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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 260 out of 5,069

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VAERS ID: 1446107 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-13
Onset:2021-06-02
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphonia, Paraesthesia, Paraesthesia oral, Slow speech
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)

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

Write-up: Tingling feeling in fingers and lip on one side and minimally in one leg, slowed speech, using words that didn''t fit (ie said "brushtooth" instead of "toothbrush"), voice sounded different to himself. No treatment. Happened late in the evening so he went to sleep under supervision and woke up completely back to normal. He remembers everything about the event. These symptoms repeated 22 days after the second dose. He is scheduled with a neurologist for Aug 9. 2021 for follow up.


VAERS ID: 1446236 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-18
Onset:2021-06-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Migraine, Oligomenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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: Rizitriptan
Current Illness: None
Preexisting Conditions: Migraines
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: After the first vaccination shot (late April 2021), my menstrual cycle was fourteen days early. After the second vaccination shot, my menstrual cycle was later than usual, arriving at about Day 31 of my cycle. My cycle is typically 26 days long. The menstruation after my second shot was exceedingly heavy and painful - I had terrible cramps, worse than normal fatigue, and very heavy bleeding. The menstruation lasted longer than normal for me (about eight days), and it was followed by a few days of spotting, which is also unusual for me. In addition to these changes in my cycle, I experienced worse than normal migraines throughout the month of June, both during menstruation and during ovulation. I typically get migraines about once or twice a month, and I was getting migraines about 3-4 times a week throughout June.


VAERS ID: 1446367 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Appointment for an MRI on July 12
CDC Split Type:

Write-up: 05/28 Second dose of vaccine 06/01 Knee cramps and pain. 06/02 Acupuncture was performed, and the pain was no longer felt after acupuncture. But two hours later the knee continued to ache. He will recover in about two weeks. 06/16 I started to have a headache in the morning, and then my dizziness continued until now. The headaches had previously only occurred on the day of the second dose and the next day. Chiropractic, acupuncture, and massage have not worked. I''m waiting for an MRI.


VAERS ID: 1446395 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Parosmia, Taste disorder
SMQs:, Taste and smell disorders (narrow)

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

Write-up: I can not taste or smell the same. Toothpaste, rice, onions, coffee and many other things do not smell and taste quite right.


VAERS ID: 1446762 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-02
Onset:2021-06-02
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW019 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi vitamin, calcium, vitamin C
Current Illness: none
Preexisting Conditions: seasonal allergies
Allergies: some antibiotics-penicillin, sulfa, a few others.
Diagnostic Lab Data:
CDC Split Type:

Write-up: tingling, pins and needles, itching all over body intermittently for 4 weeks. took Benadryl as recommended by doctor. Symptoms were very intense for 2 weeks, slowly got less frequent. It seemed to be completely gone about a week ago but then came back strongly for 2 days. Now about 80% better.


VAERS ID: 1446822 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Occasional mild tingling in fingers. Never before experienced. Lasting symptom still continues.


VAERS ID: 1447053 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Hematoma


VAERS ID: 1447130 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Hypersomnia, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), 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: Centrum Silver, Vitamin D3 5000 units daily, Acidophilus Probiotic
Current Illness: None
Preexisting Conditions: None
Allergies: Ibuprofen, Bactrim, Cipro, Penicillin, Toradol, Acetaminophen, Zofran
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Malaise at 21.5 hours after vaccination. Fever, shaking chills, nausea and vomiting, fatigue started 25 hours after vaccination. Slept for 24 hours.


VAERS ID: 1449490 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-11
Onset:2021-06-02
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: heart rate; Result Unstructured Data: Test Result:low
CDC Split Type: USPFIZER INC2021739951

Write-up: Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; This is a spontaneous report from a contactable nurse (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206) via an unspecified route of administration, in the left arm on 11May2021 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included IBS (irritable bowel syndrome). Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies were not reported. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, in the left arm on 16Apr2021 as dose 1, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any vaccines within four weeks prior to the vaccination. On 02Jun2021, the patient experienced shingles requiring medical emergency. Fainting and low heart rate. Patient received treatment for event were medications. Adverse events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1449506 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstruation irregular, Muscle spasms, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBUTEROL [SALBUTAMOL]; TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021748857

Write-up: Bleeding excessively; It was 4 days early and was the worse period she has experienced in 3 years; Extreme cramps; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female (non-pregnant) patient received 1st dose of BNT162B2 (lot#EW0196) on 30May2021 11:00 AM, vaccine location=Left arm at single dose for COVID-19 immunization. Relevant medical history was Asthma. No any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination included salbutamol (ALBUTEROL), paracetamol (TYLENOL) as needed. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps on 02Jun2021. We thought maybe it was a coincidence. She is only 15 yrs old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun2021 and I pray it was not as bad as last month after the shot. Outcome of reaction/event at the time of last observation was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts needed. No further information is expected.


VAERS ID: 1449729 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Upper respiratory tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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

Write-up: pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown. Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. 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: 1450022 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Exposure during pregnancy, Live birth, Pain in extremity, Tenderness, Thrombosis, Ultrasound scan abnormal
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins
Current Illness: N/A
Preexisting Conditions:
Allergies: Penicillin, Cephalosporins, Sulfamethoxazole - TMP, Latex
Diagnostic Lab Data: I was sent for an ultrasound also on June 3rd where they determined I had a superficial blood clot.
CDC Split Type:

Write-up: I contacted my primary care office after experiencing a tender knot on my calf for a couple of days that also became reddened on the skin surface. It was determined by ultrasound that I had a small, superficial blood clot in my lower right calf on June 3rd. We treated the blood clot at home with a compression stocking, elevation and heat, and I had a follow-up ultrasound on June 10th that indicated no change in clot location or size. I continued with home treatment and did not have any further complications. The pain and redness have resolved since that time. Prior to this pregnancy I have had two healthy pregnancies and one miscarriage at 8 weeks between those two. I delivered my third child on June 14, 2021 via C-section without complications. Baby weight was 6 lbs 15.5 oz.


VAERS ID: 1450213 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Injection site discolouration
SMQs:

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

Write-up: Upon visiting with the patient for the 2nd dose of Moderna about 4 weeks later, the patient''s arm around where they received their 1st dose of Moderna was still discolored. The patient did not seem to be too concerned as they were present to receive 2nd dose of Moderna. The 2nd dose was given in the opposite arm.


VAERS ID: 1450221 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / UNK LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (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: Upon visiting with the patient for the 2nd dose of Moderna about 4 weeks later, the patient''s skin on the arm around where they received their 1st dose of Moderna was still discolored. The patient did not seem to be too concerned as they were present to receive 2nd dose of Moderna. The 2nd dose was given in the opposite arm.


VAERS ID: 1450700 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-30
Onset:2021-06-02
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Angioplasty, Antiplatelet therapy, Blood test, Chest X-ray, Computerised tomogram, Coronary arterial stent insertion, Coronary artery occlusion, Echocardiogram, Electrocardiogram, Metabolic function test, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yes, I was taking Levothyrox, Lisinopril, and Rosuvastatin.
Current Illness: No
Preexisting Conditions: I only have high blood pressure, high cholesterol, and low Thyroid.
Allergies: I am allergic to Darvon.
Diagnostic Lab Data: I had the following: Blood test, EKG, CT Scan, Chest X-ray, Echo-Cardiogram, and a comprehensive test.
CDC Split Type: vsafe

Write-up: My wife drove me to the hospital because I had a heart attack after receiving the 2nd dosage (suffered mild cardio inflection) which meant that there was a blockage in the left circumplex artery and I had to have an angioplasty (surgical stint). I was placed on Plavix for one year along with baby aspirin indefinitely. I spent one night in the hospital as a result of the adverse event and will be starting Cardiac rehab on June 12, 2021.


VAERS ID: 1452598 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-01
Onset:2021-06-02
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye pruritus, Eye swelling, Feeling hot, Pain in extremity, Pruritus, Sleep disorder, Somnolence, Ultrasound scan, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: May 10th 1st shot - sleepy & a little itchiness on my skin May 31st 2nd shot- sleepy June 2nd - itchiness at 1:45am in the morning which woke me up. I went to the bathroom and my entire body was broken out in hives. I immediately drove to the ER and was given benadryl, prednisone, and famotidine. 30 mins afterwards the allergic reaction went away. June 30th - woke up to itchy eyes and went to the mirror both eyes swollen like a plum. Went to the clinic and was given the same medications. July 4- right leg pain and warm to touch July 6th - went back to ER to have my right leg checked, no blood clots. Dr gave me muscle relaxers July 7th- itchy all over and hives all on my body


VAERS ID: 1453766 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphonia, Cough, Dyspnoea, Fatigue, Lacrimation increased, Migraine, Nasal congestion, Pain, Rhinorrhoea, Vaccination site swelling, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Lacrimal disorders (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: VOLTAREN [DICLOFENAC]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (other medical history: Arthritis, Depression, Anxiety, PTSD); Arthritis (other medical history: Arthritis, Depression, Anxiety, PTSD); COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Depression (other medical history: Arthritis, Depression, Anxiety, PTSD); Post-traumatic stress disorder (other medical history: Arthritis, Depression, Anxiety, PTSD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021758789

Write-up: Constant migraines ?4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional. A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.


