events are non-serious; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. RA case reported as medically important but MA deems events are non-serious


VAERS ID: 1640606 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20210719; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache dull; Muscle ache; Tiredness; Fever; Fever chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25821042) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Fever chills), HEADACHE (Headache dull), MYALGIA (Muscle ache) and FATIGUE (Tiredness) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache dull) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 18-Aug-2021, PYREXIA (Fever) and CHILLS (Fever chills) had resolved. At the time of the report, HEADACHE (Headache dull) and FATIGUE (Tiredness) had resolved and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical judgement none of the events were serious (not IME listed and resolved). As this a RA, reported events seriousness is kept as per RA assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical judgement none of the events were serious (not IME listed and resolved). As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1641338 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Feeling abnormal, Headache, Influenza like illness, Malaise, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins; nac; vit c; vit d; zinc.
Current Illness:
Preexisting Conditions:
Allergies: None that I know of.
Diagnostic Lab Data: Had a negative COVID test on the 20th of August
CDC Split Type:

Write-up: First started with sore arm on the day of vaccine. Then the following day, I started to feel sick on the evening. Like the start of a flu/cold. 3rd day after the jab I had a piercing headache upon waking up, just above my left eye. Also started waking up with a painful sore throat that would come and go but was far worse in the morning. Also developed a cough that only comes at night before I go to sleep. However headache went away after 2 days. I''m now at 10 days after my first dose, and I''ve got massive brain fog, and fatigue. Too tired to exercise. Still have sore throat in the morning which feels kind of like mono/strep and a thickly cough that comes at night and is gone for the rest of the day.


VAERS ID: 1642355 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: Lactation decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: vaccination site warmth; Vaccination site pain; Vaccination site erythema; Backache; Swollen arm; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25815996) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), PERIPHERAL SWELLING (Swollen arm) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lactation decreased. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced BACK PAIN (Backache) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 16-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, BACK PAIN (Backache) was resolving, PERIPHERAL SWELLING (Swollen arm) had not resolved and VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. The patient was not enrolled in clinical trial nor tested positive for COVID-19. The patient was not pregnant nor was breastfeeding. The patient reported very painful just under the injection site has grown over the past couple of days and is still hot , on the injection site but underneath it. Treatment information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1642357 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Headache, Lymphadenopathy, Nausea, Pain, Pain in extremity, Peripheral swelling, Photophobia, Pyrexia
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: shivering; pain; swollen armpit; Swollen arm; Fever; Headache; Feeling of total lack of energy; Nausea; Light sensitivity to eye; Painful arm; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25816052) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling of total lack of energy), PAIN IN EXTREMITY (Painful arm), PHOTOPHOBIA (Light sensitivity to eye), PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), HEADACHE (Headache), CHILLS (shivering), PAIN (pain), LYMPHADENOPATHY (swollen armpit) and NAUSEA (Nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 17-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant), PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 18-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant) and LYMPHADENOPATHY (swollen armpit) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Painful arm, Headache and Nausea, at an unspecified dose and frequency and IBUPROFEN for Headache and Nausea, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Feeling of total lack of energy), PAIN IN EXTREMITY (Painful arm), PHOTOPHOBIA (Light sensitivity to eye), PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever) and HEADACHE (Headache) had not resolved, CHILLS (shivering), PAIN (pain) and LYMPHADENOPATHY (swollen armpit) outcome was unknown and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. After receiving the second dose, arm of the patient began to ache later in the day. After that the patient woke up at 1 am in immense pain due to arm and shivering/convulsing uncontrollably. On the 17-Aug-2021, the patient felt like she had been hit by a bus, could barely get out of bed or walk, very light headed and had no energy. Headache/nausea throughout the day. In the evening, the patient developed a fever and would shake uncontrollably through shivering and suddenly become very hot. Woke up in the night drenched in sweat. On 18-Aug-2021, the patient had woke up in the morning with a very swollen armpit on the side of the vaccine and it felt very tender. Treatment information for rest of the events were not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1642359 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Lethargy, Pain in extremity, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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.MOD20212

