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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 370 out of 6,867

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VAERS ID: 1632570 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO167 / 2 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chills, Cold sweat, Dyspnoea, Electrocardiogram, Headache, Heart rate increased, Hyperhidrosis, Nausea, Pain, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, magnesium, dulera, advair, albuterol
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data: Ekg, bloodwork, X-ray all completed today 8/25/2021
CDC Split Type:

Write-up: Evening and two days following vaccination had rapid heartbeat, difficulty breathing , sweating, clammy, headache, nausea, body aches and chills, and weeks later still experiencing some symptoms like difficulty breathing


VAERS ID: 1632950 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-02-17
Onset:2021-07-14
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Disturbance in attention, Herpes zoster, Pain, Rash, Thinking abnormal
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Not applicable
CDC Split Type: vsafe

Write-up: I experienced the inability to concentrate/think (felt like the days just went on and on without a distinctive beginning or ending). I also begin to see the appearance of red spots that wrapped around from my spine to approximately 1" above the belly button and continued to my right side. I went to my doctor 07/21/2021 and diagnosed me with Shingles which have been extremely painful since then.


VAERS ID: 1633628 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Rhinalgia, Rhinorrhoea
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: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 15 20 minutes the day after receiving the shot my left nostril started to run. Next day was really sore inside. Couple weeks later the right nostril has done same thing. Now both nostri feel raw inside. Just wanted to let you know of this. I was fine before hand and now nostrils are really sore .


VAERS ID: 1633800 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-17
Onset:2021-07-14
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 1 AR / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031L20A / 2 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Loss of personal independence in daily activities, Malaise, Quality of life decreased
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: After receiving both doses of Moderna COVID vaccine in January 2021 and February 2021, my mother started becoming ill. Previous to this she was active, could drive, go to the store, the hair salon and family functions. She started not feeling well in March 2021 and May 2021. In July 2021 she was admitted to the hospital for 3 days having trouble breathing. August 2021 she was admitted again for 5 days with the same breathing issues. She was released and taken to the Emergency room again within 36 hours. She was admitted to hospital for 3 days and released to a nursing home August 25,2021. Her prognosis is not good and she will probably die soon. These COVID shots have seriously injured my mother.


VAERS ID: 1634205 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Uloric
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain, tightness. Comes and goes away daily for like 2 weeks.


VAERS ID: 1636901 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Product storage error
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: Error: Improper Storage (temperature)-.


VAERS ID: 1644983 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.


VAERS ID: 1644996 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was provided by the reporter. No treatment information was provided.


VAERS ID: 1644998 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: all the patients who received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved. At the time of the report, PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1645000 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product details were provided by the reporter. No Treatment information was provided.


VAERS ID: 1645128 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-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) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.


VAERS ID: 1645421 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Malaise, Myalgia, Oropharyngeal pain, Pain in extremity, Swelling face, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL; GABAPENTINE; MYPOL [CODEINE PHOSPHATE;IBUPROFEN;PARACETAMOL]; TRILEPTAL; ALPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (Known allergies: Metal (thick needle)); Fibromyalgia; Post herpetic neuralgia; Trigeminal neuralgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100909670

Write-up: Injection site pain; Tiredness; Headache; Muscle pain; Arm pain; Swelling of the face; Throat pain; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Jul2021 at 10:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, post herpetic neuralgia, trigeminal neuralgia and allergy to metals (thick needle). Concomitant medications included S (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), gabapentin (GABAPENTINE), codeine phosphate, paracetamol, ibuprofen (MYPOL), oxcarbazepine (TRILEPTAL) and alprazolam (ALPRAM) for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jul2021 at 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, arm pain, swelling of the face, throat pain and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, arm pain, swelling of the face, throat pain and feeling unwell were not recovered at the time of this report. The lot number for BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1645441 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; VITAMIN B-12; COD LIVER OIL [COD-LIVER OIL]; KYOLIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Known allergies: asphalt); Allergy to antibiotic (Known allergies: all antibiotics except amoxicillin); Allergy to chemicals (Known allergies: industrial chemicals); Allergy to molds (Known allergies: mold); Food allergy (Known allergies: yeast); Fruit allergy (Known allergies: bananas); Gallbladder removal (No gallbladder removed 1990''s); Gastrectomy (No stomach Removed 2007); Pollen allergy (Known allergies: pollen)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Quidel test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202100917310

Write-up: Heat rash break out in crotch, behind knees; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 12Jul2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal (no gallbladder) on an unknown date in 1990''s, gastrectomy (no stomach) on an unknown date in 2007. The patient was allergic to bananas, yeast, mold, all antibiotics except amoxicillin, pollen, asphalt and industrial chemicals. Concomitant medications included vitamin c (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN), cod-liver oil (MANUFACTURER UNKNOWN) and allium sativum (KYOLIC); all for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Jul2021 at 02:00, after 48 hours of vaccination, the patient experienced heat rash break out in crotch, behind knees which was spreading daily. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 14Jul2021, the patient underwent Quidel test (nasal swab) and the result was negative. Therapeutic measures were taken as a result of the event which included treatment with self-care anti-itch stuff. The clinical outcome of the event heat rash break out in crotch, behind knees was not recovered at the time of this report.


VAERS ID: 1645654 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Disturbance in attention, Dizziness, Headache, Swelling, Vaccination site pain, Vertigo
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (if_covid_prior_vaccination: yes); Vertigo (Prior to vaccine suffered mild vertigo sometimes (seldom))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100952902

Write-up: The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo; Now after the vaccine patient has experienced headaches; The vaccine patient has experienced headaches, loss of focus; Most troubling is the vertigo and dizziness/ dizziness all the time; Swelling and pain in left armpit area; severe soreness for 5days (14Jul-19).; Swelling and pain in left armpit area; As of today, 26Jul site of injection is still sore to the touch; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), intramuscular, administered in arm left on 14Jul2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history included vertigo [Prior to vaccine suffered mild vertigo sometimes (seldom)] and COVID-19 (if_covid_prior_vaccination: yes) from an unknown date. There were no concomitant medications. On 14Jul2021, the patient experienced swelling and pain in left armpit area; severe soreness for 5days (14Jul-19). As of today, 26Jul site of injection is still sore to the touch. Most troubling is the vertigo and dizziness. Prior to vaccine, suffered mild vertigo sometimes (seldom); now after the vaccine patient has experienced headaches, loss of focus and vertigo/dizziness all the time. There was no treatment received for the events. The event ''The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo'' was assessed as serious and medically significant by the regulatory authority. The outcome of the event Armpit pain was recovered on 19Jul2021, while of the rest was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1645780 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood glucose, Blood glucose increased, Depression, Fatigue, Mental impairment, Migraine, Rheumatoid arthritis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Arthritis (narrow), Immune-mediated/autoimmune 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: Medical History/Concurrent Conditions: Allergy; Hypothyroidism; Migraine; RA
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood sugars; Result Unstructured Data: Test Result:Increased
CDC Split Type: USPFIZER INC202100962799

Write-up: RA flare; mental fogginess; extreme fatigue; increased blood sugars; joint pains; increased depression; generalized weakness; the worst migraine in over 25 years; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 10:30 (Lot Number: EW0179; at the age of 49-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypothyroidism, allergies, and migraine. Concomitant medications were not specified. The patient previously took etanercept (ENBREL) and ibuprofen (MOTRIN) for migraine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 14Jul2021, the patient experienced RA flare, extreme fatigue, increased blood sugars, joint pains, increased depression, mental fogginess, generalized weakness, and the worst migraine in over 25 years. It was reported that patient have not had a migraine in 20 years that was untreatable with Motrin (for clarification) and thought this was after not having Enbrel for weeks prior to COVID vaccination. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender''s Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1645794 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy; Seafood allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100963038

Write-up: anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications. The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.


VAERS ID: 1645888 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Product administered at inappropriate site
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELECOXIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Fibromyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100969785

Write-up: 2 weeks later still have pain; Vaccine was given very high on arm - Dr. says it was too high; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 14Jul2021 at 10:00 (age at vaccination 69 years) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia and arthritis. The patient previously took steroids and experienced drug hypersensitivity. Concomitant medication included celecoxib (List of medication patient received within 2 weeks of vaccination). Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jul2021 at 06:00, patient experienced pain and it was mentioned that vaccine was given very high on arm, doctor said it was too high. Patient did not receive any treatment for adverse events. At the time of this report, the outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646036 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-29
Onset:2021-07-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: NP THYROID; SYNJARDY; TRULICITY; XYZAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Guillain Barre syndrome; Penicillin allergy (Known allergies: Penicillin); Sulfonamide allergy (Known allergies: Sulfa)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100976547

Write-up: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jun2021 at 19:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, liothyronine (NP THYROID), metformin hydrochloride, empagliflozin (SYNJARDY), dulaglutide (TRULICITY) and levocetirizine dihydrochloride (XYZAL); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jul2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with antiviral medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1646037 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-20
Onset:2021-07-14
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Colonoscopy, Haematochezia, Haemorrhoids
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN D3; K2; ZINC; MAGNESIUM
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Blood work; Result Unstructured Data: Test Result:Great; Test Date: 20210720; Test Name: Colonoscopy; Result Unstructured Data: Test Result:internal small hemorrhoid; Comments: not bleeding at time of colonoscopy
CDC Split Type: USPFIZER INC202100976553

Write-up: Episodes of bright red Bleeding in stool; internal small hemmoroid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration in left arm on 20Apr2021 at 09:00 (at the age of 51-years-old) at dose 1, single for COVID-19 immunization. There was no medical history. The patient was very healthy. Prior to vaccination, she was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D3, menaquinone-7 (K2), zinc, and magnesium. The patient previously took prednisone and experienced allergies. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. On 14Jul2021 at 08:00, the patient experienced episodes of bright red bleeding in stool. She had a colonoscopy which showed an internal small hemorrhoid but there was no bleeding at time of colonoscopy. She has regular bowel movements and eats whole foods, no sugar, and gluten diet for 21/2 years. She was very healthy and had great blood work at the time of colonoscopy on 20Jul2021. The doctor who performed the colonoscopy said there were no other issues. The events required emergency room/department or urgent care visit. She did not receive any treatment in response to the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram, Pregnancy test, SARS-CoV-2 test, Urticaria, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endoscopic mucosal resection (This was 3 weeks before the vaccine); Polyp removal
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210528; Test Name: Pregnancy Test(Blood work); Result Unstructured Data: Test Result:Normal; Test Date: 20201116; Test Name: Covid Test; Test Result: Negative ; Test Date: 20210514; Test Name: Covid Test; Test Result: Negative ; Test Date: 20210530; Test Name: Covid Test; Test Result: Negative ; Test Date: 20210613; Test Name: Covid Test; Test Result: Negative
CDC Split Type: USPFIZER INC202101006990

