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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 308 out of 7,116

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VAERS ID: 1663004 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-15
Onset:2021-08-01
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac failure acute, Ejection fraction decreased, Left ventricular failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EF 15-20%
CDC Split Type:

Write-up: New onset systolic heart failure presented with acute decompensated heart failure


VAERS ID: 1663015 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-08-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT angio with multiple bilateral scattered pulmonary emboli are seen overall moderate severity which are basilar predominant
CDC Split Type:

Write-up: acute pulmonary embolism


VAERS ID: 1663194 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-02-25
Onset:2021-08-01
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042C20A / 2 UN / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest pain, Cough, Fatigue, Gastrointestinal disorder, Muscle strain, SARS-CoV-2 test positive, Throat clearing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vicodin; Blood Pressure
Current Illness: N/A
Preexisting Conditions: Hypertension
Allergies: N/A
Diagnostic Lab Data: COVID-19 Positive on 08/01/2021
CDC Split Type: vsafe

Write-up: I started to feel like I needed to clear my throat all the time. I was coughing so much that I pulled a muscle in my chest and it was very painful. I had GI problems for a month. I had some fatigue for about two weeks. I was tested for COVID-19 on 08/01/2021. I have still been experiencing the dry cough after a month, but the other symptoms have cleared up.


VAERS ID: 1663223 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 1 LA / IM

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

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

Write-up: Patient developed a bruise at injection site. The site was on the lower left arm, not on the deltoid muscle. The bruise was still there when she came back in for her second dose on 8/29/21.


VAERS ID: 1663808 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D22A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052EZ1A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)

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

Write-up: Sudden stabbing pain in back. Deep under shoulder blade


VAERS ID: 1665040 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Myalgia, Vaccination site mass, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PVIUS2021001189

Write-up: Painful lumpy knot at injection site; Muscle aches; Chills; Painful lumpy knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site). At the time of the report, VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication was reported. Treatment medication was not provided by the reporter.


VAERS ID: 1665391 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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:
CDC Split Type: USJNJFOC20210854979

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, 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 not reported, batch number: Unknown) 1 total dose administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was vaccinated in April and got sick with covid-19 infection in AUG-2021, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000191148 This case, from the same reporter is linked to 20210855235 and 20210855254.; Sender''s Comments: V0 - 20210854979- 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: 1665403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210856975

Write-up: DIZZINESS; CANNOT EVEN FINISH A FULL SHIFT AT WORK; NUMBNESS IN ARMS, FEET, AND NECK; TINGLING; 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: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced numbness in arms, feet, and neck. On AUG-2021, the patient experienced tingling. On AUG-2021, the patient experienced cannot even finish a full shift at work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, numbness in arms, feet, and neck, tingling, and cannot even finish a full shift at work. This report was non-serious.


VAERS ID: 1665409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820096 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chills, Computerised tomogram, Depression, Diarrhoea, Dizziness, Feeling hot, Headache, Impaired work ability, Malaise, Nasopharyngitis, Nausea, Pneumonia, Reading disorder, SARS-CoV-2 test, Tremor, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: LOSARTAN; AMLODIPINE; ASA; ZINC; VITAMIN C [ASCORBIC ACID]
Current Illness: Alcohol use; Hypertension; Non-smoker
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: negative; Test Name: CT scan; Result Unstructured Data: negative for blood clot
CDC Split Type: USJNJFOC20210857125

Write-up: FELT VERY SICK; VOMITING; DIARRHEA; HEADACHE; NAUSEOUS/GOING TO THROW UP; POSSIBLE PNEUMONIA IN RIGHT LOWER LUNG; STRUGGLING TO WORK; SOMETHING LIKE VERTIGO ( IT WAS NOT VERTIGO); COLD; FELT SHAKY; EARS GOT HOT; FELT SO DIZZY; UNABLE TO READ; DEPRESSED; VERY UPSET; CHILLS; This spontaneous report received from a patient concerned a 62-year-old White female ,not Hispanic or Latino. The patient''s weight was 186 pounds, and height was 65 inches. The patient''s concurrent conditions included: hypertension, alcohol consumption (once in a great moon holidays) and non-smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820096 and expiry: 21-Oct-2021) dose was not reported,1 total administered on 05-Aug-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for hypertension, amlodipine for hypertension, losartan for hypertension, ascorbic acid, and zinc. After one week of vaccination patient felt very sick. She was struggling to work. She stated that she was experiencing something like vertigo (but stated it was not vertigo), and had to intentionally think about her steps. She was experiencing cold, chills, headache and felt shaky. When she was at the hospital, a Computerized Tomography (CT) scan was negative for blood clots, and she was negative for COVID. She was given a Z-pak (azithromycin) for possible pneumonia in the right lower lung. She was currently on day 4 of the Z-pak and had diarrhea and was nauseous. She was also experiencing vomiting, which she described as happening before starting the Z-pak. She was upset that the only treatment she got was for pneumonia, and not for the other symptoms. Patient stated that she had never been this sick in her entire life and stated it as horrible and bad. The hospital wrote her a note that she is not better. Patient was upset and her ear was getting hot, and she continued to feel so dizzy that she felt like she was going to throw up. Patient stated that the eye movement of reading made her sicker and felt very depressed. She was drinking plenty of water and orange juice (OJ). She also started taking Zinc and Vitamin C when she got her Z-pak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very sick, struggling to work, something like vertigo (it was not vertigo), cold, chills, headache, felt shaky, possible pneumonia in right lower lung, diarrhea, nauseous/going to throw up, vomiting, ears got hot, felt so dizzy, unable to read, depressed and very upset was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210857125-covid-19 vaccine ad26.cov2.s-Possible pneumonia in the right lower lung. 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: 1665415 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Increased tendency to bruise, Pallor, Vaccination site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210857330

Write-up: SEMIPAINFUL HEADACHE THAT CAME IN WAVES; BRUISING AT INJECTION SITE; SHE IS PALE; SHE IS VERY PRONE TO BRUISING; This spontaneous report received from a patient concerned a 40 year old female. 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: Unk) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced she is very prone to bruising. On 12-AUG-2021, the patient experienced bruising at injection site. On 12-AUG-2021, the patient experienced she is pale. On 23-AUG-2021, the patient experienced semipainful headache that came in waves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising at injection site, semipainful headache that came in waves, she is pale and she is very prone to bruising was not reported. This report was non-serious.


VAERS ID: 1665416 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210857341

Write-up: REAL BAD MUSCLE ACHES; FATIGUE; FEVER; ACHY; This spontaneous report received from a patient concerned a 46 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, batch number: Unk) dose was not reported, administered on 25-AUG-2021 00:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced achy. Treatment medications included: paracetamol. On 25-AUG-2021, the patient experienced fatigue. On 25-AUG-2021, the patient experienced fever. On 26-AUG-2021, the patient experienced real bad muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and real bad muscle aches, and had not recovered from fatigue, and achy. This report was non-serious.


VAERS ID: 1665419 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Lymph node pain, Pain, Pain in extremity
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210857412

Write-up: BODY ACHES; SORE GLANDS; SORE ARM; CHILLS; HEADACHE; 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 not reported, batch number: Unknown) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced sore glands. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore glands, sore arm, chills, and headache on AUG-2021. This report was non-serious.


VAERS ID: 1665434 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Limb discomfort, Pain in extremity, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Diagnostic ultrasound; Result Unstructured Data: Blood clots
CDC Split Type: USJNJFOC20210860050

Write-up: STARTED TO GET THE SAME FEELING IN LEFT FOOT TOO; SEVERAL BLOOD CLOTS BEHIND THE CALF AND BEHIND THE KNEE; AFFECTED HEART; AFFECTED ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient''s weight was 290 pounds, and height was 66 inches. The patient''s concurrent conditions included: fibromyalgia. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 15-AUG-2021 in afternoon for prophylactic vaccination on left deltoid (arm). No concomitant medications were reported. On an unspecified date in AUG-2021, it was reported vaccine affected heart, and arm. For arms effect lasted for 3-4 days and for heart 2 days. At the time of reporting, it was completely resolved. On 20-AUG-2021, the patient experienced several blood clots behind the calf and behind the knee. It started out with lot of pain on the right side of patient''s foot. Patient took a picture of it on 20-AUG-2021. Patient saw a physician on 24-AUG-2021 as the ankle was bumpy, the physician sent patient for the ultrasound and on 25-AUG-2021 patient went for ultrasound. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clots. Patient contacted her physician but was not available, so another physician had prescribed her to start blood thinner as soon as possible. Treatment medications included: apixaban. On 27-AUG-2021 patient saw healthcare professional and was told there was several blood clots behind the calf and behind the knee. On 29-AUG-2021 patient took picture of the leg because inside of the right leg had more bumps and was swollen. Patient woke up on 30-AUG-2021 morning and 6 inches pass right knee patient was getting pain in that area. Patient started to get the same feeling in left foot too. Pain comes and goes but most of the pain was above the knee. Patient had to worry about dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from affected heart, and affected arm, and had not recovered from several blood clots behind the calf and behind the knee, and started to get the same feeling in left foot too. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210860050-covid-19 vaccine ad26.cov2.s-several blood clots behind the calf and behind the knee. 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: 1665460 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207N21N -CONSUM / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Discomfort, Hypoaesthesia, Somnolence
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOTOX
Current Illness: Alcohol use (Occasionally); Allergy to nuts; Drug allergy; Non-smoker
Preexisting Conditions: Comments: The patient was not pregnant at the time of reporting, had no medical history and she was not taking any medication on a daily basis (that was prescribed by her doctor). The patient stated earlier that she had history of getting botox, had a really bad reaction to dissolvable stitches and allergic to Isothiazoline especially in the following surgical glue; any kind of adhesives, had no history of drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210900624

Write-up: LEFT SIDED FACE TO NECK NUMBNESS; FELT SLEEPY; LEFT SIDE OF FACE FELT HEAVY; FELT HEAVINESS ON LEFT EYE; This spontaneous report received from a patient concerned a 54 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: nut allergy, alcohol user, non smoker, and cortisone allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting, had no medical history and she was not taking any medication on a daily basis (that was prescribed by her doctor). The patient stated earlier that she had history of getting botox, had a really bad reaction to dissolvable stitches and allergic to Isothiazoline especially in the following surgical glue; any kind of adhesives, had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207N21N, expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included botulinum toxin type a. On AUG-2021, the patient experienced felt sleepy. On AUG-2021, the patient experienced left side of face felt heavy. On AUG-2021, the patient experienced felt heaviness on left eye. Treatment medications included: cyanocobalamin. On 20-AUG-2021, the patient experienced left sided face to neck numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sleepy, had not recovered from left sided face to neck numbness, and the outcome of left side of face felt heavy and felt heaviness on left eye was not reported. This report was non-serious.


VAERS ID: 1665581 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045C21A / 1 LA / OT

Administered by: Military       Purchased by: ?
Symptoms: Anosmia, Headache, Nausea, Pain in extremity, Tenderness
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIMEPIRIDE; LISINOPRIL; NEURONTIN; CYMBALTA
Current Illness: Blood pressure high; Diabetes; Neuropathy
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: there was a sewer smell and she couldn''t smell it; tender; when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her; nausea; had a headache every day for almost a whole week since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (there was a sewer smell and she couldn''t smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The patient''s past medical history included Heart failure. Concurrent medical conditions included Diabetes, Blood pressure high and Neuropathy. Concomitant products included METFORMIN, GLIMEPIRIDE, LISINOPRIL, GABAPENTIN (NEURONTIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (there was a sewer smell and she couldn''t smell it). August 2021, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 220 mg. At the time of the report, ANOSMIA (there was a sewer smell and she couldn''t smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.