Write-up: exhaustion; fever; Decreased appetite; Lethargy; Headache; Pain in arm; Blurry vision; Feverish; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25816485 ) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PYREXIA (fever), PYREXIA (Feverish), LETHARGY (Lethargy), HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and VISION BLURRED (Blurry vision) in a 42-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 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and VISION BLURRED (Blurry vision) (seriousness criterion medically significant). On 17-Aug-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (exhaustion) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and DECREASED APPETITE (Decreased appetite). At the time of the report, FATIGUE (exhaustion), PYREXIA (fever), PYREXIA (Feverish), LETHARGY (Lethargy), HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and VISION BLURRED (Blurry vision) had not resolved and DECREASED APPETITE (Decreased appetite) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant medical history and concurrent conditions reported information of Unsurely if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. No concomitant medication reported. No treatment was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1642364 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-08-16
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Hypertension, Lymphadenopathy, Myalgia, Nausea, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOMETASONE FUROATE; OMEPRAZOLE; CBD OIL; PARACETAMOL
Current Illness: Fever; Hypertension; Psoriasis of scalp
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; GERD; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: hypertension; Muscle pain; Nausea; Swollen arm; Painful arm; Fever; Dizziness; Headache; Swollen lymph nodes; This case was received via Regulatory authority (Reference number: GB-MHRA-ADR 25818015) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERTENSION (hypertension), MYALGIA (Muscle pain), NAUSEA (Nausea), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), DIZZINESS (Dizziness), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen lymph nodes) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002621) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Anxiety disorder and GERD. Concurrent medical conditions included Fever, Hypertension and Psoriasis of scalp. Concomitant products included CANNABIDIOL (CBD OIL) for Anxiety disorder, PARACETAMOL for Fever, OMEPRAZOLE for GERD, MOMETASONE FUROATE for Psoriasis of scalp. On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant), DIZZINESS (Dizziness) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced HYPERTENSION (hypertension) (seriousness criteria disability and medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 18-Aug-2021, PYREXIA (Fever) was resolving, HEADACHE (Headache) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, HYPERTENSION (hypertension), MYALGIA (Muscle pain), NAUSEA (Nausea), PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Painful arm) had not resolved and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The reporter reported that patient did PCR test which was negative and other home tests were negative too. Patient reported that symptoms started after 2nd dose stage 1 hypertension. Patient was sure that there all were side effects of vaccination. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1642370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizzy spells; This case was received via A regulatory authority on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) 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. Concomitant products included SERTRALINE for an unknown indication. On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizzy spells) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Limited information regarding this event has been provided at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Limited information regarding this event has been provided at this time.


VAERS ID: 1642570 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101050225

Write-up: This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. A 20-year-old non-pregnant female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF4204, Expiration date: 31Oct2021), via an intramuscular route of administration in arm left on 16Aug2021 at 10:30 (the day of vaccination, at the age of 20-year-old), as dose 1, single for COVID-19 immunisation. The patient medical history was reported as normal. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Aug2021 at 10:30 (the day of vaccination), the patient experienced vasovagal reaction. The reporter stated the event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure included an intravenous infusion and patient was placed under observation. The reporter reported the event as non-serious. The outcome reported as recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vasovagal reaction . The case will be reassessed once new information is 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: 1642605 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Ocular hyperaemia, Oxygen saturation, Oxygen saturation decreased, Pruritus, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Solu-Cortef
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210816; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Comments: At 16:02
CDC Split Type: JPPFIZER INC202101083063