Write-up: Blurred vision; Hives on neck; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 12Jul2021 13:05 (Batch/Lot Number: EW0181) as SINGLE for covid-19 immunization. Medical history included EMR colon surgery from 01Jun2021 to an unknown date. This was 3 weeks before the vaccine and polypectomy from 17May2021 to an unknown date. There were no concomitant medications was reported. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 21Jun2021 13:00 (Batch/Lot Number: EW0180) as SINGLE for covid-19 immunization and developed Covid arm rash. On 14Jul2021 18:30, the patient had hives on neck whereas, blurred vision on 15Jul2021 18:30. The patient underwent lab tests and procedures which included EKG as normal on 28May2021, pregnancy Test (Blood work) as normal on 28May2021. Also, the patient underwent covid test as negative on 16Nov2020, 14May2021, 30May2021 and on 13Jun2021. The outcome of events was recovered on an unknown date. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1646957 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-18
Onset:2021-07-14
   Days after vaccination:208
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Myasthenia gravis
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101030530

Write-up: Myasthenia gravis; This is a spontaneous report from a contactable nurse (patient). A currently 26-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Dec2020 12:00 (at the age of 25-year-old) (Batch/Lot Number: EH9899) as dose 1, single for covid-19 immunisation. The patient had no medical history, concurrent conditions and past drug history. The patient was not pregnant. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. On 14Jul2021, the patient experienced myasthenia gravis. Treatment was received for the event which included an unspecified medication. The event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.; Sender''s Comments: The causal relationship between bnt162b2 and the event myasthenia gravis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The event occurred several months after the vaccination, and the circumstances surrounding the event was not specified. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1651411 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: California  
Vaccinated:2020-12-21
Onset:2021-07-14
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisone, prograff, mycophenylate, atenolol, norvasc, nexium
Current Illness:
Preexisting Conditions: kidney transplant, HTN, GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bell''s Pasly


VAERS ID: 1651636 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-14
Onset:2021-07-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0148 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Acute lymphocytic leukaemia, Biopsy bone marrow abnormal, Blood test, Chemotherapy, Exposure during pregnancy, Labour induction, Lymphadenopathy, Pain in extremity, White blood cell count increased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Malignant lymphomas (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (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, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, DHA, Calcium
Current Illness:
Preexisting Conditions: Minor hearing loss, moderate depression (better then), hypothyroidism (cured then)
Allergies:
Diagnostic Lab Data: Bone Marrow Biopsy, 7/27/2021, B-cell Acute Lymphoblastic leukemia/Lymphoma with t(4;11)(q21;q23) KMT2A-Rearranged
CDC Split Type:

Write-up: Pregnant 18 weeks when having the second does (6/14/2021). Arm was hurt and sore for the next 2 days. A week later, a big lymph node showed up behind my right ear (size a little bigger than half a marble). In another week, another showed up behind my left ear, and more poped out (around 10 ) all around my neck and behind my head. I went for a blood check at 7/13/2021, and got the result the next day showing 26 times more than normal white blood counts. Went to the ER that night, and got initial diagnosis of leukimea/blood cancer. I was admitted into the cancer ward in the next two days, and stayed for 3 weeks. in the first week, I had a bone marrow biopsy done and got confirmed that I got B-cell Acute Lymphoblastic Luekemia. I started receiving chemo therapy right away. 3 weeks later I was released from the hospital at 7/29/2021. That weekend, My baby died when he was 25 weeks. I had to return to the hospital and had a induction at 8/3/2021.


VAERS ID: 1654158 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Blood test, Computerised tomogram head, Gait inability, Hypoaesthesia, Immediate post-injection reaction, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Myelitis transverse, Neuralgia, Pain in extremity, Plasmapheresis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (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? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Duloxetine 60mg 1 per day Multi Vitamin
Current Illness: None
Preexisting Conditions: Anxiety Depression
Allergies: Sensitive to Tylenol
Diagnostic Lab Data: MRI of Spine 8/17/2020 Lumbar Puncture 8/19/2021 MRI and CT Brain 8/19/2021 Lumber Puncture 8/26/2021 Blood and daily labs Auto-Immune test Plasmapheresis 5 x''s IV Solumedrol x 5 day''s
CDC Split Type:

Write-up: Immediate lower back pain and thigh pain on injection Ongoing pain (back and nerve) Onset of numbness, nerve pain, and weakness in bilateral legs. Hospital stay started August 17th Diagnosed with Transverse Myelitis after 6 days. Numbness and extreme weakness in legs. Unable to walk without assistance. Treatment is still in progress.


VAERS ID: 1655915 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-23
Onset:2021-07-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Areflexia, Electroencephalogram normal, Hemiparesis, Magnetic resonance imaging normal, Mobility decreased, Seizure like phenomena
SMQs:, Peripheral neuropathy (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ashwagahnda
Current Illness: None
Preexisting Conditions: Migraines
Allergies:
Diagnostic Lab Data: Cleared of stroke activity July 14, 2021 Mri normal July 15,2021 Eeg cleared seizure activity July 15,2021
CDC Split Type:

Write-up: Weakness in left side of body, loss of mobility and reflexes. Seizure like tremors lasted 4 days


VAERS ID: 1657753 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0788C21A / 1 - / OT

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

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

Write-up: 1st dose given 29 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0788C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. The patient had no known drug allergies and no chronic or long standing health conditions. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: significant follow up : patient demographics (age, ethnicity, race) updated and narrative updated


VAERS ID: 1658521 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-11
Onset:2021-07-14
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, COVID-19, Chest X-ray, Heart rate increased, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 28 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diverticulitis, stoma.
Allergies: Shellfish
Diagnostic Lab Data: 7/14/2021: Covid test positive. 7/9/21:CXR.
CDC Split Type:

Write-up: Patient sent to ER by nurse for elevated bp and HR. Pt admitted.


VAERS ID: 1658540 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-02-12
Onset:2021-07-14
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea, Lung opacity, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, HTN
Allergies: NKA
Diagnostic Lab Data: Chest xray: airspace opacities in the lungs demonstrating a perihilar predilection. 7/15/21: Covid test-positive.
CDC Split Type:

Write-up: Pt came to ER with SOB, cough, and covid positive, onset 1 week prior. Fever and chills since 7/4/21. Covid positive on 7/9/21.


VAERS ID: 1658657 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-08
Onset:2021-07-14
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, SARS-CoV-2 test positive, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, Endometriosis, HTN, obesity.
Allergies: Benadryl, erythromycin, keflex
Diagnostic Lab Data: CXR, 7/27/21 covid test positive.
CDC Split Type:

Write-up: Pt came to ER with syncope, diagnosed with covid 19 2 days ago.


VAERS ID: 1659123 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039B21A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Headache, Pain, Pulmonary pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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: OLMESARTEN, METOPROLOL, ATVORASTATIN
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE KNOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: FEVER, HEADACHES, BODY ACHES, DIARREAH, SORE LUNGS, SHORTNESS OF BREATH, MORE HEADACHES, MORE FEVER


VAERS ID: 1659338 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Illinois  
Vaccinated:2020-12-17
Onset:2021-07-14
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELI283 / 1 UN / UN
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 2 UN / -

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram, Endoscopy, Laboratory test, Lymphadenopathy
SMQs:, 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 vitamins
Current Illness: nothing
Preexisting Conditions: obese
Allergies: none
Diagnostic Lab Data: 7/14/21 CT scan 7/22/21 endoscopy with needle biopsy 8/09/21 lg biopsy with scope, 8/11/20 bone marrow test
CDC Split Type:

Write-up: I have enlarged/bulky abdominal lymph nodes,1 being a 9cm mass of lymph nodes in my upper abd. I feel fine, my labs are all good, Drs. can''t explain it?? ***I don'' know if this is related to COVID vaccine, but thought I should tell you in case anyone else is having similar symptoms.


VAERS ID: 1659711 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Immediate body aches and fever that led to numbness and tingling in extremities. Currently, I still have continuous and constant numbness and tingling in my hands and feet and it''s been over a month since it began.


VAERS ID: 1661878 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Dyspnoea, Heart rate, Heart rate increased, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; COVID-19 (if covid prior vaccination: Yes); Food allergy; Gluten intolerance; Vegetable allergy
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC2021894434

Write-up: Chest pain; shortness of breath; elevated heart rate; fever; joint pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 13Jul2021 12:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to tomatoes, bell peppers, mushrooms, almonds, gluten sensitivity, covid-19. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 14Jul2021 11:00, the patient experienced chest pain, shortness of breath, elevated heart rate, fever, joint pain and muscle pain. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1662556 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-26
Onset:2021-07-14
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / JET

Administered by: Pharmacy       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? No
Previous Vaccinations:
Other Medications: Cortisone Hydrocortisone cream 1% Prednisone 20mg tablets
Current Illness: n/n
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: N/A


VAERS ID: 1667361 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-21
Onset:2021-07-14
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure decreased, Cough, Dizziness, Ear congestion, Nasal congestion, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Infective pneumonia (broad), Dehydration (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: D3; Calcium; Aspirin; Wellbutrin; B5; Fluticasone; Azelastine; Centrum Silver; HPR; Xyzal; Prilosec; Lopressor; Dyazide; Lipitor; Calan; Synthroid; Effexor; Hydrocortisone Valerate; Clobetasol propionate; Levothyroxine; Melatonin
Current Illness: None
Preexisting Conditions: Environmental Allergies; Bronchitis
Allergies: NKA
Diagnostic Lab Data: 7/14/2021 Just a physical
CDC Split Type: vsafe

Write-up: Cough and severe nasal congestion, Ear canal congestion, Chest congestion 2 days later. Coughing was deeper as the day pass, (7/27/2021, 8/4/2021, 8/17/2021) altitude dizziness w/BP drop, Inhaler Albuterol, Breztri, and Benzonatate.


VAERS ID: 1669618 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C2A / 1 - / OT

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

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

Write-up: Patient received 1st dose 31 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C2A) for COVID-19 vaccination. Concurrent medical conditions included GERD since 17-May-2021 and Hypotension since 17-May-2021. Concomitant products included OMEPRAZOLE from 17-May-2021 to an unknown date for GERD, BENAZEPRIL from 17-May-2021 to an unknown date for Hypotension. On 14-Jul-2021 at 2:42 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication were not reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Patient Race and ethnicity added, Concomitant medications updated, Medical history updated, facility details and Reporter details.


