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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 265 out of 8,010

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VAERS ID: 1729471 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Dyspnoea exertional
SMQs:, Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: h/o COVID-19 in 10/2020 asthma
Allergies: nka
Diagnostic Lab Data: not yet completed-- ordered cxr, ekg
CDC Split Type:

Write-up: Pt developed dyspnea on exertion and atypical chest pain following dose #1, lasting approx. 15 days-- seemed to be improving on its own by the time she got dose #2


VAERS ID: 1731200 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erectile dysfunction
SMQs:, Sexual dysfunction (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: Atorvastatin, Metoprolol, Infliximab
Current Illness: none
Preexisting Conditions: Ulcerative colitis
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erectile dysfunction


VAERS ID: 1731247 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-03-17
Onset:2021-09-05
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Electrocardiogram
SMQs:, Supraventricular tachyarrhythmias (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? No
Previous Vaccinations:
Other Medications: Candesartan, Warfarin, Carvedolol
Current Illness: none
Preexisting Conditions: Marfan''s syndrome. Both aortic and mitral valves have been replaced with mechanical valves.
Allergies: none
Diagnostic Lab Data: EKG, chest X-ray, and whatever bloodwork they ran. This was done at the emergency room.
CDC Split Type:

Write-up: Atrial fibrillation. Lasted several hours. Went to the ER to make sure I wasn''t going to die. They did some tests then sent me home. Condition was gone by the time I woke up. This is very likely not related to anything other than my medical history but thought you should have the data.


VAERS ID: 1731722 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Electrocardiogram, Electrocardiogram ambulatory, Palpitations, Sinus arrhythmia, Ultrasound scan
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: ekg, ultrasound, holter monitor, observations 9/5-9/6
CDC Split Type:

Write-up: Sinus arrhythmia, heart palpitations, light-headed/dizzy


VAERS ID: 1731793 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

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

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

Write-up: Daily nose bleeds and vaginal bleeding x 2 weeks


VAERS ID: 1731857 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Feeling cold, Hunger, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Estradiol, mag/cal, potassium, lysine
Current Illness: None
Preexisting Conditions: Seasonal allergies, occasional herpes simplex (no lesions at time of vaccine)
Allergies: Sulfa, macrobid, codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Woke at 3am (9/5) feeling achy & cold so added a blanket. Woke at 5am with body aches(whole body, from toes to head), uncontrollable shakes & vomiting (only one episode with numerous vomits of bile) & temperature of 101. Took 2 ibuprofen for aches + 2 Tylenol to reduce my temperature. Returned to bed, slept until 10:30am, waking hungry & temperature down to 98.7. Continued taking ibuprofen/Tylenol according to bottle directions. Woke at 5am(9/6) with my left arm, beneath the injection site, red/swollen/itchy/hot & temperature at 99.8. Took 2 Benadryl & continued according to Direction. Arm remained like this until 9/11. Slowly going pink.


VAERS ID: 1732791 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Preexisting Conditions: SEBORRHEA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported experiencing severe pain in the whole arm. It continues even more than two weeks after vaccination. Patient also has swelling in the arm. No fever reported. Patient took over-the counter Tylenol and Ibuprofen; also trying Voltaren gel and Lidocaine cream per his doctor''s advise.


VAERS ID: 1732829 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Electrocardiogram, Pain in extremity, Rash, Skin burning sensation, Ultrasound Doppler, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: alendronate
Current Illness:
Preexisting Conditions: Systemic lupus erythematosus, Monoclonal gammapathy of unknow significance (MGUS), osteoporosis, asthma
Allergies: plaquenil
Diagnostic Lab Data: ECG 12 lead, VAS leg venous doppler
CDC Split Type:

Write-up: abdominal rash, trunk hives, severe right thigh pain, burning skin, chest pressure


VAERS ID: 1734103 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-06
Onset:2021-09-05
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Condition aggravated, Infarction, Magnetic resonance imaging abnormal
SMQs:, Myocardial infarction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine aspirin lipitor clopidogrel hydralazine lisinopril meclozine metoprolol sertraline janumet vesicare
Current Illness:
Preexisting Conditions: HTN, DM, asthma, stroke in 2018
Allergies: latex
Diagnostic Lab Data: MRI
CDC Split Type:

Write-up: Patient presented with stroke on 9/5 patient presented with multiple acute infarcts again on 9/21


VAERS ID: 1734139 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (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: COVID-19 (If COVID prior vaccination: Yes); Sulfonamide allergy (Known allergies: Sulfa)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101175280

Write-up: fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) in left arm on 04Sep2021 at 11:00 AM as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies, COVID-19 (COVID prior vaccination: Yes), both from an unknown date and unknown if ongoing. There were no concomitant medications. Reported facility type vaccine was Pharmacy or Drug Store. Patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Patient received no other medications in two weeks. On 05Sep2021 at 07:00 AM the patient experienced fell to the ground. She had no control over my legs/legs gave out and she fell to the ground. It was reported that "the patient received her initial COVID vaccine dose on 04Sep21 at 1100. On the morning of 05Sep21 around 0700, she walked outside her back door, stepped down two steps onto the patio then took a few more steps walking onto the patio and then fell to the ground. She had no control over her legs. The very same thing happened, the very same day later that evening around 1700. Her legs gave out and she fell to the ground." The patient received no treatment for the adverse events. The clinical outcome of the events was resolved on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.


VAERS ID: 1734231 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Menstruation irregular, Urinary tract infection
SMQs:, Retroperitoneal fibrosis (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAYTULLA; NAC [ACETYLCYSTEINE]; L-METHYLFOLATE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101252050

Write-up: Lower back pain; Urinary tract infection; Irregular period; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration on 03Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (TAYTULLA), acetylcysteine (NAC), and levomefolic acid (L-METHYLFOLATE); all taken for unspecified indications from unknown dates and unknown if ongoing. On 05Sep2021, the patient experienced lower back pain, urinary tract infection, irregular period. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included an unspecified treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lower back pain, urinary tract infection, irregular period were unknown at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1735016 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray, Chest pain, Cough, Electrocardiogram, Fatigue, Full blood count, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Chest XRay , ECG, CBC 9/22/21.
CDC Split Type:

Write-up: Severe chest pain, dry cough, fatigue, heart palpitations. Being treated for possible pericarditis. I have been sick for about 3 weeks ,3 days after the vaccine. Today my heart still hurts. I will return to the Dr if pain and cough persist after medications.


VAERS ID: 1735358 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-03-03
Onset:2021-09-05
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Oversensing, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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: Sumatriptan; Singular; Estrodiol; Omeprazol; Lisinopril; Multivitamin
Current Illness:
Preexisting Conditions: Migraine
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever , fatigue, body aches, headache, everyday and on 6th of March I had severe amplified hearing were I couldn?t deal with any noise whatsoever. Just little things were so bothersome I couldn?t function all day. The next day it disappeared or I was going to doctor. I wouldn?t have been able to live that way without going crazy. I felt like I needed ear plugs.


VAERS ID: 1735488 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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:

Write-up: Site: Pain at Injection Site-Mild


VAERS ID: 1736711 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-07
Onset:2021-09-05
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3246 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Chest X-ray abnormal, Dyspnoea, Pneumonia, Pulmonary embolism, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic lung disease, Diabetes
Allergies:
Diagnostic Lab Data: 09/05/2021 Antigen+ COVID-19 test
CDC Split Type:

Write-up: Breakthrough COVID-19 case with symptom onset 9/5/2021: Shortness of breath/difficulty breathing. Hospitalized 9/5/2021-9/6/2021. Patient was admitted to the hospital the same day of testing positive at the facility. He was discharged the next day on 9/6 but then re-admitted the same day with bilateral pulmonary embolism. At time of hospitalization, noted to have pneumonia, abnormal chest x-ray, and acute respiratory distress.


VAERS ID: 1737030 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-06-22
Onset:2021-09-05
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bowel movement irregularity, Diarrhoea, Hypersomnia, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOXYL; Progesterone
Current Illness: Had a cold a couple of weeks before vaccine and got a negative COVID test prior to Vaccine
Preexisting Conditions: No
Allergies: Erythromycin; Hay fever stuff
Diagnostic Lab Data: 8/26/2021 COVID test PCR and 8/28 negative result on.
CDC Split Type: vsafe

Write-up: I have had sore throat on and off (it was regular ongoing for 10 days). Mild fever with it. I didn''t feel better taking allergy medicine. Stuffy and congested nose for 3 1/2 weeks. Unstable bowel movements some days very loose stool and some days diarrhea and that has been consistent for 3 1/2 weeks. I just slept a lot and tried to drink more fluids. Tylenol for the fever and body aches. I took a lot of Nyquil so I could sleep. Ever since I got the shot, I have had yucky symptoms, but they have been coming and going. Fever is gone and sore throat is gone but I have the congestion in nose and loose stools still remain. I saw my doctor for a regular checkup about three weeks and he didn''t have anything to help.