VAERS ID: 1665610 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-08-14
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blindness transient, Blood pressure diastolic, Blood pressure measurement, Decreased appetite, Dizziness, Fatigue, Illness, Lethargy, Thirst decreased, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOPROLOL; HYDRALAZINE; PRAZOSIN; ISOSORBIDE
Current Illness: Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Diastolic blood pressure; Result Unstructured Data: 40; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: blood pressure tanked so badly
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Still feels a little under the weather; Weak; Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Very tired; For the first 2 days, she was feeling lethargic and not wanting to eat or drink.; For the first 2 days, she was feeling lethargic and not wanting to eat or drink; For the first 2 days, she was feeling lethargic and not wanting to eat or drink; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) and LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, HYDRALAZINE, PRAZOSIN and ISOSORBIDE for an unknown indication. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) (seriousness criterion medically significant), DECREASED APPETITE (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), THIRST DECREASED (For the first 2 days, she was feeling lethargic and not wanting to eat or drink) and FATIGUE (Very tired). On 16-Aug-2021, the patient experienced BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) (seriousness criteria hospitalization and medically significant), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) (seriousness criteria hospitalization and medically significant) and DIZZINESS (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond). On an unknown date, the patient experienced ILLNESS (Still feels a little under the weather) and ASTHENIA (Weak). The patient was hospitalized on 16-Aug-2021 due to BLINDNESS TRANSIENT and UNRESPONSIVE TO STIMULI. At the time of the report, BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), DECREASED APPETITE (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), THIRST DECREASED (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), DIZZINESS (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), ILLNESS (Still feels a little under the weather) and FATIGUE (Very tired) was resolving and LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) and ASTHENIA (Weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Blood pressure diastolic: 40 (Low) 40. On 16-Aug-2021, Blood pressure measurement: abnormal (abnormal) blood pressure tanked so badly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No additional treatment medication was provided. On 14-Aug-2021, patient received first dose of Moderna COVID-19 vaccine in the left, non-dominant arm. For the first 2 days, she was feeling lethargic and not wanting to eat or drink and was very tired. By 16-Aug-2021, the patient''s blood pressure tanked so badly that she went blind and was dizzy and was not able to respond. Her husband called an ambulance, and patient was taken to emergency room and the diastolic blood pressure was 40. The patient received fluids in ER, however they were not able to raise blood pressure hence patient was in the hospital for 2 days and 1 night. Patient was tested for everything and everything else was ruled out and they concluded that this episode was from the vaccine. Patient suffers from high blood pressure usually and no one warned about the problem the vaccine could have with blood pressure. Patient was home from the hospital and still feels a little under the weather, however overall feeling a little better and was still lethargic and weak. 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. Further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.


VAERS ID: 1665618 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Impaired healing, Investigation, Postoperative wound infection, Wound haemorrhage, Wound secretion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization; Lung cancer; Lung neoplasm surgery (The patient had a non-invasive surgery 5 years ago to remove a possible cancerous mass in the lung.); Lung neoplasm surgery; Tumor
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Screening test; Result Unstructured Data: showed a possible tumor.
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Has a gaping wound, sutures not healing, wound is weeping and bleeding; Non-healing wound from a non-invasive surgery after moderna dose; Wound is weeping and bleeding; Wound is weeping and bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lung cancer, Tumor, Hospitalization, Lung neoplasm surgery (The patient had a non-invasive surgery 5 years ago to remove a possible cancerous mass in the lung.) and Lung neoplasm surgery on 20-Apr-2021. Concurrent medical conditions included Smoker and Hypertension. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced IMPAIRED HEALING (Non-healing wound from a non-invasive surgery after moderna dose), WOUND SECRETION (Wound is weeping and bleeding) and WOUND HAEMORRHAGE (Wound is weeping and bleeding). In August 2021, the patient experienced POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding) (seriousness criterion medically significant). At the time of the report, POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding), IMPAIRED HEALING (Non-healing wound from a non-invasive surgery after moderna dose), WOUND SECRETION (Wound is weeping and bleeding) and WOUND HAEMORRHAGE (Wound is weeping and bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Investigation: abnormal (abnormal) showed a possible tumor.. The reporter stated that the patient had a non-invasive surgery 5 years ago to remove a possible cancerous mass in his lung. The patient recovered fully, spent only a minimal time in the hospital for his lung to recover. on 20 Apr 2021, the patient underwent the same non-invasive surgery, which he underwent before. During the time of call, the patient still has not recovered, still has a gaping wound, sutures not healing, wound is weeping and bleeding. The reporter stated that the patient''s dead tissue from the incision was also removed. The patient consulted the doctor several times already. The patient was prescribed two rounds of 10-day antibiotics. The patient''s symptoms seems to get better during the course of antibiotics but when it ends, the symptoms eventually returns. No concomitant product use was provided by the reporter. Based on the very limited 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 very limited 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: 1665619 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein increased, COVID-19, Chest discomfort, Chest pain, Chills, Dyspnoea, Echocardiogram, Nausea, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased, Troponin, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified (Patient''s symptoms did not suggest an ischemic syndrome per cardiology notes)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210814; Test Name: CRP; Result Unstructured Data: CRP 4.6 mg/dL; Test Date: 20210816; Test Name: TRANSTHORACIC ECHOCARDIOGRAM; Result Unstructured Data: Normal left ventricular ejection fraction estimated at 55-65%. Simpson''s biplane EF is 59%.; Test Date: 20210815; Test Name: ESR; Result Unstructured Data: ESR 621 U/L; Test Date: 20210815; Test Name: Troponin; Test Result: Positive ; Result Unstructured Data: Troponin 6743 ng/L; Test Date: 20210816; Test Name: Troponin; Test Result: Positive ; Result Unstructured Data: Troponin 3247 ng/L
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Left arm soreness; Shortness of breath; Nausea; vomiting; Chills; Chest Pain; chest discomfort/Chest Pressure; Fever chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (chest discomfort/Chest Pressure), PYREXIA (Fever chills), CHILLS (Chills), PAIN IN EXTREMITY (Left arm soreness), DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and VOMITING (vomiting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Family history included Heart disease, unspecified (Patient''s symptoms did not suggest an ischemic syndrome per cardiology notes). Concurrent medical conditions included Asthma. On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness) (seriousness criterion hospitalization). In August 2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest discomfort/Chest Pressure) (seriousness criterion hospitalization) and PYREXIA (Fever chills) (seriousness criterion hospitalization). The patient was hospitalized from 15-Aug-2021 to 16-Aug-2021 due to CHEST DISCOMFORT, CHEST PAIN, CHILLS, DYSPNOEA, NAUSEA, PAIN IN EXTREMITY, PYREXIA and VOMITING. The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg every eight hours; NITROGLYCERIN for Chest pain, at a dose of UNK unit and KETOROLAC TROMETHAMINE (TORADOL) (intramuscular) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (chest discomfort/Chest Pressure), PYREXIA (Fever chills), CHILLS (Chills), PAIN IN EXTREMITY (Left arm soreness), DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and VOMITING (vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, C-reactive protein increased: 4.6 (High) CRP 4.6 mg/dL. On 15-Aug-2021, Red blood cell sedimentation rate increased: 621 (High) ESR 621 U/L. On 15-Aug-2021, Troponin: 6743 (Positive) Troponin 6743 ng/L. On 16-Aug-2021, Echocardiogram: normal (normal) Normal left ventricular ejection fraction estimated at 55-65%. Simpson''s biplane EF is 59%.. On 16-Aug-2021, Troponin: 3247 (Positive) Troponin 3247 ng/L. On an unknown date, COVID-19: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Patient reported that after receiving 2nd dose he experienced fever, chills and sharp chest pain in the mid of the left chest area. 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. This case was linked to MOD-2021-293731 (Patient Link).; 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: 1665651 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Myalgia, Pain, Pruritus, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101023331

Write-up: Have a regular pain that''s feels like someone punched in the arm like my muscle hurts over it; Neck started itching; Whole entire neck was just itching terrible and all night I was itching; Covered in hives; Still covered in hives like they didn''t go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso; Have a regular pain that''s feels like someone punched in the arm like my muscle hurts over it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: not reported), via an unspecified route of administration, administered in right arm in Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 in May2021 (a confirm case). The concomitant medications for patient were not reported. It was reported that the patient had COVID back in May a confirm case and then was told by the doctor to get the vaccine (Unspecified vaccine) anyway and she told the patient to get it at Saturday, so the patient went and got first dose. The patient got vaccinated yesterday morning on right arm, it was maybe like 10 O''clock or 11 O''clock something like that. It was Saturday whenever it was 8th or 7th the patient did not know. And it was reported that "I got it in my right arm and probably about 9 O''clock at night my neck started", On an unspecified date in Aug2021, the patient reported to "have a regular pain that''s feels like someone punched in the arm like my muscle hurts over it", but according to patient that was not the big deal but about 9 at night "neck started itching; whole entire neck was just itching terrible and all night I was itching". The patient thought maybe the patient was getting bitten by mosquito or something but then the patient went to bed. Then the patient woke up in morning and the patient was "covered in hives; still covered in hives like they didn''t go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso". The patient reported that the patient did not get hives. So, that was not, the only thing the patient did different was to take the vaccine and the patient was covered in hives and it was 8 O''clock at night and the patient was still completely covered on torso. The patient did not want to take Benadryl or something and just wanted to know why the patient having hives. The patient did not want to take the second one if the patient getting the hives. The patient did not want to get any mail. Further probing could not be done as the consumer was unwilling to share any further information at that point of time. Hence limited information available over the call. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1665658 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101030978

Write-up: Headache, after first vaccine; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 05Aug2021 (Thursday) as single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date in Aug2021 the patient experienced headache, after first vaccine. The patient stated that he was afraid, the second shot will be worse, and that was scary. The patient heard that the second shot, was worse than the first shot and all the side effects more with the second shot, than the first shot. The patient wanted to know how long do side effects last. The patient stated that few people that he know who got vaccinated, some people had more side effects than others, and some of the side effects went away quicker. He stated that he specifically had a headache, and last night took paracetamol (TYLENOL) and was effective. Outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1665662 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Breast inflammation, Breast pain, Chest pain, Erythema, Lymphadenopathy, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Peanut allergy (caller thinks in 2017.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101035202

Write-up: pain and redness around breast and areola/Left breast pain with inflamed red areola; left breast is inflamed; left arm also hurts/left arm pain; chest hurt for a few minutes; It could be a lymph node; pain and redness around breast and areola/Left breast pain with inflamed red areola; This is a spontaneous report from a contactable nurse (parent). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 09Aug2021 19:40 (at the age of 13 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history included peanut allergy from 2017 and ongoing (caller thinks in 2017). There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced pain and redness around breast and areola/left breast pain with inflamed red areola, it could be a lymph node on Aug2021, left arm also hurts/left arm pain, chest hurt for a few minutes, left breast is inflamed on 09Aug2021, pain and redness around breast and areola/left breast pain with inflamed red areola on 10Aug2021. Reported as, "13 year old female experiencing redness and pain around breast and areola after receiving first dose of Pfizer BioNTech Covid-19 Vaccine. Caller asked if the side effects can be stronger after the second dose of the Pfizer BioNTech Covid-19 Vaccine. Caller states a few minutes later, her daughter''s chest hurt for a few minutes, left breast was inflamed, and her areola was red and later reports painful. Caller states also the left breast was painful. Caller states she thought, it could be a lymph node. Caller states the side effect sheet, doesn''t say anything about the breast, but mentions lymphadenopathy.Caller states her breast is hurting but bearable. Caller states the left breast looks bigger than the right breast. Caller states her daughter''s left arm also hurts. Left breast pain with inflamed areola, caller adds that on 10Aug2021 she noticed the redness, but the left breast looked inflamed on 09Aug2021". Outcome of the event chest hurt for a few minutes was recovered on 09Aug2021, not recovered for pain and redness around breast and areola/left breast pain with inflamed red areola, left breast is inflamed, recovering for left arm also hurts/left arm pain, and unknown for it could be a lymph node. Follow up information has been requested.


