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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 549 out of 10,317

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VAERS ID: 1917346 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: None. Administration Error - dose administered 12 days after the QR code expiry date.


VAERS ID: 1917351 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Administration error: Dose administered 12 days after the expiry date.


VAERS ID: 1917732 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: None Administration Error ? dose administered 12 days after the QR code expiry date


VAERS ID: 1917774 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, No adverse event
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: None Administration Error- dose administered 12 days after QR code expiry date


VAERS ID: 1917871 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: None Administration Error- dose administered 6 days after QR code expiry date


VAERS ID: 1919638 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-18
Onset:2021-11-18
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BENAZEPRIL/HCTZ; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery calcification; COVID-19; Depression; Environmental allergy; Glaucoma; Hypertension; Hypothyroidism; Osteoporosis; Penicillin allergy; Spinal fusion; Sulfonamide allergy; UTI; Vitamin D3 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 Rapid molecular PCR test; Test Result: Positive ; Comments: Nasal Swab; Abbott ID-Now COVID-19 Rapid molecular PCR test
CDC Split Type: USPFIZER INC202101619109

Write-up: Tested positive for COVID- 19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient. A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 10:30 (Lot number: FH8020) at the age of 69 years as dose 3 (booster), single, administered in arm left, administration date 29Mar2021 12:00 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and administered in arm left, administration date 05Mar2021 12:00 (Lot number: EN6206, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 09Dec2020 (unspecified if ongoing); "frequent UTIs" (unspecified if ongoing); "spinal fusion L4-L5" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Vitamin D3 insufficiency" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "coronary calcification" (unspecified if ongoing); "Known allergies: Yes: Penicillin" (unspecified if ongoing); "Known allergies: Yes: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 21Sep2021; ATORVASTATIN; BENAZEPRIL/HCTZ; METOPROLOL. Past drug history included: Erythromycin, reaction(s): "Known allergies: Yes: Erythromycin"; Flagyl, reaction(s): "Known allergies: Yes: Flagyl"; Ciprofloxacin, reaction(s): "Known allergies: Yes: Ciprofloxacin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Tested positive for COVID- 19"; COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "Tested positive for COVID-19". The events "tested positive for covid- 19" and "tested positive for covid-19" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab; Abbott ID-Now COVID-19 Rapid molecular PCR test. Description of complaint: Patient was calling about Pfizer vaccine. Her husband believed it was a clerical thing and the sticker was left over from the day before. The first injection was 18Feb2021 and there was a sticker that had lot and Pfizer. This one after they left they saw it said Pfizer 10Mar2021 and lot number EN6206. Patient clarified concern is if they defrosted it yesterday or if it was a clerical thing that was preprinted and left over. From patient''s understanding patient stated they are supposed to use vaccine pretty quickly after being defrosted. Patient was unsure if it could be lack of efficacy or an old sticker. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953; lot EN6206, fill lot EN5339, and the formulated drug product lot EN5327. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer (site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (site name) site. Root Cause Analysis/Identif: Pfizer (site name) Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer (site name) site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953; lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specification.


VAERS ID: 1919649 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Flushing, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (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: EFFEXOR; LAMICTAL; VYTORIN; TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; High cholesterol; Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101619331

Write-up: dizzy; Itchy back of throat; tightness in chest; flush face; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; LAMICTAL; VYTORIN; TYLENOL. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: DIZZINESS (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "dizzy"; THROAT IRRITATION (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "Itchy back of throat"; CHEST DISCOMFORT (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "tightness in chest"; FLUSHING (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "flush face". The events "dizzy", "itchy back of throat", "tightness in chest" and "flush face" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, throat irritation, chest discomfort, flushing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1919675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-01
Onset:2021-11-18
   Days after vaccination:262
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202101630996

Write-up: Contracted COVID; Contracted COVID; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) (Pfizer employee) reported for an adult female patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering" and all described as "Contracted COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Nov2021, outcome "recovering", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, influenza like illness. Clinical course: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1919705 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Diarrhoea, Dizziness, Headache, Immunisation, Influenza like illness, Nausea, Neck mass, Swelling, Vaccination site mass, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OZEMPIC
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Seafood allergy; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101669525

Write-up: Painful knot in arm where injection was given; Painful knot in arm where injection was given; Painful Swelling in underarm and neck near collarbone; Painful Swelling in underarm; swelling in neck near collarbone leaving a painful knot; Flu-like symptoms; headache; dizziness; diarrhea; nausea; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:15 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (ongoing); "known allergies Seafood" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Vaccination history included: Bnt162b2 (Dose 2, lot#:EP7533, Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot#:EN6205, Left arm), administration date: 10Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Nov2021 09:00, outcome "recovered with sequelae" and all described as "Painful knot in arm where injection was given"; SWELLING (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm and neck near collarbone"; AXILLARY PAIN (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm"; NECK MASS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "swelling in neck near collarbone leaving a painful knot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "headache"; DIZZINESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "dizziness"; DIARRHOEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, swelling, axillary pain, neck mass, influenza like illness, headache, dizziness, diarrhoea, nausea. Additional Information: The patient does not have Covid prior vaccination. The patient covid was not tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1920183 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-12
Onset:2021-11-18
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Condition aggravated, Hyperglycaemia, Intensive care, Muscular weakness, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin (LIPITOR) 40 MG tablet bethanechol (URECHOLINE) 10 MG tablet budesonide-formoterol (SYMBICORT) 80-4.5 MCG/ACT inhaler citalopram (CELEXA) 20 MG tablet dexamethasone (DECADRON) 4 MG tablet dicyclomine (BENTYL) 10 MG capsule DULo
Current Illness: None known
Preexisting Conditions: Type 2 diabetes mellitus with diabetic polyneuropathy, with long-term current use of insulin (HCC) Essential hypertension Primary insomnia Chronic left-sided low back pain with sciatica Dyslipidemia Chronic obstructive pulmonary disease, unspecified COPD type (HCC) Screening for nephropathy History of cardiac arrhythmia Current every day smoker Atherosclerosis of coronary artery Cervical spinal stenosis Bulging of cervical intervertebral disc DDD (degenerative disc disease), cervical Bilateral carpal tunnel syndrome Carpal tunnel syndrome Severe episode of recurrent major depressive disorder, with psychotic features (HCC) Liver lesion Gastroesophageal reflux disease Schizoaffective disorder, bipolar type (HCC) Morbid (severe) obesity due to excess calories (HCC) Type 2 diabetes mellitus with hyperglycemia (HCC) Hypertension associated with diabetes (HCC) Psoriasis vulgaris Lactic acidosis Chronic daily headache Irritable bowel syndrome, unspecified type BMI 35.0-35.9,adult Vitamin D deficiency Adhesive capsulitis of left shoulder Ischemic colitis (HCC) Psychiatric illness Chronic back pain History of asthma Muscle weakness of lower extremity Hyperglycemia
Allergies: Bees
Diagnostic Lab Data: COVID-19 test positive on 11/18/2021
CDC Split Type:

Write-up: Patient presented to emergency department on 11/18/2021 with progressive weakness of lower extremities. He was found to be COVID-19 positive. He was admitted to intensive care unit due to need for insulin drip caused by hyperglycemia. He was treated with supplemental oxygen and dexamethasone for COVID-19 infection during admission. He was discharged home on 11/30/2021.


VAERS ID: 1920282 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Vaccine was mixed with 1.6 ml of diluent due to using a 5 ml syringe that was provided with the vaccine. MA did not realize the increments were different than a 3 ml syringe. We do no use 5 ml syringes for any of our meds or vaccines. This is what we were shipped with the vaccine.


VAERS ID: 1920303 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Covid Vaccine was mixed with 1.6 ml of diluent due to using a 5 ml syringe. We were shipped 5 ml syringes with the vaccine and we do not use this size syringe for any meds or vaccines. MA did not realize the increments were different than on a 3 ml syringe.


VAERS ID: 1920361 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33030BD / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Cystitis, Fatigue, Pain in extremity, Productive cough, Urine analysis abnormal
SMQs:, Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (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: Covid (1st and 2nd)- headache, coughing, sleepy, sore arm. (January 2021)
Other Medications: Zyrtec
Current Illness: none
Preexisting Conditions: Asthma Allergies Migraines IBS Anxiety Depression
Allergies: Dust Dust Mites Bactrim Augmentin Keflex Doxycycline
Diagnostic Lab Data: Urine test- found infection (11/22/2021)
CDC Split Type: vsafe

Write-up: I was tired and I had coughing with phlegm. I felt weak and I had a little sore arm. I had a bladder infection as well. I went to the doctors on 11/22/2021 and I got antibiotics for that.


VAERS ID: 1920414 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 RA / IM

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

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

Write-up: Client registered for a Moderna Covid-19 vaccine booster nine months after completing the Pfizer Covid-19 vaccine series (doses 1 and 2). He received a Pfizer Covid-19 vaccine booster instead of the Moderna booster which was not his preference. No adverse reactions to our knowledge


VAERS ID: 1920442 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 3 LA / IM

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

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

Write-up: VACCINE EXPIRED 10 DAYS PRIOR


VAERS ID: 1920445 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 3 LA / IM

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

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

Write-up: VACCIEN EXPIRED 11 DAYS PRIOR


VAERS ID: 1920447 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 3 LA / IM

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

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

Write-up: VACCIEN EXPIRED 11 DAYS PRIOR


VAERS ID: 1920450 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 3 LA / IM

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

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

Write-up: VACCINE EXPIRED 11 DAYS PRIOR


VAERS ID: 1920457 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 1 LA / IM

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

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

Write-up: VACCINE EXPIRED 11 DAYS PRIOR


VAERS ID: 1920460 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 1 LA / IM

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

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

Write-up: VACCINE EXPIRED 11 DAYS PRIOR


VAERS ID: 1920463 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 1 LA / IM

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

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

Write-up: Vaccine expired 11 days prior.


VAERS ID: 1920469 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 2 LA / IM

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

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

Write-up: VACCINE EXPIRED 11 DAYS PRIOR


VAERS ID: 1920741 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram head, Laboratory test, Mental status changes, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: diabetes, sleep apnea, prostate cancer in remission
Allergies: NKDA
Diagnostic Lab Data: CT brain, labs
CDC Split Type:

Write-up: syncope and altered mental status requiring hospitalization 8 days after receiving vaccine.