VAERS ID: 1737146 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-02
Onset:2021-09-05
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022M20A / UNK RA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Type 2 Diabetes, hypertension
Allergies:
Diagnostic Lab Data: Rapid test collected 9-11-2021, resulted positive
CDC Split Type:

Write-up: Fever, feverish, chills, muscle aches, runny nose, sore throat, cough, nausea, vomiting, headache, fatigue, diarrhea.


VAERS ID: 1737151 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-25
Onset:2021-09-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Chills, Cough, Fatigue, Injection site discomfort, Pyrexia, SARS-CoV-2 test negative, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi vitamins; vitamin D3
Current Illness:
Preexisting Conditions:
Allergies: Penicillin; SOFIA; Scallop; nickels
Diagnostic Lab Data: Blood work; urine sample; Covid-19 test
CDC Split Type: vsafe

Write-up: I had a fever, chills, serve fatigue, and a dry cough. The fatigue was the worst. I had some discomfort around the injection site for about 12 hours. I went to the doctor about this. They did a complete blood work and a urine sample. Everything came out normal. I also did a Covid-19 test on Sept 13th, which came back negative.


VAERS ID: 1737260 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-02
Onset:2021-09-05
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray normal, Fall, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive, Unresponsive to stimuli, Vaccine breakthrough infection, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/05/2021 PCR+ COVID-19 test
CDC Split Type:

Write-up: Breakthrough COVID-19 case with symptom onset 9/5/2021: Fever, Aches, Nausea/Vomiting. Hospitalized 9/5/2021 following fall down the stairs. 911 was called as Pt was unresponsive and taken from home address in record to Hosp where she was admitted for possible heart attack. Chest xray was clear.


VAERS ID: 1737374 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-15
Onset:2021-09-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Biopsy, Blastomycosis, Blood test, Bronchoscopy, Chest X-ray, Chest pain, Chills, Computerised tomogram abdomen, Computerised tomogram thorax abnormal, Fibrin D dimer, Fungal infection, Headache, Histoplasmosis, Influenza virus test negative, Lymphadenopathy, Night sweats, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, D-3 supplement, and b12 supplement
Current Illness: None
Preexisting Conditions: Hashimotos, CADASIL, ANA positve, Spondylo arthritis
Allergies: Amoxicillan
Diagnostic Lab Data: Three Covid tests (all negative) between 9/6/21 - 9/16/21 Bronchscopy with biopsy Two CT scans of chest and abdomen Various bloodtests
CDC Split Type:

Write-up: Began with chest pain on 9/5/21. From 9/6/21 to 9/13/21, I had 102 fevers every night, chest pain, chills, headaches, and night sweats. Visted urgent care twice. First time was given Z pack and chest xray. Symptoms did not improve. Visited second time and had flu test, strep, urine analysis; all negative/normal. Saw primary care doctor on 9/17/21 and had d- dimer blood test that was 2, so was sent to ER on suspicion of blood clot. No blood clot, but CT scan found a large mass/enlarged lymph node near my chest. Was told it could be cancer and was admitted to hospital on 9/17/21. Discharged 9/18/21. Pulmonologist suspected it was a fungal infection, not cancer. Had bronchoscopy done on 9/21/21. Blood tests are showing histoplasmosis or blastomycosis so far, but not all results are back yet. Now on anti-fungal medication, Itraconazole.


VAERS ID: 1740028 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-09
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007C21A / 2 - / OT

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

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

Write-up: Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021; product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and PRODUCT STORAGE ERROR (product storage error) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications information was not reported. No treatment medications were provided. 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21. This case was linked to MOD-2021-320876 (Patient Link).; Sender''s Comments: This case concerns a 26-year-old, male subject with no relevant medical history who was administered with an expired Spikevax product for his second dose of the vaccine. No information on the first dose received by the patient. There were no reported AEs/SAEs associated with this expired product administration. The rechallenge was not applicable in this situation. Causality was not provided by the reporter or not applicable. The benefit-risk relationship of the vaccine is not affected by this report. This case was reviewed via RA


VAERS ID: 1740175 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Hypertension, Palpitations, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (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:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101206042

Write-up: palpitations; Hypertension; injection site (entire arm from elbow to armpit) swelling; anxiety; This is a spontaneous report from a Non-contactable Other HCP (patient herself). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3183, expiry date: unknown) via unspecified route of administration, in left arm on 03Sep2021 16:30, (age at vaccination: 40-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient did not take any other vaccines in four weeks, or medications in two weeks. On 05Sep2021, patient experienced hypertension, palpitations, anxiety, injection site (entire arm from elbow to armpit) swelling. Treatment was given due to the adverse events with HTN. AE resulted in doctor or other healthcare professional office/clinic visit .It was unknown whether patient had been diagnosed with COVID-19 prior to vaccination and was not tested since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1740526 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Pneumonia, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bipolar disorder; Diabetic; High cholesterol; Penicillin allergy; Sulfonamide allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: Blood test; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210950464

Write-up: PNEUMONIA; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: bipolar, diabetic, high cholesterol, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with lamotrigine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-SEP-2021, the patient experienced suspected clinical vaccination failure as patient test positive for Covid-19. On an unspecified date, the patient experienced pneumonia, could not move, and could not do anything. Treatment medications (dates unspecified) included: lorazepam, and mirtazapine. Patient was administered Ativan and also treated with Remeron for 2 weeks. On 05-SEP-2021, the patient experienced weakness, and suspected covid-19 infection, and was hospitalized. The patient was hospitalized for 14 days and discharged on 18-SEP-2021. Patient felt week and deconditioned. They tied patient to the bed for 2 weeks. Patient stated that she could not move and could not do anything for herself and still can''t but patient was trying. They did a ton of blood work but patient didn''t remember any. Patient mentioned that she was really sick. Patient was calling to try to get Levaquin for pneumonia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) with unknown result , and on 05-SEP-2021, COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, pneumonia and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194723.; Sender''s Comments: V0: 20210950464- 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 20210950464- Covid-19 vaccine ad26.cov2.s- Pneumonia, suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1741521 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Lichen planus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR, FLONASE, ZYRTEC
Current Illness: 8/23/21 SEEN FOR URI SX. 2 NEGATIVE COVID TESTS AT HOME BEFORE VISIT
Preexisting Conditions: ASTHMA
Allergies: CASHEWS
Diagnostic Lab Data:
CDC Split Type:

Write-up: URTICARIAL RASH STARTING ON CHEST AND UPPER BACK AS WELL AS LICTHEN PLANUS LOOKING LESIONS TO TORSO.


VAERS ID: 1743717 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDRALAZINE; LOSARTAN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Diabetes; Food allergy; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101211868

Write-up: hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04Sep2021 12:30 (at the age of 62-year-old) (Batch/Lot Number: FC3184) as dose 2, single for covid-19 immunisation. Medical history included diabetes, high blood pressure, left nephrectomy and known allergies: peanuts. The patient was not pregnant. Concomitant medications included hydralazine, losartan, and metoprolol. The patient previously took Demerol and morphine and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 14Aug2021. On 05Sep2021 08:00, the patient experienced hearing loss in right ear. It was reported that the patient woke up the next morning with hearing loss in right ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and assessed as disability or permanent damage. Therapy for the event included prednisone. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.


VAERS ID: 1744451 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-24
Onset:2021-09-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Arthralgia, Blood test, Chest X-ray, Electrocardiogram abnormal, Muscle strain, Musculoskeletal chest pain, Pain, Painful respiration, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Left rib and chest X rays- 09/05/2021 EKG - 9/20 Community Health Med Check EKG- 9/20 Hospital Xray left ribs- 9/20 Hospital Blood test to check for heart attack - 9/20 Hospital
CDC Split Type:

Write-up: 09/05/21 I woke up at 230 am with left rib and shoulder pain. This pain was a radiating, sharp pain. I went to an urgent care clinic that diagnosed it as a pulled muscle. This pain resolved on 09/10/21. On 09/11/21 while sleeping I woke up to a more sever pain that was moving from my rib around my left breast. This pain resolved on 09/18/21. On 9/20/21 a different left rib started having the same symptoms. I went to the urgent care again on 09/20/21, they did an EKG and it came back abnormal. I went to the emergency room for treatment and was diagnosed with pericarditis. All three events were on the left side with the same pain as described. This pain increases when I lay down or take a deep breath. I still have pericarditis and am taking 600mg of ibuprofen every six hours for 14 days in hopes that it fully resolves. I will be getting an echocardiogram to see the severity of the pericarditis.