VAERS ID: 1665666 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Investigation, Muscle spasms
SMQs:, Dystonia (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: Medical examination; Result Unstructured Data: Test Result:everything went perfectly, his heart was fine.; Comments: Everything went perfectly, his heart was fine.
CDC Split Type: USPFIZER INC202101041470

Write-up: had a chest cramp; This is a spontaneous report received from a contactable consumer (Patient''s mother) reported for her son. A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 15Aug2021 (at the age of 15-year-old) (Batch/Lot number: Not provided) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller was calling on behalf her 15-year-old son who received the first dose of the Pfizer Covid-19 vaccine on Sunday. This morning he had a chest cramp on an Aug2021, and it disappeared, he does weights but since she had been told that the vaccine could cause heart disorders she would like to know if this may be related to the vaccine and she would like to know if people after receiving the vaccine should take care of themselves as patients in doing any activity or if it doesn''t matter. No information found. Referred caller to their HCP. She also mentioned that before the vaccine she did a medical examination on her son and everything went perfectly, his heart was fine. The patient underwent lab tests and procedures which included investigation: normal on an unspecified date everything went perfectly, his heart was fine. Outcome of event was recovered on an unspecified date in Aug2021. Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.


VAERS ID: 1665672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Renal pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101042382

Write-up: kidneys are hurting very bad; his whole body is sore; This is a spontaneous report from report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient reported that his kidneys were hurting very bad and his whole body was sore and he would also like to know if this happened to other people. The outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.


VAERS ID: 1665678 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dysphonia, Gastrooesophageal reflux disease, Hypoaesthesia, Malaise, Paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101051745

Write-up: I think it''s interfering with my acid reflux sometimes. I have some acid reflux; My voice is sort of hoarse; I threw up; Hand going numb, that affects the tingling but that''s better and it was in my elbow; Hand going numb, that affects the tingling but that''s better and it was in my elbow; Not feeling good; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I got the shot, the first shot yesterday, the Pfizer vaccine, on Aug2021, I think it was interfering with my acid reflux sometimes. I have some acid reflux and my voice is sort of hoarse and I threw up at 5:30 and I don''t feel like I am going to ''throw my gut out'' but I am not feeling so ''hot'' today and I had a problem with my hand going numb, that affects the tingling but that''s better and it was in my elbow but I think that it''s nothing with my acid reflux. I am just not feeling good. So, I want to make sure that it was okay to take some acid reflux (Unspecified Medication) and some ibuprofen. Consumer further stated, If I could take acid reflux, My voice is off. I think it is because of the throwing up and acid reflex, I think that shot (COVID-19 Vaccine) is affecting my acid reflux. I think that''s my problem. I don''t know if you have that issue but I think that''s what going on. The outcome of the events was reported as unknown.


VAERS ID: 1665690 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE318 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Deafness, Diarrhoea, Dizziness, Feeling abnormal, Headache, Insomnia, Loss of consciousness, Malaise, Migraine, Musculoskeletal stiffness, Nausea, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101068971

Write-up: Terrible migraine type headaches; He was unresponsive. It looked like he was going into a seizure. His arms went stiff, his elbows locked, his shoulder went up and his head cocked back. He was out for almost a minute; very nauseous and almost threw up; Lost his hearing; He was unresponsive. It looked like he was going into a seizure. His arms went stiff, his elbows locked, his shoulder went up and his head cocked back. He was out for almost a minute; He was unresponsive. It looked like he was going into a seizure. His arms went stiff, his elbows locked, his shoulder went up and his head cocked back. He was out for almost a minute; Cold sweats; Light headed; Everything went foggy; Serious nausea; Feels like crap; Diarrhea; Had a major headache; Hasn''t been able to sleep properly; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FE318, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 09Aug2021 at 13:00 (at the age of 31-year-old) as Dose 1, Single for COVID-19 immunization, at pharmacy/Drug Store. The patient had no medical history and concomitant medications. The patient had no family medical history relevant to adverse event. No prior Vaccinations were administered within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccination. No vaccine was administered on same date with the Pfizer vaccine. No previous immunization with the Pfizer vaccine. It was reported that the patient received his first dose of the COVID-19 vaccine (at CVS pharmacy) on 09Aug2021 and just 3 minutes after the vaccine (at 13:03) he started feeling "cold sweats", "light headed", "everything went foggy", and he "lost his hearing". He stood up to try and shake the feeling off and he did not want to pass out in his seat. He paced back and forth for about 10 seconds and could not shake the feeling. He looked at the nurse and told her he was not ok. The next thing he remembered was waking up with his head on the counter and "serious nausea". The nurse said to him she was panicking because she had been calling his name and "He was unresponsive. It looked like he was going into a seizure. His arms went stiff, his elbows locked, his shoulder went up and his head cocked back. He was out for almost a minute". After he woke up, he was "very nauseous and he almost threw up". He told the nurse he was not ok. He "feels like crap", he was nauseous. The nurse told him she had called an ambulance, but he told the nurse to cancel the ambulance because he could not afford the bill. He sat at the CVS pharmacy for about 45 minutes trying to shake the nausea. He ended up getting "diarrhea" while sitting there too. Another reaction besides the nausea for the whole day was he "had a major headache". He knew his side effects started at 3 minutes after the injection because the nurse had asked him to hang around for 10-15 minutes and he had gotten on his phone to check the time. When probing if his symptoms were still present "he states he does not feel great now but he does not feel as bad". The day after the COVID-19 vaccine he was having "terrible migraine type headaches". Ever since he received the COVID-19 vaccine he "hasn''t been able to sleep properly" (from unspecified date in Aug2021) and he normally did not have trouble sleeping. He stated he did not have any medical conditions that he knows of. He stated the nurse at the CVS pharmacy told him she was going to write a report that would be sent to the CDC. He did not remember everything she said. He asked if this report was something similar. He was not given a report or reference number from the nurse. The patient was curious about his second COVID-19 vaccine and he was terrified of getting it. He was wondering about guidance on receiving the second dose given his side effects from the first dose. The patient did not want to go through that again. The patient did not seek medical attention after the events. He did not have a primary care doctor. His insurance was Tricare Prime. No relevant tests were done. No emergency room of physician office visit was done. No investigation assessment. The patient reported that he took vaccine as he is a student and his school had mandated the vaccine. The report was submitted as non-serious. The outcome of event "hasn''t been able to sleep properly" was reported as not resolved. The outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1665696 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dysphemia, Fatigue, Feeling abnormal, Feeling hot, Headache, Insomnia, Memory impairment, Mental impairment, Myalgia, Nausea, Pain in extremity, Paraesthesia, Vaccination site pain, Weight fluctuation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsions; Hip bursitis; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101069731

Write-up: Weight fluctuates and she is about (not specified) pounds; Muscle aches it was in her shin; Tingling sensation; Have the headache everyday; Feeling in a fog/brain fog, not thinking straight; Muscle ache; Pain/tenderness in her left arm/shoulder; Slight dizziness; after she was injected she started feel the pain; Pain/tenderness in her left arm/shoulder; She could not sleep last night; She feels fever since her neck is warm.; stuttering; when she was talking to somebody and then all of a sudden her mind will be on a complete blank or lost of train of thoughts; Nausea that is persisting; Fatigue; when she was talking to somebody and then all of a sudden her mind will be on a complete blank or lost of train of thoughts; This is a spontaneous report from a contactable consumer (patient reported for self). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, shoulder) on 10Aug2021 12:00 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization (Reason for no lot number: of Pfizer Covid Vaccine: Complainant does not have the product with them at the time of call). Medical history included bursitis in right hip (diagnosed a long time ago. She had an injection for the bursitis maybe cortisone or prednisone a couple weeks prior to the vaccine), convulsions and seizures (when she was a kid she did have convulsions and seizures to two vaccines but does not know the names of the vaccines) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient history of all previous immunization with the Pfizer vaccine and any additional vaccines administered on same date of the Pfizer suspect was none reported. Patient prior vaccinations (within 4 weeks) were none reported. Prior vaccinations adverse events were none reported. Patient did not have family medical history relevant to adverse events. Patient received the first dose of the Pfizer Biontech COVID19 vaccine last Tuesday, 10Aug2021 and experienced a nausea that was persisting (Aug2021). Patient stated that it had been a week and she still had the headache every day (10Aug2021) and that she could not sleep last night (Aug2021). Patient mentioned that when she was talking to somebody and then all of a sudden her mind will be on a complete blank or lost of train of thoughts (Aug2021) then added that she was never like that. Patient said she cannot be having brain fogs since she works in the medical field and was taking care of patients. She was also a surgical technologist that prepares the sterile field and instrument and she also holds retractors. She does not know if it was from the lack of sleep or if it was from the vaccine. Patient also stated that she was not sure if she can get the second dose of the vaccine. Patient said that she does not have fever and her temperature was normal, but she feels fever since her neck was warm (Aug2021). Patient was concerned if the side effects that she had are normal and if how long would they last. Patient said she was not sure on whether to get the second dose of the vaccine because of the side effects she experienced. She also asked as for protection, if she was already protected from the first dose of the vaccine or if the first dose of the vaccine will already help in getting protection with the COVID virus. Stated she was aware of side effects and she was under the impression that they would go away within 24 to 48 hours. She has had a persistent headache every day and it was not going away. She was not sleeping. If she did sleep it was in little spurts, short spurts and then wakes back up, she was constantly fatigued. She sometimes feels she was thinking fine and then when she starts talking to people, she will lose her train thought and be in a fog (10Aug2021); Weight fluctuates and she is about (not specified) pounds (on unspecified date). She was asking if this was something that was normal or was it going to go away. She called her doctor his morning to see if she can get an evaluation and she was booked. She was concerned about the constant headache, fatigue (Aug2021), and not thinking correctly. She is fine one minute and able to talk then will lost her train of thought. She received the vaccine at work. Her left arm/shoulder was still tender when she touches it, it was not unbearable, but it was fine. Within 15 minutes of receiving the covid vaccine she started feeling slight dizziness, tingling sensation (10Aug2021) which did not last long, about an hour and then went away. She started getting a headache the same day she got the vaccine. She could not think straight and kept getting her times and dates mixed up and this was not her. She was not sure when the not sleeping started, it may have been a couple days after the vaccine. When she says fog she means if she was not speaking she feels ok, other than headache and muscle aches (10Aug2021) but when she started to talk, she does not know if it was stuttering or losing her train of thought but it was persisting off and on and an everyday thing. Reported, Muscle aches it was in her shin, it felt like someone took a board and smacked her shins really hard. She did not feel the injection and then after she was injected, she started feel the pain (10Aug2021). She did not notice pain/tenderness in her left arm/shoulder (10Aug2021) unless she touches it with her finger. She also had nausea that started within past couple or three days and the nausea was about the same. Her vaccination card it at work. There was no treatment for the events. Patient had not visited emergency room and physician office. There was no investigation assessment. Patient relevant tests were none reported. The clinical outcome of events nausea that is persisting, have the headache every day, she could not sleep last night, fatigue, Feeling in a fog/brain fog, not thinking straight, not thinking straight was not recovered; outcome of events tingling sensation, slight dizziness was recovered on 10Aug2021; outcome of events muscle ache, Muscle aches it was in her shin recovered on an unspecified date in Aug2021; outcome of events pain/tenderness in her left arm/shoulder was recovering and all other events outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1665756 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Delayed menstruation and then heavy bleeding over 7 days


VAERS ID: 1666207 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-06
Onset:2021-08-01
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 186207L / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain lower, Back pain, Flatulence, Musculoskeletal stiffness, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODOPINE, ASPIRIN, VITAMIN D, HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM
Current Illness: NONE PRIOR TO TAKING VACCINE
Preexisting Conditions: HPERTENSION
Allergies: PROCARDIA
Diagnostic Lab Data:
CDC Split Type:

Write-up: (1) Increase in body stiffness on left side and in left leg and thigh area (taking Tylenol), helps alleviate the pain temporarily (2) Increase bloating and gas (Taking Maximum Strength Gas-X), doesn''t really help (3) Increase in lower back pain and lower abdominal area (taking Tylenol), helps alleviate the pain temporarily


VAERS ID: 1666330 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-05
Onset:2021-08-01
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Laboratory test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Muscle twitching, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: imodium, iron, multivitamin
Current Illness:
Preexisting Conditions: ulcerative colitis
Allergies:
Diagnostic Lab Data: series of a bunch of labs, nothing found, and MRI of brain and cervical neck and nothing found.
CDC Split Type:

Write-up: about 3 1/2 months after the second shot i started to get alot of pins and needles feeling in my hands and feet. Also i have small muscle twitches all over body at random times. I have like a brain fog/dizziness in my head.