VAERS ID: 1671908 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-02-22
Onset:2021-07-14
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 03YL20A / 2 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Biopsy, Breast mass, Mammogram abnormal
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: Levothyroxine, Vitamins: C, D, E, Niacin, calcium
Current Illness: None
Preexisting Conditions: Hypothyroidism
Allergies: Penicillin, Demerol, Codeine
Diagnostic Lab Data: August 16th breast biopsy identified triple negative cancer in right breast, and benign mass in right axillary lymph node. I am reporting this for full disclosure, but I am not claiming vaccine was the cause.
CDC Split Type:

Write-up: Mammogram showed masses in right breast and in axillary lymph node. Referred for ultrasound and biopsy.


VAERS ID: 1674540 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-07
Onset:2021-07-14
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Mechanical urticaria
SMQs:, Hypersensitivity (broad)

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

Write-up: I have developed Dermatographia since the vaccinations. Ive never had this condition before the vaccinations and I wanted to make you aware of it.


VAERS ID: 1677238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Food allergy, Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 Virus Test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Patient has not received 2nd dose.; tested positive for COVID19 on 21-Jul-2021; Had COVID19 symptoms; Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.; This spontaneous case was reported by a consumer and describes the occurrence of FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021), COVID-19 (Had COVID19 symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.). On 18-Jul-2021, the patient experienced COVID-19 (Had COVID19 symptoms). On 21-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency. At the time of the report, FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021) and COVID-19 (Had COVID19 symptoms) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Patient administered a steroid shot due to allergic reaction experienced due to food she ate not from the vaccine on 14Jul2021.


VAERS ID: 1678937 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Rash
SMQs:, Anaphylactic reaction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash, tightness in chest, chest pain


VAERS ID: 1679345 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-02-08
Onset:2021-07-14
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Inflammation, Systemic inflammatory response syndrome, Urine analysis
SMQs:, Tumour lysis syndrome (broad), Sepsis (broad), Opportunistic infections (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: Rouvastatin, oxycodone, zolpedin, vitamin D2, Meloxicam
Current Illness: None
Preexisting Conditions: Good
Allergies: None
Diagnostic Lab Data: SEVERAL CAT SCANS, EXTENSIVE BLOOD WORK AND URINE TEST.
CDC Split Type:

Write-up: Inflammation popping up different areas of my body every day. No pain associated with it. My extensive research that the photos posted of those how had it reflects 99% sure it''s MULTI SYSTEM INFLAMMATORY SYNDROME..SEVERAL CAT SCANS, EXTENSIVE BLOOD WORK AND URINE TEST. Was told by ER doctor he had no clues what it could be.


VAERS ID: 1681473 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Body temperature, Computerised tomogram, Condition aggravated, Cough, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, Impaired work ability, Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination complication, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: 99-100.4; Test Date: 20210719; Test Name: Body temperature; Result Unstructured Data: 99-100.6; Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 20210729; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 20210729; Test Name: Blood test; Result Unstructured Data: Negative; Test Date: 20210729; Test Name: CT scan; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210908756

Write-up: SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.


VAERS ID: 1684442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Limb discomfort, Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021900055

Write-up: arm is sore; drew up 0.3mL of vaccine without diluent; This is a spontaneous report from a contactable pharmacist (patient''s mother). This pharmacist reported for a 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jul2021 at 10:00 AM, as a single dose, 0.3 ML, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her daughter and reported that she took her daughter to receive her first dose of the Pfizer Covid-19 vaccine yesterday on 14Jul2021. Caller reported that she administered the vaccine because her daughter was scared. She drew up 0.3 mL of vaccine without diluent. Caller reported this happened yesterday at 10 am. Caller asked what we should look for in an over dosage and for how long. Caller stated "she had no fever yesterday but an overdose big time. she wanted to get her on board before she was aware of what''s going on but after she knew what happened she got scared. There was really no issue except arm was sore which was common with most but if it becomes more than you can handle let me know". Caller stated "She has had no other side effects, just worried about that (myocarditis) now. She will leave it at that. As far as the over dosage and asked how many cases have you had". Outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up


VAERS ID: 1685660 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-04
Onset:2021-07-14
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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: Saltine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: I had a rash that started between my breasts. I was itchy and burning along my breastbone. It comes and goes, more in the evening. The doctor about it twice because it was not going away. She is having me go see a specialist for it.


VAERS ID: 1469724 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

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

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

Write-up: Made me have period as I do not have them and have not had them for 3 years


VAERS ID: 1470123 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nasonex nose-spray as it was cold and rainy the days prior
Current Illness:
Preexisting Conditions: Had Asthma and Allergies while I was a kid, but no issues for about 10 years now
Allergies: Lactose intolerance
Diagnostic Lab Data: Examination by the doctor will be tomorrow (15th of July)
CDC Split Type:

Write-up: Felt dizzy a few minutes after the shot, then my chest suddenly started to feel very warm, then very dizzy and my ears started ringing, finally I''ve lost consciousness for a short while. I never had issues with vaccinations or needles and wasn''t consciously afraid of the vaccine that could have caused emotional stress, I was relieved the finally I''m getting the shot, so the whole thing really surprised me, and now I want to know whether it will be safe for me to the take the second dose on the 16th of August, which, as I''ve heard, actually has side-effects for most people.


VAERS ID: 1476556 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / UNK - / -

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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210729868

Write-up: FAINTED AND WAS OUT FOR 30 SECONDS; This spontaneous report received from a patient via a company representative concerned a 24 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-JUL-2021 roughly at 10:30 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient fainted following the vaccination and was out for 30 seconds. The patient was checked by his family doctor and was sent home to rest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.. The patient recovered from fainted and was out for 30 seconds on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210729868-covid-19 vaccine ad26.cov2.s- fainted and was out for 30 seconds 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: 1480502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: PTJNJFOC20210730973

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393, expiry: UNKNOWN) dose was not reported, 1 total administered on 14-JUL-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, in the afternoon at work the patient experienced a brief loss of consciousness. According to the co-worker it lasted for less than 1 minute. It was also reported that, the patient was healthy and had no other symptoms associated with this episode and denied of having chest pain, headache, difficulty, or any others. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210730973- covid-19 vaccine ad26.cov2.s - Loss of consciousness. 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: 1484342 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-14
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002541 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Fainted during the night; Lost consciousness for one or two seconds; Pain in the arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted during the night) and LOSS OF CONSCIOUSNESS (Lost consciousness for one or two seconds) in a 31-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3004219 and 3002541) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Jul-2021 at 11:00 AM, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (Fainted during the night) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Lost consciousness for one or two seconds) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches). At the time of the report, SYNCOPE (Fainted during the night), LOSS OF CONSCIOUSNESS (Lost consciousness for one or two seconds), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches) outcome was unknown. No concomitant disease or medication. The patient did not take any treatment. Patient was not pregnant as far as she was aware. 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. Swiss affiliate comment: This spontaneous report was received from a 31-year-old female patient who received the first dose of Moderna''s COVID-19 Vaccine (mRNA1273) on 08-JUN-2021 (Batch number: 3002541, exp date: not reported; arm not specified) and the second dose on 13-JUL-2021 11:00 a.m. (Batch number: 3004219, exp date: not reported; arm not specified) for prophylaxis of COVID-19 infection. With an onset latency of a few hours after the second dose, i.e. during the night from 13- to 14-JUL-2021, at around 02:00 a.m., the patient "fainted while preparing milk for her son". She lost consciousness for one or two seconds. She also reported "mild pain in the arm" and "mild headaches". No information regarding self-treatment applied for the reported event was provided. The patient''s medical history did not include any relevant comorbidities. No concomitant medication was applied around the time of vaccination. The company assessed the case as non-serious. Company''s assessment: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Local assessment: brief episode of fainting (onset latency: a few hours after the second dose, during the night at 02:00 a.m., while preparing milk for her son; no symptoms before fainting reported; not reported whether consciousness was completely or only partially lost, we assume a reflex-mediated syncope or pre-syncope possibly triggered by non-specific triggers, however other neural and/or cardiovascular and/or comedication- or infection-related causes cannot be ruled out; patient''s physical experience after the event or after regaining consciousness was not reported; affirmatively the loss of consciousness lasted for 1 to 2 seconds, but this information shall be regarded with caution) [unlabeled / in the general healthy population no aRMMs are necessary; missing information in possibly breastfeeding women; there are multiple conditions which may cause or resemble syncope/pre-syncope, individual patient''s risks are to be evaluated based on the patient''s detailed medical and medication history although it was overall reported by the patient as not relevant. The manufacturer''s information for healthcare professionals contains no information on possible interactions of the Moderna vaccine with any other medication (since this has not been studied), but the possibility of potentiation/drug interaction cannot be ruled out]; headaches (onset latency: not specified, within 24 hours after the second dose, grade not reported but implied by verbatim as mild) [possibly covered by headache / in the general healthy population no aRMMs are necessary; missing information in possibly breastfeeding women]; pain in arm (assumed vaccination arm, medical confirmation needed) (onset latency: not specified, within 24 hours after the second dose, grade not reported but implied by verbatim as mild) [unlabeled / in the general healthy population no aRMMs are necessary; missing information in possibly breastfeeding women]. The events reported on 14-JUL-2021 are assessed as possibly related to the vaccine, but confounders cannot be ruled out in the absence of a detailed medical and obstetric history. Outcome of the events is not known.; 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: 1485579 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Deep vein thrombosis, Hyperaesthesia, Influenza, Myalgia, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Pyrexia, Upper gastrointestinal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Left; Upper; Flu; Sore throat; Arm; Painful; Touch; Shivering; Feverish/fever; Muscle ache/muscle soreness; Swollen arm; This regulatory authority case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Left), UPPER GASTROINTESTINAL HAEMORRHAGE (Upper), INFLUENZA (Flu), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Arm), PAIN IN EXTREMITY (Painful), HYPERAESTHESIA (Touch), PERIPHERAL SWELLING (Swollen arm), CHILLS (Shivering), PYREXIA (Feverish/fever) and MYALGIA (Muscle ache/muscle soreness) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PYREXIA (Feverish/fever) (seriousness criterion medically significant) and MYALGIA (Muscle ache/muscle soreness) (seriousness criterion medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Left) (seriousness criterion medically significant), UPPER GASTROINTESTINAL HAEMORRHAGE (Upper) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful) (seriousness criterion medically significant), HYPERAESTHESIA (Touch) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (Left), UPPER GASTROINTESTINAL HAEMORRHAGE (Upper), INFLUENZA (Flu), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Arm), PAIN IN EXTREMITY (Painful), HYPERAESTHESIA (Touch) and CHILLS (Shivering) outcome was unknown and PERIPHERAL SWELLING (Swollen arm), PYREXIA (Feverish/fever) and MYALGIA (Muscle ache/muscle soreness) had not resolved. No concomitant medications were provided. Patient''s left upper arm was painful to touch and move and it was swollen around the injection site. Patient reported that he never had this pain or discomfort or reaction after the first injection . The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events has been provided at this time. No further information is expected.