VAERS ID: 1454439 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Contusion, Electrocardiogram normal, Panic attack, Paralysis, Tachycardia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Dehydration (broad)

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

Write-up: Event 1: Severe Tachycardia (hr 133), elevated BP (130 over 110) with temporary paralysis. Drove to Hospital ER where BP was measured, and EKG performed. EKG was normal and I was sat in the waiting room with a "panic attack". I left the ER 2 hours later as there was no hope of a Dr seeing me within 12. Event 2: Noted today, 7/7/2021, spontaneous bruising on the right big toe. I also have a series of unexplained bruises down my left leg.


VAERS ID: 1454520 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028A21A / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear pain, Oropharyngeal pain, Upper respiratory tract infection
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Glimepiride 2mg Januvia 100mg Levemir 100 unit daily Metformin 500mg Rosuvastatin 10mg Vitamin C 1000mg
Current Illness: none
Preexisting Conditions: diabetic
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Had upper respiratory infection with sore throat and ear ache. Took over the counter cough syrup and doctor prescribed azithromycin.


VAERS ID: 1454766 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Pruritus, Pyrexia, Rash, Thermal burn, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Small fever following a flu vaccine in 2017, only lasted a day or two
Other Medications: 25 mg metoprolol tartrate 2x a day 2 fish oil pills a day
Current Illness: Developed a fever (due to vaccine) the day after second dosage but nothing else
Preexisting Conditions: Rapid heart rate due to unknown reason (have seen 3 cardiologists, have had 2 echocardiograms - normal healthy heart and electric pulses)
Allergies: None
Diagnostic Lab Data: On June 19th, I saw the doctor listed above for my urticaria. She did not have an answer obviously, but thought we should try a dosage of Prednisone, as well as taking Benadryl at night still. The next day (June 20) I began taking the dosage of Prednisone, and within an hour, I saw almost no flare up of the urticaria. For the next 4-5 days, there was nothing as I was taking a high dosage. Finally, as I was down to my last two days where I was only taking 1 pill a day (June 30th and July 1st) I saw a few small flareups of hives creeping back on my body, mostly on my hands and forearms. On July 5th, I had the biggest flare up since stopping my dosage of Prednisone. It was all over my neck, back, torso, upper arm, and leg. The next day (July 6th) I went back to the same doctor and we thought the best bet was to try the same dosage of Prednisone one more time. Today is my second day taking it and I''ve had no flareups so far. I''m just concerned what will happen once I finish my dosage once again.
CDC Split Type:

Write-up: The morning after vaccination, I came down with a fever of 100-101 F. This fever stayed with me for approx. the next 3 days. On June 2nd, while I was still somewhat having my fever, I began to break out in hives/welts all over my body. They would appear on a few areas of my body at a time, and then would go away and appear elsewhere. I presumed this was just a temporary auto-immune response, however, for the next 2-3 weeks, they would persist, all day, at varying points of the day. They itched and burned. Some were just red patches on my skin, while some had little bumps as well, and some even appeared as long thick white welts. I could scratch myself first as well, and then it would immediately appear. However, usually I did not even touch myself and they would appear. I began taking Benadryl at night to help me sleep, and although it gave a little relief, the results were always very temporary and the next morning they would be back.


VAERS ID: 1454879 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Ear discomfort, Ear infection, Hypoacusis, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test negative, Sinusitis, Tinnitus
SMQs:, Hearing impairment (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: Fever/body aches for period of 36 hours following Shingrix vaccines for prevention of shingles. Patient was 58 for first dose (
Other Medications: levothyroxine
Current Illness:
Preexisting Conditions: hypothyroidism
Allergies:
Diagnostic Lab Data: COVID test performed to rule out COVID, test result was negative
CDC Split Type:

Write-up: inner ear (left) and sinus infection requiring 10-day course of antibiotics to clear infection. Symptoms included diminished ability to hear clearly and feeling of "fullness" in ear; increased ringing in ear, runny/stuffy nose. After course of antibiotics, all symptoms cleared up.


VAERS ID: 1458776 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Generalized osteoarthritis; High cholesterol; Hypertension; Non-smoker; Osteopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract extraction; Gallbladder operation; Comments: The patient had no known allergies and no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210709043

Write-up: ON AND OFF TINNITUS; This spontaneous report received from a patient concerned a 79 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included gall bladder surgery, and cataract extraction, and concurrent conditions included hypertension, general osteoarthritis, high cholesterol, osteopenia, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced on and off tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off tinnitus. This report was non-serious.


VAERS ID: 1459931 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-05
Onset:2021-06-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 1 RA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Herpes zoster, Magnetic resonance imaging, Oropharyngeal pain, Rash, Rash pruritic, Streptococcal infection, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Buproprion; Atenolol; Hydroclorothiazide; Celecoxib; L-Thyroxine; Fenofibrate; Lovostatin; Xyzal; Restasis; Estradiol Vaginal Inserts; Clotrimazole and bethamethasone dipriopionate
Current Illness: n/a
Preexisting Conditions: obesity; high blood pressure; high cholesterol;
Allergies: ibuprofren;
Diagnostic Lab Data: strep test (6/7/2021) MRI (at ER on 6/10/2021)
CDC Split Type:

Write-up: (may be unrelated) Began having headaches on June 2, 2021, could feel but not see bumps on left back side of head...headache continued sore throat beginning 6/5/2021; diagnosed with strep on 6/7/2021; headache (radiating downward from bumps on head and upward from neck lymph nodes. Became severe, went to ER at 3:30 am on 6/10/2021; diagnosed with shingles at doctors office on 6/10/2021. Head continued until about June 15. Bumps still itchy today (July 9)


VAERS ID: 1460024 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014C21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Contacted parent today, no adverse reaction has been experienced.


VAERS ID: 1460348 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018B21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: Vaccination Error/Vaccine Misadministered Patient was registered for Pfizer vaccination on MyTurn however in the clinic was given Moderna. Vaccine was administered by an MA here in the clinic. No symptoms during the time of the administration, during the wait period for 15 minutes and currently. I verified by calling mother of patient today 7/9/21 whom denies any symptoms or concerns currently.


VAERS ID: 1461732 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Arthritis, Blood test, Cold sweat, Gait disturbance, Gait inability, Headache, Hypoaesthesia, Myalgia, Pain, Paraesthesia, Posture abnormal, Pyrexia, Sleep disorder, Surgery, Vitamin D decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, advil ,cortisone 10 volteren cream,benadryl amlodipine besalate, crestor hydrochloraxide, zoloft,hydromorphone carbamazepine
Current Illness: Sinus infection
Preexisting Conditions: No
Allergies: Percocet Lossrtan Zoloft
Diagnostic Lab Data: Full blood panel. All normal.
CDC Split Type:

Write-up: Git 1 injection June 1. No side effects at all. June 29, got 2nd injection and everything went to hell! I''ve never had so much pain in my life, and I e had 3 major surgeries! Woke up July 1,the next morning with low grade fever,cold sweats, aching hamstrings, aching guads,all joints feel inflamed, headache,stomach, Feet and hand were tingling very very bad! Could not sleep because pain excruciating! By Thursday morning, I could not walk. Walking caused more pain. I was able to walt in pain by Saturday afternoon. Sunday morning I wet to the Dr. He put me on prednisone. Did not help. Pain was so intense could barely walk. Went to dr on Wednesday. Prescribed higher doses of prednisone and gabapentin. Still have numbness in feet and hands. All joints are still inflamed. Just now being able to walk, but I have to walk in an awkward position. Dr did a full blood panel test. Everything came back normal except for low vitamin d.how long will this last??????.?