VAERS ID: 1745349 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-01
Onset:2021-09-05
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate Voltaten XR Synthroid
Current Illness: None
Preexisting Conditions: Rheumatoid Arthritis, Hashimotos
Allergies: None
Diagnostic Lab Data: Lab work is scheduled for three weeks from now.
CDC Split Type:

Write-up: Two weeks after first Moderna dose, a big flare up of my well controlled RA. I haven?t had a flare up of this magnitude and length in over a decade.


VAERS ID: 1745618 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-14
Onset:2021-09-05
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Asthenia, COVID-19, Cough, Dizziness, Exposure to SARS-CoV-2, Mobility decreased, Oxygen saturation decreased, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sinus disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: Synthroid; Lexapro; Xanax; Lunesta; Omeprazole; Symbicort; Xopenex
Current Illness: N/A
Preexisting Conditions: Asthma; Anxiety; Osteoarthritis
Allergies: N/A
Diagnostic Lab Data: Covid-19 Positive 09/10/2021
CDC Split Type: vsafe

Write-up: I was exposed on to Covid-19 on 09/02/2021 when I was flying. The symptoms started on 09/05/2021. I first got a cough and then my nose was running. I thought I had a Sinus infection but my symptoms got worse through the week. I was using my inhalers, but they weren''t making me feel better. I then lost my sense of taste and smell and the fact that it started with a cough made me think it was unusual. I visited my doctor and I was given Prednisone and some antibiotics because they thought it was a Sinus infection. I tested positive for Covid-19 and I was bedridden. On 09/21/2021 I was lightheaded and dizzy when I went outside. My Oxygen was very low at 92 and I had a slight fever. I called the doctor and she prescribed Zithromax which really seemed to help as well as more Prednisone. My inhaler helped as well as my C-Pap machine. I improved slightly over time. It has been four weeks and I still have very little energy. I lay down about three times a day and it helps. My cough has improved.


VAERS ID: 1747738 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-31
Onset:2021-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram normal, Heart rate increased, Malaise, Palpitations, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 9/5/2021: ECG and bloodwork (at ER) - normal
CDC Split Type:

Write-up: Heart palpitations, increased heart rate, increased blood pressure, shaking legs, overall feeling of unwell/uneasiness; since initial date of incidents, increased heart rate comes and goes


VAERS ID: 1747998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-26
Onset:2021-09-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 938633 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dysmenorrhoea, Dyspnoea, Injection site pain, Nausea, Vomiting, Weight, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Weight; Result Unstructured Data: Test Result:11 pounds weight gain
CDC Split Type: USPFIZER INC202101207100

Write-up: 11 lb weight gain; Nausea; Shortness of breath; Chest pain; vomiting; Severe menstrual cramps; Pain at her injection site Remodulin; This is a solicited report based on the information received from a contactable consumer (patient) via regulatory authority (MFR Control No: UNT-2021-017551). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 26Aug2021 (Batch/Lot Number: 938633; Expiration Date: 28Feb2023) and ongoing, at 0.004 ug/kg for secondary pulmonary arterial hypertension. Patient medical history was unknown. Historical vaccine included BNT162B2 for COVID-19 vaccine. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 05Sep2021, the patient experienced the events of 11 lb weight gain and nausea. On an unreported date in 2021, after her second COVID shot she had chest pain, shortness of breath, couldn''t hold anything down. The patient also had severe menstrual cramps and pain at her injection site for Remodulin. Her prescriber advised her to go to the emergency room but initially she chose not to go and then further reported to field nurse that she was feeling a little better. On 05Sep2021, 11 days after initiating IV Remodulin, the patient visited hospital emergency department and admitted to hospital with chief complaints of shortness of breath, 11 pounds weight gain, chest pain, vomiting and nausea. The action taken in response to the events for treprostinil sodium was unknown. The outcome of events weight increased, dyspnoea, chest pain, vomiting, and nausea was unknown and events dysmenorrhea and injection site pain was considered as resolving. The reporter did not provide causality for the events of weight increased, dyspnoea, chest pain, vomiting, dysmenorrhea, injection site pain and nausea. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1749337 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-29
Onset:2021-09-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax, Dyspnoea, Electrocardiogram normal, Fibrin D dimer
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lo-ovral (birth control)
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Elevated d-dimer level of 0.55 which prompted ER to do a CT scan of chest 9/8/21
CDC Split Type:

Write-up: Left-sided moderate chest pain began one week after first Moderna shot administered. Constant pressure in chest, made it a little difficult to breathe. Continued for approximately 10 days, started to decrease after about day 7. Went to the emergency room, had elevated d-dimer level (0.55), had CT scan which was normal. EKG was normal, chest x-ray normal. As of today, 9/30/21, I no longer feel the chest pain.


VAERS ID: 1749463 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-30
Onset:2021-09-05
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: testosterone, Nasonex and Allegra
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: vital signs bad
CDC Split Type: vsafe

Write-up: Severe chest pain increase.


VAERS ID: 1750316 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-03-30
Onset:2021-09-05
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Illness, Mononucleosis heterophile test negative, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative, Upper-airway cough syndrome, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Apri; spironolactone
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Covid 19 tests Rapid and PCR, negative, 9/7/2021. Strep Throat, Negative 9/7/2021. Mono Test, Negative 9/7/2021. Lab white blood cell count high 9/7/2021
CDC Split Type: vsafe

Write-up: Well I had a sore throat that started on Sunday September 5th 2021 around 4PM. Later that night, I had a fever of 101. Very sore throat, fever lasting for two days and the sore throat has lasted several weeks. I went to the DR on 9/7/2021. I was given antibiotics by the DR, a two week course. I completed that but it didn''t really make much of a difference. About a week after the medicine, I was still experiencing soreness in my throat and post nasal drip and congestion as well. It took me several weeks in order to clear that illness.


VAERS ID: 1752014 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Off label use, Therapeutic response unexpected
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: Myasthenia gravis (which gave her the chronic symptom of slurred speech)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101182533

Write-up: her speech returns to normal; received the booster or 3rd dose of the vaccine; received the booster or 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF2588),via an unspecified route of administration, administered in left arm on 05Sep2021 at 13:00 hours as DOSE 3 (BOOSTER), SINGLE (at the age of 42-years-old) for COVID-19 immunisation. The patient''s medical history included ongoing myasthenia gravis from 2017 (gave her the chronic symptom of slurred speech). Concomitant medications included pyridostigmine bromide (MESTINON); prednisone; thymomodulin (IMURONG); immunoglobulin human normal (I.V.-GLOBULIN) and mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) taken for myasthenia gravis.The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150),via an unspecified route of administration, on 01Apr2021 at 04:00 PM as DOSE 1, SINGLE (at the age of 42-years-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FW0175),via an unspecified route of administration, on 23Apr2021 at 10:00 AM as DOSE 2, SINGLE (at the age of 42-years-old) for COVID-19 immunization.It was reported that after each dose of vaccine, speech returned to normal and lasts about a week before it starts to fade. The patient with the relief of her symptoms felt like pre-sick self. The patient would like to know whether anyone else has reported this benefit from vaccination.The patient was immunocompromised and does have a chronic illness that illness was slurred speech where she could not say the number 3 or the number 6 and since she has had the 3rd dose of the vaccine, she no longer has slurred speech and could speak a lot more clearly and things were a lot better.The patient was waiting for her home nurse to come give her IVIG that she gets every three weeks and even the nurse was impressed, and she felt great after the vaccine and also mentioned this to her doctor, and she was like a needle in a haystack and with how she felt at the time of reporting. The patient felt like she might have a shot at life and felt like she did before she got sick and clarified by sick she was diagnosed with myasthenia gravis.The patient did not know what was helping her but it was something and stated does it fade and the answer was yes regarding the improvement in her slurred speech but this time she was monitoring her speaking and the speech was clear and she was not getting tired and with myasthenia gravis which she clarified was diagnosed before the vaccine in 2017 she had been on disability and whether having this shot feels like this more often she may get her life back and she had a lot of weakness and everything with her myasthenia gravis.The patient stated that the improvement in slurred speech waxes and wanes and fluctuates with her speech and before she was sick, and her speech has never been this strong or clear.The patient stated began to speak clearly after the 3rd dose of the vaccine was about 24 hours after she had the vaccine; the patient was normally a sensitive person and was nervous enough and did not have other vaccines administered the same date as the Pfizer COVID Vaccines; has been on the same medications that are immunosuppressants and started on those medications since she was diagnosed or after her diagnosis with myasthenia gravis; started accruing the medications over time when she was diagnosed and they are for the myasthenia gravis; was first started on Mestinon and went from that and they added Prednisone and Imuron. she tried Cellcept first and had been on the Imuron maybe a year and a half or two years.The patient was immunocompromised and her times of being on the Imuron maybe off due to COVID; caller clarified she was not diagnosed with COVID and has no lots, expiry dates or NDC numbers to provide for the Mestinon, Cellcept, Prednisone, or Imuron. The patient had no prior vaccinations within 4 weeks of Pfizer vaccine. The event her speech returns to normal was ongoing (not recovered). The clinical outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1752994 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-29
Onset:2021-09-05
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gait disturbance, Inappropriate schedule of product administration
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Medication errors (narrow), Hypoglycaemia (broad)