VAERS ID: 1485583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

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

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

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (fainted while sitting) and SYNCOPE (Syncope vasovagal) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (fainted while sitting) (seriousness criterion medically significant), SYNCOPE (Syncope vasovagal) (seriousness criterion medically significant), PALLOR (pale) and COLD SWEAT (clammy). On 14-Jul-2021, SYNCOPE (fainted while sitting), SYNCOPE (Syncope vasovagal) and PALLOR (pale) had resolved. In July 2021, COLD SWEAT (clammy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. On 14-Jul-2021, a couple of minutes after vaccination, the patient fainted while sitting for observation. He recovered, however, his skin turned pale and clammy. He laid down with his legs raised and in some time his skin color turned normal. The patient was observed for 25 minutes total. The report states that in the past, the patient had no symptoms associated with COVID-19 and did not test for COVID-19. At the time of the report, the patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. No treatment medication information was provided by the reporter. The report stated that the reactions reported are not related to any possible blood clots or low platelet counts. 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: 1485588 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Heavy menstrual bleeding, Nausea, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Body temperature fluctuation; Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heavy periods; Pain; Nausea; Aching joints; Vomited; This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods), PAIN (Pain), NAUSEA (Nausea), ARTHRALGIA (Aching joints) and VOMITING (Vomited) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included FLUOXETINE for an unknown indication. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On 14-Jul-2021, VOMITING (Vomited) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy periods), PAIN (Pain), NAUSEA (Nausea) and ARTHRALGIA (Aching joints) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 14-Jul-2021, Body temperature: body temperature fluctuation (Inconclusive) Body temperature fluctuation. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided by the reporter. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority


VAERS ID: 1486479 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: All fine up until 13-14 hours after administration; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (All fine up until 13-14 hours after administration) and FATIGUE (Fatigue) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included PARACETAMOL from 13-Jul-2021 to an unknown date for Generalised muscle aches. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (All fine up until 13-14 hours after administration) (seriousness criterion medically significant). At the time of the report, NAUSEA (All fine up until 13-14 hours after administration) outcome was unknown and FATIGUE (Fatigue) was resolving. On 1st dose patient was not enrolled in clinical trial. 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. Very limited information regarding this events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time


VAERS ID: 1486480 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, 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: GBMHRAWEBCOVID20210714125

Write-up: Fainting; Feeling anxious; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and ANXIETY (Feeling anxious). On 14-Jul-2021, SYNCOPE (Fainting) and ANXIETY (Feeling anxious) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information included observation after onset of the events. No additional treatment was reported. Patient reporting feeling anxious and fainted x 2 immediately after receiving vaccination. Observed and recovered afterwards 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: 1486481 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-07-14
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

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

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

Write-up: Migraine; Migraine with aura; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and MIGRAINE WITH AURA (Migraine with aura) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Migraine and Lactation decreased. Concomitant products included AMITRIPTYLINE from 01-Apr-2021 to an unknown date for Migraine aura. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MIGRAINE WITH AURA (Migraine with aura). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) and MIGRAINE WITH AURA (Migraine with aura) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient was a sufferer of them hormonally and took preventative medication but that had not been effective for migraine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication details was provided.; 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: 1486494 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: Fatigue; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and INJECTION SITE PAIN (Injection site pain) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) was resolving and INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. It was reported that Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the 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: 1486502 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMHRAWEBCOVID20210714225

Write-up: Heavy periods; This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 24-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. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) for Contraception. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy periods) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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, 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: 1486503 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

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

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

Write-up: This regulatory authority case reported by a consumer, describes the occurrence of axillary pain (armpit pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 vaccination. No medical history reported. On Jul 13, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 14, 2021, patient experienced axillary pain (armpit pain). At the time of the report, axillary pain (armpit pain) was unresolved. Diagnostic results: On an unknown date, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was unknown. No relevant concomitant medications were reported. Patient has not tested positive for COVID-19 since the vaccination. Patient was not enrolled in a clinical trial. No treatment information provided. 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: 1486504 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
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: Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Pregnancy. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were reported. No treatment medication details was reported. It was reported that the adverse event did not occur as a result of an exposure to pregnancy. This is a case of product exposure during pregnancy with associated AE [Vomiting] for this 36-year-old female. No further information was noted. 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: This is a case of product exposure during pregnancy with associated AE [Vomiting] for this 36-year-old female. No further information was noted. 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: 1486507 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Contusion, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Arm pain; Bruise; High temperature; Shivering; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), PAIN IN EXTREMITY (Arm pain), CONTUSION (Bruise), PYREXIA (High temperature) and CHILLS (Shivering) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) (seriousness criterion medically significant) and CONTUSION (Bruise) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved, PAIN IN EXTREMITY (Arm pain), CONTUSION (Bruise) and PYREXIA (High temperature) was resolving and CHILLS (Shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative. 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: 1488428 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Limb discomfort, Menstrual disorder, 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: Medical History/Concurrent Conditions: Suppressed lactation
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: a few hours after vaccine, Fainting; six hours after vaccination an extremely heavy arm; Menstrual cycle abnormal; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (a few hours after vaccine, Fainting) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suppressed lactation. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal). On an unknown date, the patient experienced SYNCOPE (a few hours after vaccine, Fainting) (seriousness criterion medically significant) and LIMB DISCOMFORT (six hours after vaccination an extremely heavy arm). At the time of the report, SYNCOPE (a few hours after vaccine, Fainting) and LIMB DISCOMFORT (six hours after vaccination an extremely heavy arm) was resolving and MENSTRUAL DISORDER (Menstrual cycle abnormal) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. The patient was menstruating heavily a few hours after receiving the vaccine and the patient''s heavy arm eased after a day. Concomitant medication use and treatment information was not 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: 1488569 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Nausea, SARS-CoV-2 test, Throat irritation
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

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

Write-up: Itchy throat; Stomachache; Joint pain; Nausea; Diarrhea; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and THROAT IRRITATION (Itchy throat) in a 47-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. Concomitant products included ESTRADIOL (ESTRADOT) for Menopause, AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA) for Sinusitis. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced THROAT IRRITATION (Itchy throat) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and THROAT IRRITATION (Itchy throat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Treatment details were not 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. 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 IME listed and resolved).; 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 IME listed and resolved).


VAERS ID: 1488618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Sexual dysfunction (broad)

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

Write-up: Rigors; Numbness in hand; Muscle weakness; Shoulder pain; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Rigors), HYPOAESTHESIA (Numbness in hand), MUSCULAR WEAKNESS (Muscle weakness), ARTHRALGIA (Shoulder pain) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Hypertension NOS. Concomitant products included AMLODIPINE for Hypertension NOS. On 14-Jul-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) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant), ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 16-Jul-2021, HYPOAESTHESIA (Numbness in hand) had resolved. At the time of the report, CHILLS (Rigors), MUSCULAR WEAKNESS (Muscle weakness), ARTHRALGIA (Shoulder pain) and ARTHRALGIA (Joint pain) was resolving. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Patient had rigors, severe body and joint pains, painful swollen numb arm and shoulder pain. 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: 1489143 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Movement disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP060509

Write-up: Suspected acute disseminated encephalomyelitis (ADEM) (pyrexia, inability to move the leg); Inability to move the leg; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (Suspected acute disseminated encephalomyelitis (ADEM) (pyrexia, inability to move the leg)) in a 32-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (Suspected acute disseminated encephalomyelitis (ADEM) (pyrexia, inability to move the leg)) (seriousness criteria hospitalization and medically significant), MOVEMENT DISORDER (Inability to move the leg) and PYREXIA (Pyrexia). The patient was hospitalized on 14-Jun-2021 due to ACUTE DISSEMINATED ENCEPHALOMYELITIS. At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (Suspected acute disseminated encephalomyelitis (ADEM) (pyrexia, inability to move the leg)), MOVEMENT DISORDER (Inability to move the leg) and PYREXIA (Pyrexia) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ACUTE DISSEMINATED ENCEPHALOMYELITIS (Suspected acute disseminated encephalomyelitis (ADEM) (pyrexia, inability to move the leg)), MOVEMENT DISORDER (Inability to move the leg) and PYREXIA (Pyrexia) to be possibly related. No concomitant medications were provided by the reporter. Treatment information was not provided by the reporter. The reporter stated that on an unknown date, body temperature before the vaccination was 36.6 degrees Celsius. The reporter stated that the patient was admitted to hospital for suspected ADEM, and that tests and treatments were being performed. No dates or results were 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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.; 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 events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.


VAERS ID: 1489932 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Illness, Nausea, Pain, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shivering; Nausea; Fever; Sickness; Ache; Sensitive skin; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PAIN (Ache), SENSITIVE SKIN (Sensitive skin), HEADACHE (Headache), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) in a 26-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 13-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness), SENSITIVE SKIN (Sensitive skin), HEADACHE (Headache), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) was resolving and PAIN (Ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient overnight after the injection woke up shivering and cold with a fever. Not long after was sick and continued with nausea for two days following. Skin has been sensitive since injection and arm has ached and is very painful and continues to be. 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: 1489934 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Groin pain
SMQs:, Osteonecrosis (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: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain groin; This regulatory authority case was reported by a consumer and describes the occurrence of GROIN PAIN (Pain groin) in a 39-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. Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)). On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced GROIN PAIN (Pain groin) (seriousness criterion medically significant). At the time of the report, GROIN PAIN (Pain groin) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter.Treatment medication use information was not provided by reporter Patient not tested positive for COVID-19 since having the vaccine Patient iwas not enrolled in clinical trial. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes that the event is does not meet any criteria for seriousness and is thus non-serious and that the case is non-serious.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes that the event is does not meet any criteria for seriousness and is thus non-serious and that the case is non-serious.