VAERS ID: 1666339 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038021A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Injection site erythema, Night sweats, Pollakiuria, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BP Lisinopril B12 Multivitamin D vitamin
Current Illness: Multiple Sclerosis
Preexisting Conditions: MS
Allergies: None
Diagnostic Lab Data: None Reported to Family Dr Was not overly concerned
CDC Split Type:

Write-up: Slight headache Large red splotch below injection site. Covered entire top of arm area?gradually disappearing Sweating during night Very hot?did not take temp EXCESSIVE urination during night?like UTI?several times?was gone by morning. Was concerned bladder or kidneys affected


VAERS ID: 1666487 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-12
Onset:2021-08-01
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Agonal respiration, COVID-19, Dyspnoea, SARS-CoV-2 test positive, Unresponsive to stimuli, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD , dementia, PTSD, hypertension, thalassemia, ischemic cardiomyopathy paroxymal Afib, PVD, Aortic stenosis,
Allergies: darvocet A 500, morphine
Diagnostic Lab Data: COVID + 8/25/2021
CDC Split Type:

Write-up: Breakthrough COVID First dose 2/19/2021. 91-year-old Hispanic male presented to the emergency department via EMS agonally breathing, extremely short of breath for 2 days and was found unresponsive/agonal. Initially tested negative on 8/1/2021 and detected with SNF transfer on 8/25/2021.


VAERS ID: 1666615 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-07-16
Onset:2021-08-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033B21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vasculitis
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: vasculitis / prednisone, colchicine, TCA cream and dicloxacillin / still active


VAERS ID: 1666814 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-07-18
Onset:2021-08-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

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

Write-up: Patient is experiencing bilateral lower extremity numbness and tingling to the point where he cannot feel his feet, he cannot feel the floor, and he is almost falling.


VAERS ID: 1666844 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Got Pfizer COVID vaccine in 8/2021, since has been having numbness, tingling in both hands and both feet. Right foot has been going numb. Has never had issues before.


VAERS ID: 1666914 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-01-21
Onset:2021-08-01
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / 1 RA / SC

Administered by: Private       Purchased by: ?
Symptoms: Culture, Urinary tract infection, Urine analysis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Plaquenil, Atorvastatin, Letrazole, Prolia
Current Illness: None
Preexisting Conditions: Arthritis; S/P breast cancer treatment (surgery, radiation, endocrine suppression); osteoporosis
Allergies: Erythro, Sulfa, Augmentin
Diagnostic Lab Data: UA 8/1/2021 and Culture
CDC Split Type:

Write-up: In August I developed and was treated for a urinary tract infection. (on the CDC phone text survey there was no place to explain further the nature of the illness).


VAERS ID: 1667397 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH DP5137 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydralazine, tizanidine, lisinopril,diclofenac 1% gel, olopataidne eye drops
Current Illness:
Preexisting Conditions:
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling and rash in upper left arm. Started a few days after vaccine and lasted about 2 weeks. Patient used ice and heat and took tylenol.


VAERS ID: 1667546 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm hurt for a few days. Pain is gone but now very itchy, has fever and bumps. It has been 2 weeks since and still having these effects. The injection site is red.


VAERS ID: 1669553 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: feel somewhat dizzy; slight chest cramp; slightly short of breathe; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe) 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. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe). At the time of the report, DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. The patient had first vaccine Friday. On Thursday, The patient felt somewhat dizzy, slight chest cramp and slightly short of breathe. Reporter did not allow further contact


VAERS ID: 1669556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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:
CDC Split Type: USJNJFOC20210855254

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SICK WITH COVID/ SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 91 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced suspected clinical vaccination failure. The patient was sick with suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick with covid/ suspected covid 19 infection, 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. This case, from the same reporter is linked to 20210854979 and 20210855235.; Sender''s Comments: V0: 20210855254-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: 1669560 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Burning sensation, Impaired work ability, Influenza, Mobility decreased, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Comments: Healthy
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: 101.2 F
CDC Split Type: USJNJFOC20210857309

Write-up: FLU SYMPTOMS (6 HOURS AFTER VACCINATION); LEFT SHOULDER HURT ACUTELY/ SEVER PAIN IN HER SHOULDER; TINGLING WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; RADIATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; COULD NOT LEFT ARM MORE THAN 45 DEGREES; COULD NOT WORK OUT; BURNING SENSATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported On AUG-2021, the patient experienced could not left arm more than 45 degrees. On AUG-2021, the patient experienced could not work out. On AUG-2021, the patient experienced burning sensation which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced tingling which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced radiation which continued for hours started on the left then moved to the right. On 24-AUG-2021, the patient experienced flu symptoms (6 hours after vaccination). On 24-AUG-2021, the patient experienced left shoulder hurt acutely/ sever pain in her shoulder. Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms (6 hours after vaccination), and shaking on 26-AUG-2021, had not recovered from left shoulder hurt acutely/ sever pain in her shoulder, and the outcome of could not left arm more than 45 degrees, could not work out, tingling which continued for hours started on the left then moved to the right, burning sensation which continued for hours started on the left then moved to the right and radiation which continued for hours started on the left then moved to the right was not reported. This report was non-serious.


VAERS ID: 1669565 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210857675

Write-up: FEELING CLAMMY; HEADACHE AT NIGHT; FEVER; This spontaneous report received from a patient concerned a 41 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, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced feeling clammy. On AUG-2021, the patient experienced headache at night. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, and the outcome of feeling clammy and headache at night was not reported. This report was non-serious.


VAERS ID: 1669569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Toothache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210858482

Write-up: TOOTHACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced toothache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of toothache was not reported. This report was non-serious.


VAERS ID: 1669572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Back pain, Body temperature, Dizziness, Feeling abnormal, Insomnia, Malaise, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210858530

Write-up: EVERYTHING SORE; BACK HURT; STOMACH SWELLING; DIZZINESS; CAN''T SLEEP WELL; FEELING OF MIGHT DIE AT ANY TIME; TEMPERATURE; ARM SORENESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 63 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, batch number: Unk) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced everything sore. On AUG-2021, the patient experienced back hurt. On AUG-2021, the patient experienced stomach swelling. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced can''t sleep well. On AUG-2021, the patient experienced feeling of might die at any time. On AUG-2021, the patient experienced temperature. On AUG-2021, the patient experienced arm soreness. On AUG-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the everything sore, back hurt, stomach swelling, temperature, dizziness, not feeling well, can''t sleep well, feeling of might die at any time and arm soreness was not reported. This report was non-serious.


VAERS ID: 1669575 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Nausea, Neck pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gluten sensitivity; Hashimoto''s disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210858781

Write-up: PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hashimoto''s, and gluten sensitivity dairy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.


VAERS ID: 1669587 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210900562

Write-up: ITCHY RASH ON STOMACH TO RIGHT SIDE UNDER RIBS AND BREASTS AND ON RIGHT ARM ON THE TOP TO HER ELBOW/ ITCHY DOTS ON ARM; This spontaneous report received from a patient concerned a 52 year old female. 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: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. Treatment medications (dates unspecified) included: hydrocortisone, and calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. This report was non-serious.


VAERS ID: 1669604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Chills, Fatigue, Feeling abnormal, Headache, Menstruation irregular, Pain, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210903177

Write-up: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number Unknown dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body wobble. On AUG-2021, the patient experienced feel shook literally from the cells out. On AUG-2021, the patient experienced down hard with ache. On AUG-2021, the patient experienced sudden menstruation. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced odd headache. On 31-AUG-2021, the patient experienced heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on AUG-2021, and the outcome of down hard with ache, chills, odd headache, sudden menstruation, heart palpitations, body wobble, and feel shook literally from the cells out was not reported. This report was non-serious.


VAERS ID: 1669608 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC. MOD2021

Write-up: Itchy and irritating rash; Itchy and irritating rash; The rash is on my left forearm, left hand, right abdomen and right breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast). At the time of the report, RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided. No treatment medications were provided.


VAERS ID: 1669639 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Pain, Renal pain, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: ELIQUIS
Current Illness: Arterial disorder (Has tiny arteries which causes blood to flow slower); Cholesterol (takes cholesterol pill); Wheelchair user (patient is wheelchair user)
Preexisting Conditions: Medical History/Concurrent Conditions: Leg amputation (Right leg)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Weight; Result Unstructured Data: 80 pounds before taking vaccine , now 78 pounds
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Pain in her kidney; So painful that she couldn''t stand or get out of bed/ Still takes her half an hour to get out of bed; Losing weight and being "skin and bones"; So much pain that she screamed; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Pain in her kidney), BEDRIDDEN (So painful that she couldn''t stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The patient''s past medical history included Leg amputation (Right leg). Concurrent medical conditions included Cholesterol (takes cholesterol pill), Arterial disorder (Has tiny arteries which causes blood to flow slower) and Wheelchair user (patient is wheelchair user). Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced RENAL PAIN (Pain in her kidney), BEDRIDDEN (So painful that she couldn''t stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed). On 01-Aug-2021, RENAL PAIN (Pain in her kidney) had resolved. On 04-Aug-2021, BEDRIDDEN (So painful that she couldn''t stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Weight: 78 pounds (Low) 80 pounds before taking vaccine , now 78 pounds. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Additional concomitant medication includes cholesterol medication (one pill at night). Treatment information was not provided.


VAERS ID: 1669642 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939893 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Pruritus
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: When running short distance felt like out of breath; Itching on both arms/Generalised itching; Arms becoming reddish; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish), HYPERHIDROSIS (Sweating) and DYSPNOEA (When running short distance felt like out of breath) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced DYSPNOEA (When running short distance felt like out of breath). At the time of the report, PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and DYSPNOEA (When running short distance felt like out of breath) had not resolved and HYPERHIDROSIS (Sweating) outcome was unknown. 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. The concomitant medications were not reported. The treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added new event, event onset date, outcome and updated patient details and reporter information.