VAERS ID: 1920838 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, No adverse event
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: None. Administration Error - dose administered 12 days after the QR code expiry date.


VAERS ID: 1920988 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: None. Administration Error - dose administered 12 days after the code expiry date.


VAERS ID: 1921443 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 06F21A / 3 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Rash morbilliform, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuva Ring
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Nothing done yet
CDC Split Type:

Write-up: Started the evening of 11/18 ? my left back thigh and inner right thigh were itchy. I could feel a bunch of small bumps. At 1:30am I woke up with intense itchiness. I took a picture to see the bumps. They were smallish welts/hives that looked similar to the reaction I have to mosquito bites. I put on over the counter hydrocortisone, which helped calm the itching. Then, I started to notice that I was getting itchy other places ? my back, side, stomach. I continued to put hydrocortisone to ease the itchiness. By 8am on Friday the 19th, I had red patches in various places ? legs, stomach, back, upper arms. I took a Claritin and continued to use hydrocortisone to ease the itching throughout the day. The hives would come and go throughout the day. 11/20 ? woke up with red itchy patches in armpit and surrounding area, back, thighs/groin/leg crease area. I took Benadryl and used hydrocortisone throughout the day. The areas continued to stay red, would itch and hives/welts would come and go. I went to Urgent Care that evening. While I mentioned to the medical assistant that I think it could have been caused by my booster, I don?t think I relayed that information to the NP who treated me. I received a shot of mtheylprednisolone 125mg and famotidine 40mg at urgent care and a prescription for hydroxyzine 25mg. Shortly after the shot in the butt, my lower back burst into hives. The NP told me if it didn?t get better soon that I need to go to the ER. The hives eventually went away within the hour. Interestingly, when I took the bandaid off from shot, my skin was bright red where the bandaid adhered to my body. No itching or hives, just bright red. I then started to notice that my skin would turn red with the smallest ?trauma? ? scratching, holding a bag on my arm, seams from clothes. Sometimes it would cause hives to appear and itch. 11/21 ? I woke up with all of the red patches gone, no itching, no hives. The red patches that I had in my leg crease and lower back had turned brown (not my normal skin color). By 11/22, the brown color had disappeared. I continued to take the hydroxyzine. 11/22 ? most of the day was free of any redness, hives and itching. By the evening, I had started to notice red areas on my arm, back, and stomach. But I don?t recall it being too itchy. 11/23 ? Woke up with a red itching and hurting patch in my armpit and surrounding area. I took Benadryl (not hydroxyzine because I had to work and feared the drowsiness) and used hydrocortisone. That evening, I used my son?s Aveeno Baby eczema balm on my armpits to try and prevent another flare. 11/24 ? woke up with large red patches/flares on my thighs and sides, hips, back. I used Eucrin baby eczema cream to help and continued with Benadryl. I would take Benadryl during the day and hydroxyxzine in the evening/bed. 11/25 ? random and various areas continued to flare and itched. Continued the same: eczema creams, Benadryl and hydrocortisone. 11/26 ? Now, I?m having small red bumps all over my stomach and thighs. Sort of looked like measles. The measles like red bumps persisted. They were bothersome and lightly itchy. Still had random areas flare and itch. 11/27 ? I started to notice red marks on my face, but they didn?t itch or hive and would disappear relatively quickly. For the most part, the flares/patches/hives were concentrated to legs, upper arms, stomach, back and backs of legs. Neck, face, lower arms and lower legs were not affected. But now I?m starting to notice that red marks appear on lower arms and face but quickly go away. 11/29 ? the bumps appeared again on the back of my thighs ? as it did when it first started. Also present on back. 11/30 ? had some ?trauma? to arm from rubbing against purse. Red marks and hives appeared. 12/1 ? woke up with hives now appearing on top of thighs, side of back/hips, and leg crease area again. And were itchy again. Red patches appeared on upper arm/armpit area. Until this point, my feet hadn?t really been affected. This evening, I had intense itching on my left foot. It turned red, but no hives. The redness and itchiness eventually went away within 30-40 mins. 12/2 ? went to family nurse practitioner about it. And to get a referral to the dermatologist and she also recommended a referral to an allergist. She prescribed cetirizine 10mg daily for the next three weeks. 12/3 ? most of the day was mild. Very little redness, itching and hives. However, as I approached the 24 hour mark for the cetirizine, I?m noticing various areas starting to itch. I have an appointment with a NP in dermatology on Dec 13.


VAERS ID: 1921672 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-19
Onset:2021-11-18
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atelectasis, Blood culture negative, Blood lactic acid, Brain natriuretic peptide normal, COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea, Exposure to SARS-CoV-2, Feeling abnormal, Haemoglobin normal, Hypoxia, Inflammatory marker test, Liver function test normal, Lung opacity, Malaise, Myalgia, Nasal congestion, Pneumonia, Pyrexia, SARS-CoV-2 test positive, Serum ferritin normal, Troponin normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen PRN, albuterol PRN, alendronate, amlodipine, atorvastatin, calcium, cyanocobalamin, vitamin D, fluticasone, furosemide, norco PRN, letrozole, multi vitamin, nitro PRN, pantoprazole
Current Illness:
Preexisting Conditions: DCIS of the right breast with wide excision of the affected area. Also has history of breast cancer with mastectomy on the left side. Did receive adjuvant whole breast radiation for the right breast issues. Is on ongoing oral chemotherapy. Hypertension with associated heart disease. Some gait ataxia with history of falls. Hyperlipidemia. Nonobstructive coronary artery disease. Osteoporosis. Osteoarthritis.
Allergies: None
Diagnostic Lab Data: 11/18/21 chest xray: Right lower lung opacities could represent atelectasis or pneumonia. Recommend follow-up imaging to resolution. 11/18/21 COVID19: positive
CDC Split Type:

Write-up: Patient is a 78-year-old female who presented to the emergency department on 11/18/21 with complaint of fever, diffuse myalgias and malaise. She is a poor historian. States onset of symptoms was yesterday at some point. States he had some nasal congestion and felt some chills and generally felt poorly. She is fully vaccinated for COVID with the Moderna vaccine completed about 6 months ago. Is uncertain where she would have exposed. In the emergency department she was noted to have fever of just under 103�. She has been doing some extra work of breathing with borderline hypoxia. She denies that she has been wheezing. States she has been coughing but no purulent sputum. No nausea or vomiting. Blood pressure has been stable. Secondary to the borderline respiratory status and her fever she is being admitted to the hospital.Chest x-ray was positive for right lower lung atelectasis and also had COVID test that was positive. Cardiac BNP, troponin, blood cultures are all negative. The patient was admitted in the hospital and also tried IV , then ceftriaxone and azithromycin, and patient tolerated fairly well, and also had infection markers. Ferritin was 124 and cardiac BNP was negative. Lactic acid was only 1.37. Troponin was negative. White blood count and hemoglobin were normal. Liver function tests were normal and patient was able to walk fairly well in the room with no hypoxia and down to 89 for a few seconds and then came back up, and she is comfortable going home. Patient was advised to be discharged on p.o. dexamethasone for a few more days and p.o. Levaquin every other day for 5 more doses, and follow up as an outpatient. Discharged on 11/20/21


VAERS ID: 1921801 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-12
Onset:2021-11-18
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Fatigue, Headache, Myalgia, Respiratory tract congestion
SMQs:, Rhabdomyolysis/myopathy (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: Caltrate 1,200mg daily Vitamin D3 1,000 IU daily Multivitamin daily Fish Oil 1,000mg daily Omeprazole daily Sucralfate 1 gram BID
Current Illness: None Documented
Preexisting Conditions: Gastroesophageal reflux disease, colitis, osteopenia, bile-induced gastritis, history of breast cancer.
Allergies: Augmentin - Diarrhea Codeine - Nausea Compazine - Nausea Erythromycin - Nausea
Diagnostic Lab Data:
CDC Split Type:

Write-up: Contracted COVID after being fully vaccinated. No booster. Headache, congestion, fatigue, muscles aches.


VAERS ID: 1921844 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-20
Onset:2021-11-18
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044B21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Extra dose administered, Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acyclovir 400mg BID allopurinol 300mg daily Vitamin C 500mg daily Vitamin D3 1000 IU daily Pepcid 20mg prn ibuprofen prn levothyroxine 75mcg daily multivitamin daily olanzapine 5mg daily prn ondansetron 8mg q8hrs prn metamucil prednisone 40
Current Illness: None documented
Preexisting Conditions: thyroid enlargement, dyslipidemia, essential hypertension, chronic lymphocytic leukemia, malignant tumor of the breast, hypothyroidism, anemia, overweight, diverticular disease, history of polyp of colon
Allergies: penicillin - Hives
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient contracted COVID after being fully vaccinated. Booster 11/17/2021 (not infected in the two weeks after) 0.25mL; IM; Right Deltoid; 020F21A Fever, cough, headache, sore throat, fatigue, muscle aches.


VAERS ID: 1922667 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051F21A / 3 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; WARFARIN; METOPROLOL; GABAPENTIN
Current Illness: Chronic kidney disease; CVA; Drug allergy (Statins); Drug allergy (Requip); Drug allergy (Benadryl); Supraventricular tachycardia
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The patient''s past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Benadryl), Drug allergy (Requip), Drug allergy (Statins), Supraventricular tachycardia, CVA and Chronic kidney disease. Concomitant products included AMLODIPINE, WARFARIN, METOPROLOL and GABAPENTIN for an unknown indication. On 18-Nov-2021 at 10:47 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment information were provided. The via was first punctured on 17-NOV-2021 at 9 am. No temperature excursions were reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received includes updated reporter address, patient demographics (Height, weight, race, ethnicity), allergies, medical history, concomitant medications, time and site of vaccine administration.