VAERS ID: 1489936 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210713; 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: Ache; Late period; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache) and MENSTRUATION DELAYED (Late period) in a 27-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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). At the time of the report, PAIN (Ache) and MENSTRUATION DELAYED (Late period) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. 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: 1489938 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: 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: Discomfort; Arm discomfort; This regulatory authority case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) and LIMB DISCOMFORT (Arm discomfort) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 04-Oct-2020 to 10-Oct-2020. On 03-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On an unknown date, the patient experienced DISCOMFORT (Discomfort). The patient was treated with PARACETAMOL for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort) outcome was unknown and LIMB DISCOMFORT (Arm discomfort) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. Concomitant medication use information was not provided by reporter. Patient had "Covid arm" like discomfort to injected arm starting 12 days after vaccine.extreme discomfort feels like someone kneeling on the muscle at injection site. Patient was not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial; 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. However, details regarding diagnostics/ diagnosis/ treatment administered is required for further assessment.


VAERS ID: 1489939 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: headache; lethargy; Fever; Painful arm; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), LETHARGY (lethargy), PYREXIA (Fever) and PAIN IN EXTREMITY (Painful arm) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 20-Mar-2020 to 01-Nov-2020. On 14-Jul-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 14-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and LETHARGY (lethargy) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) and LETHARGY (lethargy) outcome was unknown and PYREXIA (Fever) and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. 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. Details regarding concomitant medications and medical history, and treatment details are required for further assessment. At present, all the evens appear to be non-serious. There is no contact detail and follow-up is not possible.; 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. Details regarding concomitant medications and medical history, and treatment details are required for further assessment. At present, all the evens appear to be non-serious. There is no contact detail and follow-up is not possible.


VAERS ID: 1489954 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Nauseous; Hot flushes; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and HOT FLUSH (Hot flushes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced NAUSEA (Nauseous) and HOT FLUSH (Hot flushes). On 15-Jul-2021, HOT FLUSH (Hot flushes) had resolved. At the time of the report, NAUSEA (Nauseous) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications on use were not provided. Treatment information was not provided by the reporter.; 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: 1489958 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Insomnia, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Slight temperature; Chills; Sleeplessness; This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), PYREXIA (Slight temperature) and CHILLS (Chills) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced INSOMNIA (Sleeplessness) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced PYREXIA (Slight temperature) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 15-Jul-2021, PYREXIA (Slight temperature) and CHILLS (Chills) had resolved. At the time of the report, INSOMNIA (Sleeplessness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Not tested positive for covid -19 test. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Not applicable) 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. Events seriousness captured; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured.


VAERS ID: 1489959 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Lymphadenopathy, Palpitations, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Palpitations; Dizziness; Pulsatile tinnitus; Glands swollen; This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), DIZZINESS (Dizziness), TINNITUS (Pulsatile tinnitus) and LYMPHADENOPATHY (Glands swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), TINNITUS (Pulsatile tinnitus) (seriousness criterion medically significant) and LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations) and TINNITUS (Pulsatile tinnitus) was resolving and DIZZINESS (Dizziness) and LYMPHADENOPATHY (Glands swollen) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication information provided. No relevant treatment medication information 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: 1489992 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea
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: Body mass index increased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Period pains; This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Body mass index increased. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Period pains) had not resolved. The concomitant medications on use were not provided. 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 event, a causal relationship cannot be excluded. Event seriousness captured as per Regulatory Authority assessment; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness captured as per Regulatory Authority assessment


VAERS ID: 1492154 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE; VITAMIN D [VITAMIN D NOS]
Current Illness: Hay fever
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Body temperature; Ache; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hay fever. Concomitant products included CETIRIZINE HYDROCHLORIDE for Hay fever, VITAMIN D [VITAMIN D NOS] for an unknown indication. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced BODY TEMPERATURE (Body temperature). At the time of the report, PAIN (Ache) had not resolved and BODY TEMPERATURE (Body temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 14-Jul-2021, the patient recorded body temperature and had not recovered from it. Patient also suffered from changes in body temperature on 14-JUL-2021, its not clear from SD whether it is high or low temperature to capture it as an event and outcome of the event is not recovered at the tim e of report. 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. However, the event appears to be non-serious at present.; 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. However, the event appears to be non-serious at present.


VAERS ID: 1492161 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Discomfort, Headache, Influenza, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Discomfort; Flu like symptoms; Joint pain; Fever chills; Headache; Chest pain; Flu symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHEST PAIN (Chest pain), INFLUENZA (Flu symptoms), ARTHRALGIA (Joint pain), PYREXIA (Fever chills) and HEADACHE (Headache) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Headache. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion disability), INFLUENZA (Flu symptoms) (seriousness criterion disability) and HEADACHE (Headache) (seriousness criterion disability). On an unknown date, the patient experienced DISCOMFORT (Discomfort) (seriousness criterion disability), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and PYREXIA (Fever chills) (seriousness criterion disability). At the time of the report, DISCOMFORT (Discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had not resolved, CHEST PAIN (Chest pain) and INFLUENZA (Flu symptoms) was resolving and PYREXIA (Fever chills) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication were provided. It was reported that symptoms were severe causing significant discomfort and concern. The flu like symptoms were on a scale that patient never experienced before. Patient was 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: 1492192 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Pyrexia, Rash, Rash pruritic, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red itchy rash appeared at vaccine site; Rash; Red itchyrash appeared at vaccination site; Flu like symptoms; Fever; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH PRURITIC (Red itchy rash appeared at vaccine site), RASH (Rash), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red itchyrash appeared at vaccination site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No medical history was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced RASH PRURITIC (Red itchy rash appeared at vaccine site) (seriousness criterion medically significant) and VACCINATION SITE ERYTHEMA (Red itchyrash appeared at vaccination site) (seriousness criterion medically significant). 16-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 16-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved, RASH PRURITIC (Red itchy rash appeared at vaccine site) and VACCINATION SITE ERYTHEMA (Red itchyrash appeared at vaccination site) outcome was unknown and RASH (Rash) was resolving. Patient''s COVID-19 Virus test was negative on an unknown date. The concomitant medications information was reported. No treatment information was provided. Reaction did not happened after first dose. 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: 1492208 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune neutropenia, Chills, Fatigue, Mouth ulceration, Oral pain, Pain in extremity, SARS-CoV-2 test, Urinary tract infection
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Full blood count normal; Oral pain; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210718; 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: febrile; constitutional symptoms; rigors; oral pain; oral ulceration; arm pain; Autoimmune neutropenia; This regulatory authority case was reported by a physician and describes the occurrence of FATIGUE (febrile), URINARY TRACT INFECTION (constitutional symptoms), CHILLS (rigors), ORAL PAIN (oral pain), MOUTH ULCERATION (oral ulceration), PAIN IN EXTREMITY (arm pain) and AUTOIMMUNE NEUTROPENIA (Autoimmune neutropenia) in a 29-year-old male patient 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. The patient''s past medical history included Oral pain and Full blood count normal in August 2018. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MOUTH ULCERATION (oral ulceration) (seriousness criteria hospitalization, medically significant and life threatening) and PAIN IN EXTREMITY (arm pain) (seriousness criteria hospitalization, medically significant and life threatening). 14-Jul-2021, the patient experienced AUTOIMMUNE NEUTROPENIA (Autoimmune neutropenia) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced FATIGUE (febrile) (seriousness criteria hospitalization, medically significant and life threatening), URINARY TRACT INFECTION (constitutional symptoms) (seriousness criteria hospitalization, medically significant and life threatening), CHILLS (rigors) (seriousness criteria hospitalization, medically significant and life threatening) and ORAL PAIN (oral pain) (seriousness criteria hospitalization and life threatening). At the time of the report, FATIGUE (febrile), URINARY TRACT INFECTION (constitutional symptoms), CHILLS (rigors), ORAL PAIN (oral pain), MOUTH ULCERATION (oral ulceration) and PAIN IN EXTREMITY (arm pain) had resolved and AUTOIMMUNE NEUTROPENIA (Autoimmune neutropenia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient reported day following vaccination, developed unilateral arm pain around injection site, some oral ulceration, and constitutional symptoms. Arm pain resolved, but oral ulceration worsened as did constitutional symptoms. This morning felt much worse, with subjective fevers and rigors at home, oral pain was severe and limiting oral intake. Presented to ED and found to be febrile with an isolated neutropoenia and admitted for further investigation and empirical Abx for febrile neutropoenia. On an unknown date, FBC shows isolated neutropoenia, with normal Hb & Plts. Blood film shows true neutropoenia with no blasts, reactive lymphoctyes, slight monocytosis with mature looking monocytes. U+Es normal, Isolated hyperbilirubinaemia of around 30. CRP elevated. Viral serology negative thus far for HIV, HTLV, HBV, HCV, EBV & CMV. Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.