VAERS ID: 1461911 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Asthenia, Blood cholesterol increased, Blood creatine, Blood potassium, Fatigue, Full blood count, Haemoglobin, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prescriptions: buspirone, bupropion, fluticasone OTC: cetirizine hydrochloride Dietary supplements: one a day vitamin, 4000 IU vitamin D, 400 mg chelated magnesium, 1400 mg fish oil, 1000 mg berberine, 316 mg turmeric, 500 mg maca, 200 mc
Current Illness: None.
Preexisting Conditions: Depression, allergies, high cholesterol
Allergies: None known.
Diagnostic Lab Data: All tests performed came back with within normal range, except for total cholesterol, which was high. Tests performed included complete blood count, non-fasting lipid panel, hemoglobin A1c, thyroid stimulating hormone, potassium, creatinine and calculated glomerrular filtration rate, erythrocyte sedimentation rate, and alanine aminotransferase.
CDC Split Type:

Write-up: Approximately 10 hours after injection, a sore throat and fever occurred. The sore throat persists 5 weeks later, although lessened in severity. Fatigue occurred around day 11 after the vaccine. Debilitating fatigue and weakness occurred around day 22 and persisted for 4 days, lessening to general fatigue and weakness thereafter and persisting as of date of report. Sore throat, fatigue, and weakness persist with no end date as of this report.


VAERS ID: 1462060 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site induration, Injection site nodule, Pyrexia, Rash erythematous, Rash pruritic, Scab
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Keppra, Vimpat, clonazepam, topamax, Vitamin B 100 complex, stool softner, aspirin, clarion, magnesium
Current Illness: None
Preexisting Conditions: Osteoarthritis, brain tumor, migraine, seizures, aneurysm, stroke, Tias
Allergies: Red dye, fire ants, reglan, Lamictal, depakote
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever around 101 for 3 days, hard/swollen knot at injection site, rash that broke out on right side of neck going down straight line to into my breast that was red/ itchy and eventually scabbed over and still have scars in placed


VAERS ID: 1463733 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

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

Write-up: Caused rectal bleeding no pain for averaged 4 hours a day


VAERS ID: 1464109 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-02-26
Onset:2021-06-02
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Biopsy skin, Dermatitis, Lichenoid keratosis, Pathology test, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxin 125 mg , Asacol 800 mg, Ursodiol 250mg 2/day .,
Current Illness: None
Preexisting Conditions: Osteoporosis
Allergies: Allergy to latex
Diagnostic Lab Data: Pathology report , skin biopsy
CDC Split Type:

Write-up: Rash , Lichenoid or interface dermatitis .


VAERS ID: 1464734 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0P11 / 1 LA / IM

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

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

Write-up: Spreading rash that started in left groin. it spread rapidly down leg, up the side of the abdomen and into the armpit. Rash was very itch and very red/irritated. It also started to looking like it was bruising as it healed. Rash was unaffected by Benadryl or antibiotics. Was prescribed steroids and it cleared up after about 2.5 weeks.


VAERS ID: 1464789 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: This patient received his first Covid dose on 04/28/2021 Moderna Lot #047B21A. He received his second dose on 6/2/2021 which was Pfizer Lot #EW0179. The CDC was contacted and they told him to return in 6 weeks and to receive another dose of either Moderna or Pfizer to complete his series. There was no apparent adverse outcome.


VAERS ID: 1465132 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Neck pain, Pain, Vaccination site pain
SMQs:, Arthritis (broad)

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

Write-up: Patient is complaint about a sharp pain in the vaccinated arm. She claims she feel shocks from the vaccine site to all the way to the patient''s neck. Patient is planning to see a doctor.


VAERS ID: 1465999 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Epistaxis, Fatigue, Headache, Intensive care, Laboratory test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: venlafaxine 1.875 mg daily Advil 400 mg as needed Marajuana user
Current Illness: Depression Anxiety
Preexisting Conditions: Bulging Disks in neck Nerve damage Depression Anxiety
Allergies:
Diagnostic Lab Data: 6/2/2021. In ICU for 12 days. Many Test done
CDC Split Type:

Write-up: Tired headache bloody nose Brain Bleed Stroke 6/2/2021


VAERS ID: 1466696 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-03-29
Onset:2021-06-02
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratidine 10mg, Omeprazole 20mg, Emergen C
Current Illness:
Preexisting Conditions:
Allergies: Shellfish, Amoxicillin, Penicillin, Phenergan
Diagnostic Lab Data: Labs 6/6/21, MRI''s 7/10/21
CDC Split Type:

Write-up: Muscle weakness in Legs, numbness and tingling. Dizziness, difficulty walking. Numbness and tingling in arms. Neurology referral, MRI''s. Still being evaluated.


VAERS ID: 1467015 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-05-13
Onset:2021-06-02
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Band neutrophil percentage, Blood creatine phosphokinase MM normal, Blood creatine phosphokinase normal, Blood pressure increased, Borrelia test, Borrelia test negative, Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray normal, Chest pain, Chlamydia test negative, Coronavirus test negative, Cytomegalovirus test negative, Decreased appetite, Diarrhoea, Echocardiogram normal, Electrocardiogram ST segment abnormal, Enterovirus test negative, Epstein-Barr virus antibody negative, Feeling hot, Fibrin D dimer increased, Heart sounds abnormal, Human metapneumovirus test, Human rhinovirus test, Hypophagia, Influenza A virus test negative, Influenza B virus test, Lymphocyte percentage, MERS-CoV test negative, Monocyte percentage increased, Mycoplasma test negative, N-terminal prohormone brain natriuretic peptide increased, Neutrophil percentage, Pyrexia, Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative, Respiratory viral panel, Respirovirus test, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Tachycardia, Troponin I increased, Troponin increased, White blood cell count normal
SMQs:, Cardiac failure (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Rhinorrhea and nasal congestions (seasonal allergies) treated with Cetirizine 10 mg by mouth once a day. Not taking at the time of vaccination.
Preexisting Conditions: Autism Spectrum Disorder, obesity, anaphylaxis (peanuts, tree nuts, shellfish), and seasonal allergies
Allergies: Anaphylaxis to peanuts, tree nuts, and shellfish. No known drug allergies.
Diagnostic Lab Data: Initial labs in the local ER showed a Troponin I High Sensitivity of 2,508.1 ng/L, B Type Natriuretic Peptide of 196.0 pm/mL, CRP of 7.2 mg/dL, and D-Dimer of 660 ng/mL. WBCs were normal (8.08 k/mcL) with 50% segs, 10% bands, 26% lymphs, and 12% monos. Chest X-ray was read as normal, and an EKG showed nonspecific ST wave abnormalities. Labs at the hospital showed elevated Troponin I (repeated every 6 hours) of 3.13, 1.43, 0.94, and 0.68 ng/mL (discharged after the 0.68 ng/mL). Repeat N-Terminal BNP was 557 pg/mL, CK was 150 U/L, with 100% CK-MM fraction. ESR was 33 mm/hr, and repeat CRP was 5.99 mg/dL. NP PCR for SARS-CoV-2 through the county on June 3, 2021 was negative, and a respiratory panel (influenza A H1/H1-2009, H3, B, parainfluenza virus 1/2/3/4, multiplex coronavirus nCoV/MERS/SARS, RSV A & B, chlamydia pneumonia, mycoplasma pneumonia, human meapneumovirus & human rhinovirus/enterovirus PCR all negative. SARS-CoV-2 NP PCR negative x 2 (repeated after 24 hours in the hospital). CMV (IgM & PCR) negative; EBV (VCA IgM/IgG & EGNA IgG, & PCR of blood) negative; Lyme Antibodies (IgM/IgG) negative; Parechovirus and Enterovirus PCR of blood/plasma negative; SARS-CoV-2 IgM positive and IgG negative; SARS-CoV-2 IgG was positive. Told me that they ordered SARS-CoV-2 nucleocapsid and spike protein antibodies, but this was not done. EKGs were normal, and ECHO normal.
CDC Split Type:

Write-up: On June 2, 2021, he awoke and complained of feeling hot, tired, and not hungry. His mother had been sick with acute gastroenteritis symptoms 2 days earlier. Over the course of the day, he had a fever to 101.6 F, and began to have loose stools (twice). He received Ibuprofen 400 mg by mouth every 6 hours for the fever, and drank plenty of fluids. On June 3, 2021, he continued to have fevers to 101.5 F, loose stools (twice again), and poor oral intake of food. I canceled his scheduled 2nd Pfizer-BioNTech vaccine, and got him a NP swab test for SARS-CoV-2 through the health department. On June 4, 2021, he had no fever but now complained of a rubbing left parasternal chest pain. On physical examination, his BP was elevated (130s/90s), he had a slight tachycardia (90s), and was afebrile. On auscultation, I heard a S4 gallop and took him immediately to the local ER.