VAERS ID: 1922955 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 2 LA / OT

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Tinnitus
SMQs:, Lack of efficacy/effect (narrow), Hearing impairment (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sudden hearing loss; Tinnitus
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Pcr; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101626093

Write-up: got covid right now 18Nov2021 tested positive; I started to have ringing in my ears right after my 2nd dose.; got covid right now 18Nov2021 tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: Ek5730) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sudden hearing loss" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "not recovered", COVID-19 (medically significant) with onset 18Nov2021, outcome "not recovered" and all described as "got covid right now 18Nov2021 tested positive"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "I started to have ringing in my ears right after my 2nd dose.". The events "got covid right now 18nov2021 tested positive", "got covid right now 18nov2021 tested positive" and "i started to have ringing in my ears right after my 2nd dose." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19, tinnitus and included treatment with Steroid injection. Clinical course: I started to have ringing in my ears right after my 2nd dose. The tinnitus has not improved. I got covid right now 18Nov2021 tested positive. The tinnitus has worsened. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Product Quality Group provided investigational results on [22Nov2021] for [bnt162b2]: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EK5730 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EK5730, fill lot EK3313, and the formulated drug product lot EK3312. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL1283 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL1283, fill lot EL1281, and the formulated drug product lot EL1279. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.


VAERS ID: 1922956 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Limb discomfort, Overdose, Product preparation error
SMQs:, Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Verbatim: COVID-19)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101626100

Write-up: extremely tired; her arm is killing her; she gets dizzy when she raises up; Head is hurting; inadvertently administered doses that were undiluted; inadvertently administered doses that were undiluted; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team. A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:20 (Lot number: FF2587, Expiration Date: 20Dec2021) as dose number unknown, 0.4 ml single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Aug2021 (unspecified if ongoing), notes: Verbatim: COVID-19. The patient''s concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "inadvertently administered doses that were undiluted"; FATIGUE (medically significant) with onset 19Nov2021, outcome "unknown", described as "extremely tired"; LIMB DISCOMFORT (medically significant) with onset 19Nov2021, outcome "unknown", described as "her arm is killing her"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "unknown", described as "she gets dizzy when she raises up"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Head is hurting". Clinical course: Nurse stated that they administered several doses of the purple cap Covid 19 vaccine yesterday, but they had a staff member that assisted and inadvertently administered doses that were not diluted to 5 different patients. 4 patients were female, and 1 was male. The male patient was born in (year withheld). 2 of the female patients were born in (year withheld), 1 of the female patients was born in (year withheld), and the other female patient was born in (year withheld). Three patients were given the dose as the 1st dose, 1 was a booster dose, and 1 was a 2nd dose. This patient received an undiluted dose of the vaccine yesterday at 11:20am. Caller states that she has talked to the patient twice today. This morning the patient said that she was extremely tired, her arm is killing her, and she gets dizzy when she raises up. The patient didn''t want to be seen by anybody and just wanted to rest. The patient stated that she feels like she did when she had Covid in Aug2021. She told the nurse that she woke up with these symptoms at 5am this morning. When the caller talked with her this afternoon, the patient stated that her head wasn''t hurting quite as bad. The events did not require emergency Room visit and physician Office visit. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AEs.; Sender''s Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events Overdose, Product preparation error, Fatigue, Limb discomfort, Dizziness, and Headache and BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-202101630079 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630078 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630076 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630077 same reporter/drug, similar event, different patient


VAERS ID: 1922958 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Chills, Immunisation, Pain, Pyrexia, Seizure, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: Test Result:103.3 Fahrenheit; Comments: 17:00
CDC Split Type: USPFIZER INC202101626196

Write-up: Fainting in the shower with white out vision; Uncontrollable shaking and convulsions; Fever of 103.3 degrees F.; Uncontrollable shaking and convulsions; Body Aches; Chills/Teeth Chattering; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, was the patient did not diagnose with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 07:00 AM), administration date: 09Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021 11:30, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Fainting in the shower with white out vision"; SEIZURE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (Nov2021), PYREXIA (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021) and all described as "Fever of 103.3 degrees F."; TREMOR (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Uncontrollable shaking and convulsions"; PAIN (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Body Aches"; CHILLS (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Chills/Teeth Chattering". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) 103.3 Fahrenheit, notes: 17:00. Since the vaccination, has the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1922965 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Echocardiogram, Magnetic resonance imaging, Ophthalmoplegia, Ultrasound scan
SMQs:, Guillain-Barre syndrome (broad), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MONTELUKAST; ATORVASTATIN; LIPITOR; METFORMIN; BREO ELLIPTA; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19 (diagnosed with COVID-19 prior to vaccination); Diabetes; Fruit allergy (Apples allergy); Obesity; Penicillin allergy; Seafood allergy; Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Name: 2-d Echo; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Test Name: Carotid ultrasound; Result Unstructured Data: Test Result:Unknown
CDC Split Type: USPFIZER INC202101628047

Write-up: Internuclear ophthalmoplegia, left eye; This is a spontaneous report received from a contactable reporter(s) (Physician). A 51-year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation at drug Store. Relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Apple'' allergy" (unspecified if ongoing), notes: Apple'' allergy; "COVID-19" (unspecified if ongoing), notes: diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: MONTELUKAST; ATORVASTATIN; LIPITOR; METFORMIN; BREO ELLIPTA; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 19Oct2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: OPHTHALMOPLEGIA (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Internuclear ophthalmoplegia, left eye". The patient was hospitalized for ophthalmoplegia (hospitalization duration: 3 day(s)). The event "internuclear ophthalmoplegia, left eye" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: unknown; magnetic resonance imaging: unknown; ultrasound scan: unknown. Therapeutic measures were taken as a result of ophthalmoplegia with Stroke workup, aspirin, ophthalmology and neurology evaluation. Clinical Course: Patient developed Internuclear ophthalmoplegia, left eye, 9 days after the second dose which required 3 days of hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1922968 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, Headache, Malaise, Parosmia
SMQs:, Taste and smell disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Known allergies: No Other medical history: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101629555

Write-up: Headache since injection; Smelling a feet odor that is not there; some loss of taste and smell; some loss of taste and smell; overall unwell feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache since injection"; PAROSMIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Smelling a feet odor that is not there"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "some loss of taste and smell"; MALAISE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "overall unwell feeling". Therapeutic measures were not taken as a result of headache, parosmia, ageusia, anosmia, malaise. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn''t receive any other vaccines within 4 weeks and didn''t receive any other medications in two weeks. Known allergies: No, other medical history: None. The vaccine was administrated in Pharmacy/drug store. Since the vaccination, the patient has not been tested for COVID-19. The events didn''t result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1922973 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Overdose, Product preparation error, Vaccination site pain
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630078

Write-up: arm was extremely sore; inadvertently administered doses that were undiluted / Received dose that was not diluted; inadvertently administered doses that were undiluted / Received dose that was not diluted; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [19Nov2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. A 40 year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm right, administration date 18Nov2021 11:30 (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 40 years as dose 3 (booster) 0.4 ml, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Family Medical History Relevant to AE was None. Relevant Tests was None. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Moderna covid vaccine (Moderna Covid Vaccine, 1st dose: 08Jan2021, Lot: 039K20A, Expiry: 29Jan2021), administration date: 08Jan2021, when the patient was 40 years old, for COVID-19 immunization; Moderna covid vaccine (Moderna Covid Vaccine, 2nd dose: 05Feb2021, Lot: 007M20A, Expiry: 06Mar2021), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 immunization; Flu shot (Flu shot on 29Sep2022, Manufacturer: Seqires, Lot: Z3MK7, Expiry: 30Jun2022.), administration date: 29Sep2021, when the patient was 40 years old, for Immunization. Events following prior vaccinations were None. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 18Nov2021 11:30 and all described as "inadvertently administered doses that were undiluted / Received dose that was not diluted"; VACCINATION SITE PAIN (medically significant) with onset 19Nov2021, described as "arm was extremely sore"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Nov2021 11:30 and all described as "Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster"; IMMUNISATION (non-serious) with onset 18Nov2021 11:30, described as "Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster.". Clinical course: Nurse said they administered several doses of the purple cap presentation of the Pfizer-BioNTech Covid-19 Vaccine on 18Nov2021. HCP said they had a float staff member that assisted and inadvertently administered doses that were undiluted. She said it was administered to 5 different patients. 4 were female and 1 was male. She said 3 were given as the 1st dose, 1 as the booster dose, and 1 as the 2nd dose. This report is for one of the female patients. Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster. Reporter seriousness for received dose that was not diluted was medically significant. On 19Nov2021, patient experienced arm was extremely sore. The event did not require a visit to Emergency Room nor the Physician Office.; Sender''s Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events Headache cannot be ruled out. 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.,Linked Report(s) : PFIZER INC-202101626100 same reporter/drug, similar event, different patient


VAERS ID: 1922974 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Chest discomfort, Headache, Investigation, Overdose, Product preparation error
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), 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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: GERD; Nicotine dependence
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: chest x-ray; Result Unstructured Data: Test Result:no acute findings; Test Date: 202111; Test Name: Lab work; Result Unstructured Data: Test Result:no acute findings
CDC Split Type: USPFIZER INC202101630079

Write-up: inadvertently administered doses that were undiluted; inadvertently administered doses that were undiluted; Severe headache and couldn''t lift his head off the bed; Chest was uncomfortable; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. A 23-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:00 (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 23 years as dose number unknown, 0.4 ml single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Nicotine dependence" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (hospitalization, medically significant), OVERDOSE (hospitalization, medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "inadvertently administered doses that were undiluted"; HEADACHE (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Severe headache and couldn''t lift his head off the bed"; CHEST DISCOMFORT (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Chest was uncomfortable". The patient was hospitalized for product preparation error, overdose, headache (start date: 18Nov2021, discharge date: 19Nov2021, hospitalization duration: 1 day(s)). The events "inadvertently administered doses that were undiluted", "inadvertently administered doses that were undiluted", "severe headache and couldn''t lift his head off the bed" and "chest was uncomfortable" were evaluated at the emergency room visit. Clinical course was reported as follows. The nurse said they administered several doses of the purple cap presentation of the Pfizer-BioNTech Covid-19 Vaccine on 18Nov2021. HCP said they had a float staff member that assisted and inadvertently administered doses that were undiluted. She said it was administered to 5 different patients. HCP wants to know if the patients need to be revaccinated. This patient received an undiluted dose of the vaccine yesterday at 11am. The reporter stated the patient called her last night and said that he was experiencing a severe headache and couldn''t lift his head off the bed and his chest was uncomfortable. He said he started noticing the symptoms about 30 minutes prior to calling her. Caller states that she sent him to the ER at when he called her; he arrived in the ER. By the time he got to the ER the chest discomfort was gone. The hospital admitted him overnight for observation. The patient left on 19Nov2021 at 11:05 in the morning. The patient was very dramatic in the ER. Lab work and chest x-ray were completed while he was in the hospital with no acute findings. An ECHO was ordered, but he left the hospital before it was done.; Sender''s Comments: Based on the available reported information, the causal association between the events product preparation error, overdose and headache and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. ,Linked Report(s) : US-PFIZER INC-202101626100 same reporter/drug/event, different patient