VAERS ID: 1669643 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-24
Onset:2021-08-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0780214 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Hot flush, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: USMODERNATX, INC.MOD20212

Write-up: Shortness of breath; Hot flush; Wife has been sweating for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Wife has been sweating for 4 days), DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0780214) for COVID-19 vaccination. No Medical History information was reported. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021 at 10:30 AM, the patient experienced HYPERHIDROSIS (Wife has been sweating for 4 days). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush). At the time of the report, HYPERHIDROSIS (Wife has been sweating for 4 days) had not resolved and DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) outcome was unknown. 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 medications were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added patient details and new events and event outcomes were added


VAERS ID: 1670346 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Blood test, Chest X-ray abnormal, Dyspnoea, Malaise, Pneumonia, Suspected COVID-19, Ventilation/perfusion scan abnormal
SMQs:, Anaphylactic reaction (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diabetes medication High blood pressure medication High Cholesterol medication
Current Illness:
Preexisting Conditions: COPD Diabetes
Allergies: Levaquin Amitraz Compazine
Diagnostic Lab Data: X-ray Lung Scan Blood work
CDC Split Type: vsafe

Write-up: After receiving the vaccine, I felt sick to my stomach, and I had a hard time breathing. So I went to the hospital, and the doctors did a lung x-ray which looked bad. Then they did a lung scan and thought it looked like I had covid, but the results showed I had pneumonia. I was hospitalized for 4 days.


VAERS ID: 1670441 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939901 / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Headache, Impaired work ability, Influenza like illness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 1976 Swine Flu
Other Medications: Amlodipine 5mg.
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none. I did not go to the doctor. Just took the week off work, rested, fluids. tylenol.
CDC Split Type:

Write-up: symptoms were the same after both vaccines and started the day after and lasted approximately a week. Basically flu like symptoms. Fever, bad chills, achy all over, headache, weakness.


VAERS ID: 1670508 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 1 LA / IM

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

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

Write-up: pt started to feel faint before shot and pt in and out of frozen catatonic state. head started to fall back. called for pharmacist. out for 3 to 5 minutes and felt better and wanted the shot...nothing happened after the shot. this all occurred before the shot due to anxiety and this has happened to the pt before


VAERS ID: 1670548 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-09
Onset:2021-08-01
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, C-reactive protein normal, Chest X-ray abnormal, Cough, Decreased appetite, Diarrhoea, Exposure to SARS-CoV-2, Lung infiltration, Oxygen saturation decreased, Procalcitonin, Serum ferritin increased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient is a 92 year old male, past medical history of CHB s/p PPM ICD, dementia, chronic CHF, CAD, hypertension presents to the ER with progressive weakness and cough for the past 2 weeks. Family reports that he has been having a couple day history of diarrhea with poor appetite. No further episodes of diarrhea in the ER. Patient denies any pain but feels generally weak but not short of breath. Multiple family members have tested positive recently for COVID-19. He was vaccinated x2 for COVID-19 in February/March 2021. Patient is require supplement her O2 however has not had signs of inflammatory worsening. Chest x-ray repeat on 08/06/2021 shows bilateral lower lobe lung infiltration. Oxygenation is 2 L on nasal cannula which is keeping a 95 percent sat unfortunately dropped to 86 percent on room air. Ferritin levels 2000 wondered 16, CRP is 0.35, procalcitonin 0.04 and he is otherwise stable for home care. Discussed this with patient''s daughters 1 of whom is a physician to other 1 is his caregiver who he lives with however she also has COVID-19 although does not have pneumonia and is physically fit for caregiving


VAERS ID: 1670756 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: On 9/2/2021, notified that a 17 year old patient was vaccinated with the J&J vaccine on 8/1/21. Upon further investigation, the vaccinator had overlooked the patient?s age when vaccinating and therefore did not report the incident to the clinical lead. After looking into the incident, the mother of the patient was contacted and confirmed that the patient was dosed with J&J. Janssen Pharmaceuticals, Inc. was contacted by RN for further guidelines, but no data is available at this time.


VAERS ID: 1670862 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-02-26
Onset:2021-08-01
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014U204 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Electrocardiogram abnormal, Electroconvulsive therapy
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: Wellbutrin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EKG
CDC Split Type: vsafe

Write-up: July 26th I had my normal physical exam and it looked like I had AFib. I made an appointment with my doctor the next day who said I have AFib as well. He got me scheduled for a procedure on August 10th. I received an electroshock to get my heart beat corrected and it worked. August 16th I started experiencing very short 10 second weaknesses that came and went. I checked my blood pressure and it read 86/55 which is low so I informed my doctor about it. August 26th they gave me a prescription midodrine which is for low blood pressure. I am going to see that doctor again to get fitted for a meter that I''ll wear for 10 days to check the status of my heart.


VAERS ID: 1672355 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Colorado  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210905656

Write-up: OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 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, batch number: 1808980, and expiry: 18-SEP-2021) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced off-label use. On 01-AUG-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious.


VAERS ID: 1672416 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Erythema, Joint swelling, Oedema peripheral, Pain in extremity, Peripheral coldness, Skin discolouration
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: it''s making his entire arm hurt. It happened exactly 7 days after the shot.; on the same arm of his shot, his elbow swelled up and started in the middle of the night; It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it; It looked like it had fluid in it and it kept getting bigger; It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it; it turned brown after a few days; it felt cold to the touch, not hot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (it felt cold to the touch, not hot), JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), PAIN IN EXTREMITY (it''s making his entire arm hurt. It happened exactly 7 days after the shot.), ERYTHEMA (It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it) and SKIN DISCOLOURATION (it turned brown after a few days) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), PAIN IN EXTREMITY (it''s making his entire arm hurt. It happened exactly 7 days after the shot.), ERYTHEMA (It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it), OEDEMA PERIPHERAL (It looked like it had fluid in it and it kept getting bigger) and ARTHRALGIA (It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it). In August 2021, the patient experienced PERIPHERAL COLDNESS (it felt cold to the touch, not hot) and SKIN DISCOLOURATION (it turned brown after a few days). The patient was treated with IBUPROFEN in August 2021 for Pain in extremity, at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) in August 2021 for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PERIPHERAL COLDNESS (it felt cold to the touch, not hot), JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), ERYTHEMA (It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it), SKIN DISCOLOURATION (it turned brown after a few days), OEDEMA PERIPHERAL (It looked like it had fluid in it and it kept getting bigger) and ARTHRALGIA (It was red. It hurt, but it didn''t have inflammation in it / down to where his elbow is and all the way around it) was resolving and PAIN IN EXTREMITY (it''s making his entire arm hurt. It happened exactly 7 days after the shot.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were provided.


VAERS ID: 1672434 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Neck pain, Oropharyngeal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: sore throat; Pressure on the right side of neck; Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included TERBINAFINE and METOCLOPRAMIDE for an unknown indication. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). In August 2021, NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved. Concomitant medication included Birth control. No treatment medication was reported. Patient had confirmed she has not visited her primary care yet.


VAERS ID: 1672478 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood sugar; Result Unstructured Data: Higher than normal.
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Mild soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness of the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Mild soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Mild soreness of the arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood glucose: high (High) Higher than normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided.


VAERS ID: 1672562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / UNK - / OT

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

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

Write-up: Fever; Chills; Her body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided.


VAERS ID: 1672778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Feeling hot, Gait disturbance, Hyperhidrosis, Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (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: USMODERNATX, INC.MOD20212

Write-up: sweating a lot/she was sock and wet; her walking gait was affected; her legs feel very weak; feels hot; she doesn''t feel and it was horrible last night; muscle pain; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot) and FEELING ABNORMAL (she doesn''t feel and it was horrible last night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn''t feel and it was horrible last night) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn''t feel and it was horrible last night) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported by reporter.


VAERS ID: 1672805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anosmia, Decreased appetite
SMQs:, Taste and smell disorders (narrow), Immune-mediated/autoimmune disorders (broad)

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

Write-up: no smell; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (no smell) and DECREASED APPETITE (no appetite) 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. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (no smell) and DECREASED APPETITE (no appetite). At the time of the report, ANOSMIA (no smell) and DECREASED APPETITE (no appetite) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications was provided. No treatment medications was provided. Reporter did not allow further contact


VAERS ID: 1672814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache
SMQs:

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

Write-up: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) 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. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. No concomitant medications were provided. Treatment information was not provided. The reporter wanted to know if the patient could take Ibuprofen.


VAERS ID: 1672884 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-23
Onset:2021-08-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Haemoptysis, Influenza like illness, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: High
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Slept almost all day, all night; Had symptoms like the flu for like a week after she took the first shot; Was just real fatigued; Low grade fever like a 99.5/Had fever; Coughing; Coughing a blood; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HAEMOPTYSIS (Coughing a blood), SOMNOLENCE (Slept almost all day, all night), INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) and PYREXIA (Low grade fever like a 99.5/Had fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COUGH (Coughing), HAEMOPTYSIS (Coughing a blood) and PYREXIA (Low grade fever like a 99.5/Had fever). On an unknown date, the patient experienced SOMNOLENCE (Slept almost all day, all night), INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) and FATIGUE (Was just real fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing), HAEMOPTYSIS (Coughing a blood) and PYREXIA (Low grade fever like a 99.5/Had fever) had not resolved, SOMNOLENCE (Slept almost all day, all night) and FATIGUE (Was just real fatigued) outcome was unknown and INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 99.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Patient stated that she was exposed to it probably about 8 days ago. However, she was not coughing a lot, it was not tremendous and it was not constant. Patient was scheduled for her second dose tomorrow but she was not sure about taking it and wanted to find out if she should take it or postpone until she got better. Reporter did not allow further contact


VAERS ID: 1672960 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19 during the first part of August) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (tested positive for COVID-19 during the first part of August). At the time of the report, COVID-19 (tested positive for COVID-19 during the first part of August) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 test. 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 reported. No treatment information was provided.


VAERS ID: 1673002 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-01-15
Onset:2021-08-01
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027L20A / 2 - / OT

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

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

Write-up: Chills; Fever; Tiredness; Achiness; Sore arm; Her arm became swollen, red at injection site, and very itchy; Her arm became swollen, red at injection site, and very itchy. It was a knot that was the size of her palm; Her arm became swollen, red at injection site, and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 027L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Platelet disorder. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy. It was a knot that was the size of her palm) and VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy). On 19-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness) and MYALGIA (Achiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy. It was a knot that was the size of her palm), VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy) and MYALGIA (Achiness) outcome was unknown. Concomitant medication include daily chemotherapy pill. Treatment also include lots of ice. Patient had the symptoms 24 hours after the third dose and she was in bed for 48 hours and now reporter says that it was going away at the time of reporting. This case was linked to MOD-2021-294214, MOD-2021-294229 (Patient Link).


VAERS ID: 1673013 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-23
Onset:2021-08-01
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dysgeusia, Headache, Illness, Incorrect dose administered, Influenza like illness, Myalgia, Nightmare, Pruritus, Pyrexia, Rash erythematous, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leukemia
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised (compromised immune system with leukemia)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: fever; Result Unstructured Data: which would bring it down for 4 hours before raising again; Test Date: 202108; Test Name: fever; Result Unstructured Data: up to 103
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: patient received 3rd dose on 19-Aug-2021; She has been "so sick"; a horrible metallic taste in her mouth; she "felt like she had the flu"; red rash; very hot rash; itchiness/itching; it "has been a nightmare."; fever up to 103; headache; muscle pains/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu") and RASH ERYTHEMATOUS (red rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893, 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), PRURITUS (itchiness/itching), NIGHTMARE (it "has been a nightmare."), PYREXIA (fever up to 103), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness). On 19-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In August 2021, PRURITUS (itchiness/itching) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), NIGHTMARE (it "has been a nightmare."), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness) outcome was unknown and PYREXIA (fever up to 103) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: bring it down for 4 hours (Low) which would bring it down for 4 hours before raising again. In August 2021, Body temperature: up to 103 (High) up to 103. No concomitant products was provided by the reporter. The patient had been using ice on her arm as a self-treatment method and her itching symptom went away. This case was linked to MOD-2021-294276 (Patient Link).