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

Write-up: Not able to walk/had a hard time walking unless she held on to something; first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days); This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088021A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days)). On 15-Sep-2021, the patient experienced GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) (seriousness criterion disability). On 05-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days)) had resolved. At the time of the report, GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) outcome was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. About 10 days after the second dose of vaccination, patient found herself not able to walk. When she got up, she had a hard time walking unless she held on to something. Company comment: This report concerns a 50 year old female patient with no relevant medical history who experienced an unexpected serious event of gait disturbance (reported as not able to walk or have hard time walking). The event was reported with a seriousness criteria of disability. The event occurred approximately 10 days after vaccination with second dose of mRNA-1273. Based on the current available information, inappropriate schedule of vaccine administration (as the latency between the 2 vaccine doses is more than 35 days) was considered as an additional event. The rechallenge was assessed as not applicable as the event happened after the second dose of the vaccine. The outcome of the event was reported as unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. The onset date for the event of gait disturbance was found to be discrepant in the SD, however it was captured as per the reported information in the SD narrative.; Sender''s Comments: This report concerns a 50 year old female patient with no relevant medical history who experienced an unexpected serious event of gait disturbance (reported as not able to walk or have hard time walking). The event was reported with a seriousness criteria of disability. The event occurred approximately 10 days after vaccination with second dose of mRNA-1273. Based on the current available information, inappropriate schedule of vaccine administration (as the latency between the 2 vaccine doses is more than 35 days) was considered as an additional event. The rechallenge was assessed as not applicable as the event happened after the second dose of the vaccine. The outcome of the event was reported as unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. The onset date for the event of gait disturbance was found to be discrepant in the , however it was captured as per the reported information in the narrative.


VAERS ID: 1756054 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation factor V level; Polycystic ovarian syndrome; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101226405

Write-up: Internal itching on extremities mainly arms hands and face. Sometimes feet and legs.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received 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 05Sep2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Factor V, PCOS, Type 2 Diabetes. Concomitant medication included clonazepam (KLONOPIN) and metformin taken for an unspecified indication. Patient had no known allergies and no past drug event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 05Sep2021 the patient experienced internal itching on extremities mainly arms hands and face, sometimes feet and legs. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the event with Zyrtec (once a day). Since the vaccination the patient was not tested for COVID-19. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1756499 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tresiba and humalog insulin
Current Illness: None
Preexisting Conditions: Type 1 diabetes
Allergies: Penicillins, sulfa, latex
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Raw inside of mouth


VAERS ID: 1756587 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / 1 LA / IM

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

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

Write-up: Moderna vaccine received on 8/28/2021 and caused a red spot the size of a quarter. 9/5/2021 the red spot started itching and turned into a raised hive with hot feel and then a couple days later arm turned red in a circle 2 1/2 inches wide.


VAERS ID: 1757867 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-29
Onset:2021-09-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lethargy, Myalgia, Pyrexia, Rash, Tenderness, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Fever; Soreness in the muscles of the left upper arm; Covid arm; Tenderness in the left upper arm; Lethargic; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drug was not reported. Treatment medication included topical spray of all natural mint and eucalyptus and anti-allergic medications to alleviate the symptoms. It was reported that patient was supposed to take second dose on 26-SEP-2021.


VAERS ID: 1758741 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-03
Onset:2021-09-05
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 UN / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1758957 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-22
Onset:2021-09-05
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase normal, Aspartate aminotransferase normal, Atrial fibrillation, Bilirubin conjugated increased, Blood alkaline phosphatase normal, Blood bilirubin increased, Bradycardia, COVID-19, COVID-19 pneumonia, Cardiac monitoring abnormal, Chest X-ray, Colonoscopy abnormal, Cough, Delirium, Echocardiogram, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram QT prolonged, Endotracheal intubation, Gastrointestinal haemorrhage, Haemostasis, Infrequent bowel movements, Intensive care, Lung assist device therapy, Mechanical ventilation, Oesophagogastroduodenoscopy abnormal, Pneumonia klebsiella, Rectal lesion, Rectal ulcer haemorrhage, Retching, Right ventricular dilatation, SARS-CoV-2 test positive, Shock haemorrhagic, Tidal volume decreased, Unresponsive to stimuli, Vascular cauterisation
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (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: None
Current Illness: None
Preexisting Conditions: Elevated LFTs and inguinal hernia
Allergies: nkda
Diagnostic Lab Data: Results as of 10/4/2021 11:15 9/26/2021 04:30 ALT: 36 AST: 35 ALKP: 49 TBILI: 5.6 (H) BILID: 2.4 (H) 9/27/2021 03:20 ALT: 27 ALKP: 69 TBILI: 3.7 (H) BILID: 1.0 (H) 9/28/2021 03:20 ALT: 26 ALKP: 87 TBILI: 2.6 (H) BILID: 0.8 (H) 9/29/2021 03:53 ALT: 26 ALKP: 89 TBILI: 2.2 (H) BILID: 0.7 (H) 9/30/2021 03:30 ALT: 31 ALKP: 78 TBILI: 2.2 (H) BILID: 0.5 (H) 10/1/2021 03:30 ALT: 23 ALKP: 80 TBILI: 2.2 (H) BILID: 0.7 (H) 10/2/2021 04:15 ALT: 23 AST: 21 ALKP: 81 TBILI: 2.1 (H) BILID: 0.7 (H) 10/3/2021 03:15 ALT: 23 AST: 20 ALKP: 85 TBILI: 1.8 (H) BILID: 0.6 (H) 10/4/2021 03:45 ALT: 16 AST: 18 ALKP: 61 TBILI: 1.5 (H) BILID: 0.6 (H)
CDC Split Type:

Write-up: 55 year old male, vaccinated with J&J on 6/22/2021 who tested positive for COVID-19 on 9/1 ultimately requiring intubation on 9/17 and VV ECMO cannulation on 9/24, CVICU course complicated by: 1. Hemorrhagic shock 2/2 GIB (rectal ulcers) s/p colonoscopy and clipping -- $g hemodynamically stable, low dose pressors, stable 2. Delirium 3. Bradycardia 4. Klebsiella pneumonia PLAN: NEURO: Sedation - paralytics off 9/27 - limited dex (caution with bradycardia), continue propofol, continue versed, dilaudid gtts -$g weaning as tolerated - Gabapentin q8 -$g increased to 600mg TID on 10/2, seroquel 100mg qhs. Added seroquel 50mg PO BID to try to wean other drips on 10/2. - monitor prolonged Qtc when adding oral agents -$g QTc on EKG from 10/3 was 451 - Of note, does overbreathe the vent, gags and coughs, but not following commands and not moving extremities so if he does not wake up with aggressive weaning of sedation today, may need to consider head CT in the next 24-48H. CARDIAC: Normal biventricular function Afib - resolved on 9/22 Baseline bradycardia - DC amio given bradycardia noted 9/27-9/29 - Minimize dex gtt - repeat TTE 9/27 relatively stable, normal EF, mildly dilated RV with normal RV function - on and off neo/vaso as needed for MAP goal $g 65mmHg PULM: COVID PNA s/p VV ECMO cannulation. S/p toci on 9/8, remdesivir (9/6-9/10) - CXR daily - Continue low tidal volume ventilation for plateau < 25 and minimize FiO2 - s/p solumedrol taper to 9/23-9/27. - consult ENT for trach once off isolation ECMO: - Keep flows $g 4L/min to maintain oxygen saturations $g80% (assuming SVO2 $g 55%, based on desired goal: DO2/VO2 $g 3). - Started bival 9/28, goal PTT 40 to 60, at goal FEN/GI: GIB 2/2 rectal ulcerations. S/p emergent EGD/colonoscopy (9/26): no evidence of upper GI source; 2 rectal ulcers found w/ pulsating arterial lesions; hemostasis obtained w/ 5x clips, cautery, and epi injection. - TF on 9/28, no active bleeding since GI clipping 9/26 - No rectal tube given rectal clips - Per GI conversation 9/30, ok to give rectal enema if absolutely needed, but would try suppository first - Goal is BM daily - GI ppx with PPI - Continue bowel regimen, last BM: 10/2 with stool. Given high OGT output on 10/3 and no BM yet on 10/3, restarted reglan 5mg IV Q6H x 8 doses and also gave 1 dose of lactulose as well.