VAERS ID: 1922975 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Bedridden, Blood test, Bone pain, Feeling abnormal, Illness, Immunisation, Pain, Paralysis, Spinal pain
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteonecrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FAMOTIDINE; ALLOPURINOL; PRIMIDONE; TAMSULOSIN HYDROCHLORIDE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; SUCRALFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney stone (I remember I had a kidney stone past one time (History) and that is very painful.)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: USPFIZER INC202101630094

Write-up: I was paralyzed; every bone of my body hurt; every joint hurt; my entire vertebrae hurt; I was in such pain /my entire body, every bone of my body hurt, every joint hurt; I could not get out of bed; I was in terrible shape; I was so sick; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 89 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had a kidney stone" (unspecified if ongoing), notes: I remember I had a kidney stone past one time (History) and that is very painful. Concomitant medication(s) included: FAMOTIDINE; ALLOPURINOL; PRIMIDONE; TAMSULOSIN HYDROCHLORIDE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; SUCRALFATE. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Bnt162b2 (Dose:02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PARALYSIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "I was paralyzed"; BONE PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "every bone of my body hurt"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "every joint hurt"; SPINAL PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "my entire vertebrae hurt"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in such pain /my entire body, every bone of my body hurt, every joint hurt"; BEDRIDDEN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I could not get out of bed"; FEELING ABNORMAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in terrible shape"; ILLNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was so sick". The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of immunisation, paralysis, bone pain, arthralgia, spinal pain, pain, bedridden, feeling abnormal. The patient was taking Ibuprofen along with some other pain medication (Unspecified medications) to ease the pain and still the patient was not right. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1922989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dizziness, Drug ineffective, Headache, Nasal congestion, Nasopharyngitis, Paranasal sinus discomfort, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Vestibular 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: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Rapid COVID test; Test Result: Positive
CDC Split Type: USPFIZER INC202101632648

Write-up: Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The patient was fully vaccinated with 3 Pfizer shots. The booster was given on 24Aug2021. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1922998 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood iron, Blood test, Feeding disorder, Immunisation, Insomnia, Investigation, Pain in extremity, Parosmia, Physical examination
SMQs:, Taste and smell disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Thyroid disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Tinnitus (Caller states she had tinnitus off and on on before but it was in her right ear)
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Iron; Result Unstructured Data: Test Result:Little low; Comments: Iron was a little low; Test Date: 202110; Test Name: Blood work; Result Unstructured Data: Test Result:Everything came back just; Test Date: 202110; Test Name: Hormones; Result Unstructured Data: Test Result:Everything came back just; Test Date: 202110; Test Name: Physical; Result Unstructured Data: Test Result:Everything came back just
CDC Split Type: USPFIZER INC202101638037

Write-up: Unable to sleep or eat and states this is "not manageable"; Everything smells like burning rubber, burning hair, burning flesh; Unable to sleep or eat and states this is "not manageable"; Booster; Little upper left arm, a little ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 52-years-old female patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: FC3184) administered in arm left, administration date 18Nov2021 (at 11:15) (age at the time of vaccination was 52-years-old) as DOSE 3 (booster), SINGLE for covid-19 immunization. Relevant medical history included: "Thyroid" (ongoing); "She had tinnitus off and on before but it was in her right ear" (unspecified if ongoing), notes: Caller states she had tinnitus off and on before but it was in her right ear. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Batch/Lot Number: ER8727, Expiration date: Jul2021), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Bnt162b2 (2nd Dose, Batch/Lot number: EW0176, Expiry date: Aug2021), administration date: 14May2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Smelling something like, I keep smelling something burning, everything smell burnt", "Tinnitus/Tinnitus Left Ear / ringing in my left ear". The following information was reported: FEEDING DISORDER (non-serious), INSOMNIA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "Unable to sleep or eat and states this is "not manageable""; PAROSMIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Everything smells like burning rubber, burning hair, burning flesh"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Little upper left arm, a little ache"; IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Caller stated she received her third shot of PFIZER vaccine, booster on 18Nov2021. Starting 19Nov21 to present, everything smells like burning rubber, burning hair, burning flesh, keep thinking something was smouldering on fire, it was something was smelling that was not there. It was the same whether she was in her house, in her car, or outside. She was becoming unable to sleep or eat and states this was not manageable. She had a previous adverse event from the second dose received in the primary series, tinnitus in her left ear, which resolved spontaneously. She would like to know if smelling something that was not there was a reported side effect, and what the duration can be expected to be. Anatomical location of administration of the vaccine: She stated that she had this on her left arm, little upper left arm, a little ache, just a slight bit of achy pain, muscle pain but nothing that was fine the administration site was fine. Other medical conditions: She stated that well the only thing that she was diagnosed with physical was some ANEMIA, so she was already taking some iron supplements for five days before had the shot, but this booster made like she said that, like the smell of burning rubber, melting hair. Still taking : She stated that yes, she skipped it yesterday. She skipped her medications for two days but that smell was getting worse. Other medications: She stated no. Lab test: She stated yes. She had a full physical, had everything done, had test on full physical with full blood work, hormones, (voice not clear), had everything done and that was about four weeks ago. Everything came back just perfectly fine, iron was a little low. Prior vaccinations (within four weeks): She got the COVID Vaccine. Tetanus you know every ten years. She was due for it but her doctor said to wait. She had not yet, tetanus till 2012 and no other vaccines, no regular flu shot she never had flu. Treatment: She stated no. It was only three days, but it was scary, she kept thinking. No treatment for it, she just smelled, it was not, just in the house. It was in the car, it was outside and fresh air so, it was like everywhere she just kept looking around if something was melting or burning. No additional Vaccines Administered on Same Date of the PFIZER Suspect. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events following prior vaccinations. No relevant tests done. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.


VAERS ID: 1923000 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Eye swelling, Lymphadenopathy, Muscle spasms, Nausea, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFLUCAN; MACROBID [CLARITHROMYCIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sulfonamide allergy (Multiple family members allergy to sulfa)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101638177

Write-up: Extreme nausea; dizzy; off balance; swollen eyes; red eyes; severe cramps; swollen armpit lymphnode; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FJ1620) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple family members allergy to sulfa" (unspecified if ongoing), notes: Multiple family members allergy to, sulfa. Concomitant medication(s) included: DIFLUCAN; MACROBID [CLARITHROMYCIN]. Past drug history included: Cipro, reaction(s): "Known Allergy: Cipro"; Bactrim for Known Allergy: bactrim; Sulfa antibiotics for Known Allergy: Sulfa antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "Extreme nausea"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "dizzy"; BALANCE DISORDER (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "off balance"; EYE SWELLING (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen eyes"; OCULAR HYPERAEMIA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "red eyes"; MUSCLE SPASMS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "severe cramps"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen armpit lymphnode". Therapeutic measures were not taken as a result of nausea, dizziness, balance disorder, eye swelling, ocular hyperaemia, muscle spasms, lymphadenopathy. Additional information: The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination included birth control, difulcan, Macrobid. Device Date was 22Nov2021.


VAERS ID: 1923182 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-11-13
Onset:2021-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Headache, Pyrexia, SARS-CoV-2 test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin prn Melatonin prn
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Covid test on 11/30- negative
CDC Split Type:

Write-up: 11/18 threw up 1 time 11/18-11/30 off and on tummy ache and headaches 11/30 threw up 1 time, headache, tummy ache, low grade fever 99.7


VAERS ID: 1923255 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-10-30
Onset:2021-11-18
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058E21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Renal pain, Vasculitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None that I know of.
Diagnostic Lab Data:
CDC Split Type:

Write-up: SORE ARM - 4 days after the first and second shot - Not treated. HEADACHES - Bad headaches 2 1/2 weeks after the first shot for about 4 days. More mild headaches again after the second shot continue. I rarely get headaches. Not treated BODY ACHES - for 4 days after the first and second shot - Not Treated FEVER - of about 99.5 F for 3 days after the first and second shot. Not treated. LEFT KIDNEY PAIN - For six days after the second shot which has gone away. Not treated VASCULITIS - Bulging temporal veins on the side of my forehead for 3 days after the second shot. Not treated.


VAERS ID: 1923555 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-10-02
Onset:2021-11-18
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301458A / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32030BD / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram normal, Laboratory test normal, Migraine, Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorthiazide, potassium, ginger root, vitamin D, low dose aspirin, multivitamin, Zyrtec
Current Illness:
Preexisting Conditions: Hypertension
Allergies: Macrobid and sulfa antibiotics
Diagnostic Lab Data: Hospital visit on November 18, 1st day of symptoms. Lab tests and ekg were all normal. Diagnosed with vertigo.
CDC Split Type:

Write-up: Vertigo daily since November 18th. I?ve never had vertigo issues before now. The vertigo is causing migraines more frequently.


VAERS ID: 1924518 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dry skin, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Developed a rash on my back and neck, raised, dry, patchy areas slightly raised. Of note, as a healthcare provider several other colleagues also noted a similar rash 7-10 days after receiving booster MRNA vaccine. This is a minor inconvenience but fascinating and worth sharing in the event others note a rash.


VAERS ID: 1924577 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 RA / IM

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

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

Write-up: Patient given booster dose at age 17, which she should be 18.