VAERS ID: 1492225 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, 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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; 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: Sickness; Fatigue; Painful arm; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), ILLNESS (Sickness), HEADACHE (Headache) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), ILLNESS (Sickness), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that after received second dose after 20mins, he had hot flushes not sure if related to vaccine or stress at getting needle.On 15-Jul-2021 along with sore arm he feel sick, tired and fatigued and also have a headache. Patient was not enrolled in clinical trial. No concomitant medications and medical history were provided by the reporter. 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. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received: Event added.; 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: 1492750 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210740589

Write-up: PRODUCT QUALITY COMPLAINT; SYNCOPE; This spontaneous report received from a consumer via social media concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-JUL-2021, the patients experienced syncope. On 15-JUL-2021, the patients reported product quality complaint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product quality complaint and syncope was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186256.; Sender''s Comments: V0: 20210740589-COVID-19 VACCINE AD26.COV2.S-Syncope and Product quality complaint. 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: 1493519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Dyspnoea, Echocardiogram, Hypertension, Malaise, Presyncope, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Undergone cardio
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Echocardiogram; Result Unstructured Data: No Changes; Test Date: 20210720; Test Name: Blood pressure; Result Unstructured Data: 180/110
CDC Split Type: BRJNJFOC20210743673

Write-up: HYPERTENSION / PRESSURE WAS 180 BY 110; SYNCOPE LIKE SYMPTOM; DYSPNEA; DIZZY; SUDDEN MALAISE; WEAK; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included undergone cardio. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Echocardiogram (NR: not provided) No Changes. On 14-JUL-2021, patient experienced fever which was until 16-JUL-2021. On 20-JUL-2021, He was hospitalized with sudden malaise, pressure 180/110 and dyspnea. He felt weak, dizzy as if he was going to have syncope and also when measured the high blood pressure and heart rate signals. His echocardiogram had no changes. Laboratory data included: Blood pressure (NR: not provided) 180/110. In MAR-2021, he already underwent cardio. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-JUL-2021, and the outcome of sudden malaise, hypertension / pressure was 180 by 110, dyspnea, weak, syncope like symptom and dizzy was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210743673-covid-19 vaccine ad26.cov2.s-hypertension / pressure was 180 by 110, syncope like symptom, dyspnea, dizzy . 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). 20210743673-covid-19 vaccine ad26.cov2.s-Sudden malaise, weak. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1496337 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906995

Write-up: Facial droop; Swelling; This is a spontaneous report. A 31-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 14Jul2021, (at the age of 31-year-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine; Patient was not enrolled in clinical trial. On 14Jul2021, the patient experienced facial droop and swelling. The patient stated that the about 10 minutes after the vaccine he noticed his left side of his face feeling a bit heavy and almost a numb feeling. A few hours later it''s still felt the same. Later in the day it still felt the same and was feeling as If it was swollen too. The following morning when he woke up the feeling was almost gone. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. The outcome of the event facial droop and swelling was recovered on 15Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1496349 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: MILLINETTE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Lumpy node uber armpit still swollen. Happened with first vaccine; Swollen glands; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands) 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. Concomitant products included ETHINYLESTRADIOL, GESTODENE (MILLINETTE) for an unknown indication. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (Lumpy node uber armpit still swollen. Happened with first vaccine). At the time of the report, LYMPHADENOPATHY (Swollen glands) had not resolved and LYMPHADENOPATHY (Lumpy node uber armpit still swollen. Happened with first vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient was reporting Lumpy node Uber armpit still swollen. Happened with first vaccine but didn''t think it was related at the time. 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. Event seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1496370 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dizziness, Fatigue, Hypoaesthesia, Musculoskeletal chest pain, Nervousness, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: Shaky feelings; Low back pain; Pain in extremity; Swollen arm; Fatigue; Rib pain; Numbness; Dizzy; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), MUSCULOSKELETAL CHEST PAIN (Rib pain), HYPOAESTHESIA (Numbness), NERVOUSNESS (Shaky feelings), BACK PAIN (Low back pain), PAIN IN EXTREMITY (Pain in extremity), DIZZINESS (Dizzy) and FATIGUE (Fatigue) in a 25-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. Concomitant products included HYOSCINE BUTYLBROMIDE (BUSCOPAN) and NORETHISTERONE (NORIDAY) for Adenomyosis, CYCLIZINE for Nausea. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant) and DIZZINESS (Dizzy) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), NERVOUSNESS (Shaky feelings) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 14-Jul-2021, MUSCULOSKELETAL CHEST PAIN (Rib pain) had resolved. On 15-Jul-2021, NERVOUSNESS (Shaky feelings), PAIN IN EXTREMITY (Pain in extremity) and DIZZINESS (Dizzy) had resolved. On 16-Jul-2021, HYPOAESTHESIA (Numbness), BACK PAIN (Low back pain) and FATIGUE (Fatigue) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had not resolved. 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: 1496389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Myopericarditis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-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) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with COLCHICINE for Myopericarditis, at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter provided a negative COVID-19 test at an unknown date. Concomitant medications were not provided by the reporter. It was reported that the patient did receive non-specified analgesia for myopericarditis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was unknown. Based on the current available information and temporal association between the use of the product and the 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: 1496960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: positive; Test Name: Body temperature; Result Unstructured Data: 36.5-38.5?C
CDC Split Type: NLJNJFOC20210740812

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION,(FEVER,FEELING SICK); This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975, expiry: unknown) dose was not reported, frequency 1 total administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient experienced fever, which was continuing for 3 days. On 15-JUL-2021, she was tested positive for COVID-19 (suspected COVID-19 infection) despite vaccination 6 weeks ago (suspected clinical vaccination failure). On 16-JUL-2021, she was feeling sick. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 36.5-38.5?C. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection,(fever, feeling sick), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186270 The suspected product quality complaint has been confirmed to be void: N based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: 20210740812-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1497625 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Chills, Fatigue, Headache, Hyperhidrosis, Malaise, Paraesthesia, Presyncope, Pyrexia, SARS-CoV-2 test, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: FLUOXETIN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Anxiety attack; Chills; Fever; Fatigue; fainted; Vomiting; Headache; Pins and needles; Near fainting; Generally unwell; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Generally unwell), PARAESTHESIA (Pins and needles), PRESYNCOPE (Near fainting), HYPERHIDROSIS (Sweating), ANXIETY (Anxiety attack), VOMITING (Vomiting), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and SYNCOPE (fainted) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included FLUOXETINE HYDROCHLORIDE (FLUOXETIN) for Anxiety. On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). 14-Jul-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). 14-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). 14-Jul-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Generally unwell) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), ANXIETY (Anxiety attack) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, MALAISE (Generally unwell), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving, PARAESTHESIA (Pins and needles), PRESYNCOPE (Near fainting), HYPERHIDROSIS (Sweating), ANXIETY (Anxiety attack), VOMITING (Vomiting) and PYREXIA (Fever) had resolved and CHILLS (Chills) and SYNCOPE (fainted) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. No treatment medication was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1497633 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Blood test, Chest discomfort, Electrocardiogram, Fatigue, Feeling cold, Heart rate, Middle insomnia, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood Tests; Result Unstructured Data: clear; Test Name: ECG; Result Unstructured Data: came back clear.; Test Name: HEART RATE; Result Unstructured Data: suddenly my heart beat got much faster; 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: Shaking; Night sleep; Tingling sensation; Sore arm; i was left tired; my heartbeat got much faster; feeling of something pressing on my chest; i was very cold; Anxiety attack; This regulatory authority case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety attack), TREMOR (Shaking), MIDDLE INSOMNIA (Night sleep), PARAESTHESIA (Tingling sensation) and PAIN IN EXTREMITY (Sore arm) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002615) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ANXIETY (Anxiety attack) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced TACHYCARDIA (my heartbeat got much faster), CHEST DISCOMFORT (feeling of something pressing on my chest) and FEELING COLD (i was very cold). On an unknown date, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), MIDDLE INSOMNIA (Night sleep) (seriousness criterion medically significant), PARAESTHESIA (Tingling sensation) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and FATIGUE (i was left tired). At the time of the report, ANXIETY (Anxiety attack) had not resolved, TREMOR (Shaking), MIDDLE INSOMNIA (Night sleep), PARAESTHESIA (Tingling sensation) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and TACHYCARDIA (my heartbeat got much faster), CHEST DISCOMFORT (feeling of something pressing on my chest), FEELING COLD (i was very cold) and FATIGUE (i was left tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) clear. On an unknown date, Electrocardiogram: normal (normal) came back clear.. On an unknown date, Heart rate: increased (High) suddenly my heart beat got much faster. On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. The patient also reported that a week after vaccination, his heart beat got much faster and he had a feeling of something pressing on his chest. Then, he got a tingling sensation in both arms followed by really intense shaking (he was very cold but not sweating). This cycle repeated twice and he went to the A&E. He was left tired but after a good night sleep he felt better. Had three days of no symptoms and then he had another episode on Monday 19th, almost ten days after his dose. Not as intense as the first (less shaking) but still pretty grim. Treatment information 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. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1499755 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood lactic acid, Headache, Migraine, Muscular weakness, Myalgia, Pain in extremity, Pyrexia, Thyroid disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE SODIUM; MULTIVITAMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood iron decreased; Blood urea; Chickenpox; Cough; Flu; Fungal infection; Hay fever (Tree pollen); Henoch Shonlein purpura (which wrecked my iron levels, made me vomit for weeks on end, gave me reactive arthritis, reduced my weight excessively and generally annoying for my kidney function. I eventually got treated with 20mg of prednisolone stepping down to 5mg/day, ferrocontin folic, and various anti-bacterial drugs. HSP symptoms often returned on and off every three or four years. My last episode was treated in 2006. The original GP had only seen this in children and had given me gentamicin. Normally before getting symptoms I got a / get a sore throat and a rash - papura. My previous GPs often mistook this as a fungal infection which slowed down treatment in recent times. With the episode in 2006 I did have a ultrasound and usual 24hr urea checks.); Henoch-Schonlein purpura (At the age of 21 whilst living in London.*); Kidney function abnormal; Malaria (Suspected); Measles (Mild); Migraine; Muscle cramps; Polio; Purpuric rash; Rash; Reactive arthritis; Scarlet fever (Suspected); Sore throat; Tetanus; Ultrasound scan; Unintentional weight loss; Urea; Vaccination site mass; Varicella-like rash; Vomiting; Weight; Whooping cough
Allergies:
Diagnostic Lab Data: Test Name: lactic acid; Result Unstructured Data: low; Test Name: thyroid; Result Unstructured Data: Low
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: weakness; migraine; weakness; muscle pain; fever; headache; Slight temperature; Painful L arm; This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MIGRAINE (migraine), MUSCULAR WEAKNESS (weakness), PAIN IN EXTREMITY (Painful L arm), MYALGIA (muscle pain), PYREXIA (fever), PYREXIA (Slight temperature) and HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. * Symptoms often returned on and off every three or four years. My last episode was treated in 2006. Normally before getting symptoms I got a / get a sore throat and a rash - papura. My previous GPs often mistook this as a fungal infection which slowed down treatment in recent times. With the episode in 2006 I did have a ultrasound and usual 24hr urea checks. My parents tell me I reacted pretty badly to the whooping cough vaccine and subsequently caught it. I do believe that I also had Scarlet fever. I always had up-to-date polio, tetanus and diphtheria vaccines, I caught chicken pox and also mild measles. I don''t recall having mumps, but it would have also been mid childhood. Bacille Calmette-Gu?rin (BCG) vaccine - had minor reaction on first test - so no main jab. For work period in Angola - had Yellow Fever jab - lasted for ten years. Not renewed, I did return once with suspected malaria - French Dr''s gave me quinine based drugs and some other items that were not NHS approved at the time. - 1997 I have not taken a flu vaccine. As a child, flu and common colds and even during late twenties and early thirties would keep me bedridden for between 1 day to a week or so. Usually now colds or coughs only last one or two days. Anything longer has often coincided when my weight has gone up and my thyroxine levels have dropped. I sort of suspect that I may have had something weird this and last year but not really definitive. What I have noticed is wearing a mask has reduced my hay fever - (tree pollen being my usual problem). Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s past medical history included Henoch Shonlein purpura (which wrecked my iron levels, made me vomit for weeks on end, gave me reactive arthritis, reduced my weight excessively and generally annoying for my kidney function. I eventually got treated with 20mg of prednisolone stepping down to 5mg/day, ferrocontin folic, and various anti-bacterial drugs. HSP symptoms often returned on and off every three or four years. My last episode was treated in 2006. The original GP had only seen this in children and had given me gentamicin. Normally before getting symptoms I got a / get a sore throat and a rash - papura. My previous GPs often mistook this as a fungal infection which slowed down treatment in recent times. With the episode in 2006 I did have a ultrasound and usual 24hr urea checks.) in 1995, Fungal infection, Kidney function abnormal, Scarlet fever (Suspected), Muscle cramps, Sore throat, Varicella-like rash, Vaccination site mass, Hay fever (Tree pollen), Tetanus, Measles (Mild), Malaria (Suspected) in 1997, Weight, Vomiting, Polio, Cough, Urea, Rash, Flu, Migraine, Henoch-Schonlein purpura (At the age of 21 whilst living in London.*), Blood iron decreased, Reactive arthritis, Unintentional weight loss, Purpuric rash, Ultrasound scan, Blood urea, Whooping cough and Chickenpox. Previously administered products included for Hypothyroidism: LEVOTHYROXINE TEVA; for Pertussis immunisation: BORDETELLA PERTUSSIS; for Tuberculosis immunisation: BCG; for Yellow fever immunisation: YELLOW FEVER VACCINE; for Immunisation: DT IPV VACCINE; for an unreported indication: DTPA IPV HIB VACCINE (DTPA IPV VACCINE - reacted pretty badly to the Whooping cough vaccine and subsequently caught it), YELLOW FEVER VACCINE, PREDNISOLONE, FERROCONTIN FOLIC, GENTAMICIN, THYROXINE, MANNITOL, IRON, LACTIC ACID and MAGNESIUM. Past adverse reactions to the above products included Adverse drug reaction with BCG; and Fever with LEVOTHYROXINE TEVA. Concomitant products included LEVOTHYROXINE SODIUM for Hypothyroidism, MULTIVITAMIN for an unknown indication. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful L arm) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced PYREXIA (Slight temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (weakness) (seriousness criterion medically significant), MIGRAINE (migraine) (seriousness criterion medically significant), MUSCULAR WEAKNESS (weakness) (seriousness criterion medically significant), MYALGIA (muscle pain) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Pain and Body temperature increased, at an unspecified dose and frequency; IBUPROFEN for Pain and Body temperature increased, at a dose of 200 mg and VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness) and PYREXIA (fever) had not resolved, MIGRAINE (migraine), MUSCULAR WEAKNESS (weakness), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown and PAIN IN EXTREMITY (Painful L arm) and PYREXIA (Slight temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid: low (Low) low. On an unknown date, Thyroid disorder: low (Low) Low. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient had multi-vitamins and drinks with potassium, magnesium, Vitamin A-E and Bs. Concomitant medication also included levothyroxine sodium anhydrous Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received from regulatory authority: Based on the follow up information this case was upgraded from non-serious to serious; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.