VAERS ID: 1467115 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-21
Onset:2021-06-02
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood cholesterol increased, Heavy menstrual bleeding, Hyperlipidaemia, Hypertension, Menstrual disorder
SMQs:, Dyslipidaemia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Lipodystrophy (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: hypertension, hyperlipidemia, high cholesterol, mennhorrhagia, abnormal menstrual cycles


VAERS ID: 1467302 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-05-12
Onset:2021-06-02
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril, Gemfibrozil
Current Illness: None
Preexisting Conditions: HTN, HLD
Allergies: None
Diagnostic Lab Data: MRI lumbar spine showing intrathecal enhancement surrounding the cord and extending to the L5-S1 level CSF protein 828
CDC Split Type:

Write-up: The patient developed paresthesias and weakness in the legs approximately 2 weeks after the vaccine. After the thorough work-up he was diagnosed with Guillain-Barr? syndrome. He was treated with IVIG and has had some improvement.


VAERS ID: 1470254 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-22
Onset:2021-06-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

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

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

Write-up: Pt c/o feeling tired/fatigue, usually feeling exhausted during evening time on/off since she got her 2nd dose covid vaccine Pfizer on 05/22/2021. Also stated she got low grade fever this morning but did not check temperature. She stated she is checking her O2 sat and PR regularly at home,O2 sat remains $g95% and HR between 70s-90s. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. urgent care provider visit scheduled for consultation.


VAERS ID: 1470261 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Pain, Respiratory tract congestion
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

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

Write-up: Pt c/o severe body aches, congested, diarrhea 3-4 times since morning, headache. Reports dizziness and weakness in emergency screening. Pt was advised to call 911 or go to nearest ED for further treatment and evaluation,


VAERS ID: 1470321 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-04
Onset:2021-06-02
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Caffeine consumption, Dizziness, Electrocardiogram normal, Feeling abnormal, Headache, Hypertension, Migraine, Palpitations, Panic attack, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (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: Albuterol, Symbicort, Testosterone, Bupropion
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Aspirin
Diagnostic Lab Data: EKG at urgent care facility resulted in no abnormalities at the time (Heart issues are random and not happening at that time).
CDC Split Type:

Write-up: 1. Extreme panic attacks currently persisting 24/7 after second Moderna Covid shot. Xanax helps some but extremeness returns when it wears off. 2. Extreme migraine headaches started two weeks after first Moderna Covid shot. Tapered down to low/moderate headache until second shot a month later when extremeness returned. Has tapered down to chronic (24/7) mild headache. 3. Moderate vertigo/dizziness persisting 24/7. Body feels like it''s moving on it''s own. 4. Random heart palpitations, random high blood pressure. Typically have low blood pressure due to genetics (so low at times I pass out, Cardiogenic Syncope). 5. Caffeine intake exasperates all the above in extreme manner.


VAERS ID: 1470814 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-08
Onset:2021-06-02
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Computerised tomogram head, Confusional state, Dizziness, Echocardiogram, Electroencephalogram, Magnetic resonance imaging head, Nausea, Repetitive speech, Transient global amnesia, Transient ischaemic attack, Ultrasound Doppler, Urine analysis
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), 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), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: lupus flare with blistering on rib cage, 64 yrs old December 28th, 2020, shingrex !st dose
Other Medications: synthroid 0.2mg dly bupropion SR 450mg dly prempro 4.25/1.5mg dly iron 27mg dly vit D3 25mg x3 dly calcium citrate w D3 630mg x2 dly multi vit dly cevimeline 30mg dly srarted March2021 Started April 2021 Breo 200mg inhaler dly and combivent
Current Illness: none
Preexisting Conditions: sjorgrens since 2017 lupus since 2011 asthma-newly dx in April 2021
Allergies: plaquinel-decreased WBC''s and retinal scaring phenylephrine-extreme facial swelling contrast dye-hives arms,face and torso shingrex vac-lupus flare with 1/2 dollar size blistering to rib cage.
Diagnostic Lab Data: CT, MRI of the head Carotid dopplers Heart echo EEG Blood work, UA
CDC Split Type:

Write-up: June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.


VAERS ID: 1471653 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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: NO INFO AVAILABLE
Current Illness: NO KNOWN
Preexisting Conditions: NO KNOWN
Allergies: NO KNOWN DRUG AND FOOD ALLERGY
Diagnostic Lab Data: NONE AVAILABLE
CDC Split Type:

Write-up: PATIENT NOTIFIED PHARMACY OF SORE ARM EVEN AFTER A MONTH OF VACCINATION. PATIENT STATED PAIN IN GETTING BETTER BUT NOT COMPLETELY GONE. NO REDNESS OR RASH IN THE INJECTION SITE.


VAERS ID: 1475424 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Fatigue, Gait disturbance, Influenza like illness, Mobility decreased, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient began having flu-like symptoms the following day after the vaccine. Felt achy, fatigue and not wanting to get out of bed even on vacation. That lasted for 2 weeks and still not great even now. The patient''s spouse reported trouble walking, stumbling, falling and gait. The patient developed a cough a few weeks ago and is currently being treated with antibiotics called in from the physician. The patient has not see a physician for diagnosis. I encouraged the patient to be evaluated as soon as possible


VAERS ID: 1475426 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-27
Onset:2021-06-02
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

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

Write-up: I got Bell?s Palsy, 2 weeks after I received the shot.


VAERS ID: 1477782 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-23
Onset:2021-06-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin, Dermatitis bullous
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Skin biopsy (6/14/2021): H&E consistent with linear IgA or neutrophilic dermatosis but DIF negative
CDC Split Type:

Write-up: Bullous skin disease (clinically consistent with Linear IgA, however DIF negative), began 10 days after vaccination (no new medications or recent illness otherwise). Stabilized with prednisone but has not resolved as of 7/16/2021


VAERS ID: 1478279 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dehydration, Headache
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

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

Write-up: Dehydrated, headaches.


VAERS ID: 1478641 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-23
Onset:2021-06-02
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram, Discomfort, Echocardiogram, Electric shock sensation, Electrocardiogram, Oropharyngeal pain, Pericarditis, Vibratory sense increased
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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: Levothyroxin Nexium Vitamin D supplement
Current Illness: Wegener''s granulomatosis Hypothyroidism
Preexisting Conditions: Wegener''s Granulomatosis
Allergies: None
Diagnostic Lab Data: EKG Echocardiogram CT Scan Chest Xray blood tests (Tests performed at Medical Center Hospital on 6/2)
CDC Split Type:

Write-up: Approximately 1 week after the injection, noticed heaviness in chest and sore throat only. New type of discomfort that I''d never felt before. These symptoms improved in about a week, only to return after an extremely painful visit to the ER for stabbing chest pain on 6/2. I had felt the sore throat and heaviness in my chest 1 week after the vaccine, but though nothing of it until after the ER visit. When they gave me anti-inflamatory medicine, the pain subsided, to reveal the exact same chest heaviness sensation and further bouts of peri-carditis, chronic chest pain since 6/2. Random incidents of entire body vibrating, and electrical jolts in the left side of my chest with no known cause, as these sensations are occuring at rest.


VAERS ID: 1479430 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-05-11
Onset:2021-06-02
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (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: Escitalopram, multi-vitamin, vitamin d
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Joint pain in hips and knees. Seeing chiropractor for event. With no relief, I am seeing my primary on July 19.


VAERS ID: 1480381 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-04-20
Onset:2021-06-02
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Cerebrovascular accident, Headache, SARS-CoV-2 test negative
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (High blood pressure)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: PRPFIZER INC2021841425

Write-up: Loss of balance, headache, and stroke; Loss of balance, headache, and stroke; Loss of balance, headache, and stroke.; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 20Apr2021 at 09:00 (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: En6206), via an unspecified route, administered in left arm on 30Mar2021 at 09:00 (at the age of 73-years-old) for covid-19 immunisation. Patient has no known allergies. Patient received other unspecified medications within 2 weeks of vaccination (name of medications not specified). Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On 02Jun2021, the patient experienced loss of balance, headache, and stroke. The events resulted in emergency room/department or urgent care. The patient was hospitalized for loss of balance, headache and stroke for 5 days. Treatment was received for events as medical care and medications. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested for covid-19, sars-cov-2 nasal swab test: negative on 30Jun2021. Outcome of events was recovering. Follow-up attempts are needed. Further information is requested.