VAERS ID: 1924893 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline, culturelle women''s probiotic, women''s multivitamin, emergenc+
Current Illness:
Preexisting Conditions: Seasonal allergies
Allergies: Peniciilin, cephalosporins, peaches
Diagnostic Lab Data: No tests as of yet.
CDC Split Type:

Write-up: Itchy skin. When scratch skin turns red and bumps appear, itches more. Benadryl helps relieve itchiness. Redness goes away within a few hours if not scratched. Cortizone 10 helps relieve itchiness. Itchiness is all over body, though not all at once. Random spots will be itchy, then a different spot later. Itchiness started about 10 days after booster. Visited doctor the next day. Also started a new probiotic around that time. Immediately stopped taking that. Suggested claritin daily, benadryl as needed, and once a day singulair for a week. Symptoms somewhat improved but did not go away. Benadryl was most helpful. A week later (10 days after first symptoms), stopped singulair and started with prednisone. Probiotic was unlikely bc ongoing reaction. Stopped all other vitamins, still taking sertraline. 6 day course starting with 30mg decreasing 5mg each day. Prednisone didn''t really seem to help. Itchiness was worst just before bed. Had to take benadryl + pain killer (tylenol while on prednisone, otherwise ibuprofen) to get to sleep. Able to sleep through the night with that. Prednisone course is done now and still itchy. Have another dr appointment tomorrow (~2.5 weeks after symptoms started, 4 weeks after booster shot).


VAERS ID: 1924986 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amylase normal, Arthralgia, Blood thyroid stimulating hormone, Dizziness, Dysgeusia, Facial discomfort, Fatigue, Flushing, Full blood count normal, Glycosylated haemoglobin, Laboratory test, Lipase normal, Metabolic function test, Myalgia, Nausea, Paraesthesia, Vitamin B12
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Unspecified
Other Medications: Aciphex, cartia, tadalfil, fluticasone nasal, singular, sertraline, losartan, doxazosin, claritin
Current Illness: None reported
Preexisting Conditions: GERD, hypertension, pre-diabetes, insomnia, anxiety, and prostate enlargement
Allergies: Aspirin, benazepril, codeine, macrolides, and penicillin
Diagnostic Lab Data: Normal amylase, lipase, cbc, cmp, hgbA1C, TSH, vitamin B12, and RPR
CDC Split Type:

Write-up: Immediate dizziness followed by myalgias, arthralgias, and a bitter taste in his mouth. 2 days later he developed nausea with tingling in his hands and feet, fatigue, facial pressure, and flushing


VAERS ID: 1925084 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Angioedema, Burning sensation, Erythema, Oedema, Rash papular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Angioedema. 2 hours after immunization, patient noted erythema, edema and burning sensation in bilateral hands followed by lower back and buttocks. Patient given diphenhydramine 12.5mg PO x2 by mother. Edema and burning resolved, rash progressed to papular eruption. Treated with topical diphenhydramine by mother. Rash completely resolved after approximately two days. No pruritus. No urticaria. No facial or airway symptoms. No GI symptoms. No change in level of consciousness.


VAERS ID: 1925323 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051F21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Condition aggravated, Diarrhoea, Feeling abnormal, Headache, Injection site pain, Injection site swelling, Insomnia, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna Dose 1 & 2- 2021
Other Medications: Anti-hypertension and Pain medications, Xarelto
Current Illness: None
Preexisting Conditions: chronic pain, amputee, hypertension, type 2 diabetic.
Allergies: Dilaudid, paradine, Bactrim; cats and dogs, grasses.
Diagnostic Lab Data: None
CDC Split Type: vsafe

Write-up: I had pretty significant site pain and swelling. I had diarrhea and that persisted for about 3 or 4 days. It started the day after and it kind of hung around. I was also shaky and kind of felt like I had low blood sugar but I don''t have low blood sugar. I had a headache. I''m out of work right now because I had surgery in September and I still have open lesion and so I didn''t miss work because of the vaccine. I had fever and chills that were worse with this one and it got to where it disrupted my sleep, too. I got a 1/2 dose and for the first day I didn''t feel that much but that 2nd day it really hit me and it was the worst out of all three. I had a routine Dr appointment in early march after the 2nd dose and I brought it up to them and by then I was just about over it but this last one I have a home health nurse and I talked to her about it and she asked their Doctor and they didn''t feel like I was in any kind of danger or anything.


VAERS ID: 1926172 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Extra dose administered, Injection site erythema, Injection site swelling, Lymphadenopathy, Muscle disorder, Pain, Pyrexia, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling in armpit lymph node on left side where shot was given, muscle where injected is caved in like if the medicine killed muscle fibers off once the swelling went down, this was the worst of the three vaccines. The fever body aches chills fever were terrible. Went away within a days time, but injection site was swollen and red for approximately 6 days. After that, muscle tissue in the area is missing and skin lost some sensation to touch compared to the rest of my upper arm surrounding the injection site.


VAERS ID: 1926177 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FS8757 / 3 AR / SYR
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER - / UNK AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Lethargy
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Received Flu vaccine at same time as 3rd covid vaccine booster
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: For 4 hours : Rapid resting heart rate (120-130bpm when normal is 70-75bpm) for 4 hours. Lethargy. Shortness of breath & lightheadedness to the point where I thought I''d faint. Headache. After 2-3 hours Took 1 advil, waited an hour, then 1 tylenol & rested. Recovered after light rest.


VAERS ID: 1927692 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Body temperature, Chills, Condition aggravated, Dry throat, Euphoric mood, Feeling jittery, Hypoaesthesia, Injection site pain, Migraine, Nervous system disorder, Neuralgia, Pain, Paraesthesia, Pyrexia, Sleep disorder, Somnolence, Therapeutic response unexpected
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Autoimmune disorder; Drug allergy (The patient experienced drug allergy when treated with Proton pump inhibitors (PPIs)); Non-smoker; Penicillin allergy; Spinal stenosis; Sulfonamide allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Comments: The patient had no history of drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: 100.1 F; Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: 99.3 F
CDC Split Type: USJNJFOC20211143069

Write-up: MILD GASTROINTESTINAL (GI) UPSET; JITTERY; SLEEPY; MIGRAINE/HEADACHE; MINIMAL SLEEP; CHILLS; TINGLING TO FEET; NUMBNESS TO FEET; INJECTION SITE SORENESS; HIGH FEVER; NERVOUS SYSTEM DISORDER; FLARE UP; LIGHTS GOT BRIGHT/EUPHORIA/FELT LIKE SHE TOOK AMPHETIMINES; VISION GOT SHARPER MOMENTARILY, SPEEDED UP AND WAS THINKING SHARPER; BODY ACHES; PARCHED DRY THROAT; NEUROPATHIC PAIN; This spontaneous report received from a patient concerned a 72-year-old female. Initial information received on 18-NOV-2021 was processed with additional information received on 22-NOV-2021. This case was reassessed as serious based upon new information received from the patient on 22-NOV-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: spinal stenosis, migraines, neuro inflammatory, penicillin allergy, topical sulpha drugs allergy, nonsmoker, and non-alcohol user. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid, proton pump inhibitors (PPIs) and macrogol. On an unspecified date, the patient previously received initial covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced citrus taste and throat burning (Captured : 20211159138). The patient received a booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported (dose number in series was 2), 1 total administered on 18-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, evening of injection, the patient experienced sleepy as if she took a tranquilizer, slight chills and achy and by 23:00 the patient experienced fever of 99.3 F (high of fever), body aches, parched dry throat, injection site soreness and minimal sleep. On 18-NOV-2021, the patient also experienced "lights got bright/euphoria," neuropathic pain, tingling to feet, numbness to feet, headache, vision got sharper momentarily, "speeded up" and was "thinking sharper" (therapeutic response unexpected) and felt like she took amphetimines. The patient also experienced neuro inflammatory "flare up" (coded as nervous system disorder, and flare up). Laboratory data included: Body temperature ( not provided) 99.3 F, 100.1 F. On 20-NOV-2021, the patient experienced migraine and the next day (21-NOV-2021) she experienced mild gastrointestinal (GI) upset and jittery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nervous system disorder, flare up, lights got bright/euphoria/felt like she took amphetimines, body aches, tingling to feet, and numbness to feet on 18-NOV-2021, vision got sharper momentarily, speeded up and was thinking sharper, parched dry throat, sleepy, migraine/headache, minimal sleep, and chills on 20-NOV-2021, mild gastrointestinal (GI) upset, jittery, and high fever on 21-NOV-2021, and injection site soreness on 22-NOV-2021, and had not recovered from neuropathic pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211159138.; Sender''s Comments: V0: 20211143069-covid-19 vaccine ad26.cov2.s- nervous system disorder, flare up. 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: 1927763 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-04-12
Onset:2021-11-18
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 706363 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Fall, Fatigue, Feeling abnormal, Flushing, Headache, Heart rate, Influenza like illness, Lymphadenopathy, Pain, Pain in extremity, Pruritus, Respiratory rate, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness: Blood pressure high; Obesity (Gained 20lbs since the pandemic 2020 to 2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals (Allergy to Sulfa drugs , reaction was Rash); Drug allergy (Allergy to Lisinopril, Reaction was Incessant coughing)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: 98.6 �F; Test Date: 20211119; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20211119; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: The injection site was sore; mild headache; Worse kind of flu/I had the flu; I would have lost my life; Flushing; had a terrible fall; Her arm pain was worse; over all body ache; Itching; Swelling above her left collarbone/my left clavical swelled to about the size of a golf ball; She had head to toe pain, Everything hurt/ I was curled up in a ball writhing in pain; Fatigued and tired,wagged out/''I felt fatigued/ I was fatigued for several days,; lymphatic swelling/my left clavical swelled to about the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Worse kind of flu/I had the flu), FEELING ABNORMAL (I would have lost my life), FLUSHING (Flushing), FALL (had a terrible fall) and PAIN IN EXTREMITY (Her arm pain was worse) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 706363 and 706363) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high since 01-Jan-1999, Allergy to chemicals (Allergy to Sulfa drugs , reaction was Rash) in 1990, Drug allergy (Allergy to Lisinopril, Reaction was Incessant coughing) in 2007 and Obesity (Gained 20lbs since the pandemic 2020 to 2021) since 01-Jan-2002. Concomitant products included BISOPROLOL from 02-Feb-2018 to an unknown date for Blood pressure high. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Worse kind of flu/I had the flu), FEELING ABNORMAL (I would have lost my life), FLUSHING (Flushing), FALL (had a terrible fall), PAIN IN EXTREMITY (Her arm pain was worse), PAIN (over all body ache), PRURITUS (Itching), SWELLING (Swelling above her left collarbone/my left clavical swelled to about the size of a golf ball), PAIN IN EXTREMITY (She had head to toe pain, Everything hurt/ I was curled up in a ball writhing in pain), FATIGUE (Fatigued and tired,wagged out/''I felt fatigued/ I was fatigued for several days,), LYMPHADENOPATHY (lymphatic swelling/my left clavical swelled to about the size of a golf ball) and HEADACHE (mild headache). On 20-Nov-2021, the patient experienced VACCINATION SITE PAIN (The injection site was sore). The patient was treated with EPINEPHRINE at an unspecified dose and frequency. On 19-Nov-2021, INFLUENZA LIKE ILLNESS (Worse kind of flu/I had the flu), FLUSHING (Flushing), PAIN IN EXTREMITY (Her arm pain was worse), PAIN (over all body ache) and PRURITUS (Itching) had resolved. On 22-Nov-2021, FALL (had a terrible fall) and PAIN IN EXTREMITY (She had head to toe pain, Everything hurt/ I was curled up in a ball writhing in pain) had resolved. On 26-Nov-2021, SWELLING (Swelling above her left collarbone/my left clavical swelled to about the size of a golf ball) and LYMPHADENOPATHY (lymphatic swelling/my left clavical swelled to about the size of a golf ball) had resolved. On 01-Dec-2021, FATIGUE (Fatigued and tired,wagged out/''I felt fatigued/ I was fatigued for several days,) and HEADACHE (mild headache) had resolved. On 02-Dec-2021, VACCINATION SITE PAIN (The injection site was sore) had resolved. At the time of the report, FEELING ABNORMAL (I would have lost my life) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Blood pressure measurement: inconclusive (Inconclusive) Inconclusive. On 19-Nov-2021, Body temperature: 98.6 (High) 98.6 �F. On 19-Nov-2021, Heart rate: inconclusive (Inconclusive) Inconclusive. On 19-Nov-2021, Respiratory rate: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient reported that after they got the booster dose, their arm pain was worse as well as the swelling above their left collarbone. On the night of the booster dose vaccination, Patient was also treated with Antihistamines, Steroids, oxygen with result none. This case was linked to MOD-2021-400089, MOD-2021-400081 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up received contain significant information such as, HCP reporter information, Allergy, concomitant medication, treatment, Batch lot number, Event''s Start date and Stop date, Outcome of the events were updated