VAERS ID: 1673014 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Myalgia, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Arm went to itching; Redness /has a pretty good size red; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm went to itching), ERYTHEMA (Redness /has a pretty good size red) and MYALGIA (Arm was sore) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. Concomitant products included LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red). In August 2021, the patient experienced MYALGIA (Arm was sore). In August 2021, MYALGIA (Arm was sore) had resolved. At the time of the report, PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that her arm was sore for 3 days and on the 11th day, it went to itching, red and has a pretty good size red. She only put alcohol on it, she did not take any medications. She was due to receive the second dose of the vaccine on 01-Sep-2021 and wanted to know if she should receive it.


VAERS ID: 1673015 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Intentional dose omission, Limb discomfort, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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: Medical History/Concurrent Conditions: COVID-19 (Did not receive the monoclonal antibody drip treatment.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Blurry vision; Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves; Brain fog; She was not going to get the next dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (Did not receive the monoclonal antibody drip treatment) in March 2021. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose). At the time of the report, VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had some underlying conditions. No concomitant medications were provided. Treatment information was not provided. This case was linked to MOD-2021-294440 (Patient Link).


VAERS ID: 1673085 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Hot flush, Paraesthesia, Skin reaction, Swelling, Swelling face, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: arms started shaking, legs started shaking; tingling in arms, tingling in legs; Hot flashes; swelling of her neck; swelling of her face; Skin reactions; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck) and SWELLING FACE (swelling of her face) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by reporter. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced TREMOR (arms started shaking, legs started shaking) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms, tingling in legs) (seriousness criterion hospitalization), HOT FLUSH (Hot flashes) (seriousness criterion hospitalization), SWELLING (swelling of her neck) (seriousness criterion hospitalization) and SWELLING FACE (swelling of her face) (seriousness criterion hospitalization). In August 2021, the patient experienced ANXIETY (anxiety). On an unknown date, the patient experienced SKIN REACTION (Skin reactions). The patient was hospitalized from 12-Aug-2021 to 18-Aug-2021 due to HOT FLUSH, PARAESTHESIA, SWELLING, SWELLING FACE and TREMOR. The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck), SWELLING FACE (swelling of her face) and SKIN REACTION (Skin reactions) outcome was unknown and ANXIETY (anxiety) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was hospitalized from 12-Aug-2021 to 18-Aug-2021. Lab investigation performed included EKG, stress test, MRI of her brain and spine, bloodwork, and a CT of her lungs with unknown result. 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, more information is required for further assessment. Follow up is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. Follow up is expected.


VAERS ID: 1673142 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Feeling abnormal, Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; Pacemaker syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101002323

Write-up: Injection site pain; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; They both don''t have energy to cook or anything and are sleeping a lot.; They both don''t have energy to cook or anything and are sleeping a lot.; They are in a fog and can''t think/Feel like they''ve been run over by a car; This is a spontaneous report from a contactable consumer (patient''s daughter) via Medical Information team. An 84-year-old female patient (reporter''s mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7484; Expiration Date: 30Sep2021, NDC 59267-1000-02), dose 2 via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. Medical history included pacemaker, fall from 13Feb2021. The patient''s concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, expiration date 30Aug2021, NDC number: 59267-1000-02) dose 1 via an unspecified route of administration on 12Jul2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. The patient had nothing with the first one, she was just tired and sluggish and worn out all a week. This started the day of the vaccine and lasted a week or so, she didn''t even want to cook or eat. This improved then she got second dose. Since receiving second doses, patient have been experiencing "injection site pain which was swelling, red, and hot" on 02Aug2021. Her mother''s site "was really hot" and "looks like the size of a baseball". Duration of pain at the injection site after Dose 2 was 2.5 days. They want to know if these reactions are normal and how to treat. Asked what if the reaction last longer than 2 days. The patient''s looks like a baseball on her arm. The patient''s arm is so hot she could fry an egg on her arm. The patient''s arm did not bleed when she took the Band-Aid off. In Aug2021, she felt she had been run over by a car. She does not have energy to cook or anything and sleeping a lot. The patient feels like she was in a fog and can''t think in Aug2021. The patient''s arm was red and very very hot. The redness started right away. Outcome of the events injection site pain which was swelling, red, and hot was not recovered; for other events was unknown. Follow up information completed.no further information expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202100999212 Same reporter/product, similar event, different patient


VAERS ID: 1673158 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Interchange of vaccine products
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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 INC202101008491

Write-up: Chest pain; I have the AstraZeneca on July 24 the 1st shot and then I had Pfizer 2nd one; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, on 31Jul2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19, lot number and expiry date were not reported), via an unspecified route of administration, on 24Jul2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient reported that on 01Aug2021, the patient experienced Chest pain and I have the AstraZeneca on 24lthe 1st shot and then I had Pfizer 2nd one on an unspecified date in 2021. The patient stated, "Well little bit concerned, I have the AstraZeneca (Further not clarified hence captured as Unspecified vaccine) on July 24 the 1st shot and then I had Pfizer 2nd one the Pfizer (Confirmed as Covid 19 vaccine) Yes, the Pfizer would be second one the 1st one is 24Jul AtraZeneca the second one was Pfizer I took it on July 31st on the Aug 1st, I had chest pain and I didn''t go and see doctor today." The patient stated, "the reason I called is just wanna ask how bad would this chest pain going to be and how long would it it last normally the CDC has indicated it last may be 14 days." Further probing could not be done as the consumer was not willing to provide further information. Outcome of the events was unknown.


VAERS ID: 1673166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Ear pain, Malaise, Pain, Pain in extremity
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015181

Write-up: Chest aches; Legs and whole body hurts; Legs and whole body hurts; Left ear hurts; Not feeling well; This is a spontaneous report from a contactable consumer. This consumer (patient''s wife) reported for a male patient (reporter''s husband). A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on 05Aug2021 as DOSE 2, SINGLE for COVID-19 Immunisation. The patient''s medical history and concomitant medications were not reported. He previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 Immunisation. The patient was not feeling well, chest aches, legs and whole body hurts and left ear hurts. Reporter agreed that she will contact her husband''s healthcare provider and she stated that patient got the second vaccine on the previous day of reporting. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and requested during follow up.


VAERS ID: 1673175 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101015941

Write-up: Sometime just have aches and some pains like in your feet and like in legs may be; Sometimes I have ache and pains like in your feet your legs, and something like that; This is a spontaneous report from a contactable consumer. This was reported by consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified rout of administration on 05Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced aches and some pains like in your feet and like in legs may be, sometimes had ache and pains like in feet and reported that "aches and some pains like in your feet and like in legs may be; Sometimes I have ache and pains like in your feet your legs, and something like that and stated that was just wondering to people sometimes tells, I had a one of your first Covid shot Pfizer and I was, on Thursday and I was wondering the sometime just have aches and some pains like in your feet and like in legs may be. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673176 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site swelling
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015958

Write-up: My injection site is really swollen on my arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered on Arm on 05Aug2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug 2021, the patient had my injection site is really swollen on my arm. At the time of reporting, the outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101015971

Write-up: menstrual cycle has been very long and heavy; menstrual cycle has been very long and heavy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3180) via an unspecified route of administration on 30Jul2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications was not reported. The patient had first (dose) Vaccine shot on Friday (30Jul2021). She received her menstrual cycle that following week (Aug2021) and her menstrual cycle had been very long and heavy and she was not sure if it was because of the Pfizer vaccine. The patient was calling to figure out this. Outcome of the events was unknown.


VAERS ID: 1673179 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:102
CDC Split Type: USPFIZER INC202101016002

Write-up: my fever spikes up to like 102; Diarrhea; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 03Aug2021 (lot number: EW0171), at an unknown route, dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced my fever spikes up to like 102, diarrhea and headache. The patient laboratory investigation included fever was 102 on Aug2021 date. The patient started spiking a fever like four days after took the shot. Took the COVID-19 shot on Tuesday and had headache since then and then started spiking the fever yesterday which is four days after taking the shot and some like passing diarrhea but fever spikes up to like 102. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673184 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Feeling abnormal, Headache, Heart rate, Heart rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result:Fast; Comments: fast heart rate
CDC Split Type: USPFIZER INC202101022543

Write-up: Extreme headache; Vomiting; fast heart rate; Chest pain; having a bad reaction; This is a spontaneous report from a contactable consumer. A male patient (son) of unspecified age and gender received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: FA7484, Expiration date: Unknown), on 06Aug2021 on left upper arm as Dose 2 single for covid 19 immunization. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date as Dose 1,Single for Covid 19 immunisation. On an unspecified date in Aug2021 patient experienced Extreme headache, vomiting, fast heart rate, chest pain and also having a bad reaction and also stated if they can spend the time to go through all that and they did not know where the pen was at it was middle of night and were not at home as they were travelling on vacation. Reporter also mentioned they were not sure that they should take their son to the emergency room or not. Reporter stated that patient had not experienced nausea. No therapeutic treatments were received. On an unspecified date in Aug2021 Lab test included heart rate(fast). The outcome of the events were reported as unknown. Follow-up attempts completed. No further information expected


VAERS ID: 1673185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101022603

Write-up: Swollen armpits on the side of his injections site; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: UNKOWN), via an unspecified route of administration, administered in Arm Left 06Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. In Aug 2021, had swollen armpits on the side of his injection site which was his left arm (lymphadenopathy). He stated that he had the packet that mentioned swollen lymph nodes and wanted to know how he could treat it. The clinical outcome of the armpits on the side of his injections site was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673188 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USPFIZER INC202101024573

Write-up: My stomach was hurting pretty bad, it''s kind of like if you have gas; My left arm, it''s got sore for about 3 days went away; This is a spontaneous report from a contactable consumer (patient). An 84-years-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0167, expiry date: un-known) via unspecified route of administration, on 05Aug2021, as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, and got sore (my first and second shot in my left arm, it''s got sore for about 3 days went away). Patients medical history and concomitant medications were not reported. After second dose, on an unspecified date in Aug2021, patient got sore for about 3 days went away. This morning five days from last shot, patient woke up and stomach was hurting pretty bad, it''s kind of like if you have gas, your stomach will be when you have gas, okay and patient never had a stomach ache in morning. Patient was 84 years old and was just curious as to whether a similar problem might have been reported on this, as such. The outcome of event for pain in arm was recovered on an unspecified date in Aug2021, and stomach ache it was unknown. .