VAERS ID: 1481653 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-13
Onset:2021-06-02
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Amnesia, Brain injury, Brain oedema, Culture throat positive, Dysarthria, Electroencephalogram abnormal, Hallucination, Headache, Intensive care, Laboratory test, Loss of consciousness, Lumbar puncture abnormal, Meningoencephalitis viral, Pharyngitis streptococcal, Pyrexia, Sensory loss, Viral infection, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Agranulocytosis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Omeprazole (20mg )/day
Current Illness: Experienced cold-like symptoms around 4/7/2021.
Preexisting Conditions: None
Allergies: Allergic to Acetaminophen
Diagnostic Lab Data: Many tests on multiple dates between 6/2 - 6/7 and 6/13 - 6/16. EEG with abnormal results stemming from brain swelling. Negative results for all virus tested (i.e. herpes). Positive strep test (6/3). Doctor mentioned mosquito-borne virus was also unlikely, but did not test to our knowledge.
CDC Split Type:

Write-up: I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.


VAERS ID: 1483437 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Parosmia, SARS-CoV-2 test, Taste disorder
SMQs:, Taste and smell disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Covid-19 Test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab: negative
CDC Split Type: USPFIZER INC2021830835

Write-up: Sense of smell is distorted; Can''t taste normally; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female non-pregnant patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0168, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 as dose 1, single (at the age of 19-year-old) and received for BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0176 and Expiration date was not reported), via an unspecified route of administration, on an unspecified date of 2021, as dose 2, single (at the age of 19-year-old) for COVID-19 immunisation. The patient medical history included COVID-19, prior to vaccination from an unknown date to an unknown date. Patient concomitant medications were not reported. On 02Jun2021, patient''s sense of smell was distorted and can not taste normally as well, specifically, coffee and toothpaste does not taste good, onions and rice also smell bad. Other things as well do not smell or taste quite right. Patient had been tested for COVID-19, post vaccination by nasal swab on 15Jun2021 and results were negative for COVID-19. Patient received no treatment for both the events. The outcome of both the events was not resolved. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1483922 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram abnormal, Myocarditis, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Turmeric 2 days following vaccine
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Bloodwork, CT scan
CDC Split Type:

Write-up: Heart palpitations and inflammation


VAERS ID: 1483985 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-23
Onset:2021-06-02
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

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

Write-up: admitted with heart failure


VAERS ID: 1484530 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-20
Onset:2021-06-02
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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

Write-up: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.


VAERS ID: 1487238 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Injection site pain, Limb discomfort, Loss of personal independence in daily activities, Pain, Pain in extremity, X-ray limb normal
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ***List as reported by the patient with details provided if readily available*** -levothyroxine -lisinopril -aspirin 81 mg daily -nitroglycerin 0.4 mg SL tabs as needed -meloxicam daily as needed -vitamin D3 5000 units once weekly -vitamin
Current Illness: None reported.
Preexisting Conditions: ***List as reported by the patient*** -hearing impairment requiring a sign language interpreter -hypothyroidism -hypertension -angina -anxiety/panic attacks -arthritis -previous renal cysts requiring biopsy
Allergies: ***List as reported by the patient*** -Bactrim -doxycycline -erythromycin -Tavist -prednisone -adhesive tape
Diagnostic Lab Data:
CDC Split Type:

Write-up: The morning following vaccination, the patient reported pain and heaviness in middle portion of her left arm (the arm that received the vaccine). The patient stated that the pain was fairly localized around the elbow area, with the area of the pain starting about six inches below the elbow and stopping about six inches above the elbow. The pain made normal activities uncomfortable and became more intense as the day progressed. The patient also reported noticing occasional shooting pains originating at her shoulder and traveling down her left arm. She did not mention any systemic signs or symptoms nor did she report any areas of redness or swelling. After about a week of the elbow-area pain, the patient sought care at an urgent care provider who ordered x-rays of her arm, which did not show any detectible damage. After that visit, the patient saw her primary care doctor for the arm pain as well as for routine care. The patient noted that the provider suggested possible nerve involvement due to the vaccine and/or its administration and mentioned to the patient that the arm pain should improve over the next few months. The patient regularly sees her primary care doctor and a cardiology due to poorly controlled hypertension.


VAERS ID: 1487441 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anosmia, Decreased appetite, Dizziness, Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications at the time of vaccination.
Current Illness: No illnesses at the time of vaccination.
Preexisting Conditions: No chronic or long-standing health conditions.
Allergies: No know allergies
Diagnostic Lab Data: No medical test or labs were performed.
CDC Split Type: vsafe

Write-up: I started to feel nauseous, loss of my appetite, lightheaded, hot flashes and I loss my smell. The only thing I could do was drink liquids,


VAERS ID: 1490455 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-05-25
Onset:2021-06-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, COVID-19, COVID-19 pneumonia
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to the ED on 6/2/2021 for covid-19 infection. On 6/9/2021 patient presented to the ED and was subsequently hospitalized for pneumonia due to covid-19 virus. On 6/16/2021 patient presented to the ED with STEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving first dose of covid vaccination.


VAERS ID: 1493711 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-11
Onset:2021-06-02
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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

Write-up: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.


VAERS ID: 1493918 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-05-18
Onset:2021-06-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram ST segment elevation, Pericarditis, Red blood cell sedimentation rate normal, Troponin normal
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A-Information pulled from State level pulled report, details limited.
Current Illness: N/A-Information pulled from State level pulled report, details limited-report indicated no comorbidities.
Preexisting Conditions: N/A-Information pulled from State level pulled report, details limited-report indicates no comorbidities.
Allergies: N/A-Information pulled from State level pulled report, details limited
Diagnostic Lab Data: Vitals: Temp 36.9 Celsius Resp: 16 HR: 71 BP 115/71 O2: 98 CXR: 02 Jun -WNL EKG of June 2, 2021 at 11: 24 shows a normal sinus rhythm with ventricular rate of 67, minimal diffuse ST elevation consistent with pericarditis, no blocks Troponin Levels: 02 Jun- Normal
CDC Split Type:

Write-up: Dx:Pericarditis He complains of retrosternal chest pain that he first noted 01 Jun 2021. He stated he first noted it after eating some warm food at lunchtime yesterday and described it as an "achy" discomfort that does not radiate. It was intermittently mild throughout the day yesterday but worse when he woke up today. Stated that does make him feel mildly short of breath. Pt c/o acute chest pain with dyspnea upon exertion Seems like a straight forward very mild case. Had f/u cardiology appointment on 6/11. Normal CRP and ESR 6/11. ECG 6/11 still with diffuse ST elevation. Scheduled for ECHO. Phone message later stated ECHO normal


VAERS ID: 1493940 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002CZ1A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051CZ1A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dehydration, Diarrhoea, Headache, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Dehydration (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: None.
Current Illness: None.
Preexisting Conditions: None
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain in arm at injection site, headaches, dehydration, chest pains, muscle aches, diarreah


VAERS ID: 1494289 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-13
Onset:2021-06-02
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Fatigue, Headache, Vaccination complication
SMQs:

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: MELOXICAM BUPROPION IBUPROFEN CEFTIRIZINE BIOTIN VITAMIN B-1 MULTIVITAMIN OMEPRAZOLE BALCYCLOVIRE MORTIRPRIPTYLLINE CITALOTRAM VITAMIN D
Current Illness: NONE
Preexisting Conditions: ARTHRITIS BACK PAIN HERNIATED DISK KIDNEY STONES DEPRESSION
Allergies: OCTOPUS CALAMARI
Diagnostic Lab Data: NONE
CDC Split Type: vsafe

Write-up: COVID TOE FATIGE HEADACHE


VAERS ID: 1497491 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Inappropriate schedule of product administration, Lip swelling, Peripheral swelling, Rash, Urticaria, Urticaria chronic
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTEUM PLUS; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021873060

Write-up: This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in arm left on 30May2021 at 11:00 (at the age of 33-years-old) (Lot Number: EW0175, Expiry date: Unknown) as dose 2, single for COVID-19 immunization. Vaccination Facility Type was pharmacy/ drug store. The patient medical history was reported as nothing. Concomitant medications included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS); colecalciferol (VITAMIN D) and probiotics both taken for an unspecified indication, start and stop date were not reported. Known allergies reported as no. Patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in arm left on 09Apr2021 at 12:00 PM (at the age of 33-years-old) (Lot Number: EW0173, Expiry date: Unknown) as single for COVID-19 immunization and did not experience any adverse reaction. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. If other vaccine in four weeks was no. The patient experienced chronic urticaria, lips swollen, rash, hives, tiredness and swollen feet on 02Jun2021 05:00. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with Methylprednisolone in response to the events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1371001 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002333 / 2 RA / IM

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

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

Write-up: Fever at 39 Celsius degress, right arm deltoid muscle pain


VAERS ID: 1371145 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002545 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: iatrogenic pulmonary embolism (2001)
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: swelling hardening itching redness on the left arm


VAERS ID: 1373146 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypertension, Sciatic nerve neuropathy, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Co- codamol
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left Sciatic nerve Vaccine induced neuropathy, hypertension