VAERS ID: 1927816 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: expired booster doses given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster doses given) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster doses given). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired booster doses given) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the vials remained in frozen storage until day it was thawed then administered. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact


VAERS ID: 1928014 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Overdose, Pain in extremity, Product preparation error
SMQs:, Drug abuse and dependence (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Celiac disease; CLL; Crohn''s
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630077

Write-up: Fatigue; arm was extremely sore; inadvertently administered doses that were undiluted; inadvertently administered doses that were undiluted; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team. A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:15 (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 51 years as dose number unknown, 0.4 ml single for COVID-19 immunisation. Relevant medical history included: "CLL" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Crohn''s" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "inadvertently administered doses that were undiluted"; FATIGUE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Fatigue"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "unknown", described as "arm was extremely sore". Clinical course: Nurse stated that they administered several doses of the purple cap Covid 19 vaccine yesterday, but they had a staff member that assisted and inadvertently administered doses that were not diluted to 5 different patients. 4 patients were female, and 1 was male. The male patient was born in (year withheld). 2 of the female patients were born in (year withheld), 1 of the female patients was born in (year withheld), and the other female patient was born in (year withheld). Three patients were given the dose as the 1st dose, 1 was a booster dose, and 1 was a 2nd dose. This patient received an undiluted dose of the vaccine yesterday at 11:20am. Caller states that she has talked to the patient twice today. This morning the patient said that she was extremely tired, her arm is killing her, and she gets dizzy when she raises up. The patient didn''t want to be seen by anybody and just wanted to rest. The patient stated that she feels like she did when she had Covid in Aug2021. She told the nurse that she woke up with these symptoms at 5am this morning. When the caller talked with her this afternoon, the patient stated that her head wasn''t hurting quite as bad. The events did not require emergency Room visit and physician Office visit. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AEs. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of fatigue,pain in extremity,product preparation error,overdose. 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,Linked Report(s) : US-PFIZER INC-202101626100 same reporter/drug, similar event, different patient


VAERS ID: 1928071 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101690338

Write-up: booster; Rash; Hives were coming like every night almost every day; I took the booster shot then the hives became so much severe; Hives were coming like every night almost every day; I took the booster shot then the hives became so much severe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient (Himself). A 40-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FG3527) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 15Oct2021. Vaccination history included: Bnt162b2 (Dose 2, date: 21Apr, Lot number: ER8729, All of them were on my left arm.), administration date: 21Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Rash", "Hives were coming like every night almost every day; I took the booster shot then the hives became so much severe"; Bnt162b2 (Dose 1, date : in Apr, Lot number: ER8737, All of them were on my left arm.), administration date: Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Rash"; Bnt162b2 (Dose 1, date: in Apr, Lot number: ER8737, All of them were on my left arm.), administration date: Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Hives were coming like every night almost every day; I took the booster shot then the hives became so much severe". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:30, outcome "unknown", described as "booster"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; URTICARIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "Hives were coming like every night almost every day; I took the booster shot then the hives became so much severe". Therapeutic measures were taken as a result of rash, urticaria, condition aggravated. Additional Information: It was reported that the patient wants to report the side effect after he got the COVID Vaccine booster shot. Yes, that''s the booster shot actually it''s (incomplete sentence), so far, he got like 3 shot and he have the side effect. He was getting the rash and hives. He can explain it more so, he got the vaccine in Apr, his second shot was 21Apr and around Sep and Oct he started having hives, actually minor but it was getting more and more every day, by that time he called doctor and then he started taking antihistamine in the medicines to suppress the hives and hives were coming like every night almost every day if he don''t take the antihistamine ''it usually goes fast and takes time to go away'' (Not clarified over the call) so he started taking every day and then he took the booster shot a couple weeks ago without knowing (incomplete sentence) it''s actually 18Nov and he didn''t know the hives could be related to the COVID Vaccine but he took the booster shot then the hives became so much severe. When paraphrased the concern, consumer stated, "So I am suspecting it could be related to COVID Vaccine through Pfizer vaccine. he found a website and there were lot of people discussing the same thing (Further clarification unknown, hence split case was not made). So, he just wanted to report hoping this can ''arise'' some awareness." Other medical conditions: Consumer stated, "No, I never had allergic reaction before, like prior to COVID Vaccine (Further clarification unknown)." Treatment in response to adverse event: Consumer stated, "Zyrtec, I think it is a major brand for the antihistamine. Dose of Zyrtec: Consumer stated, "I am taking 5 mg daily. I have something that I want to explain, so it helps me for the hives but at the same time Zyrtec makes me drowsy so, I tried another antihistamine which is called Allegra but that was not effective, so I change back to Zyrtec, so Zyrtec seems like it is more effective." Time of vaccination: Consumer stated, "The first shot I got in morning maybe between 10 or 11am. The 2nd shot was about the similar time like 11 or 10am. The booster shot I got it at 5:30 pm, in the afternoon." Patient received Flu vaccine prior to vaccination within 4 weeks: (Unspecified Flu Vaccine). Follow-up attempts are completed. No further information is expected.


VAERS ID: 1928096 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Nausea, Nervousness, Oligomenorrhoea, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Fertility disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Asthma; Food allergy (Known allergies: Coconut); Fruit allergy (Known allergies: Kiwi, olives); Penicillin allergy (Known Allergies: Penicillin)
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Eurofins PCR; Test Result: Negative ; Test Date: 20211123; Test Name: Eurofins PCR; Test Result: Negative
CDC Split Type: USPFIZER INC202101706815

Write-up: Emesis; Loose stools; Extended menstrual cycle; Nausea; Dizziness; Very nervous; Itching at the injection site; Redness at the injection site; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient. A 32-year-old female patient (unknown if pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Nov2021 at 20:00 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma"; "Allergic rhinitis"; "Fruit allergy", notes: Known allergies: Kiwi, olives; "Food allergy", notes: Known allergies: Coconut and "Penicillin allergy", notes: Known Allergies: Penicillin. Concomitant medications included: ZYRTEC; ALBUTEROL and MELATONIN. The following information was reported: NAUSEA (non-serious) with onset 18Nov2021 at 20:15, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Nausea"; DIZZINESS (non-serious) with onset 18Nov2021 at 20:15, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Dizziness"; VOMITING (non-serious) with onset 19Nov2021 at 08:00, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Emesis"; DIARRHOEA (non-serious) with onset 19Nov2021 at 08:00, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Loose stools"; VACCINATION SITE PRURITUS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae" (28Nov2021), described as "Itching at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae" (28Nov2021), described as "Redness at the injection site"; OLIGOMENORRHOEA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Extended menstrual cycle"; NERVOUSNESS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Very nervous". The events "Nausea", "Dizziness", "Emesis", "Loose stools", "Itching at the injection site", "Redness at the injection site", "Extended menstrual cycle" and "Very nervous" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pruritus and vaccination site erythema which included PREDNISONE oral tablet x 5 days with relief noted/BENADRYL over the counter (OTC). Additional Information: Latency of the events nausea and dizziness was 15 minutes and for the events of emesis and loose stools was 12 hours. The patient felt improvement after day 12. The event of nausea was intermitted for approximately 8 days. The events of itching and redness at the injection site (lasted 10 days) and had a bullseye like appearance. The second dose was due 12/9 hence the patient was very nervous about it. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1928282 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-08
Onset:2021-11-18
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Irritability, Neck pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINS NOS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: swollenness of their neck; pain in their neck near the lymph nodes on the left side; it is a little annoying/It bothers them every once in a while; numbness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side), IRRITABILITY (it is a little annoying/It bothers them every once in a while) and HYPOAESTHESIA (numbness in the arm of the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 032M20A and 026B21A) for COVID-19 vaccination. Concomitant products included VITAMINS NOS for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in the arm of the injection). On an unknown date, the patient experienced SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, qhs. In November 2021, HYPOAESTHESIA (numbness in the arm of the injection) had resolved. At the time of the report, SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while) had not resolved. No medical history were reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Non-significant follow-up received.