VAERS ID: 1759240 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-03-06
Onset:2021-09-05
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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: Insulin Motrin Blood pressure meds Depression meds Pain meds
Current Illness: None
Preexisting Conditions: Diabetic Low thyroid Depression
Allergies: Penicillin Bee stings
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore arm


VAERS ID: 1759280 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Diplopia
SMQs:, Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Double vision after first and second dose of the Moderna vaccine, 02/15/2021 and 03/15/2021.
Other Medications: Multivitamin ASA 81 mg Zyrtec 10 mg Metoprolol Succinate ER 25 mg Vitamin C 500 mg Calcium citrate +D 630mg Zinc 50 mg Glucosamine/chondroitin Fish Oil 1,200 mg
Current Illness:
Preexisting Conditions: Chronic lymphocytic leukemia Mitral valve prolapse Palpitations
Allergies: Macrodantin
Diagnostic Lab Data:
CDC Split Type:

Write-up: September 5, 2021, horizontal double vision upon awakening lasting 20 minutes. September 10, 2021, horizontal double visio upon awakening lasting 40 minutes. I experinceed similar episodes following the first and second doses of the vaccine and submitted a VAERS for both today. I was seen by my Primary Care Physician, an opthalmologist and a neuro-opthalmologist following the second episodes. A cause for the double vision was not determined but the clinicians said it was not related to the vaccine. Since the double vision occurred following the third dose I felt reporting it was warranted.


VAERS ID: 1759378 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-18
Onset:2021-09-05
   Days after vaccination:199
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9265 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Novel Coronavirus PCR- Detected (9/5/2021)
CDC Split Type:

Write-up: Pt is 77 yo male s/p Pfizer COVID-19 vaccination: dose 1 on 1/28 and dose 2 on 2/18. Past medical history significant for HTN, T2DM who presented with fever and SOB with recent COVID19 diagnosis. He was treated with remdesivir and dexamethasone and symptomatically improved prior to home. He completed 5 days of remdesivir and his O2 needs were improving, though he still required 2lpm NC O2 at rest and on exertion. He was set up for home o2 as he otherwise felt improved and eager to go home. He declined services. He will complete the total 10d of dexamethasone. He can stop isolation/quarantine after 9-12 ( 10d from initial + testing).


VAERS ID: 1759663 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aggression, Anger, Impatience, Libido increased, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hostility/aggression (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro, 10mg, Ibuprofen 200mg
Current Illness:
Preexisting Conditions: Fatty Liver, Social anxiety and depression
Allergies: Bactrim, Codeine
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Increased anger and aggression, less patience. Level of anger has increased as well to the point of heart palpations. An increase in libido.


VAERS ID: 1761195 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-04
Onset:2021-09-05
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031L20A / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1761449 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Injection site pain, Intermenstrual bleeding, Menstrual disorder, Musculoskeletal stiffness, Pyrexia, Smear cervix, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: None
Allergies: none
Diagnostic Lab Data: Papsmear and blood tests were normal. After the 2nd dose, I had pelvic ultrasound and found cyst in my ovary. I will have another pelvic ultrasound to follow up.
CDC Split Type:

Write-up: 2 days after the first vaccine, I had vaginal bleeding. I already had my period the week before the vaccine. I went to my primary doctor and all vaginal exam, including papsmear were normal. 2 days after the 2nd dose I started to have spotting again. This is different spotting I had experience prior to start of my menstrual period. Yesterday, 10/4/21, I noticed in the morning that my upper right arm was stiff and the injection site was tender. Everytime I move my right arm, the injection site hurts. The day of the 2nd dose, I also had mild fever and right arm severe pain and muscle pain/aches/sore. My right arm continues to be painful and feeling stiff where the injection site is. I am afraid of paralysis from the vaccine.


VAERS ID: 1761615 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac failure, Chest X-ray, Electrocardiogram, Intensive care, Laboratory test, Myocarditis
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: losartan 25 mg bid, Metoprolol XL 25 mg daily, spironolactone 25 mg daily.
Current Illness: rare bruising
Preexisting Conditions: none
Allergies: estrogen, OC
Diagnostic Lab Data: labs, EKG, chest x-ray
CDC Split Type:

Write-up: acute myocarditis/heart failure requiring ICU admission after vaccine


VAERS ID: 1761646 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761667 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761681 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761688 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761691 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761704 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761929 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood folate, C-reactive protein, Electromyogram, Electrophoresis protein, Full blood count, Immunology test, Magnetic resonance imaging, Metabolic function test, Neuralgia, Rash, Vision blurred, Vitamin B12
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: PCN
Diagnostic Lab Data: 10/4: SPEP, CRP, CMP, CBC, Folate, B12, Lyme titer Pending: EMG, MRI right brachial plexus
CDC Split Type:

Write-up: Patient comes in today for neuropathic pain. Patient is a new patient today. He reports that on September 3rd he he received his 1st dose of the Pfizer COVID vaccination in his left deltoid. The next day he had abnormal sensation in his right arm which developed into a flat rash from elbow to shoulder as well as a painful neuropathic type pain. The rash quickly subsided but the pain spread into the midline of the neck. Over the next week symptoms moved to the other arm legs and around the chest and back. The pain is worse at night. He presented to the ER where he was started initially on Percocet then on Lyrica for questionable herpes zoster though the rash has subsided and was never vesicular. He discontinued the Lyrica on his own and never use the Percocet. He continues to have symptoms though they are improving. Upon further questioning she also reports some weakness as well as blurred vision during that time. He never had a history of a vaccine reaction. He has received multiple vaccine but has not received 1 since. He does not routinely get the flu vaccine. He has no significant neurological history in the family.


VAERS ID: 1762125 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 2 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Attention deficit hyperactivity disorder, Chills, Condition aggravated, Cystitis, Decreased appetite, Diverticulitis, Eye pain, Headache, Malaise, Nephrolithiasis, Night sweats, Obsessive-compulsive disorder, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific inflammation (broad), Glaucoma (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Has been to the ER x2.
CDC Split Type:

Write-up: The patient was sick with a fever (over 105) and chills, body aches, night sweats, loss of appetite, headache, and painful eyes, followed by what feels like a kidney stone, bladder infection, and diverticulitis. Worsening of ADHD and OCD. Phone call with provider office & received no assistance. The person on phone hung up on her.


VAERS ID: 1762266 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Migraine
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: UNKOWN
Preexisting Conditions: MIGRAINES
Allergies: NONE
Diagnostic Lab Data: UNKNOWN
CDC Split Type:

Write-up: MIGRAINE THAT LASTED 2 WEEKS, TREATMENT UNKNOWN


VAERS ID: 1765063 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-09
Onset:2021-09-05
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1765182 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-09-05
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK UN / SYR

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

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

Write-up: COVID 19


VAERS ID: 1765433 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-03
Onset:2021-09-05
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin, Vit D2, ezetimibe, Trelegy Ellipta, levothyroxine, silodosin
Current Illness:
Preexisting Conditions: aortic valve replacement, asthma, CAD, COPD, CKD, hypothyroid, hx of tobacco use, hyperlipidemia
Allergies: levaquin
Diagnostic Lab Data:
CDC Split Type:

Write-up: 9/5/21 SOB and cough start 9/10/21: pt presents to ED with SOB/cough and test positive for COVID. treated with remdesivir, Decadron, oxygen and oral zinc discharged 9/13 9/26/21: re-presents switch continued hypoxia leading to further treatment with baratinib discharged 9/30 to follow up with PCP


VAERS ID: 1768079 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-29
Onset:2021-09-05
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 2 UN / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1768175 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-08-31
Onset:2021-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injected limb mobility decreased, Sleep disorder, Vaccination site 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor, Vasotec 20mg
Current Illness:
Preexisting Conditions: chronic asthma, hypertension, cholesterol
Allergies: Aspirin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient refers that after the administration of their second dose of the vaccine, she feels persistent and burning pain in the area of the vaccine administration. On a scale of 10. Patient refers not to having visited her DR. but having taken ADVIL, and administered topical "VIKS" and patches of the brand "DRAGON". Patient reports that her symptoms have not improved and have difficulty moving her arm due to pain and not being able to "sleep on that side".