VAERS ID: 1499772 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Dysgeusia, Ear pain, Headache, Hypoaesthesia oral, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELOCON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Ear ache; Numbness of tongue; Headache; Palsy Bells; change in taste; This regulatory authority case was reported by a consumer and describes the occurrence of BELL''S PALSY (Palsy Bells), EAR PAIN (Ear ache), HYPOAESTHESIA ORAL (Numbness of tongue) and HEADACHE (Headache) in a 42-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. Concomitant products included MOMETASONE FUROATE (ELOCON) from 01-Jun-2021 to an unknown date for Skin dry. On 09-Jul-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 14-Jul-2021, the patient experienced BELL''S PALSY (Palsy Bells) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced EAR PAIN (Ear ache) (seriousness criteria hospitalization and disability), HYPOAESTHESIA ORAL (Numbness of tongue) (seriousness criteria hospitalization and disability), HEADACHE (Headache) (seriousness criteria hospitalization and disability) and DYSGEUSIA (change in taste). At the time of the report, BELL''S PALSY (Palsy Bells), EAR PAIN (Ear ache), HYPOAESTHESIA ORAL (Numbness of tongue), HEADACHE (Headache) and DYSGEUSIA (change in taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported began with severe headache on right side with ear ache on same side. Face ache. Then numbness of tongue and change in taste. Then inability to blink one eye or move one side of face or mouth. Vaccine was administered on right arm. Gradual onset over 3-4 days. Treatment information was not provided. On unknown date Bloods, ECG and chest scan were performed and results were not specified. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment.


VAERS ID: 1499776 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Diarrhoea, Dysphagia, Headache, Hyperhidrosis, Malaise, Migraine, Musculoskeletal stiffness, Myalgia, Pain, Peripheral swelling, Pruritus, Pyrexia, Somnolence, Speech disorder, Vaccination site erythema, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: itchy; mumbling; pain; sweat was running of me like i was in a shower; move my limbs they were to stiff; belly was sore and tender; didnt eat just sips of water that hurt to swallow; arm where i had the injection went red and itchy; arm where i had the injection went red and itchy; headaches; Aching joints; Appetite lost; Feeling sick; Diarrhoea; Swollen arm; Sleepy; Migraine; Muscle pain; Fever; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itchy), SPEECH DISORDER (mumbling), PAIN (pain), MIGRAINE (Migraine), DECREASED APPETITE (Appetite lost), MALAISE (Feeling sick), DIARRHOEA (Diarrhoea), PERIPHERAL SWELLING (Swollen arm), SOMNOLENCE (Sleepy), HYPERHIDROSIS (sweat was running of me like i was in a shower), MUSCULOSKELETAL STIFFNESS (move my limbs they were to stiff), ABDOMINAL PAIN (belly was sore and tender), DYSPHAGIA (didnt eat just sips of water that hurt to swallow), VACCINATION SITE ERYTHEMA (arm where i had the injection went red and itchy), VACCINATION SITE PRURITUS (arm where i had the injection went red and itchy), MYALGIA (Muscle pain), PYREXIA (Fever), HEADACHE (headaches), CHILLS (Chills) and ARTHRALGIA (Aching joints) in a 39-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 Lactation decreased. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion disability), SOMNOLENCE (Sleepy) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability) and CHILLS (Chills) (seriousness criterion disability). On 15-Jul-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion disability), MALAISE (Feeling sick) (seriousness criterion disability), DIARRHOEA (Diarrhoea) (seriousness criterion disability), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion disability) and ARTHRALGIA (Aching joints) (seriousness criterion disability). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion disability), SPEECH DISORDER (mumbling) (seriousness criterion disability), PAIN (pain) (seriousness criterion disability), HYPERHIDROSIS (sweat was running of me like i was in a shower) (seriousness criterion disability), MUSCULOSKELETAL STIFFNESS (move my limbs they were to stiff) (seriousness criterion disability), ABDOMINAL PAIN (belly was sore and tender) (seriousness criterion disability), DYSPHAGIA (didnt eat just sips of water that hurt to swallow) (seriousness criterion disability), VACCINATION SITE ERYTHEMA (arm where i had the injection went red and itchy) (seriousness criterion disability), VACCINATION SITE PRURITUS (arm where i had the injection went red and itchy) (seriousness criterion disability) and HEADACHE (headaches) (seriousness criterion disability). The patient was treated with PARACETAMOL at an unspecified dose and frequency. On 17-Jul-2021, DECREASED APPETITE (Appetite lost), MALAISE (Feeling sick), DIARRHOEA (Diarrhoea), SOMNOLENCE (Sleepy), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Aching joints) had resolved. At the time of the report, PRURITUS (itchy), SPEECH DISORDER (mumbling), PAIN (pain) and HEADACHE (headaches) had not resolved, MIGRAINE (Migraine) and PERIPHERAL SWELLING (Swollen arm) was resolving and HYPERHIDROSIS (sweat was running of me like i was in a shower), MUSCULOSKELETAL STIFFNESS (move my limbs they were to stiff), ABDOMINAL PAIN (belly was sore and tender), DYSPHAGIA (didnt eat just sips of water that hurt to swallow), VACCINATION SITE ERYTHEMA (arm where i had the injection went red and itchy) and VACCINATION SITE PRURITUS (arm where i had the injection went red and itchy) outcome was unknown. The fever left her skin on fire to the point and she could not feel her lips. Her head felt like it was bordering on exploding it was even worse if she bent over and in her laying down position did not help. She still getting headaches on and off now. She was bed bound and had to be looked after. Slept most of it as she could not stay awake for long it was out of her control and apparently, she could not speak clearly just mumbling. Her arm where she had the injection went red and itchy, spread to the size of her opened hand and ballooned up and was only now going. She gone to hospital, but she was to scare to go. She used paracetamol which did not work and loads of ice pack over her body and around her head which helped. Concomitant medication information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1499812 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Lymph node pain, Malaise, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Unwell
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: High; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: HIGH; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: HIGH
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Lymph node pain; Breathlessness; Sore throat; General malaise; High temperature; Frequent headaches; Generalised muscle aches; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness), OROPHARYNGEAL PAIN (Sore throat), MALAISE (General malaise), LYMPH NODE PAIN (Lymph node pain), PYREXIA (High temperature), HEADACHE (Frequent headaches), MYALGIA (Generalised muscle aches) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Pregnancy and Unwell in March 2020. On 14-Jul-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) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), MALAISE (General malaise) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Frequent headaches) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant) and LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. On 16-Jul-2021, PYREXIA (High temperature) and MYALGIA (Generalised muscle aches) had resolved. On 18-Jul-2021, DYSPNOEA (Breathlessness), LYMPH NODE PAIN (Lymph node pain) and HEADACHE (Frequent headaches) had resolved. On 21-Jul-2021, OROPHARYNGEAL PAIN (Sore throat), MALAISE (General malaise) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Body temperature: high (High) High. On 15-Jul-2021, Body temperature: high (High) HIGH. On 16-Jul-2021, Body temperature: high (High) HIGH. Concomitant products were not applicable. The patient mentioned she does not take any regular medications, including birth control. Patient reported that she was unable to exercise due to horrendous fatigue for a full week after the jab and she''s usually on the go every day with a workout or run and yoga. With the first jab she also felt fatigued, but only for a day. The second jab was much worse. 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: 1500216 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: At 10:02, Blood pressure 76/45 mmHg; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: At 10:06, Blood pressure 98/67 mmHg; Test Date: 20210714; Test Name: Blood pressure; Test Result: Inconclusive; Result Unstructured Data: At 10:12, Blood pressure 130/72 mmHg; Test Date: 20210714; Test Name: Blood pressure; Test Result: Inconclusive; Result Unstructured Data: at 10:23, Blood pressure 112/58 mmHg; Test Name: Body temperature; Test Result: Inconclusive; Result Unstructured Data: 36.8 degrees Celsius before vaccination; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: At 10:02, pulse rate 39; Test Date: 20210714; Test Name: Pulse rate; Test Result: Inconclusive; Result Unstructured Data: At 10:12, pulse rate 68; Test Date: 20210714; Test Name: Oxygen saturation; Result Unstructured Data: 99%.
CDC Split Type: JPTAKEDA2021TJP059990