VAERS ID: 1928627 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-17
Onset:2021-11-18
   Days after vaccination:274
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 4381494 / 1 UN / IM
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN T306683 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19 pneumonia, Hyperglycaemia, Hypokalaemia, Hyponatraemia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine, aspirin, clobetasol, DULoxetine, gemfibrozil, gemfibrozil, glimepiride, indapamide, lisinopril, loratadine, meloxicam, metFORMIN, metoprolol, raNITIdine, simvastatin,
Current Illness: No
Preexisting Conditions: Hypokalemia, AKI (acute kidney injury), Hyponatremia Accelerated hypertension, obesity
Allergies: Penicillins, sulfa drugs, gapapentin
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient is a 78-year-old female who was admitted with COVID-19 pneumonia and acute renal failure, hyponatremia, hypokalemia, and hyperglycemia with history of type 2 diabetes. The patient did not qualify for remdesivir and was placed on Decadron. The patient was on room air by day of discharge. The patient was seen in consultation with Nephrology and Pulmonary Medicine during the course of admission here along with Infectious Disease. By day of discharge, she was cleared by both Pulmonary Medicine, Infectious Disease, and as such the patient is being discharged home with doxycycline for a week. Clearance was also requested from Nephrology regarding the serum sodium, which was obtained.


VAERS ID: 1928633 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-17
Onset:2021-11-18
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / 1 UN / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Dyspnoea, Hypoxia, Oxygen saturation decreased, Rales, Rhonchi
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 (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen, allopurinol, amlodiPINe, Cholecalciferol, clotrimazole, docusate, FIBER, fluticasone, hydrALAZINE, hydrocortisone, metoprolol, pantoprazole, PROCTOSOL, traMADol,
Current Illness: No
Preexisting Conditions: Cellulitis, Obesity, Rhabdomyolysis, UTI
Allergies: Penicillins, Aspirin, Clindamycin, Doxazosin, Erythromycin, Hydrochlorothiazide, Ibuprofen, Indomethacin, Meclizine, Meperidine, Morphine, Oxytetracycline, Propoxyphene, Spironolactone,
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11/18 Pt to ED from a HCF with c/o of low sat and COVID concerns. Per staff, pt sat at 89 on RA and was started on 3 L NC. HCF ED doctor wanted pt evaluated once she was started on O2. 11/19 The patient was started on remdesivir for COVID pneumonitis. 11/20 Have scattered rales and rhonchi. Pt short of breath. 11/27 Mild Hypoxia, currently saturating 98% on 3 L. On decadron remdisivir . 11/29 No acute issues overnight.


VAERS ID: 1928711 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-02
Onset:2021-11-18
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Pain, Paranasal sinus discomfort, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Astatine
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: bacterium, seasonal allergies
Diagnostic Lab Data: Covid-19 test
CDC Split Type: vsafe

Write-up: I had headache, body ache, and very tired for 24 hours. Then I was tested positive for covid-19 on Nov 18th. I had sore throat, stuff nose, and very tired. I developed a fever of 102. I had body ache, chills, and SOB. I had a headache and I was coughing. I had sinus pressure.


VAERS ID: 1928739 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-11-08
Onset:2021-11-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Patients mother stated and wrote incorrect birthday on vaccine admin record. Stated they were not in the registry because they had just moved. When pharmacist later tried to add a patient a near match was found - RPH called primary physician (mother also stated they didn''t have a physician) and informed them of the situation. They said no second dose was authorized to be given. RPH called mother to clarify details- mother again stated child was five years old and registry must be incorrect but failed to provide any documentation proving date of birth. No adverse events were reported


VAERS ID: 1928770 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia, Thrombosis, Ultrasound scan abnormal, Ventilation/perfusion scan
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: High blood pressure and high cholesterol meds
Current Illness: none
Preexisting Conditions: high blood pressure, high cholesterol
Allergies: none
Diagnostic Lab Data: EKG 3 times, and a Sonogram on the left arm and the sonogram showed a large blood clot in the arm, And the hospital did a test on the lungs that came back clear.
CDC Split Type:

Write-up: from my shoulder to my fingers in my left arm I have pain that comes and goes and there is tingling and it goes numb. I went to urgent care and they sent me to the hospital. The hospital has done several tests and found a large blood clot in the arm that had the injection. The doctors have stated it is very likely that when the Covid vaccine injection was given it coagulated the blood and formed a clot and that is likely what I am dealing with. I am in Hospital and have been here for one full day but it is unclear when I will get out of the hospital.


VAERS ID: 1928849 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 3 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood follicle stimulating hormone, Blood oestrogen, Blood thyroid stimulating hormone, Progesterone, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fluticasone, buspirone, nexplanon
Current Illness: none
Preexisting Conditions: anxiety, COVID 19 07/23/2021
Allergies: epsom salts
Diagnostic Lab Data: work up starting 12/07/2021, FSH, TSH, estrogens, progesterone previfem
CDC Split Type:

Write-up: new onset vaginal bleeding


VAERS ID: 1928960 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the agency, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1928963 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19 Vaccine formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9% NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9% NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1928979 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1928990 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1928999 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: none
CDC Split Type:

Write-up: Widespread ongoing hives onset: 11/18/21


VAERS ID: 1929057 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 077C21B / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Electrocardiogram abnormal, Ventricular extrasystoles
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tadalafil, modafinil, testosterone, elavil, kratom
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: ECG diagnosis PVC?s
CDC Split Type:

Write-up: Frequent PVC events (greater than 20-25%)


VAERS ID: 1929108 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 012H21B / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Cardiac monitoring, Dizziness, Echocardiogram, Extra dose administered, Fatigue, Feeling abnormal, Heart rate increased, Hot flush, Paraesthesia, Presyncope
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline, daily multivitamin, vitamin D/C and zinc on need basis
Current Illness: sinus infection/cold the two weeks before
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Went to see a doctor on December 3rd, was written off as "anxiety attack," Talked with my community and was able to speak with a cardiologist on December 7th who is requesting a 24 hour heart monitor and heart echo. His initial unofficial diagnosis is POTS as a result of the booster.
CDC Split Type:

Write-up: I felt extremely tired a few hours after vaccine, however I knew that was a normal side effect so it didn''t bother me. The next day I had extreme fog, a daily/normal task took a lot more effort. I kept telling my husband I feel "off." I went to the grocery store in which I suddenly got a hot flash and dizziness and had to sit down immediately before I was about to pass out. That was on November 18th. Then I was feeling semi normal again until December 1st, exactly two weeks after my booster. I had another episode in which I felt like I was going to pass out, my heart rate spiked, I felt dizzy, tingling in feet and hands, and had to lay down to get it under control. This continued to happen each day from December 1st-December 4th. I haven''t had a ''almost passing out'' episode again but I do have to be very intentional with breathing and I have to sit a lot of the day from fatigue. I''m a very active, healthy 39 year old that works out typically 4-5 days a week, so this sudden urge to have to stop and catch my breathing isn''t normal.


VAERS ID: 1929235 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, Underdose
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1929246 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1929283 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, Underdose
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1929380 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-06
Onset:2021-11-18
   Days after vaccination:226
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 AR / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / 1 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Asthenia, Atrial fibrillation, Blood sodium decreased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Coagulation test normal, Condition aggravated, Cough, Dyspnoea, Fibrin D dimer, Fluid intake restriction, Full blood count normal, Hyponatraemia, Lung opacity, Metabolic function test normal, Panic attack, Procalcitonin increased, Prohormone brain natriuretic peptide increased, Refusal of treatment by patient, Respiratory tract congestion, SARS-CoV-2 test positive, Troponin increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 325 MG tablet aspirin 81 MG chewable tablet Biotin w/ Vitamins C & E (HAIR/SKIN/NAILS PO) Cyanocobalamin (VITAMIN B12 PO) ferrous sulfate 325 (65 Fe) MG delayed release tablet guaiFENesin (MUCINEX) 600 MG 12 hr table
Current Illness: NA
Preexisting Conditions: Essential hypertension Acquired hypothyroidism Weakness Longstanding persistent atrial fibrillation (HCC) Chronic anemia Nonrheumatic mitral valve regurgitation Iatrogenic pulmonary embolism and infarction (HCC) Hyponatremia Unspecified severe protein-calorie malnutrition (HCC) Community acquired pneumonia of right lung
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalized (11.24.21; 11.29.21-12.3.21); COVID-19 positive (11.18.21; 11.29.21); fully vaccinated Hospitalized 11.24.21 - Hospital (pt. sates that last night she began having a hard time catching her breath ; 94-year-old female with currently with Covid, with history of atrial fibrillation brought in by ambulance from her home with shortness of breath. Worsened breathing started last night and continued throughout the day today. Cough and congestion that she has had is actually getting better. ED Course - The patient was staffed with Dr. who did not examine the patient. She is in A. fib. CBC unremarkable. BMP with out any acute concerns. Coags are normal. D-dimer 0.91, age corrected is normal. Initial troponin 40.4, 2-hour repeat 38.1. proBNP 8305. Chest x-ray with findings of COVID-19 pneumonia, no Congestive heart failure or effusion. On repeat exam, found the patient to be having a panic attack. I ordered 0.25 mg of Ativan IV but she refused the IV for nursing. She did eventually calm down on her own. She qualifies for monoclonal antibody therapy is that she is at day 10 today however she is refusing this infusion as well. She is refusing admission to the hospital. She signed out AGAINST MEDICAL ADVICE. ED nurse has been in close contact with the patient''s son who will be picking her up tonight. She is instructed to return to the ER with worsening symptoms. She should continue her aspirin daily. Follow-up with primary doctor as soon as she is cleared of Covid. She was agreeable with the plan. Condition at Discharge: Stable; COVID-19 pneumonia, Anxiety, Atrial fibrillation, history of Admission Date: 11/29/2021 Discharge Date: 12/3/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Weakness [R53.1] HOSPITAL COURSE: Patient is a 94 year old female who presented with weakness and cough. She was COVID positive on 11/18 and had increasing weakness at home. She came to the ER for evaluation. In the ER she had a CXR showing right infrahilar opacities, her BNP was elevated at 3627 and her sodium was low at 120. Her procalcitonin was elevated and she was started on rocephin/azithro for CAP coverage. She was admitted to the hospitalist team for further management. Her sodium slowly improved with fluid restriction and salt tabs and she remained asymptomatic. She was given a prescription for salt tabs at discharge. She was given a prescription for ceftin to complete her course of antibiotics. Her cough improved throughout her stay. She was evaluated by PT/OT who recommended SAR. Rehab was arranged by care management. On the day of discharge the patient was feeling well and was eager to get to rehab. She will need follow up labs in the next 5-7 days to recheck her sodium level.