VAERS ID: 1373150 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-06-02
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxazosin Hydrocortisone, Propranolol, Omeprazole, Amlodipine
Current Illness: Covid post Covid vaccination
Preexisting Conditions: Adrenalectomy, Bilateral Renal Calculi
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Abdominal pain,


VAERS ID: 1383300 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fainting; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-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. Corrective treatment was unknown. 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: 1389948 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5843 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021661596

Write-up: Syncope; This is a spontaneous report from a contactable other hcp downloaded from the RA-WEB. Regulatory authority report number [GB-MHRA-WEBCOVID-202106021105002920-G0TLN], Safety Report Unique Identifier [GB-MHRA-ADR 25404133]. A 23-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA5843), via an unspecified route of administration on 02Jun2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was unsure if patient had symptoms associated with COVID-19 and did a COVID-19 test. Patient did not get enrolled in clinical trial. On 02Jun2021, the patient experienced syncope. On the same day i.e. 02Jun2021, patient was recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1389980 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy; Shellfish allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021648886

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 02Jun2021 10:30 (batch/lot Number: unknown) at the age of 31-year-old as single dose for covid-19 immunisation. Medical history included allergy to shellfish (crustacean), and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient''s concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient experienced anaphylactic shock on 02Jun2021 10:45 within 8 minutes of vaccine being given, adrenaline was required as well as IV Antihistamines. Steroid course and antihistamine course required for 3 days after the vaccine. The event was reported as serious (hospitalization for 1 day, medically significant, life threatening). The event resulted in Emergency room/department or urgent care. Outcome of event was recovering. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.


VAERS ID: 1391239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Nausea; Fatigue; Painful arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included CITALOPRAM for Anxiety, PARACETAMOL for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication information was not provided. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. 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.; 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: 1391240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial No historical conditions provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Cough; Fever; Muscle ache; Painful arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle ache), PAIN IN EXTREMITY (Painful arm) and COUGH (Cough) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial No historical conditions provided by the reporter. Concomitant products included OMEPRAZOLE for Oesophageal acid reflux. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), MYALGIA (Muscle ache), PAIN IN EXTREMITY (Painful arm) and COUGH (Cough) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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: 1391241 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Headache, Muscle spasms, Myalgia, Nausea, Syncope, Visual tracking test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETASONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Visual tracking test; Result Unstructured Data: Visual tracking test abnormal
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle cramps; Headache; Muscle ache; Nausea; Tiredness; Fainting; Chest pain; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included BECLOMETASONE for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Muscle ache), NAUSEA (Nausea) and FATIGUE (Tiredness). On 03-Jun-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps). On 02-Jun-2021, NAUSEA (Nausea) had resolved. At the time of the report, SYNCOPE (Fainting) had resolved with sequelae, CHEST PAIN (Chest pain) had resolved, MUSCLE SPASMS (Muscle cramps) outcome was unknown and HEADACHE (Headache), MYALGIA (Muscle ache) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Visual tracking test: abnormal (abnormal) Visual tracking test abnormal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Last year, patient had blood test and nothing was found in his result. Last year patient had experienced a half-blocked sensation in his nose and ears, which may also be linked to more regular head rushes than usual. Patient didn''t had a visual tracking test, but could feel his vision tracking was strange on the day and especially the next day. Patient has not had symptoms associated with COVID-19. 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.; 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: 1393549 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, Pain in extremity, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Arm achey; Hallucination; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-May-2021 at 5:15 PM, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021 at 2:30 AM, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm achey). At the time of the report, HALLUCINATION (Hallucination) was resolving and PAIN IN EXTREMITY (Arm achey) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-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. No concomitant medication was reported. Corrective treatment was unknown. 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: 1393551 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site rash, Urinary retention
SMQs:, Anticholinergic syndrome (broad), Hypersensitivity (narrow)

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

Write-up: Urinary retention; Injection site rash; This regulatory authority case was reported by a consumer and describes the occurrence of URINARY RETENTION (Urinary retention) in a 34-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. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced URINARY RETENTION (Urinary retention) (seriousness criterion medically significant). 02-Jun-2021, the patient experienced INJECTION SITE RASH (Injection site rash). At the time of the report, URINARY RETENTION (Urinary retention) outcome was unknown and INJECTION SITE RASH (Injection site rash) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment medications were not reported. 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: 1393557 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Cold sweat, Diarrhoea, Dizziness, Epistaxis, Heart rate, Heart rate decreased, Heart rate normal, Hot flush, Hyperhidrosis, Lymphadenopathy, Malaise, Myalgia, Nausea, Oxygen saturation, Paraesthesia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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: MULTIVITAMINS WITH MINERALS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXI; SERTRALINE
Current Illness: Peanut allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: in low 60s despite being anxious; Test Date: 20210601; Test Name: Heart rate; Result Unstructured Data: Low; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: normal; Test Date: 20210601; Test Name: oxigen saturation; Result Unstructured Data: normal; Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Syncope vasovagal; later the same day; general malaise; immediately felt faint; Dizzy; Sweaty; Hot flush; Tingling feet/hands; Slow pulse; Malaise; Diarrhoea; Swollen lymph nodes; nausea; Muscle soreness; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope vasovagal) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Anaphylaxis. Concurrent medical conditions included Peanut allergy. Concomitant products included MULTIVITAMINS WITH MINERALS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE;ZINC] and SERTRALINE for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced SYNCOPE (Syncope vasovagal) (seriousness criterion medically significant), EPISTAXIS (later the same day), MALAISE (general malaise), COLD SWEAT (immediately felt faint), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweaty), HOT FLUSH (Hot flush), PARAESTHESIA (Tingling feet/hands), HEART RATE DECREASED (Slow pulse), MALAISE (Malaise), DIARRHOEA (Diarrhoea), LYMPHADENOPATHY (Swollen lymph nodes), NAUSEA (nausea) and MYALGIA (Muscle soreness). At the time of the report, SYNCOPE (Syncope vasovagal), EPISTAXIS (later the same day), MALAISE (general malaise), COLD SWEAT (immediately felt faint), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweaty), HOT FLUSH (Hot flush), PARAESTHESIA (Tingling feet/hands), HEART RATE DECREASED (Slow pulse) and NAUSEA (nausea) had resolved and MALAISE (Malaise), DIARRHOEA (Diarrhoea), LYMPHADENOPATHY (Swollen lymph nodes) and MYALGIA (Muscle soreness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood pressure measurement: 60 (Low) in low 60s despite being anxious. On 01-Jun-2021, Heart rate: low (Low) Low. On 01-Jun-2021, Heart rate normal: normal (normal) normal. On 01-Jun-2021, Oxygen saturation: normal (normal) normal. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment medication 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: 1393559 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Dizziness, Fatigue, Headache, Malaise, 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), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: unwell; Dizziness; Headache; Feverish; Fatigue; Anxiety; This regulatory authority case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) in a 35-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. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced ANXIETY (Anxiety) (seriousness criterion medically significant), DIZZINESS (Dizziness), HEADACHE (Headache), PYREXIA (Feverish) and FATIGUE (Fatigue). On an unknown date, the patient experienced MALAISE (unwell). At the time of the report, ANXIETY (Anxiety), DIZZINESS (Dizziness), HEADACHE (Headache), PYREXIA (Feverish) and FATIGUE (Fatigue) had not resolved and MALAISE (unwell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-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 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: 1393562 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Hypoaesthesia, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201223; 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: Numbness in feet; Numbness in hand; Light-headed; Weakness; Fever; Chills; Tiredness; Nausea; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in feet), HYPOAESTHESIA (Numbness in hand), DIZZINESS (Light-headed), ASTHENIA (Weakness), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in feet) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 03-Jun-2021, HYPOAESTHESIA (Numbness in feet), HYPOAESTHESIA (Numbness in hand), DIZZINESS (Light-headed), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved, ASTHENIA (Weakness) was resolving. At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, 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 medications was reported. 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.; 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: 1393567 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Heart rate, Metamorphopsia, Muscle twitching, Syncope, Tremor, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), 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: Drug allergy (paracetamol - rash in neck and feeling of tightness in throat); Food allergy (Allergic to sriracha - inflammation of lips)
Preexisting Conditions: Medical History/Concurrent Conditions: Ventricular tachycardia (One episode of super ventricular tachycardia in 2015 or 2016 - at which time I was hospitalised, no further experiences.)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: blood pressure checked 3 times during this entire period and each time was ''in the range of normal''.; Test Date: 20210602; Test Name: Heart rate; Result Unstructured Data: heart rate checked 3 times during this entire period and each time was ''in the range of normal''.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: vision become distorted ( kaleidoscopic / '' broken glass '' vision ) in the moments leading up to passing out; twitching; Trembling/shaking; Distorted vision; Headache; Syncope convulsive; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope convulsive), VISION BLURRED (vision become distorted ( kaleidoscopic / '' broken glass '' vision ) in the moments leading up to passing out), MUSCLE TWITCHING (twitching), TREMOR (Trembling/shaking), METAMORPHOPSIA (Distorted vision) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Ventricular tachycardia (One episode of super ventricular tachycardia in 2015 or 2016 - at which time I was hospitalised, no further experiences.). Previously administered products included for an unreported indication: EPIPEN and PARACETAMOL. Concurrent medical conditions included Drug allergy (paracetamol - rash in neck and feeling of tightness in throat) and Food allergy (Allergic to sriracha - inflammation of lips). On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced SYNCOPE (Syncope convulsive) (seriousness criterion medically significant), TREMOR (Trembling/shaking) (seriousness criterion medically significant), METAMORPHOPSIA (Distorted vision) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced VISION BLURRED (vision become distorted ( kaleidoscopic / '' broken glass '' vision ) in the moments leading up to passing out) (seriousness criterion medically significant) and MUSCLE TWITCHING (twitching) (seriousness criterion medically significant). On 02-Jun-2021, SYNCOPE (Syncope convulsive), TREMOR (Trembling/shaking), METAMORPHOPSIA (Distorted vision) and HEADACHE (Headache) had resolved. At the time of the report, VISION BLURRED (vision become distorted ( kaleidoscopic / '' broken glass '' vision ) in the moments leading up to passing out) and MUSCLE TWITCHING (twitching) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Blood pressure measurement: normal (normal) blood pressure checked 3 times during this entire period and each time was ''in the range of normal''.. On 02-Jun-2021, Heart rate: normal (normal) heart rate checked 3 times during this entire period and each time was ''in the range of normal''.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Patient stayed under observation for approximately 1 hour. Stated that vision remained unusual for a duration afterwards, color appeared vivid and illuminated. Left approximately 2h after vaccine being administered. No treatment information 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. 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. No further information is expected at this time