VAERS ID: 1673193 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Bone disorder, Gait disturbance, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vertigo
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (It started after her husband passed away 4 years ago but after about a year and half it went away.); Penicillin allergy (Allergic to Penicillin NDC, Lot, Expiration: Unknown, it was 58 Years Ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101028159

Write-up: Pain in left arm; excruciating pain in legs then started in arms; Weakness; Wakes her up and feels like an ice pick in the bones; clarifies it is not in the joint or muscle, it feels like it is in the bone; Can barely walk; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 30Jul2021 17:00 (at the age of 63 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history included ongoing vertigo, hypertension (It started after her husband passed away 4 years ago but after about a year and half it went away), allergic to Penicillin NDC (it was 58 years ago). Family medical history relevant to adverse event was none. There were no concomitant medications. No investigation assessment. Patient historical vaccine included TETANUS VACCINE on an unspecified date for immunisation and experienced no reaction (tetanus shot a while back, no reaction). Patient did not received any other vaccine within 4 weeks of COVID vaccine. The patient experienced excruciating pain in legs then started in arms, weakness, wakes her up and feels like an ice pick in the bones; clarifies it is not in the joint or muscle, it feels like it is in the bone, can barely walk on 01Aug2021, pain in left arm on 03Aug2021. Reported as, patient received the first dose of the Pfizer Covid 19 Vaccine on 30Jul2021, after 48 hours, experiencing. excruciating pain in legs then started in arms, experiencing weakness. She used to walk 4 miles and can barely walk around the neighborhood pond. She went to her doctor and she said it was normal but it has been 10 days now and it hasn''t went away. She states it wakes her up and feels like an ice pick in the bones. Caller clarifies it was not in the joint or muscle, it feels like it is in the bone. She states the pain is in the left arm and both legs. When she went to the doctor it was just in her legs but now it is also her arm. Treatment received included still trying to walk and taking Tylenol. Outcome of all the events were not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Crohn''s disease; Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101048426

Write-up: pain; swelling of right arm; a round lump the size of a "50 cent piece"/where she got the shot she has a lump; dizziness; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Aug2021 as single dose for covid-19 immunization. Medical history included, diabetes mellitus, and Crohn''s disease from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as single dose for covid-19 immunization and experienced dizzy. The patient concomitant medications were not reported. On unknown date in Aug2021, the patient experienced pain, swelling of right arm, and a round lump the size of a "50 cent piece" and dizziness. It was reported that, she got the second Pfizer shot yesterday morning and she woke up this morning, and where she got the shot, she has a lump. She was calling about the covid vaccine. She was asking if it was normal. She has a side effect sheet and does not see it. The first shot she got was fine, she had no pain, nothing. Yesterday when she got the second shot, she did experience dizziness. She did get dizzy with the first shot and it passed in one or two hours and was not concerned about that part. She got her second shot in her right arm and her right arm was swollen and she has a lump, it was not a big lump. She was diabetic and has Crohn''s disease and she was not sure if that has anything to do with it. She got the shots through her doctor and that has been her doctor for seven years. The outcome of the event pain resolved on unknown date in Aug2021, while the outcome of other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Oropharyngeal pain
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101052537

Write-up: Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter''s mother). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EY0584, Expiry date: was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Reporter stated, So, his/ her mom had a shot a week ago that day (07Aug2021) and she mean she had sore throat for the last almost three days and she had the diarrhea (Aug2021). Do he/she need to take for the check or was that the regular side effect for the shot. The clinical outcome of events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1673215 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood test, Chest pain, Continuous positive airway pressure, Electrocardiogram, Fibrin D dimer, Fibrin D dimer increased, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Troponin, X-ray
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CK; Result Unstructured Data: Test Result: normal; Test Date: 202108; Test Name: CK; Result Unstructured Data: Test Result: Ok; Test Date: 202108; Test Name: blood test; Result Unstructured Data: Test Result: Ok; Test Date: 202108; Test Name: CPA; Result Unstructured Data: Test Result: Ok; Test Date: 202108; Test Name: ECG; Result Unstructured Data: Test Result: Ok; Test Date: 202108; Test Name: D-Dimer HS level; Result Unstructured Data: Test Result: High; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:124 beats per minute; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:58 beats per minute; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result: High; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result:80-100; Comments: Sitting in bed, heart rate is ok; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result: Jumps to 112-121; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result: heart rate skyrockets to 120; Test Date: 2021; Test Name: Troponin; Result Unstructured Data: Test Result: normal; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result: Ok; Test Date: 202108; Test Name: X-ray; Result Unstructured Data: Test Result: Ok.
CDC Split Type: USPFIZER INC202101057747

Write-up: experienced increased heart rate; Caller got scared and delayed her second dose until 07Aug2021; chest pain; D-Dimer HS level is high; This is a spontaneous report from a contactable pharmacist (patient). A 45-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Aug2021 18:00 (Lot Number: EW0198) (at age of 45-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 06Mar2021 (at age of 45-year-old) (Lot Number: EN6205) for COVID-19 Immunization and experienced a tachycardia response, prickling pain all over body, jerking body, headache, and left side of face was tingling. The patient experienced increased heart rate (medically significant) on 07Aug2021, chest pain(non-serious) on Aug2021, d-dimer hs level is high (non-serious) on Aug2021, caller got and delayed her second dose until 07aug2021 (inappropriate schedule of product administration) (non-serious) on 07Aug2021. Event details: The patient received her first dose of the Pfizer Covid-19 Vaccine on 06Mar2021 and experienced a tachycardia response. The patient got scared and delayed her second dose until 07Aug2021. For the past week she has experienced increased heart rate with any activity she does. Her heart rate remains stable while at rest. Any movement can cause her heartrate to go up to as much as 124 beats per minute that she recorded. But, she has also experienced her heart rate drop to 58 beats per minute. She says it fluctuates. Caller''s doctor tested her CK and Troponin levels and they both came back as normal. She read an article that said that patients with a diagnosis of COVID-19 can experience an increase to their heartrate and blood pressure. She read that the antibodies triggers the receptors to cause the increase and she thinks that the Pfizer COvid-19 Vaccine acts in the same way. Received the Pfizer COVID vaccine second dose on Saturday, 07Aug2021. For past week, heart rate has been increased. On Monday (Aug2021), went to primary doctor and was sent to a cardiologist. Cardiologist did ECG and said it was ok. Thursday (Aug2021) had chest pain, got scared and went to the ER. There, the ER did all the tests, X-ray, CPA, and the blood test to check Troponin and CK level, was told everything was ok. Was told her D-Dimer HS level is high. Discharged and sent home. Put on a Holter Monitor. Wearing Holter monitor since Friday (13Aug2021) , took it off today (16Aug2021)and sent to the lab. Heart rate was still high. Sitting in bed, heart rate is ok, from 80-100. If she started moving, standing up, or doing light housework, heart rate jumps up really high. Jumps to 112-121. Cannot do anything else for the whole week. If she''s resting, she''s ok. Then moving around the house, heart rate skyrockets to 120. Has appointment with cardiologist on 28Aug2021 for an ECHO to find out if anything is wrong. Received second dose on 07Aug2021 at 18:00. By 20:00 on 07Aug2021, she noticed the increase in heart rate. She went to the hospital, but was not admitted. Confirmed she was discharged from the Emergency Room. The outcome of the events was unknown.; Sender''s Comments: Based on strong temporal relationship the causal association between the event heart rate increased and the usage of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1673217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Dizziness, Headache, Lethargy, Malaise, Nausea, Pain, Pyrexia, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Fever; Result Unstructured Data: Test Result:102
CDC Split Type: USPFIZER INC202101057991

Write-up: vision blurriness; a severe headache; a fever of 102; chills; body aches; nausea; lethargy; dizziness; not feeling all that great/was pretty sick; This is a spontaneous report from a contactable other health professional (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experienced a severe headache, a fever of 102, chills, body aches, nausea, lethargy, vision blurriness and dizziness. She was still experiencing a dull headache and vision blurriness. Patient reported she had several unpleasant side effects and still not feeling all that great. Patient was wondering if the second dose was more severe because she was pretty sick this time, and if she should get the second dose. Patient''s second dose was due on 01Sep2021. The patient underwent lab tests and procedures which included body temperature was 102 in Aug2021. The outcome of events "vision blurriness, headache" was not recovered; of other events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1673225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101064028

Write-up: flu like symptoms; headache; muscle ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FA7485) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The Patient reported that he and his wife got vaccinated yesterday (on 16Aug2021), and are experiencing some flu like symptoms. He was wondering if there was any reason they could not take Tylenol or Ibuprofen. He and his wife decided to get a 3rd vaccination; that it had been over 6 months and they are over 65, not immunocompromised. Patient stated now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1673226 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acne, Headache, Hyperhidrosis, Pain, Pain in extremity, Pruritus, Pyrexia, Rash, Skin disorder, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065820

Write-up: rashes; like lots all over his body/rash in the hand; Fever; body is aching/body pain; Sweating; Headache; legs, and soreness; having a reaction; chemical reaction with his skin; breaking out like with pimples; Itchy; getting swollen; This is a spontaneous report from two contactable consumers (patient''s wife and patient''s son). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s son stated the patient was having a reaction through a chemical reaction with his skin like, he was breaking out like with pimples in Aug2021 and asked if that was normal. The patient also had like a rash over, rash like rash in his body that he was just like make some itchy and getting swollen and then fever and then like legs, and soreness. The patient''s son said the patient had like rashes and like lots all over his body and he had headache and then sore and all that. The patient''s wife stated the patient got the rashes and he had fever and his body was aching. The patient had not gone to the hospital yet. She stated they got the shot yesterday (15Aug2021) and 2 hours later the patient got the fever, sweating, pain and body pain and rash in the hand. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1673239 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101076148

Write-up: misses her period/I have never ever missed a period and I missed a period; I am experiencing side effects from the shot; This is a spontaneous report from a contactable consumer (patient herself). A 39-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181), via an unspecified route of administration on 10Aug2021 (age at vaccination: 39 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date in August2021, she missed her period/ have never ever missed a period, she was experiencing side effects from the shot. She has always been in incredible health. She wanted to know what damage has been done to her that she might not be able to fix, she needs to get the ball rolling on how to get her body back to functioning the way it should, wants to know what the vaccine has done that has impacted her body not make it work. The outcome of the events was unknown. There was no product quality complaint (PQC) present. The lot number for the vaccine was not provided and will be requested during follow up.


VAERS ID: 1673258 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-03-28
Onset:2021-08-01
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Oropharyngeal pain, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Multiple sclerosis (Diagnosed either in 2010 or 2011, somewhere in there.)
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Covid-19; Result Unstructured Data: Test Result:Negative; Test Date: 20210803; Test Name: Covid-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101077102

Write-up: they all tested positive for COVID-19 after their COVID-19 vaccination; they all tested positive for COVID-19 after their COVID-19 vaccination; sore throat; symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 (at the age of 39 years old) as Dose 2, single for covid-19 immunization. Medical history included multiple sclerosis Diagnosed either in 2010 or 2011, somewhere in there. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, single for covid-19 immunization. The patient concomitant medications were not reported. The patient experienced they all tested positive for covid-19 after their covid-19 vaccination on 03Aug2021, sore throat and symptoms on an unspecified date in Aug2021. You should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. Please be sure to discuss any questions about receiving the Pfizer-BioNTech COVID-19 vaccine and if you have COVID-19 or develop COVID-19 after receiving the first dose with your vaccination provider, doctor, or other health care professional." Caller''s "daughter tested positive for delta variant of COVID-19 last 03AUG2021 and had Multiple Sclerosis". Caller wanted to know if there is a time period for her daughter to wait before she gets the booster dose of the Pfizer BioNTech COVID-19 vaccine. Caller''s daughter got off isolation last Monday, 16AUG2021. The dates for tested positive for the delta variant was reported from date 03 Aug2021 to 16 aug2021.No lot number was provided because caller does not have a copy of her daughter''s COVID vaccine record card. The caller mentioned about product complaint due to her daughter having delta variant covid infection. The patient underwent lab test and procedure which included covid-19 result included negative on 02Aug2021 and positive on 03Aug2021. The outcome of the event they all tested positive for COVID-19 after their COVID-19 vaccination was recovered on 16Aug2021 and the outcome of other events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1673265 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Hypoaesthesia, Nausea, Oropharyngeal pain, Throat irritation, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101081579

Write-up: anaphylactic reaction; Throat was closing up/tighten, sore and itchy throat; Everything was going numb; Nauseous; sore and itchy throat; sore and itchy throat; This is a spontaneous report from a contactable consumer (patient''s mother). A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FC3181), via an unspecified route of administration, administered in left arm on 19Aug2021 at around 15:30 as dose 1, single (at the age of 15 years), for covid-19 immunization, at pharmacy. Vaccine was not administered at military facility. It was told that they should get it, needs to be done, protection when going back to school, doctor recommended it. Medical history was not reported. There were no concomitant medications (Other Products: No). There was no family medical history relevant to adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The patient previously received Flu shot (Vaccination Date: Unknown) and had an allergic reaction to the Flu shot. Caller did not know the date of this vaccine or the NDC, Lot Number, or Expiry date for the vaccine. Caller states that this occurred when her daughter was in Kindergarten. Caller stated her daughter had all of her other vaccines and never had any reactions. There were no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. The mother reported that, her daughter got the first dose of the Pfizer-BioNTech Covid-19 Vaccine and on the same day on 19Aug2021, experienced anaphylactic reaction (tighten, sore and itchy throat), everything was numb and she was nauseous that lead to them ending up in urgent care and emergency department to be further treated. She explained in detail that, her daughter was taken to the Emergency Room and as a corrective for all the events she was given an EpiPen that helped immediately and her daughter was also given steroids and was monitored, admitted, and treated in the Emergency Room for 5 hours. She said that her daughter was currently sleeping in her bedroom and was doing better, and she had to go pick up more medication for her daughter this morning that she would take for the next 10 days. She stated it was so scary yesterday. Patient Medical was not continuing. No investigation assessment was done. Adverse events resulted in visit to emergency room and physician office. There were no relevant tests. The outcome for all the events was reported as recovering, at the time of report. Follow-up attempts completed. No further information expected.