VAERS ID: 1768662 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-05
Onset:2021-09-05
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007M2014 / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002A21A / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough, Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: None Reported
Allergies:
Diagnostic Lab Data: SARS CoV 2 Antigen Positive on 9/7/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 2/1/2021 Dose #2 03/05/2021. C/O fever, chills, muscle aches, runny nose, sore throat, loss of taste/smell, headache, fatigue, and cough/onset 9/5/2021


VAERS ID: 1771826 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-31
Onset:2021-09-05
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 019B21A / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive Covid-19 from an urgent care, unknown type.
CDC Split Type:

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


VAERS ID: 1771901 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate increased, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: TORADOL; dexamethasone; magnesium; vit D; B total; CoQ10; FLEXERIL; ZOMIG; dihydroergotamine; CONCERTA
Current Illness: No
Preexisting Conditions: Migraines; With my allergy situation - that''s where I start to fall into the immune system issues - my doctor says I''m the most allergic reactive patient she has.
Allergies: Erythromycin; food allergy syndrome
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: Sept 5, I noted elevated heart rate that didn''t miss any exertion level or stress level. It was a single event and I was able to back it down with rest and then it resolved itself. Then on Sept 12, I had another tachycardia event where heart rate was up in the 120s and then I couldn''t get it back on September 12 - but I could get it back down into the low 100s. It now continues and comes and goes. It could be another medication that caused it - most likely Dethamexazone -I was taking a pill in August something. And then I got a a first infusion of it in an IV infusion of it. I started getting infusions that included Dethamexazone of it in September 15th and I got it for five days; I don''t know.


VAERS ID: 1772187 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-26
Onset:2021-09-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO172 / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Testicular pain, Ultrasound scan abnormal, Varicocele
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Fertility disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Chostocondritis in chest
Preexisting Conditions: Heart palpitations
Allergies: None
Diagnostic Lab Data: Sono with L varicocele and fatty proliferation of cord. 09/25/2021
CDC Split Type:

Write-up: Developed a varicocele in my left testicle, and constant pain. Started almost two weeks after COVID-19 vaccination with Pfizer/BioNTech.


VAERS ID: 1775030 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Dizziness, Fatigue, Heart rate increased, Insomnia, Motion sickness, Nausea, Orthostatic hypotension, Palpitations, Paraesthesia, Poor peripheral circulation, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: 9/4 ? 9/5 - Fatigue 9/6 - 9/13: Heart flutters/palpitations (3-5 times a daily). Head rushes at times so severe, I prepared to faint but would subside (2-3 times a day). Half of the head rushes while having had been seated at my desk for over an hour straight. Nausea. Circulation issues in legs/feet during any posture outside of standing; tingling feet while sitting and standing; constant movement necessary. Chest tightness, chest burning sensation throughout the day. Car sickness. Difficulty sleeping, heart racing and heart palpitations waking me. 9/13 ? 9/16: All of the same symptoms, however, less frequent/intense. 9/17 - present: Circulation issues still present, heart rate quickly rises and difficult


VAERS ID: 1775130 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-26
Onset:2021-09-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bronchitis, Chest X-ray, Chest pain, Costochondritis, Cough, Headache, Influenza like illness, Musculoskeletal chest pain, Nasopharyngitis, Pain, SARS-CoV-2 test negative, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine daily for hypothyroidism .50 mcg
Current Illness: None
Preexisting Conditions: None aside from general anxiety (not currently taking meds but have Rx for Lorazepam if needed) And hypothyroidism as stated above.
Allergies:
Diagnostic Lab Data: Chest x rays (2x) 1 negative COVID test (nasal swab) on Sept 21 (approx)
CDC Split Type:

Write-up: Within 10 days I had symptoms of headache, sinus congestion, body aches, chest pain and mild dry cough. It turned into a bad ?cold or flu-like? feeling. I did an E- visit thru my insurance company because I thought I had a secondary infection starting. They prescribed Augmentin for 10 days. I took and it didn?t help. I then went to medical facility and they did Rx for Z Pack. It didn?t help and my chest was hurting so bad I thought my ribs were broken. Went back to them and they called in an inhaler for acute bronchitis. XRay showed no pneumonia. Diagnosed me finally with costochondritis. Gave Keterolac shot that did not help. Now I am just fighting it at home and the pain has intensified all around my rib cage. I have been putting off my 2nd vaccine dose because of illness and PA?s recommendation.


VAERS ID: 1775666 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-18
Onset:2021-09-05
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atelectasis, Blood culture negative, Blood lactic acid, Blood pH normal, Bronchiectasis, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Condition aggravated, Lung disorder, Lung opacity, PCO2 decreased, PO2 decreased, Procalcitonin, SARS-CoV-2 test positive, White blood cell count normal
SMQs:, Asthma/bronchospasm (broad), Lactic acidosis (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (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, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Apixaban, acetaminophen PRN, albuterol PRN, atorvastatin, levothyroxine, tamsulosin, trelegy ellipta, triamcinolone ointment, vitamin C, benadryl PRN, carvedilol, ferrous sulfate, furosemide, isosorbide mononitrate, milk of magnesia
Current Illness:
Preexisting Conditions: COPD, asthma, HLD, CAD, a-fib on Eliquis, hypothyroidism, and BPH Allergic conjunctivitis, Allergic rhinitis, Arthritis, Asthma, Bronchiectasis without acute exacerbation (HCC), COPD, mild (HCC), Coronary atherosclerosis of native coronary artery, Eczema, Hearing loss, Hyperlipidemia, Hypothyroidism, Knee pain, right, On anticoagulant therapy, Other nonspecific (abnormal) findings on radiological and other examinations of body structure, Pruritus, Rhinitis medicamentosa, and Sinusitis.
Allergies: erythromycin, levofloxacin, clarithromycin
Diagnostic Lab Data: 9/13/21 COVID19: positive 9/13/21 CTA chest: PE negative, Nonspecific patchy areas of ground-glass opacification with bilateral upper lobe predominance not typically a feature of COVID-19 involvement. Chronic bronchiectatic changes with superimposed atelectasis along the periphery of the bilateral lower lobes 9/17/21 chest xray: Bilateral airspace disease with parenchymal changes more prominent from prior examination some locations bilaterally. Infection/inflammation must be considered. 9/23/21 chest xray: Continued bilateral airspace disease, right greater than left, consistent with prior examination. This may be infectious/inflammatory in etiology.
CDC Split Type:

Write-up: Presented to the ED on 9/13/21 from the nursing home after his SpO2 saturations were found to be 81%. Patient tested positive for COVID on 9/5/2021. Patient received both series of Moderna Vaccine, completed on 4/15/21. -COVID positive, CT of chest showed no sign of PE, nonspecific patchy areas of ground-glass opacification with bilateral upper lobe predominance not typically a feature of COVID-19 involvement. Chronic bronchiectatic changes with superimposed atelectasis along the periphery of the bilateral lower lobes. -WBC 8.06, lactic 1.45, procal 0.27 -ABG: pO2 52.4, pCO2 23.7, pH 7.45 -Initiate COVID protocol -Prophylactically start on doxycycline and ceftriaxone -Blood cultures x2 pending, continue to follow -Patient received 125 solumedrol in route to ED, will continue with dexamethasone Q6H -Supplemental O2 to maintain saturations $g92%, currently saturating 94% on 2L. On admission 9/13/21, pt was treated with IV antibiotics, IV Decadron and low maintenance IVF. On 9/15/21 Remdesivir was started. ID consulted for methicillin resistant staph coagulase negative bacteremia. Antibiotics Switched from Doxycycline to Vancomycin. Final Repeat Blood cultures from 9/18 were negative. IV line continued to blow, so IV Vancomycin switched to Oral Zyvox on 9/25/21. ID recommending to continue for 1 week after discharge. Discharged on 9/30/21


VAERS ID: 1775955 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / OT

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

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

Write-up: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048f21a) for COVID-19 vaccination. The patient''s past medical history included Panic attack. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Myalgia, at an unspecified dose and frequency. On 06-Sep-2021, MYALGIA (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant was not specified. This case was linked to MOD-2021-339110.


VAERS ID: 1779256 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-31
Onset:2021-09-05
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anosmia, COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive, Sinusitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: Birth Control, and Zertic and Muti-Vitmin for Women Lisinprim 10mg once daily, for High blood pressure
Current Illness: No
Preexisting Conditions: High Blood pressure
Allergies: Sulfa , and Penicilian
Diagnostic Lab Data: Rapid test
CDC Split Type: vsafe

Write-up: September the 5th she began coughing and she thought she had sinus infection under was a fever on 8th of September of under 100, tested positive on September 8th 2021, initial vaccination was March 31, 2021. Was advise to take tylernol and musinex and delcim for the caught. Lost sense smell 09/07/2021 still recovering from sense of smell.


VAERS ID: 1782309 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-01
Onset:2021-09-05
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: Antigen Test administered on 9/7/2021
CDC Split Type:

Write-up: Patient Contracted COVID-19


VAERS ID: 1782458 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-07
Onset:2021-09-05
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040A21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chills, Diarrhoea, Dyspnoea, Fatigue, Feeling abnormal, Nasopharyngitis, Pain, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: I take a prescription medication for thyroid
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Covid test, positive, Covid test negative
CDC Split Type: vsafe

Write-up: It started on Monday and we had fevers, chills, aches, diarrhea, exhaustion, it felt like I was dead, my inhalers did not work. I did not have the lack of smell or taste. I thought I had a cold until my children said we should get tested. We went to urgent care and got tested for Covid. They did not give us any medications because they thought it was just a cold. By that night they called us and said the results were positive. They asked a bunch of questions to see if we qualified for monoclonal infusions and we did. I got in in Friday and within 22 minutes I could breath. It was phenomenal. It was like it stopped Covid. We tested ourselves on October 1st and it came back negative.