Write-up: wheezing; dyspnoea; decreased oxygen saturation (SAT); Anaphylaxis; ocular hyperaemia; itchy skin; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124323. The patient was a 42-year and 6-month-old female (age at vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. The patient had a history of asthma bronchial. The patient had ocular hyperaemia and itching on the body after the first dose of bnt162b2 (COMIRNATY) on 26Jul2021. On 26Jul2021, the patient previously received the first dose of bnt162b2 (COMIRNATY). On 16Aug2021 at 15:52 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Aug2021 at 16:00 (8 minutes after the vaccination), the patient experienced anaphylaxis. On 16Aug2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: At 15:35, after vascular access was maintained with saline, drip infusion of hydrocortisone sodium succinate (SOLU-CORTEF) 200 mg and saline 100 mL was started. At 15:52, when half of the drip infusion solution of SOLU-CORTEF was instilled, the patient received the vaccination. At 16:00, the patient experienced ocular hyperaemia and itchy skin. One ampoule of dexchlorpheniramine maleate (POLARAMINE) was intravenously injected. At 16:02, dyspnoea, wheezing, and decreased oxygen saturation (SAT) developed, epinephrine (BOSMIN) 0.3 mL was intramuscularly injected, and oxygen uptake was increased. At 16:13, the patient inhaled salbutamol sulfate (VENETLIN). Drip infusion of SOLU-CORTEF 200 mg and saline 100 mL was additionally given. At 16:24, the wheezing disappeared. Oxygen uptake was decreased. At 16:55, the drip infusion of SOLU-CORTEF was completed. At 17:05, the needle of the drip infusion was removed, and the patient went back home. The reporting physician classified the event as serious (Life-threatening) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1642716 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852750

Write-up: ABDOMINAL PAIN; VAGINAL BLEEDING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100808] concerned a 34 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021 at 05:00, the patient experienced abdominal pain, vaginal bleeding and was hospitalized (date and days unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from abdominal pain, and vaginal bleeding. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852750-COVID-19 VACCINE AD26.COV2.S- abdominal pain, vaginal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1653714 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Monoplegia, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Lamaline
Current Illness: Fibromyalgia, Osteoarthritis
Preexisting Conditions: Fibromyalgia
Allergies:
Diagnostic Lab Data: I have not yet been able to contact my doctor, he is on vacation.
CDC Split Type:

Write-up: I have one leg with a beginning of paralysis since the vaccination and there I begin to have pain in the muscles of the other leg and arms.


VAERS ID: 1654712 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Paraesthesia, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? 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: CHLORPHENAMINE; CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101075736

Write-up: swelling; parathesia; Allergy; 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-202108181231403890-L6UXZ), Safety Report Unique Identifier (GB-MHRA-ADR 25817155). A 30-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF3319) via an unspecified route of administration on 16Aug2021 (at the age of 30-years-old) as dose 1 single for COVID-19 immunization. Medical history included suppressed lactation, hypersensitivity, anxiety. Known allergy to shellfish. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications included chlorphenamine (CHLORPHENAMINE) taken for hypersensitivity from 16Aug2021 to an unspecified stop date, citalopram (CITALOPRAM) taken for anxiety from 01Mar2021 to an unspecified stop date. On 16Aug2021, the patient had experienced allergy. On an unspecified date, the patient had experienced swelling and parathesia. The patient''s hospitalization was prolonged as a result of events swelling, paratheia and allergy. Therapeutic measures were taken as a result of allergy (hypersensitivity), swelling (swelling), parathesia (paraesthesia). It was reported that patient developed rapid onset peri orbital swelling and parathesia to the chin after 1st Pfizer injection. Patient was kept in hospital for 7 hours for monitoring and sent home after steroid treatment. 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 COVID-19 virus test: negative (No-Negative COVID-19 test) on an unspecified date. The outcome of the event allergy was resolved with sequelae while unknown for the other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1654734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Myocarditis, Palpitations, Pyrexia, SARS-CoV-2 test, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:subtle features on ECG; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Trop; Result Unstructured Data: Test Result:79 -$g 53
CDC Split Type: GBPFIZER INC202101093153

Write-up: High temperature; chest pains; palpitations; Myocarditis; This is a spontaneous report from a contactable physician received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108210918358140-4RQ0R. Safety Report Unique Identifier GB-MHRA-ADR 25831476. A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Aug2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced high temperature on an unspecified date, chest pains on an unspecified date, palpitations on an unspecified date, myocarditis on 16Aug2021. The patient was a professional sportsman, had chest pains and palpitations during training following second Pfizer vaccine. The patient attended A&E trop raised persisting. Followed up ECG with sports cardiologist confirmed suspected myocarditis. No previous cardiac history. No possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date, troponin: 79 -$g 53 on an unspecified date, electrocardiogram: subtle features on ECG on an unspecified date. The report is serious with seriousness criteria hospitalization prolonged, disability, medically significant, life threatening. The outcome of the event myocarditis was not recovered. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1654888 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852418