VAERS ID: 1673279 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN0179 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood iron, Blood iron increased, Muscle spasms, Pain in extremity, Skin discolouration
SMQs:, Dystonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic (Additional Information for Other Conditions: found out last year)
Allergies:
Diagnostic Lab Data: Test Name: Iron level; Result Unstructured Data: Test Result:high; Comments: Her iron level is high
CDC Split Type: USPFIZER INC202101082276

Write-up: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN0179), via an unspecified route of administration (at the age of 57-years), administered in arm right on 11Aug2021 at 16:30 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from 2020 to an unknown date additional Information for other conditions: found out last year. There were no concomitant medications. The vaccination was administered at hospital. On an unspecified date in Aug2021, the patient experienced burnt mark on her right arm/dark patch on her right arm, her iron level is high, soreness and muscle spasms. Caller was calling about receiving the first dose of the Pfizer Covid-19 vaccine; her iron level is high per DSU agent. Caller is a 57 year old female who received the first dose of the Pfizer Covid-19 vaccine on 11Aug2021 and states that she is not calling because of her iron level is high. Caller states that after the first dose of the Pfizer Covid-19 vaccine that she had complaints of soreness, muscle spasms, and a burnt mark on her right arm. Caller describes the burnt mark as a dark square that was at her injection site on the right shoulder. Stated that it looks like a suntan; one part is darker than the other. Caller was asking if a burnt mark at the injection site is a side effect that has been re-ported for the Pfizer Covid-19 vaccine? She got her shot, she got something on her arm, a patch, or dark mark on her arm, like it was burnt. Is that normal? Caller mentions she was driving. Adds her next dose on 01Sep2021. Caller reported that she noticed the dark patch on her right arm; she thought it was where the band aid came off; but it looked burnt; a couple of days later after the vaccination she noticed it. It is staying the same. Caller asked can she call back because she has somewhere to go? She does not have time to finish the report right now. Received follow up call from consumer regarding the Pfizer COVID 19 Vaccine. She just spoke with someone at Pfizer Drug Safety and had to run into the store, so she was calling back. She would like to know what was wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. She did not wish to provide an email or date of birth. There was no product complaint to report. Medical information request: She would like to know what is wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. The patient underwent lab tests and procedures which included blood iron: high on and unspecified date and her iron level is high. The clinical outcome of the event burnt mark on her right arm/dark patch on her right arm was reported as not recovered while for other events was reported as unknown.


VAERS ID: 1673290 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Fall, Head injury, SARS-CoV-2 test, Walking aid user
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (He is a survivor of a brain aneurysm with subarachnoid hemorrhage (Apr2015)); Subarachnoid hemorrhage (He is a survivor of a brain aneurysm with subarachnoid hemorrhage (Apr2015))
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: Nasal Swab; Test Result: Negative ; Comments: covid test post vaccination: Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: in ER, Covid test date: 19Aug2021, Covid test result: Negative
CDC Split Type: USPFIZER INC202101082634

Write-up: The second fall he hit his head and had to go to ER; causing my husband to fall twice in one week; dizziness causing my husband to fall twice in one week; walking with walker and assistance; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on Aug2021 11:00 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included aneurysm from Apr2015 to an unknown date He was a survivor of a brain aneurysm with subarachnoid hemorrhage. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Aug2021 13:00, 1 week after vaccine, the patient had onset of dizziness causing to fall twice in one week on an Aug2021. The second fall he hit his head and had to go to emergency room (ER). Hospitalized for 1 night. Still dizzy and walking with walker and assistance on Aug2021. The adverse event resulted in patient to visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Aug2021 covid test post vaccination: Nasal Swab, in ER. The patient received treatment with neuro test and Antivert for dizziness. The seriousness of the event was considered as Hospitalization, Disability or permanent damage. Since the vaccination, the patient had been tested for COVID-19. Outcome of the event was not resolved.


VAERS ID: 1673298 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Hypokinesia, Muscle disorder, Muscular weakness, Paraesthesia, Paralysis, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Generalized anxiety disorder; Pain disorder associated with psychological factors; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101082725

Write-up: Paralysis in the hand arm or shoulder; Lack of muscle control in the hand arm and shoulder; Loss of sensation in the hand arm and shoulder; Sharp stabbing pain in shoulder; Numbness and tingling; Numbness and tingling; Overall muscle weakness; Limited range of motions and movements; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at the age of 25 years non pregnant on 31Jul2021 (Batch/Lot Number: Ew0164) as DOSE 1, SINGLE for covid-19 immunisation. Facility Type Vaccine: Pharmacy or Drug Store. Medical history included depression, generalised anxiety disorder, sleep disorder, somatic symptom disorder. There were no concomitant medications. The patient experienced paralysis in the hand arm or shoulder (disability) on 01Aug2021 with outcome of not recovered, lack of muscle control in the hand arm and shoulder (disability) on 01Aug2021 with outcome of not recovered, loss of sensation in the hand arm and shoulder(disability) on 01Aug2021 with outcome of not recovered, sharp stabbing pain in shoulder (disability) on 01Aug2021 with outcome of not recovered, numbness and tingling (disability) on 01Aug2021 with outcome of not recovered, overall muscle weakness (disability) on 01Aug2021 with outcome of not recovered and limited range of motions and movements (disability) on 01Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of events: oral steroids


VAERS ID: 1673303 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Pyrexia, SARS-CoV-2 test
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Covid test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101082933

Write-up: Result:Positive; Result:Positive; Allergy like symptoms followed by a fever.; Allergy like symptoms followed by a fever.; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 30-years-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Aug2021 the patient experienced result was positive (COVID-19 and drug ineffective). On an unspecified date in Aug2021, patient experienced allergy like symptoms followed by a fever. The AEs resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient had received any treatment for adverse events. The patient underwent lab tests and procedures which included SARS-COV-2 test (post vaccination) which was positive on 22Aug2021. The outcome of event COVID-19, allergy like symptoms followed by a fever was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1673307 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Lip pruritus, Lip swelling, Near death experience, Pallor, Tongue pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: Rheumatoid arthritis (Diagnosed with about 6 years ago.)
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101084034

Write-up: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673316 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-18
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN0171 / 3 LA / OT

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Colitis ulcerative, Diarrhoea, Extra dose administered, Headache, Pain
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Ulcerative colitis (she was first diagnosed with Ulcerative Colitis in 2015)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101084308

Write-up: having a Ulcerative colitis flare up; I got my booster yesterday; Headache; Diarrhea; Achiness; terrible stomach pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0171) via intramuscular, administered in Arm Left on 18Aug2021 10:20 (at the age of 44-year-old) as dose 3, single for covid-19 immunisation. Medical history included colitis ulcerative (she was first diagnosed with Ulcerative Colitis in 2015) and hypothyroidism from an unspecified date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202) via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6200) via an unspecified route of administration on 22Mar2021 as dose 2, single for covid-19 immunisation. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 18Aug2021 10:40 the patient experienced having a Ulcerative colitis flare up, Consumer stated that in the past diagnosed with Ulcerative Colitis and she did not have any issues or any side effects with her first or second dose. It was just with yesterday you know after her shot she had a slight headache and achiness and then this morning she just had really a terrible stomach pain. she was experiencing now a flare up of Ulcerative colitis. It was like combining of her intestines like heading (Not clarified) so it was just like a flare up of the Ulcerative Colitis. Consumer stated that Ulcerative Colitis it has been many years. she would say for 7 to 8 years ago. She states two months ago she was taking a medication called Canasa and her getting up for you right now. It was like a suppository. Consumer stated, she has not taking anything currently but that was the medicine she was prescribed in the past. Consumer stated, she called Gastroenterologist to and left a msg for the nurse and she trying to get a call back from the doctors. It was just really bad stomach pain about 07:45 this morning and then like, she had some Diarrhoea and then it some of side (Not Clarified). The way the doctor explains before happened this like the ulcer and ulcerative colitis with burns of like your Intestinal lining. The adverse events terrible stomach pain, Diarrhoea was result in visit to emergency room/ Physician Office Visit. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Temperature; Result Unstructured Data: Test Result:99 degrees; Test Date: 20210822; Test Name: Temperature; Result Unstructured Data: Test Result:101+ degrees; Test Date: 20210823; Test Name: Temperature; Result Unstructured Data: Test Result:Around 101 degrees
CDC Split Type: USPFIZER INC202101089966

Write-up: Pressure headache; Chills; Had 99 degrees temperature on Saturday (21Aug2021)/On Sunday (22Aug2021), caller''s temperature was at 101+ degrees/Today (23Aug2021), her temperature was still at around 101 degrees; Arm was hurting a little; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pressure headache on 23Aug2021, chills on 22Aug2021, arm was hurting a little on Aug2021, had 99 degrees temperature on Saturday (21aug2021)/on Sunday (22aug2021), caller''s temperature was at 101+ degrees/today (23aug2021), her temperature was still at around 101 degrees on 21Aug2021. The patient underwent lab tests and procedures which included body temperature: 99 degrees on 21Aug2021, body temperature: 101+ degrees on 22Aug2021, body temperature: around 101 degrees on 23Aug2021. The outcome of the event pyrexia was not recovered, the outcome of the events headache, chills, pain in extremity was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Illness, Nasopharyngitis, Nausea, Oropharyngeal pain, Productive cough
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (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 INC202101090081

Write-up: complaints of cold; sore throat; coughing up dark brown phlegm; extreme headache; nausea; feels weak; feels really sick; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that after vaccine, she was fine for two to three days. But, after 2-3 days of vaccination, on an unspecified date in Aug2021, patient started having complaints of cold, sore throat, coughing up dark brown phlegm, extreme headache, nausea, feels weak, and feels really sick and was very tired. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673339 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Headache, Pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: USPFIZER INC202101090214

Write-up: feel sleepy; headache; body ache; feels weakness; This is a spontaneous report received from a contactable consumer(patient). A male patient received BNT162B2 (COMIRNATY- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 16Aug2021 night, at dose1, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine made by Pfizer on Monday night of last week, 12 hours later on 17Aug2021 he began to feel sleepy, headache and body ache, today he still had a headache and felt weakness, the patient wants to know if this is normal. He has been taking serum (PENDING CLARIFICATION). The outcome of the events for feel sleepy and body ache were unknown while for headache and body ache were not recovered at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.


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