VAERS ID: 1782487 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-25
Onset:2021-09-05
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 070M20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002A21A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782508 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-19
Onset:2021-09-05
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782844 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Menstruation irregular, Polymenorrhoea
SMQs:, Dementia (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin, iron supplement, stool softener, Gabapentin 100mg
Current Illness: n/a
Preexisting Conditions:
Allergies: none known
Diagnostic Lab Data: Abnormal pap cells on pap smear 9/27/21; ultrasound 10/08/21 and colposcopy to be completed 11/3/21.
CDC Split Type:

Write-up: Dark brown to black menses begin and lasted 3 days. LMP 8/18-8/20 and was not due to start until 9/16/21., subsequently begin bleeding again, 10/8-10/9. Additional reactions included tiredness and brain fog.


VAERS ID: 1784850 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-19
Onset:2021-09-05
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 - / -

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

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

Write-up: COVID 19.


VAERS ID: 1787047 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Asthenia, Aura, Balance disorder, Blepharospasm, Bradycardia, Cardiac flutter, Dizziness, Fatigue, Hot flush, Muscular weakness, Paraesthesia, Pulse abnormal, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tachyarrhythmia terms, nonspecific (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 20mg, Multi-vitamin, fiber caps, Collagen powder
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09/03/2021: Felt flushed a few hours after shot 09/04/2021: Felt flushed and had rush of anxiety 09/05/2021: Tinnitus; ringing in both ears started 09/06/2021: Episodes of heart fluttering 09/07/2021: Started to feel weak, tired, light-headed and thready, faint pulse. Aura, pins and needles in extremities. 09/08/2021: Legs and arms felt weak 09/09/2021: Overall weakness - especially in legs. Bradycardia 56bpm. Dizzy spells - off balance. Eye twitching 10/15/2021: Still experiencing constant ringing in both ears.


VAERS ID: 1675268 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045D21A / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Finasteride
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day 1: Fever, aches, swollen arm at injection site. Day 2: Swollen arm. Day 7: No symptoms. Arm pain subsided. Day 10: Woke up extremely itchy, rashes/hives on calves, forearms, underarms, chest, stomach, back, neck, facial cheeks, rear cheeks. Reporting just to help development.


VAERS ID: 1678300 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Nausea, Oligomenorrhoea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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:

Write-up: Nausea, fatigue, fever, chills. Late/possibly missed menstrual cycle


VAERS ID: 1693845 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test normal, Chest pain, Electrocardiogram normal, Head discomfort, Headache, Muscle spasms, Pain in extremity
SMQs:, Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Heart cramp. Tight j''ai. Pain in all left side ( top of the head) arm and leg( until the heel) Ex: 10/09/2021 5:42pm 5-48 pm c''est pain Headache and fatigue(6,01pm) 6,27pm heart cramp left side 6h40pm 6h49 to 7h02 pm chest pain Elbow joint 7h06pm Chest pain 8h38pm ;10.25pm Heavy pressure top of the head 10.10pm to 10:42pm 11h11 11h31 pm chest and arm a sec spam


VAERS ID: 1695138 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210918754

Write-up: GUILLAIN-BARR? SYNDROME; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 5 decade old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total administered to deltoid on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-SEP-2021, the patient experienced Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210918754-covid-19 vaccine ad26.cov2.s-Guillain-Barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1699169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: lot of pain; Spasms; This case was received (Reference number: GB-MHRA-ADR 25896986) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Spasms) and PAIN (lot of pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Mental disorder. Concomitant products included FLUOXETINE for Mental disorder. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MUSCLE SPASMS (Spasms) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (lot of pain) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Spasms) had not resolved and PAIN (lot of pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The Treatment information was not provided. Reported that Full body spasms with a lot of pain . Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.


VAERS ID: 1699174 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Obstructive airways disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: airway occluded; Syncope; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25897066) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of OBSTRUCTIVE AIRWAYS DISORDER (airway occluded) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced SYNCOPE (Syncope). On an unknown date, the patient experienced OBSTRUCTIVE AIRWAYS DISORDER (airway occluded) (seriousness criterion medically significant). On 05-Sep-2021, SYNCOPE (Syncope) had resolved. At the time of the report, OBSTRUCTIVE AIRWAYS DISORDER (airway occluded) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vaccinated patient laying down as had had a syncope episode with first dose of vaccine. Approximately 10 minutes post second vaccine, had a syncope episode lasting approximately 30 seconds, and airway occluded. Assisted to lay flatter and rolled onto side, airway cleared. Laboratory test including BP: 138/76 P:67. The symptoms resolved after approximately 2 minutes. Remained flat for a further 10 minutes and then gradually assisted to sit up. After 30 minutes able to be discharged, accompanied by partner. The patient was not enrolled in clinical trial. The patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant product was not provided. Treatment medication was not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1699723 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Myalgia, Renal pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Kidney pain
Preexisting Conditions: Medical History/Concurrent Conditions: Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Cold sweat; Kidney pain; Muscle ache; Vomiting; This case was received (Reference number: GB-MHRA-ADR 25898507) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain), MYALGIA (Muscle ache), VOMITING (Vomiting) and COLD SWEAT (Cold sweat) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Vomiting. Concurrent medical conditions included Kidney pain. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced COLD SWEAT (Cold sweat) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (Kidney pain) and MYALGIA (Muscle ache) had not resolved, VOMITING (Vomiting) was resolving and COLD SWEAT (Cold sweat) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. Patient experience Intense kidney pain and full body muscle aches and episodes of vomiting followed by cold sweats. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company 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. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1699724 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: CITALOPRAM; CLENIL MODULITE
Current Illness: Anxiety; Asthma NOS; Nauseated; Vomited
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nauseated; Vomited; Tiredness; Muscle ache; This case was received via the RA (Reference number: GB-MHRA-ADR 25898536) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), FATIGUE (Tiredness), NAUSEA (nauseated) and VOMITING (Vomited) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nauseated, Vomited, Anxiety and Asthma NOS. Concomitant products included CITALOPRAM from 30-Jul-2020 to an unknown date for Anxiety, BECLOMETASONE DIPROPIONATE (CLENIL MODULITE) from 01-Feb-2018 to an unknown date for Asthma NOS. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseated) (seriousness criterion medically significant). On 06-Sep-2021, VOMITING (Vomited) had resolved. At the time of the report, MYALGIA (Muscle ache) and FATIGUE (Tiredness) had not resolved and NAUSEA (nauseated) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment medication was not provided by the reporter. The patient felt nauseated at about 4.30am on the 6th Sept. Vomited at about 5am. When the patient woke up in the morning she felt fine. Her muscles are aching still since last night, including her legs. She was very tired. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.


VAERS ID: 1699725 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Flu-like aching; Diarrhea; Aching in limb; Headache; Chills; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25898531) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Aching in limb), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching), PAIN IN EXTREMITY (Aching in limb) and PYREXIA (Fever) had not resolved and DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug information provided. No concomitant drug information provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1699726 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Injection site pain, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Shortness of breath; Dizziness; Pain injection site; High temperature; Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 25898805) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), INJECTION SITE PAIN (Pain injection site), PYREXIA (High temperature) and NAUSEA (Nausea) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), INJECTION SITE PAIN (Pain injection site), PYREXIA (High temperature) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment medications provided. Post vaccination patient not tested positive for COVID-19. It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1701567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Illness
SMQs:, Pseudomembranous colitis (broad), 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: GBPFIZER INC202101160880

Write-up: Diarrhea; Sickness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109050953474730-NU7RD with Safety Report Unique Identifier of GB-MHRA-ADR 25896997. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and had not undergone a COVID-19 test. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 05Sep2021, 2 days after vaccination, the patient experienced diarrhea and sickness; both the events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events diarrhea and sickness was not recovered at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1701570 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101160947

Write-up: Heart racing; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109051754013450-IXTEN with Safety Report Unique Identifier of GB-MHRA-ADR 25897242. A patient of an unknown age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19 or a COVID-19 test. It was reported that the patient did not test positive for COVID-19 since having the vaccination. The patient was not enrolled in a clinical trial. On 05Sep2021, the patient experienced heart racing; which was reported as serious for being medically significant. The clinical outcome of the event heart racing was resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (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: YASMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101160949