Write-up: RIGHT SIDE BODY WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority, PH-PHFDA-300101231] concerned a 60 year old male patient. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced right side body weakness, and was hospitalized (date unspecified) and number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right side body weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210852418-Covid-19 Vaccine AD26.COV2.S-Right Side Body weakness-This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1656982 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Depression, Photophobia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Bp; Result Unstructured Data: Test Result:low
CDC Split Type: GBPFIZER INC202101064472

Write-up: Depressive episode; Photophobia; Fainting episode/faint; BP was low; This is a spontaneous report from a contactable physician received from the The regulatory authority report number is GB-MHRA-APPCOVID-20210816105425. Safety Report Unique Identifier GB-MHRA-ADR 25803390. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Fe3380), via an unspecified route of administration on 16Aug2021 (at the age of 19-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced depressive episode, photophobia, BP was low (BP recovered within 5 min) all on an unspecified date; and fainting episode/faint on 16Aug2021. It was reported that fainting episode within 5 min of LOC (presented as reported). Full recovery within 5 mins. Relevant investigations or lab tests included BP was low on an unspecified date. The outcome of event fainting episode/faint was resolved on 16Aug2021 (same day), BP was low resolved on unspecified date, whereas all other events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1657183 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood urine present, Inappropriate schedule of product administration, Investigation, Kidney infection, SARS-CoV-2 test, Urinary tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; MEBEVERINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Irritable bowel syndrome; Lactation decreased; Sciatica
Allergies:
Diagnostic Lab Data: Test Name: physical assessment for pain by the doctor; Result Unstructured Data: Test Result:unknown results; Test Name: Urine infection test; Result Unstructured Data: Test Result:UTI; Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101064671

Write-up: kidney infection; blood in urine; Inappropriate schedule of vaccine administered; UTI; 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-202108161117349290-4LTZQ, Safety Report Unique Identifier GB-MHRA-ADR 25803475. A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319) via an unspecified route of administration on 13Aug2021 (at the age of 27-years-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of BNT162B2 vaccine on 16Jun2021 as dose 1, single for COVID-19 immunization and experienced bad UTI. Medical history included lactation decreased, sciatica, irritable bowel syndrome, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication(s) included lansoprazole taken for gastrooesophageal reflux disease from 18Oct2019 to an unspecified stop date; mebeverine taken for irritable bowel syndrome from 20Jun2019 to an unspecified stop date. The patient experienced blood in urine, kidney infection, inappropriate schedule of vaccine administered on an unspecified date and UTI on 16Aug2021. All events were reported as medically significant. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative, investigation: UTI, investigation: unknown. Therapeutic measures were taken as a result of kidney infection, UTI. This was the second time it happened. Her first vaccine she received on 16Jun2021 and within couple of days she had a really bad UTI. Didn''t think much of it, just called her doctors, got a course of antibiotics for 5 days and it cleared fine. Now within three days of her second vaccine she was riddled with pain in lower abdomen and back, experienced severe pain passing urine and went to a walk in clinic to get treatment, by that time she was also passing blood in urine. The doctor tested her sample and diagnosed her with bladder and kidney infection for which she received another 5days course of antibiotics. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of blood in urine, kidney infection, inappropriate schedule of vaccine administered was unknown. The outcome of UTI was recovering. No follow-up attempts are possible. No further information expected.