VAERS ID: 1931537 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051F21A / 3 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain lower, Abdominal rebound tenderness, Appendicitis, Computerised tomogram abdomen abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: Fever, chills, N/V and flu-like symptoms from previous 2-dose series of Moderna vaccines (received 01/05/2021 and 02/03/2021)
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: CT scan (11/23/2021)
CDC Split Type:

Write-up: Generalized abdominal pain that started 2 days following the booster shot (11/18/2021). Over the course of 5 days, pain localized to the right lower quadrant with rebound tenderness. Diagnosed with acute appendicitis per abdominal/pelvic CT scan (11/23/2021).


VAERS ID: 1931539 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Shingles outbreak that has since improved but is still present, 34 years old, 20 OCT 2021, Covid19 vaccine, Pfizer.
Other Medications: Valtrex
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Headache worsening over 24 hours, improving and subsiding after 72 hours. Fever within 24 hours peaking at 103F and remaining there for 12 hours. Dizziness at the same time as headache onset. Lasting approximately 36 hours Chills lasting 6 hours. Fatigue and body aches lasting approximately 48 hrs.


VAERS ID: 1931452 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1931460 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: 107 patients who were administered with the vaccine past the published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. No concomitant medications were reported. This case was linked to MOD-2021-405476 (Patient Link).


VAERS ID: 1931465 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: patient received the expired vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021 at 11:36 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021 at 11:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.). On 18-Nov-2021 at 11:36 AM, EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that upon delivery of each vaccine order (021B21A- feb-2021 and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received contains patient demographics.


VAERS ID: 1931466 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021 at 11:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021 at 11:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021 at 11:35 AM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that upon delivery of each vaccine order (021B21A- feb-2021 and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine. No concomitant medication details was provided. No treatment medication details was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received on 06-DEC-2021 included suspect product and patient demographics details.


VAERS ID: 1931516 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-11
Onset:2021-11-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID PCR Test; Test Result: Positive ; Comments: No other testing or investigations performed other than COVID PCR Test which was performed as throat swab
CDC Split Type: USPFIZER INC202101647214

Write-up: sores in his mouth; diagnosed with Covid-19 via a PCR test with symptom (fever); This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the parent. An 8-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly administered in the left arm on 11Nov2021 19:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient has no relevant family history. The patient had no predisposing factors. There were no concomitant medications. There are no other vaccines administered on same date with the Pfizer vaccine considered as suspect. The parent reported that her 8-year-old son who received the first dose of the orange cap Pfizer Covid-19 vaccine on 11Nov2021 and was diagnosed with Covid-19 via a PCR test on 21Nov2021. The parent stated that her son is scheduled to receive his second dose of the orange cap Pfizer Covid-19 vaccine on 02Dec2021 and inquired if her son receives the second dose of the orange cap Pfizer Covid-19 vaccine, will it overwhelm his system with antibodies. She also inquired if myocarditis be more likely or any other issues with having too many antibodies after receiving the Pfizer Covid-19 vaccine and diagnosis of Covid-19 after receiving the vaccine and if it is not recommended for him to get the second dose of the orange cap Pfizer Covid-19 vaccine while being symptomatic with Covid-19. The reporter added that the patient had onset of COVID on 18Nov2021, with COVID PCR Test performed on 21Nov2021 which verified diagnosis as positive for COVID. She further described symptoms to include onset of fever on 18Nov2021 and he got sores in his mouth today (23Nov2021). She thinks the event is getting worse, symptoms getting worse. She has not heard of sores in the mouth being a symptom of COVID but does not know what else that would be related to. The patient underwent the following laboratory tests and procedures was sars-cov-2 test: (21Nov2021) positive with notes of no other testing or investigations performed other than COVID PCR Test which was performed as throat swab. The adverse events did not require emergency room visit or physician office visit. The patient was not hospitalized. The outcome of the events was not recovered. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1931527 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / OT

Administered by: Private       Purchased by: ?
Symptoms: Bradycardia, Heart rate, Nausea
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Heart rate; Result Unstructured Data: Test Result:40
CDC Split Type: USPFIZER INC202101653781

Write-up: heart rate dropped into the 40''s; nausea; This is a spontaneous report received from a contactable reporter(s) (Physician) via COVAES. A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not received any other vaccines in 4 weeks. The following information was reported: BRADYCARDIA (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "heart rate dropped into the 40''s"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "nausea". The patient underwent the following laboratory tests and procedures: heart rate: (18Nov2021) 40. Therapeutic measures were not taken as a result of bradycardia, nausea. After waiting 15 minutes, as the patient was leaving, he had nausea and heart rate dropped into the 40s for 10-plus minutes. Since vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and 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: 1931585 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101676932

Write-up: just slept the day after; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose number unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "just slept the day after". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1931603 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101711169

Write-up: Two days after the shot had ringing in ears. First, it was both ears but the left ear stopped ringing. Now the right ear stops and starts ringing. It is a mild noise.; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient. An 80-year-old female patient (not pregnant) received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Nov2021 at 13:00 (Lot number: FH8027) at the age of 80 years as dose 3, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site: left arm), administration date: 23Feb2021 at 10:15, when the patient was 79 years old and BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site: left arm), administration date: 23Mar2021 at 10:00, when the patient was 79 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 at 13:00, outcome "unknown", described as "Dose received 3/ dose number=3"; TINNITUS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Two days after the shot the patient had ringing in her ears. First, it was both ears but the left ear stopped ringing. Then the right ear stopped and started ringing. It was a mild noise". Therapeutic measures were not taken as a result of tinnitus. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.


VAERS ID: 1931768 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021 at 11:33 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided. No treatment medications were provided.


VAERS ID: 1931858 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported. Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.


VAERS ID: 1932146 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1932338 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-07-13
Onset:2021-11-18
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / UNK - / -

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

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

Write-up: hospitalized due to COVID


VAERS ID: 1932372 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

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

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

Write-up: Rash to underarm next day with itching


VAERS ID: 1932390 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-17
Onset:2021-11-18
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cerebral haemorrhage, Cerebrovascular accident, SARS-CoV-2 test positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/19/21 SARS-CoV-2 (COVID-19) detected
CDC Split Type:

Write-up: 11/18/21 presents to EC ED as transfer with "hemorrhagic CVA". PMHx "left PCA CVA on 81mg ASA, DM2, HTN, hypothyroidism".


VAERS ID: 1932393 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-14
Onset:2021-11-18
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/18/21 SARS-CoV-2 (COVID-19) by NAA detected
CDC Split Type:

Write-up: 11/18/21 presents to EC ED with "worsening shortness of breath". PMHx "CHF, COPD, hypertension, diabetes".


VAERS ID: 1932442 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness transient, Deafness transitory, Dizziness, Hyperhidrosis, Injection site reaction, Insomnia, Restlessness, Tinnitus, Vision blurred, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Two minutes in felt a wave of restlessness originating at injection point. Then sweating, dizzyness Eyesight nearly gone, replaced with a blur and couldn''t make out anything besides little pinholes in the center. Hearing replaced with a loud noise that drowned out everything else around me. 5 minutes after having all these symptoms together, eyesight came back. 3 minutes after that, hearing came back. Couldn''t sleep properly for three nights afterwards but that fixed too.


VAERS ID: 1932478 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-08
Onset:2021-11-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad)

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

Write-up: Tinnitus started about 1 1/2 weeks after vaccination with initial dizziness. Tinnitus is increasing steadily. Suspecting vaccine adverse event since nothing else in my medical history or environment changed. Tinnitus is now pretty significant and increasing.


VAERS ID: 1932604 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFI30135BA / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Mechanical ventilation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: HX OF EPILEPSY
Preexisting Conditions: HX OF EPILEPSY
Allergies: UNKNOWN
Diagnostic Lab Data: UNKNOWN
CDC Split Type:

Write-up: PT RECEIVED VACCINE AT 3 PM, BY 6 PM PT WAS HAVING SEIZURES THAT RESULTED GOING OT HOSPITAL. PT WAS IN HOSPITAL FOR 6 DAYS AND ON THE VENT FOR 4 DAYS. MD AT HOSPITAL STATED THAT IT WAS FROM THE COVID VACCINE AND ADVISED TO MAKE A REPORT.


VAERS ID: 1932664 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 065F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Herpes zoster
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Opportunistic infections (broad)

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

Write-up: Blood pressure went up. Right side of face was covered with blisters. Went to the ER dx with Shingles


VAERS ID: 1932665 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

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

Write-up: Patient was given the childhood dose of pfizer 5 - 11 year old dose. She recently turned 12.


VAERS ID: 1932687 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Blood magnesium, Blood thyroid stimulating hormone, Chest X-ray, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Laboratory test, Metabolic function test, Palpitations, Tachycardia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/28 - EKG, CXR, labs (CBC, CMP, Troponin X 2, BNP, D-dimer) 12/01 - EKG, labs (Mag, TSH, CMP) 12/08 - Echo, Holter monitor
CDC Split Type:

Write-up: Palpitations and tachycardia at rest, dyspnea on minimal exertion. No specific treatment. Improving on own


VAERS ID: 1932689 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

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

Write-up: Given the childhood dose versus adolescent/ adult


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