Write-up: Swollen lymph nodes; Muscle ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109052023483360-WDQVP, Safety Report Unique Identifier of GB-MHRA-ADR 25897356. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380), via an unspecified route of administration on 04Sep2021, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19 and had not had a COVID-19 test. The patient was not enrolled in clinical trial. Concomitant medications included ethinylestradiol, drospirenone (YASMIN) for contraception, from an unknown date and unknown if ongoing. On 05Sep2021, the patient experienced swollen lymph nodes and muscle ache; both events were reported as serious for being medically significant. The clinical outcome of the events swollen lymph nodes and muscle ache was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1701574 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Diarrhea; Headache; Faint; Sweaty; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25898437) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Faint), HYPERHIDROSIS (Sweaty), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and HEADACHE (Headache) 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 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweaty) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint), HYPERHIDROSIS (Sweaty), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsure if patient has had symptoms associated with COVID-19 No concomitant medication reported. No treatment was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1701604 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fatigue, Frequent bowel movements, Hyperhidrosis, Insomnia, Nausea, Pollakiuria, Pyrexia, SARS-CoV-2 test, Sweating fever
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; OMEPRAZOLE; PENTASA
Current Illness: Crohn''s (On regular medication); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis))
Preexisting Conditions: Medical History/Concurrent Conditions: Cold; Fuzzy head; Joint ache
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sweating fever; Frequent bowel movements; Insomnia; Urination frequency of; Inappetence; Sweating easily; Drenching sweats; Nausea; Fever chills; Fever; Tiredness; Joint ache; This case was received via regulatory authority. (Reference number: GB-MHRA-ADR 25903703) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), INSOMNIA (Insomnia), POLLAKIURIA (Urination frequency of), DECREASED APPETITE (Inappetence), HYPERHIDROSIS (Sweating easily), HYPERHIDROSIS (Drenching sweats), NAUSEA (Nausea), PYREXIA (Fever chills), PYREXIA (Fever), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fuzzy head, Joint ache and Cold. Previously administered products included for Product used for unknown indication: Ibuprofen. Concurrent medical conditions included Crohn''s (On regular medication) since 2019 and Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis)). Concomitant products included CITALOPRAM for Anxiety, MESALAZINE (PENTASA) for Crohn''s, OMEPRAZOLE for Crohn''s disease. In 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), POLLAKIURIA (Urination frequency of) (seriousness criterion medically significant), DECREASED APPETITE (Inappetence) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating easily) (seriousness criterion medically significant), HYPERHIDROSIS (Drenching sweats) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, SWEATING FEVER (Sweating fever), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), INSOMNIA (Insomnia), POLLAKIURIA (Urination frequency of), DECREASED APPETITE (Inappetence), HYPERHIDROSIS (Sweating easily), HYPERHIDROSIS (Drenching sweats), NAUSEA (Nausea), PYREXIA (Fever chills), PYREXIA (Fever), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient couldn''t take ibuprofen due to Crohn''s disease so used cold and flu remedy tablets or paracetamol. Patient was on bed rest. Patient had swelling of glands in left underarm as well as sensitivity/ache in left arm especially injection site, red mark at injection site, joint aches, fuzzy brained. Company Comment: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.


VAERS ID: 1701606 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-09-05
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Nausea, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Shaking; High temperature; Muscle pain; Headache; inappropriate schedule of vaccine administered; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25903721) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), TREMOR (Shaking), PYREXIA (High temperature), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 24-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 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 06-Sep-2021, the patient experienced TREMOR (Shaking) (seriousness criterion disability), PYREXIA (High temperature) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability) and HEADACHE (Headache) (seriousness criterion disability). On 05-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, NAUSEA (Nausea), TREMOR (Shaking), PYREXIA (High temperature), MYALGIA (Muscle pain) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was unsure if she has had symptoms associated with COVID-19. Patient is neither pregnant, nor is currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded, however, inappropriate schedule of vaccine administered may be a cofounder and disability seems unlikely.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded, however, inappropriate schedule of vaccine administered may be a cofounder and disability seems unlikely.


VAERS ID: 1701608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Headache; Flu like symptoms; Fatigue; Fever; Nausea; This case was received via the Regulatory Authority RA (Reference number: GB-MHRA-ADR 25904833) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA, NAUSEA, HEADACHE, INFLUENZA LIKE ILLNESS, and FATIGUE in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL from 01-Aug-2021 to an unknown date for Cold. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (seriousness criterion medically significant), NAUSEA (seriousness criterion medically significant) and FATIGUE (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced HEADACHE (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (seriousness criterion medically significant). At the time of the report, PYREXIA, NAUSEA, HEADACHE, INFLUENZA LIKE ILLNESS, and FATIGUE was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. Treatment details were not provided. Symptoms started 7 hours after having vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1701629 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-09-05
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature abnormal, Chest pain, Cough, Drug ineffective, Headache, Liver function test, Muscle spasms, Myalgia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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? 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: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:had some temperature; Test Name: LFT; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210906; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101180658

Write-up: Tested positive for covid-19; Tested positive for covid-19; he had some temperature; Cramps; Developed cough; Chest pain; Headache; Muscular pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) on 01Jun2021 as dose 2, single and on 10May2021 as dose 1, single, both via an unspecified route of administration for COVID- 19 Immunisation. Relevant medical history and concomitant medications were not reported. It was reported that on 06Sep2021, the patient tested positive for covid-19. Patient said he got his two shots of Pfizer this springtime. On 05Sep2021 (Sunday afternoon) he started with symptoms headache, muscular pain. On 06Sep2021 (Monday morning) he had some temperature, cramps and developed cough with chest pain. The patient underwent lab tests and procedures which included liver function test (LFT) on unspecified date with unknown results. 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: 1702143 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, Eye oedema, Oedema mouth
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101163586

Write-up: Oedema mouth; Dysphonia; eye oedema; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21125956. A 48-year and 4-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number: FF5357; expiration date: 30Nov2021), via an unspecified route of administration on 05Sep2021 15:57 (the day of vaccination) (at the age of 48-year and 4-month-old), as dose 1, single, for COVID-19 immunisation. Medical history included allergy. The patient''s concomitant medications were not reported. On 05Sep2021 16:37, 40 minutes after the vaccination (the same day of the vaccination), the patient experienced mouth oedema, dysphonia and eye oedema and was admitted to the hospital due to the events. The patient did not experienced dypnoea. The outcome for the events was unknown. The reporting physician classified the event as serious (hospitalized) and assessed that the causality between the event and BNT162B2 as unassessable. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1702274 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-05
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: This case received via the regulatory authority (reference number: JP-TAKEDA-2021TJP088479) on Sep 5, 2021 and forwarded to Moderna on Sep 14, 2021. This case, reported by a physician, received via Moderna''s adverse reaction reporting site (TASK0021482). Anaphylaxis assessed serious. On Aug 8, 2021, patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On Sep 5, 2021, at 10:39, patient received the 2nd dose of this vaccine. At 10:42, anaphylaxis developed suddenly. Queasy and vomiting developed as gastrointestinal symptoms. At 11:20, mild skin/mucosal symptoms and strange sensation of pharynx (symptoms resolving). The outcome of anaphylaxis reported as resolving. No follow-up investigation possible. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Sender''s comments: Very limited information regarding this event(s) provided at this time. Further information requested.


VAERS ID: 1702275 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-05
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: This case received via the regulatory authority (reference number: JP-TAKEDA-2021TJP088509) on Sep 5, 2021 and forwarded to Moderna on Sep 14, 2021, reported by a physician, received via Moderna''s adverse reaction reporting site (TASK0021483). Anaphylaxis assessed serious. On Aug 8, 2021, patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On Sep 5, 2021, at 10:39, patient received the 2nd dose of this vaccine. At 11:20, anaphylaxis developed suddenly. At 11:30, strange sensation of pharynx developed. Thereafter, the symptoms of anaphylaxis reported as resolving. No follow-up investigation will be possible. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Sender''s comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1703611 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache, Myalgia, Psoriasis, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: feeling worse; Diarrhea; Vomited; Shortness of breath; Muscle ache; Tired all the time; Headache; Light-headed; High temperature; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25910427) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PSORIASIS (feeling worse), HEADACHE (Headache), DIZZINESS (Light-headed), PYREXIA (High temperature), DYSPNOEA (Shortness of breath), MYALGIA (Muscle ache), FATIGUE (Tired all the time), VOMITING (Vomited) and DIARRHOEA (Diarrhea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tired all the time) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced PSORIASIS (feeling worse) (seriousness criterion medically significant). On 08-Sep-2021, DIZZINESS (Light-headed) and VOMITING (Vomited) had resolved, FATIGUE (Tired all the time) was resolving. At the time of the report, PSORIASIS (feeling worse), HEADACHE (Headache), PYREXIA (High temperature), DYSPNOEA (Shortness of breath) and DIARRHOEA (Diarrhea) had not resolved and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication was provided. No Treatment medication was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


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