VAERS ID: 1657187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       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: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101064500

Write-up: Ringing in ears; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority . The regulatory authority report number is , Safety Report Unique Identifier GB-MHRA-ADR 25803626. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 15Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr)). Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 16Aug2021, the patient experienced ringing in ears. The event was assessed as medically significant. The clinical outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1657206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inflammation, Scar pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101064600

Write-up: shivers; Inflammation; Scar pain; This is a spontaneous report from a contactable consumer. received from the Regulatory Agency . The regulatory authority report number is GB-MHRA-WEBCOVID-202108161432074670-MWEBS. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25804416. A 27-years-old non-pregnant female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 15Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history included lactation decreased. The patient concomitant medications were not reported. The patient previously received BNT162B2 for COVID-19 immunization and BCG. The patient experienced shivers, inflammation on 16Aug2021, scar pain on 16Aug2021. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not pregnant. The patient was not currently breastfeeding. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not currently breastfeeding. The site of the recent injection is clear and not inflamed. The scar of tuberculosis vaccine is however bright red and extremely painful, touching it also causes shivers down leg on that side of body. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The events were eventually medically significant. The outcome of the events was not recovered for scar pain, Inflammation and unknown for shivers. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1657207 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Hypotension, Pain in jaw, SARS-CoV-2 test, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: Idiopathic angioedema
Allergies:
Diagnostic Lab Data: Test Name: hypotension; Result Unstructured Data: Test Result:103/64; Comments: 103/64; Test Date: 20210613; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101064625

Write-up: jaw pain; swelling of tongue; hypotension; Angioedema; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108161508057420-4QYBV. Safety Report Unique Identifier GB-MHRA-ADR 25804625. A 29-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Lot Number: FE3380), via an unspecified route of administration on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included idiopathic angioedema from 2016 to 2018. Patient had a history of idiopathic recurrent angioedema lasting roughly 2 years from 2016-2018. The patient states that the symptoms they experienced were very similar to their normal angioedema symptoms. Patient had no symptoms associated with COVID-19. The patients concomitant medications were not reported. The patient had experienced angioedema on 16Aug2021. On an unspecified date the patient had experienced jaw pain, swelling of tongue, hypotension. Patient described swelling of tongue that mildly obstructed airway but did not make the patient short of breath. Additionally, had bilateral jaw pain, worse in the left side. One observation showed mild hypotension at 103/64. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event angioedema seriousness was assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): positive on 13Jun2021 Yes - Positive COVID-19 test, Hypotension: 103/64 on an unspecified date 103/64. The outcome of the events was angioedema was not recovered and jaw pain, swelling of tongue, hypotension was unknown. Reaction Does your report relate to possible blood clots or low platelet counts. If yes, we will ask you additional questions at the end of this report: No No follow-up attempts are possible, No further information is expected


VAERS ID: 1657224 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Heart rate, Hypoaesthesia, Oxygen saturation, Pharyngeal hypoaesthesia, Swollen tongue, Thrombosis
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bell''s palsy; Lactose intolerance
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:Unknown Results; Test Name: blood test; Result Unstructured Data: Test Result:Unknown Results; Test Name: Pulse; Result Unstructured Data: Test Result:Unknown Results; Test Name: SPO2; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202101064770

Write-up: blood clots; Numbness facial; Swollen tongue; Numbness throat; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108161816496640-IM4HX Safety Report Unique Identifier GB-MHRA-ADR 25806332. A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FE3380), dose 2 via an unspecified route of administration, administered in Deltoid Left on 16Aug2021 as dose 2, single for covid-19 immunisation. Medical history included lactose intolerance, bell''s palsy from 2016 to an unknown date. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as dose 1, single for COVID-19 immunization. The patient experienced blood clots on an unspecified date. On 16Aug2021 16:40, the patient experienced numbness facial, swollen tongue, numbness throat. Seen and assessed as suitable for 2nd Pfizer vaccine today. Same given into Left deltoid. Stayed in the centre for 15 minutes and observed, no apparent problems up to the point of leaving the centre building. Set off to drive away back home and felt the symptoms come on, returned to the centre where he was seen and assessed by (With held) & himself. (With held) advised the need for attending A&E for further investigations or blood test. Contacted ambulance service to arrange transport via ambulance.Observations remained within normal limits, no problems with airway and remained fully alert and conversing with us.Ambulance not rated as a priority as patient alert and breathing without any difficulty.Symptoms started to resolve but not fully. Reassessed by (With held) conversation with A&E consultant . (With held) & patient made the decision to allow him(the patient) to travel to A&E by his own car now to be assessed etc.Patient left the centre at 18.50. Symptoms started at approx 16.40. The report did not relate to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results, blood test: unknown results, heart rate: unknown results, oxygen saturation: unknown results. The outcome of the event blood clots was reported as not recovered and outcome of all the other events was reported as recovering. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1657234 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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? 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 INC202101064553