VAERS ID: 1393571 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Melaena, Pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: No change whilst i waited 15 minutes; Pain; Burning sensation; Painful arm; Swollen arm; This regulatory authority case was reported by a consumer and describes the occurrence of MELAENA (No change whilst i waited 15 minutes) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) 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 IBUPROFEN for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) and PERIPHERAL SWELLING (Swollen arm). On an unknown date, the patient experienced MELAENA (No change whilst i waited 15 minutes) (seriousness criterion medically significant), PAIN (Pain) and BURNING SENSATION (Burning sensation). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, MELAENA (No change whilst i waited 15 minutes), PAIN (Pain) and BURNING SENSATION (Burning sensation) had resolved and PAIN IN EXTREMITY (Painful arm) and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient took Ibuprofen and paracetamol for the events. Nurse commented that I bled a lot. No change whilst the patient waited 15 minutes, left and could barely use arm to drive to change gear, pain has continued all of the second day struggling to dress and do mundane normal activities. Have never experienced this much pain following an injection. Have taken ibuprofen and paracetamol. On 15-Jan-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Yes - Positive COVID-19 test. It was also reported that patient has not tested positive for COVID-19 since having the vaccine (discrepancy - conflicting information). 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. After receiving the vaccine, patient experienced large pain with burning sensation. Nurse said that the patient bleed a lot. Patient experienced swelling in the area of injection, very high pain.; 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: 1395320 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

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

Write-up: Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 33-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Inflammatory arthritis, Lactation decreased and Rheumatoid arthritis. Concomitant products included SULFASALAZINE for Inflammatory arthritis, SERTRALINE for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Joint pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Joint pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. On the day following vaccine the patient experienced widespread joint pain, particularly in my knees, ankles and wrists but also mildly in fingers and shoulders. This was ongoing but manageable with paracetamol and rest. Patient had a history of inflammatory arthritis but have no had any flares of joint pain or systemic inflammation for over 2 years. My arthritis was well controlled by medication 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: 1396974 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Injection site pain, Migraine, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOOTS PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: SARS-CoV-2 test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Migraine headache; Dizzy spells; Fatigue; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), DIZZINESS (Dizzy spells), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included PARACETAMOL (BOOTS PARACETAMOL) from 06-May-2021 to 06-May-2021 for Headache. On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Jun-2021, DIZZINESS (Dizzy spells) had resolved. At the time of the report, MIGRAINE (Migraine headache), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-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. 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: 1397777 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain, Pain in extremity, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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: Nausea; Fever; Vomiting; Chills; Nausea; Fatigue; Muscle ache; Pain; painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), VOMITING (Vomiting), MYALGIA (Muscle ache), CHILLS (Chills), the first episode of NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and the second episode of NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN IN EXTREMITY (painful arm). On 03-Jun-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), the first episode of NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Pain), MYALGIA (Muscle ache), FATIGUE (Fatigue) and PAIN IN EXTREMITY (painful arm) had not resolved, VOMITING (Vomiting) was resolving, CHILLS (Chills) had resolved and last episode of NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not pregnant, Patient was not currently breastfeeding. No concomitant medication was reported. No treatment medication was reported. 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: 1397780 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, 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: Anaphylaxis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: very tired; headache; Migraine; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (very tired), MIGRAINE (Migraine) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Anaphylaxis. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced MIGRAINE (Migraine) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced FATIGUE (very tired) (seriousness criteria disability and medically significant) and HEADACHE (headache) (seriousness criteria disability and medically significant). At the time of the report, FATIGUE (very tired) and HEADACHE (headache) was resolving and MIGRAINE (Migraine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) has not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient Concomitant medication 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 these 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 these events, a causal relationship cannot be excluded.


VAERS ID: 1397784 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef).)
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swollen lymph nodes; Headache; Swollen arm; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Ehlers-Danlos syndrome. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef).). On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was reported. No treatment information was provided. The patient did not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient did not tested positive for COVID-19 since having the vaccine. 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: 1397786 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Eye pain, Headache, Hypoaesthesia, Pain, Pain in extremity, Restlessness, SARS-CoV-2 test, Sight disability
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Numb legs and parts of my face; Restless; Arm is very achy; Eye pain; Headache; Shivering; body numbness; Sight disability; Ache; This regulatory authority case was reported by a consumer and describes the occurrence of SIGHT DISABILITY (Sight disability), HYPOAESTHESIA (Numb legs and parts of my face), RESTLESSNESS (Restless), PAIN IN EXTREMITY (Arm is very achy), PAIN (Ache), EYE PAIN (Eye pain), HEADACHE (Headache), CHILLS (Shivering) and HYPOAESTHESIA (body numbness) 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 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced SIGHT DISABILITY (Sight disability) (seriousness criterion medically significant), EYE PAIN (Eye pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). 03-Jun-2021, the patient experienced HYPOAESTHESIA (body numbness) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numb legs and parts of my face) (seriousness criterion medically significant), RESTLESSNESS (Restless) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Arm is very achy) (seriousness criterion medically significant). At the time of the report, SIGHT DISABILITY (Sight disability), PAIN (Ache), EYE PAIN (Eye pain), HEADACHE (Headache), CHILLS (Shivering) and HYPOAESTHESIA (body numbness) had not resolved and HYPOAESTHESIA (Numb legs and parts of my face), RESTLESSNESS (Restless) and PAIN IN EXTREMITY (Arm is very achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Patient has not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment information were reported. Patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial, not pregnant and not currently breastfeeding. The patient reported numb legs and parts of face, headache, slight sight issue, arm is very achy, cannot lay on it or touch it, could not drive as cannot change gear. Generally achy all over and restless. Hot and cold flushes. 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: 1397789 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20201214; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: fever; Aching in arm where injection was given; Nausea; Shivers; Muscle ache; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (Nausea), CHILLS (Shivers), MYALGIA (Muscle ache) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 09-Dec-2020 to 05-Jan-2021. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Aching in arm where injection was given). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (Aching in arm where injection was given) outcome was unknown, NAUSEA (Nausea) and MYALGIA (Muscle ache) had not resolved and CHILLS (Shivers) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. 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. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not listed).; 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 criteria none of the events was serious (not listed).