Write-up: Consciousness disturbed; Vasovagal reaction; This regulatory authority case was reported by a physician and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Consciousness disturbed) and PRESYNCOPE (Vasovagal reaction) in a 20-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Consciousness disturbed) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reaction) (seriousness criterion medically significant). On 14-Jul-2021, ALTERED STATE OF CONSCIOUSNESS (Consciousness disturbed) and PRESYNCOPE (Vasovagal reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: 76/45 mmhg (Low) At 10:02, Blood pressure 76/45 mmHg, 98/67 mmhg (Low) At 10:06, Blood pressure 98/67 mmHg, 130/72 mmhg (Inconclusive) At 10:12, Blood pressure 130/72 mmHg and 112/58 mmhg (Inconclusive) at 10:23, Blood pressure 112/58 mmHg. On 14-Jul-2021, Heart rate: 39 (Low) At 10:02, pulse rate 39 and 68 (Inconclusive) At 10:12, pulse rate 68. On 14-Jul-2021, Oxygen saturation: 99% (normal) 99%. On an unknown date, Body temperature: 36.8 degrees celsius (Inconclusive) 36.8 degrees Celsius before vaccination. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ALTERED STATE OF CONSCIOUSNESS (Consciousness disturbed) and PRESYNCOPE (Vasovagal reaction) to be possibly related. Concomitant product was not provided by the reporter. On 14-Jul-2021, at 09:58, while on observation patrol, the patient declared in a mosquito-like voice that something was strange. After that consciousness, the patient experienced coma scale of 100, and rolling of his eyes and complexion ill developed, and radial artery was non-palpable. At 10:00, he was placed on stretcher and the his lower legs were raised. At 10:02, improvement was noted with JCS 0. At 10:23, blood pressure BP improved to 112/58, and observation was completed. Medicinal 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: 1500250 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXJNJFOC20210745143

Write-up: HAD FIFTEEN SEIZURES; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, Expiry: Unknown) dose was not reported, 1 total administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-JUL-2021, the patient had fifteen seizures, and was hospitalized (date and days were unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had fifteen seizures was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210745143-COVID-19 VACCINE AD26.COV2.S- HAD FIFTEEN SEIZURES. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1501727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C11-05 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: PCR; Result Unstructured Data: diagnosis was confirmed
CDC Split Type: CHJNJFOC20210743845

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female. The patient''s height, and weight were not reported. The concurrent condition of patient included non-smoker at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C11-05 and expiry: unknown) dose was not reported with frequency 1 total administered on 23-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021 (approximately 6 weeks after vaccination), the patient experienced confirmed covid-19 infection and acquired relatively mild (flu-like) symptoms (clinical vaccination failure) with no fever and cough were reported. On 18-JUL-2021 the diagnosis was confirmed by polymerase chain reaction (PCR) test. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed Covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186724.; Sender''s Comments: V0:20210743845 -Covid-19 vaccine ad26.cov2.-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210743845-Covid-19 vaccine ad26.cov2.s-Confirmed Covid 19 infection. 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: 1502272 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea, Neck pain, Photosensitivity reaction, Skin warm
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (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: Pulmicort Vitamins c, d, B2, B12
Current Illness:
Preexisting Conditions: ME/CFS POTS Asthma
Allergies: Dust
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme headaches (worst of my life), neck pain, photosensitivity, nausea, dizziness, exhaustion (bed bound), brain fog, neck area very hot. Two weeks on, still exhausted, dizzy, bed bound, and with brain fog.


VAERS ID: 1504155 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Diarrhoea, Dizziness, Pain of skin, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: pyrexia; Result Unstructured Data: Test Result:pyrexia; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906820

Write-up: Diarrhoea; Skin pain; Aching joints; Pyrexia; Dizziness; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107152039463530-9VNYX, Safety Report Unique Identifier GB-MHRA-ADR 25659485. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 38-year-old on 14Jul2021 (Lot Number: FC9001) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, Allergy. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient was previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for COVID-19 immunization. Concomitant medication included fexofenadine (Manufacturer unknown) taken for Allergy from 01Jan2005. The patient experienced aching joints (medically significant) on 14Jul2021, pyrexia (medically significant) on 14Jul2021, dizziness (medically significant) on 14Jul2021, diarrhoea (medically significant) on 15Jul2021, skin pain (medically significant) on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test), body temperature: pyrexia on 14Jul2021. The outcome of event pyrexia was recovering. The outcome of other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1504206 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Blood test, Chest X-ray, Pruritus, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 2021; Test Name: chest x-ray; Result Unstructured Data: normal; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative for covid 19
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: hives; itchy; Giant hives; This regulatory authority case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Giant hives) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced ANGIOEDEMA (Giant hives) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (hives) and PRURITUS (itchy). At the time of the report, ANGIOEDEMA (Giant hives) was resolving and URTICARIA (hives) and PRURITUS (itchy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Chest X-ray: normal (normal) normal. In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative for covid 19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient had a severe reaction of hives starting with both her fingers and hands moving towards the limbs and similarly with the toes of the foot and moving upwards. the hives were reported to be very itchy and sore. As treatment, the patient was administered heavy steroid doses along with 2 types of antihistamines to try resolve the issue. 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: 1504218 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness postural, Headache, Hypoaesthesia, Musculoskeletal chest pain, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: Numbness facial; Dizzy on standing; Chest pain; Head pain; Swollen arm; Rib pain; Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib pain), PAIN IN EXTREMITY (Pain in arm), HYPOAESTHESIA (Numbness facial), DIZZINESS POSTURAL (Dizzy on standing), PERIPHERAL SWELLING (Swollen arm), CHEST PAIN (Chest pain) and HEADACHE (Head pain) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and HEADACHE (Head pain) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness facial) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 15-Jul-2021, MUSCULOSKELETAL CHEST PAIN (Rib pain) and HYPOAESTHESIA (Numbness facial) had resolved. On 16-Jul-2021, PAIN IN EXTREMITY (Pain in arm), DIZZINESS POSTURAL (Dizzy on standing) and HEADACHE (Head pain) had resolved. On 17-Jul-2021, CHEST PAIN (Chest pain) had resolved. On 18-Jul-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medication list was not reported. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1504530 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002619 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZYLORIC
Current Illness: Gout
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Test Result: 36.4 {DF}; Result Unstructured Data: body temperature before the vaccination: 36.4 degrees Celsius
CDC Split Type: JPTAKEDA2021TJP060766

Write-up: Vasovagal reflex (dizziness on standing up, palpitations, heaviness of the head, chest pressure sensation); This regulatory authority case was reported by a physician and describes the occurrence of PRESYNCOPE (Vasovagal reflex (dizziness on standing up, palpitations, heaviness of the head, chest pressure sensation)) in a 61-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002619) for COVID-19 vaccination. Concurrent medical conditions included Gout. Concomitant products included ALLOPURINOL (ZYLORIC) for an unknown indication. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PRESYNCOPE (Vasovagal reflex (dizziness on standing up, palpitations, heaviness of the head, chest pressure sensation)) (seriousness criterion hospitalization). At the time of the report, PRESYNCOPE (Vasovagal reflex (dizziness on standing up, palpitations, heaviness of the head, chest pressure sensation)) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Body temperature: 36.4 ?C (normal) body temperature before the vaccination: 36.4 degrees Celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PRESYNCOPE (Vasovagal reflex (dizziness on standing up, palpitations, heaviness of the head, chest pressure sensation)) to be possibly related. No Treatment information were provided by the reporter. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 61-year-old male hospitalized with a serious unexpected event of presyncope. Event latency 3 minutes after first dose mRNA-1273. Event resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter''s Comments: The symptoms were considered as vasovagal reflex. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 61-year-old male hospitalized with a serious unexpected event of presyncope. Event latency 3 minutes after first dose mRNA-1273. Event resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1504532 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Clonic convulsion, Cold sweat, Fall, Oral contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: before the 1st dose of the vaccine, 36.5 degree Celsius
CDC Split Type: JPTAKEDA2021TJP060768

Write-up: Clonic convulsion; Bruise of the right maxillary area (upper lip); Fall; Cold sweat; This regulatory authority case was reported by a physician and describes the occurrence of CLONIC CONVULSION (Clonic convulsion) in an 18-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced CLONIC CONVULSION (Clonic convulsion) (seriousness criterion medically significant), ORAL CONTUSION (Bruise of the right maxillary area (upper lip)), FALL (Fall) and COLD SWEAT (Cold sweat). At the time of the report, CLONIC CONVULSION (Clonic convulsion), ORAL CONTUSION (Bruise of the right maxillary area (upper lip)), FALL (Fall) and COLD SWEAT (Cold sweat) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (normal) before the 1st dose of the vaccine, 36.5 degree Celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CLONIC CONVULSION (Clonic convulsion), ORAL CONTUSION (Bruise of the right maxillary area (upper lip)) and FALL (Fall) to be possibly related. No further causality assessment was provided for COLD SWEAT (Cold sweat). No concomitant medication details was provided. No treatment medication details was provided. At 15:28, the patient suddenly fell forward from a chair and bruised the right maxillary area (upper lip). Clonic convulsions lasted for approximately 10 to 15 seconds. The patient had a slight conjunctival pallor and cold sweat. Soon the patient became awake and alert. There had been no abnormalities in the vital signs throughout the time. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded The events 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 events, a causal relationship cannot be excluded


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