Write-up: Faint; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108162052000850-ZC280. Safety Report Unique Identifier GB-MHRA-ADR 25806450. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 16Aug2021 as 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. The patient not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 16Aug2021, the patient experienced faint. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1657268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest X-ray, Chest pain, Electrocardiogram, Musculoskeletal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Result Unknown; Test Name: chest X-ray; Result Unstructured Data: Test Result:Result Unknown; Test Name: ECG; Result Unstructured Data: Test Result:Result Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101064578

Write-up: musculoskeletal pain; Chest pain; This is a spontaneous report from a contactable consumer, This report is received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108162224356180-LKRDH and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25806819. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Not known), via an unspecified route of administration on 14Aug2021, as dose 2, single for COVID-19 immunisation. The patient''s medical history included suppressed lactation (from an unknown date and unknown if ongoing). Patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as a dose 1, single for COVID-19 immunization. Concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date No - Negative COVID-19 test; blood pressure, chest X-ray, electrocardiogram were unknown results. On an unspecified date, the patient experienced musculoskeletal pain. On 16Aug2021, the patient had chest pain. It was reported that sudden onset of chest pain. Ambulance attendance and attendance in emergency department. Put down to musculoskeletal pain even though no muscle strain or injury to incur this. Seriousness for the events was reported as medically significant. The outcome of the event musculoskeletal pain was not resolved and the event chest pain was resolving. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1657273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101064494

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer or other non-health care professional. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108162302028420-B7BA4, Safety Report Unique Identifier GB-MHRA-ADR 25807116. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on 15Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Not had a covid-19 test. Patient was not enrolled in clinical trial. On 16Aug2021, the patient had experienced armpit pain. Patient has not tested positive for covid-19 since having the vaccine. The event was serious (medically significant). Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1657284 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Muscle twitching, SARS-CoV-2 test
SMQs:, Dyskinesia (broad), Dystonia (broad), 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 Date: 20210815; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101064596

Write-up: Muscle twitching; Chest pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108170625084380-5QAJB. (Safety Report Unique Identifier: GB-MHRA-ADR 25807989). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), dose 2 via an unspecified route of administration on 16Aug2021 as dose 2, single for COVID-19 immunization (at the age of 32-years). The patient medical history and patient''s concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route on an unknown date for covid-19 immunization. Patient did not have symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient experienced muscle twitching and chest pain on 16Aug2021. Events were reported as medically significant. The patient underwent lab test which included COVID-19 virus test negative on 15Aug2021 (no-negative COVID-19 test). The outcome of muscle twitching was recovered on 16Aug2021, while another event was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1657285 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101064656

Write-up: Nausea gravidarum; Fever chills; Aches & pains in legs; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108170707216970-AA31W, Safety Report Unique Identifier GB-MHRA-ADR 25808145. A 38-year-old non-pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 2, single (at the age of 38-years-old) for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Concomitant medications was not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 16Aug2021, the patient experienced headache; and on 17Aug2021, 1 day after vaccination, the patient experienced nausea gravidarum, fever chills, aches and pains in legs. The reporter assessed the events as serious- medically significant. The outcome events were not resolved at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1657309 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Blood pressure measurement, Breast pain, Contusion, Fatigue, Feeling hot, Heart rate, Hypoaesthesia, Lymphadenopathy, Mammogram, Mastitis, Myalgia, Nasopharyngitis, Pain, Pain in extremity, Pyrexia, Rash erythematous, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Functional lactation disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown Results; Test Name: pulse; Result Unstructured Data: Test Result:Unknown Results; Test Name: mammogram; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101081381