VAERS ID: 1397790 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a 32-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (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 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: 1397794 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold-stimulus headache, Feeling abnormal, Feeling drunk, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (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: Allergic reaction (to insect bites.)
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: Ice cream headache; Foggy feeling in head; Nausea; Feeling drunk; This regulatory authority case was reported by a consumer and describes the occurrence of FEELING DRUNK (Feeling drunk), COLD-STIMULUS HEADACHE (Ice cream headache), FEELING ABNORMAL (Foggy feeling in head) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Concurrent medical conditions included Allergic reaction (to insect bites.). On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced FEELING DRUNK (Feeling drunk) (seriousness criterion medically significant), FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced COLD-STIMULUS HEADACHE (Ice cream headache) (seriousness criterion medically significant). At the time of the report, FEELING DRUNK (Feeling drunk), FEELING ABNORMAL (Foggy feeling in head) and NAUSEA (Nausea) was resolving and COLD-STIMULUS HEADACHE (Ice cream headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. As reported Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medications were not reported. Treatment information was not 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: 1397795 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Patient has not tested positive for COVID-19 since having the vaccine.); Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Headache; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. Concurrent medical conditions included COVID-19 (Patient has not tested positive for COVID-19 since having the vaccine.). On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. 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: 1397798 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE; SIRDUPLA; SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
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: 5 hours after receiving the injection; Allergic reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SIRDUPLA) for Asthma, LORATADINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE) and FLUTICASONE PROPIONATE for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (5 hours after receiving the injection). On 02-Jun-2021, HYPERSENSITIVITY (Allergic reaction) had resolved. At the time of the report, VOMITING (5 hours after receiving the injection) 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. 2.5 hours after receiving the injection, patient started to get an allergic reaction - tongue started swelling and her lips prickled. She took a loratadine and called 111, who ordered an ambulance. The paramedics took her observations, which were normal, and the loratadine had started to take effect. They concluded that as the reaction was mild, she didn''t need to be taken to hospital. The patient did not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient did not tested positive for COVID-19 since having the vaccine. 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: 1397802 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ear pain, Fatigue, Headache, Hyperaesthesia, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: skin super sensitivity; extreme sore arm; earache; inability to lift it; fatigue; headache; Fever; Sensitive skin; Pain in arm; Frontal headache; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (skin super sensitivity), PAIN IN EXTREMITY (extreme sore arm), EAR PAIN (earache), SENSITIVE SKIN (Sensitive skin), PAIN IN EXTREMITY (Pain in arm), HEADACHE (Frontal headache), NAUSEA (inability to lift it), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever) 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 and Suspected COVID-19 from 16-Mar-2020 to 20-Mar-2020. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), HEADACHE (Frontal headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERAESTHESIA (skin super sensitivity) (seriousness criterion medically significant), PAIN IN EXTREMITY (extreme sore arm) (seriousness criterion medically significant), EAR PAIN (earache) (seriousness criterion medically significant), NAUSEA (inability to lift it) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, HYPERAESTHESIA (skin super sensitivity), PAIN IN EXTREMITY (extreme sore arm), EAR PAIN (earache), NAUSEA (inability to lift it), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown and SENSITIVE SKIN (Sensitive skin), PAIN IN EXTREMITY (Pain in arm), HEADACHE (Frontal headache) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medications were 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: 1397803 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Feeling abnormal, Headache, Influenza like illness, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SAYANA PRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (unsure when symptoms started, unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu like symptoms; Foggy feeling in head; Nausea; Headache; Joint pain; Pain, ache; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain, ache), FEELING ABNORMAL (Foggy feeling in head), NAUSEA (Nausea), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (unsure when symptoms started, unsure when symptoms stopped). Concomitant products included MEDROXYPROGESTERONE ACETATE (SAYANA PRESS) for Contraception. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (Pain, ache) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and PAIN (Pain, ache), FEELING ABNORMAL (Foggy feeling in head), NAUSEA (Nausea), HEADACHE (Headache) and ARTHRALGIA (Joint pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. The patient reported that arm pain is quite severe - unable to raise arm above elbow, general flu like symptoms. Patient was not enrolled in clinical trial, was not tested positive for COVID-19 since having the vaccine, and not had a COVID-19 test. 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: 1397810 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Chills, Lymphadenopathy, Myalgia, Nausea, Peripheral swelling, SARS-CoV-2 test, Sweating fever
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Taste and smell disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shivers; Muscular pain; Swollen glands; Nausea; Sweating fever; Loss of taste; Loss of smell; Stomach ache; Swollen arm; This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever) in a 32-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 and Suspected COVID-19 from 07-Jan-2021 to 10-Jan-2021. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 03-Jun-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ABDOMINAL PAIN UPPER (Stomach ache), LYMPHADENOPATHY (Swollen glands), NAUSEA (Nausea) and MYALGIA (Muscular pain). On 04-Jun-2021, the patient experienced CHILLS (Shivers). At the time of the report, SWEATING FEVER (Sweating fever), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ABDOMINAL PAIN UPPER (Stomach ache), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen glands), NAUSEA (Nausea), CHILLS (Shivers) and MYALGIA (Muscular pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event,s 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,s a causal relationship cannot be excluded.


VAERS ID: 1397826 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Painful arm), FATIGUE (Exhaustion) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced FATIGUE (Exhaustion) (seriousness criterion medically significant). On 04-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Ache), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Exhaustion) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was 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: 1398078 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Culture, Deafness unilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Nasal culture; Result Unstructured Data: Test Result:negative
CDC Split Type: ITPFIZER INC2021680297

Write-up: Immediate left ear hearing loss; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional (patient) reported for herself. A 45-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FC2229, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 01Jun2021 at 17:00 pm (age at vaccination was 45 years) as 1st dose, single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Jun2021 at 08:00 am, the patient experienced immediate left ear hearing loss. The patient performed a nasal culture which resulted negative on 04Jun2021. The patient was visited by a physician and treated with Pharmacological treatment and hyperbaric chamber. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event was unknown.


VAERS ID: 1398210 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002180 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Vaccination site erythema
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: House dust allergy; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 35.7 degrees Celsius
CDC Split Type: JPTAKEDA2021TJP034945AA

Write-up: Local erythema; Anaphylaxis; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002180) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pollen allergy and House dust allergy. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Local erythema). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) was resolving and VACCINATION SITE ERYTHEMA (Local erythema) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 35.7 35.7 degrees Celsius. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No further causality assessment was provided for VACCINATION SITE ERYTHEMA (Local erythema). No concomitant medication was reported.. The time to the onset was 10 minutes. Patient experienced sudden, acute progressive, cutaneous, local erythema with no vagal reflux. No circulatory, respiratory and gastrointestinal symptoms were present. No treatment medication 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 event, a causal relationship cannot be excluded. Causality with Moderna vaccine: Related.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1398211 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002180 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Body temperature
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36? C
CDC Split Type: JPTAKEDA2021TJP035182

Write-up: Angioedema; This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002180) for COVID-19 vaccination. The patient''s past medical history included Anaphylaxis. Concurrent medical conditions included Allergy. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). On 02-Jun-2021, ANGIOEDEMA (Angioedema) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.0? c (Inconclusive) 36? C. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANGIOEDEMA (Angioedema) to be possibly related. Concomitant product use was not provided by the reporter. After 30 minutes of vaccination patient rapidly developed progressive local angioedema and discomfort in the oral cavity as an allergic reaction. Adrenaline was not administered. No treatment information was 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: 1398270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210617521

Write-up: FEVER: 40.5 TO 42 DEGREES CELSIUS; COLD CHILLS; FEELING UNWELL; NAUSEA; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [NL-LRB-00564076] concerned a 44 year old female. The patient''s weight was 65 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose 0.5ml, administered on 01-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-JUN-2021, the patient experienced fever: 40.5 to 42 degrees celsius, cold chills, feeling unwell, nausea and headache. Laboratory data included: Hyperpyrexia (not provided) Fever: 40.5 to 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from cold chills, feeling unwell, headache, and fever: 40.5 to 42 degrees celsius. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210617521-covid-19 vaccine ad26.cov2.s -Hyperpyrexia. 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: 1398602 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple allergies
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210620631

Write-up: URTICARIA OR WELTS; ITCHY RASH; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-895973] concerned a 44 year old male with unknown ethnicity and race. The patient''s height, and weight were not reported. The patient''s concurrent conditions included multiple allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection , intramuscular, batch number: 21C13-03 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 02-JUN-2021 for covid-19 vaccination. The drug start and last period was 1 day. No concomitant medications were reported. On 02-JUN-2021, the patient experienced urticaria or welts and itchy rash. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 02-JUN-2021. The patient was recovering from urticaria or welts, and itchy rash. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210620631-Covid-19 vaccine ad26.cov2.s- urticaria or welts, and itchy rash.. This event(s) is labeled per RSI and is therefore considered potentially related.


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