Write-up: bacterial infection; red rash; Mastitis; painful left breast; Very swollen lymph nodes; Breast hot to touch; Sore breast; swelling; feeling progressively; numbness of arm; aching of arm; Axillary lymph nodes enlarged; Arms/Lats feeling bruised; fever; hot; cold; pain; fatigue; Lymph nodes enlarged; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108191216526740-KJM7W Safety Report Unique Identifier GB-MHRA-ADR 25822964. A 31-year-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FE3380, Expiry date was not reported) (at the age of 31-year-old), via an unspecified route of administration, administered in Arm Left on 16Aug2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, suspected covid-19 from an unknown date and unknown if ongoing (Unsure when symptoms started Unsure when symptoms stopped), clinical trial participant from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient is not currently breastfeeding. The patient is not pregnant at the time of vaccination. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration as dose 1, single for COVID-19 immunization. The patient experienced fever/ hot & cold, pain, hot, cold, fatigue, lymph nodes enlarged on 16Aug2021; numbness of arm, aching of arm, axillary lymph nodes enlarged, arms/lats feeling bruised on 17Aug2021; painful left breast, swelling, feeling progressively, mastitis, very swollen lymph nodes, breast hot to touch, sore breast on 18Aug2021; bacterial infection, red rash on 19Aug2021. The patient underwent lab tests and procedures which includes blood pressure measurement was unknown results on an unspecified date, heart rate was unknown results on an unspecified date, Mammogram was unknown results on an unspecified date, sars-cov-2 test was negative (No - Negative COVID-19 test) on an unspecified date. The clinical course was reported as follows 16Aug21 experienced pain/swelling of left arm & muscles surrounding shoulders (latissimus dorsi) following 2nd Pfizer vaccination. Fever (hot & cold) and fatigue. Took x2 paracetamol and drank lots of water.17Aug21 on-going pain, aching of arm, numbness of arm and fingers. Arms/Lats feeling bruised. On-going fever. Took x2 paracetamol AM & PM, drank water. 18Aug21 woke up AM with swelling & painful left breast. Very swollen and enlarged lymph nodes armpit. Red & inflamed ''wiggly'' line tracking from nipple to underarm. Breast hot to touch and sore. On-going fever and feeling progressively worse. Phoned GP but could not get appointment same day. Looked online at NHS (ph no) advice. Took x2 paracetamol, drank water & put a cold/hot compress to decrease swelling. 19Aug21 breast still inflamed, hot to touch and painful. Red rash still visible and not decreased. Phoned GP again & offered emergency app. GP confirmed bacterial infection (Mastitis) and very swollen lymph nodes (left armpit). Not breastfeeding or pregnant. Prescribed antibiotics - 14 days Flucloxacillin (x4 per day). Explained to GP about recent vaccination, GP thinks possible immune response to vaccine but cannot rule-out if linked or not. Advised to contact GP after 7 days if rash/swelling has not decreased as may require referral for mammogram & further testing/examinations. Patient has not tested positive for COVID-19 since having the vaccine. The events outcome red rash, fever/ hot & cold, swelling, hot, Cold, feeling progressively, numbness of arm, aching of arm, bacterial infection, pain, fatigue, lymph nodes enlarged, mastitis, axillary lymph nodes enlarged, arms/lats feeling bruised, painful left breast, very swollen lymph nodes, breast hot to touch, sore breast with the outcome was not recovered. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1657330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Headache, Illness, Myalgia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Ache
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101081423

Write-up: Blurred vision; Aching joints; Diarrhoea; Sickness; Headache; Tenderness muscle; This is a spontaneous report from a contactable consumer. This is a report received from theRegulatory authority report number GB-MHRA-WEBCOVID-202108200101495460-JOUDQ, Safety Report Unique Identifier GB-MHRA-ADR 25826661. A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 15Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing and ongoing ache. Concomitant medication included paracetamol taken for ache. Patient did not have symptoms associated with COVID-19 and did not have a COVID-19 test. Patient was not pregnant at the time of vaccination and was not currently breastfeeding. Historical vaccine included previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On 16Aug2021, 1 day after receiving bnt162b2 second dose, the patient experienced blurred vision, aching joints, diarrhoea, sickness, headache, tenderness muscle. Patient was not enrolled in clinical trial. The events were assessed as serious as medically significant. The outcome of events blurred vision, aching joints, diarrhoea, sickness, headache, tenderness muscle was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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